tag:blogger.com,1999:blog-11111240274412394392024-03-03T16:26:24.614-08:00Vitamin Consultancy eMemo ArchivesThis private blog replaces the earlier archives I had posted on the Internet and includes various memos sent to the clients of the VitaminLawyer.com (now the Vitamin Consultancy). It includes archived copies of memos from 2004 through 2007 and subsequent memos will be posted as they are issued.Health Freedom of Choice Bloghttp://www.blogger.com/profile/15606420362458868870noreply@blogger.comBlogger221125tag:blogger.com,1999:blog-1111124027441239439.post-55069260860339389472023-10-18T09:29:00.002-07:002023-10-18T09:37:02.114-07:00Congress Sneaks Another Bone to Big Pharma!<p> <strong style="text-align: center;">New Peptide Rules</strong></p><p></p><p><span style="font-size: 13px;"><span style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif;">Congress subtly changed the definition of a 'biological product' to give Big Pharma control of the sale of proteins to treat disease. As usual such maneuvers leave loopholes within the loopholes...</span></span></p><p><span style="font-size: 13px;"><span style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif;">"The FDA had previously stated its interpretation of the statutory terms “protein” and “chemically synthesized polypeptide” in the amended statutory definition of “biological product.” The FDA interprets the term “protein” to mean any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size. Alternatively, the FDA previously interpreted the term “chemically synthesized polypeptide” to mean any alpha amino acid polymer that is made entirely by chemical synthesis and is greater than 40 amino acids, but less than 100 amino acids in size.</span></span></p><p></p><p><span style="font-size: 13px;"><span style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif;">A “chemically synthesized polypeptide” was not a “biological product” and was not going to be regulated as a drug under the FD&C Act unless the polypeptide otherwise met the statutory definition of a “biological product.” This definition was scientifically appropriate, but at the last minute, the latest appropriations bill (enacted in December of 2019) further amended the definition of “biological product” to remove “(except any chemically synthesized polypeptide).” Now, in the definition ... there is no differentiation between protein and polypeptide." [1]</span></span></p><p></p><p><span style="font-size: 13px;"><span style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif;">The new definition is:</span></span></p><p></p><p><span style="font-size: 13px;"><span style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif;">"Biological Product – A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings." [2]</span></span></p><p></p><p><span style="font-size: 13px;"><span style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif;">Note that the parenthetical “(except any chemically synthesized polypeptide)” has been removed.</span></span></p><p></p><p><span style="font-size: 13px;"><span style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif;">FDA further states:</span></span></p><p></p><p><span style="font-size: 13px;"><span style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif;">"Under this final rule, the term protein means any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. This final rule is intended to clarify the statutory framework under which such products are regulated." [3]</span></span></p><p></p><p><strong><span style="font-size: 13px;"><span style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif;">Under the new definition, as interpreted by FDA, any "protein" 40 or less amino acids is still available as a "food" product. Any naturally </span></span></strong><span style="background-color: white; font-family: "Trebuchet MS", Trebuchet, Verdana, sans-serif;"><span style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif;"><b><span style="font-size: x-small;">occurring</span></b></span></span><strong><span style="font-size: 13px;"><span style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif;"> protein that is not chemically changed appears to still qualify as a food and thus as a Medical Food. Doctors may recommend Medical Foods for the dietary management of health conditions.</span></span></strong></p><p>--------------</p><p><span style="font-size: 10px;">[1] https://bengreenfieldlife.com/article/supplements-articles/peptides-fda/</span></p><p><span style="font-size: 10px;">[2] "This final rule codifies the Food and Drug Administration’s (FDA or Agency) interpretation of the statutory term “protein” that the Agency previously described in guidance (Ref. 1). This final rule does not finalize the FDA’s interpretation of “chemically synthesized polypeptide” because section 605 of the Further Consolidated Appropriations Act, 2020 (Public Law 116-94) (FCA Act) removed the parenthetical “(except any chemically synthesized polypeptide)” from the category of “protein” in the definition of “biological product” in section 351(i) of the Public Health Service Act (PHS Act). F" -- https://www.fda.gov/media/135421/download</span></p><p><span style="background-color: white; color: #666666; font-family: "Trebuchet MS", Trebuchet, Verdana, sans-serif; font-size: 10px;">[3] https://www.federalregister.gov/documents/2020/02/21/2020-03505/definition-of-the-term-biological-product</span></p>Health Freedom of Choice Bloghttp://www.blogger.com/profile/15606420362458868870noreply@blogger.com0tag:blogger.com,1999:blog-1111124027441239439.post-11448694773729237992023-10-06T08:00:00.008-07:002024-02-13T10:17:36.986-08:00MoCRA: Modernization of Cosmetics Regulation Act of 2022<p> <b>MoCRA: Modernization of Cosmetics Regulation Act of 2022</b></p><p></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/a/AVvXsEiG7sr1tWH70enmvH_Z2wHhrba1Zr4MoKYNdaw9ki24HjODFgBk3JYujdk1mRDK2mv22T4W4cFDm0zAozh4YaGjwrAbMet32-K8Zi4H615kysXiFrD_dh6cjiywaOnT1LkbiUI4MIKXqmb_iOk-8hi4CmjeP1bX35TkDJkNDG2dp2Vh72hHbGBFXqMLmsI" style="margin-left: 1em; margin-right: 1em;"><img alt="" data-original-height="302" data-original-width="402" height="240" src="https://blogger.googleusercontent.com/img/a/AVvXsEiG7sr1tWH70enmvH_Z2wHhrba1Zr4MoKYNdaw9ki24HjODFgBk3JYujdk1mRDK2mv22T4W4cFDm0zAozh4YaGjwrAbMet32-K8Zi4H615kysXiFrD_dh6cjiywaOnT1LkbiUI4MIKXqmb_iOk-8hi4CmjeP1bX35TkDJkNDG2dp2Vh72hHbGBFXqMLmsI" width="319" /></a></div><br /><p></p><p></p><div style="text-align: center;"><b>UPDATE: SOPs Consistent with MoCRA Now Available!</b></div><b><div style="text-align: center;"><b>Email ralph.fucetola@gmail.com with "MoCRA SOPs" in Subject Line</b></div></b><p></p><p>Last year Congress adopted the first comprehensive amendment to the cosmetic laws since 1938. The Modernization of Cosmetics Regulation Act of 2022 — MoCRA — empowers FDA by making mandatory various previously ‘voluntary’ requirements for cosmetics sold to Americans. In summary:</p><blockquote style="border: none; margin: 0px 0px 0px 40px; padding: 0px; text-align: left;"><p>Mandatory facility and product registration</p><p>Adherence to cosmetics Good Manufacturing Practices (GMPs)</p><p>Adverse event reporting</p><p>Safety substantiation</p><p>Additional labeling requirements</p><p>New enforcement powers and records access for FDA</p></blockquote><p>The new law goes into effect on December 29, 2023. FDA expects to have an online registration system by then. I will be working closely with my clients to make sure their cosmetic products meet the new standards.</p><p>Once MoCRA takes effect registration will no longer be voluntary but will be required for every cosmetics manufacturing facility, regardless of where it is located.</p><p>FDA defines cosmetics at “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)”</p><p>“…by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product. “ https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap#Definecosmetic</p><p>Email me at ralph.fucetola@gmail.com with “Cosmetics” in the subject line to get started. Each of your cosmetic products must be registered. This is immediately important for all cosmetic-label-owners and for manufacturing facilities that handle cosmetics.</p><p>See also: <a href="http://www.ProfessionalSafetyDossier.com">www.ProfessionalSafetyDossier.com</a></p><p>Additional Notes:</p><p>1. All cosmetic products will have to register with FDA, providing:</p><blockquote style="border: none; margin: 0px 0px 0px 40px; padding: 0px; text-align: left;"><p>Place of manufacture </p></blockquote><blockquote style="border: none; margin: 0px 0px 0px 40px; padding: 0px; text-align: left;"><p>Product category</p><p>Ingredients (fragrances, flavors & colors)</p><p>FDA will assign a product listing number.</p></blockquote><p>2. FDA will propose a Good Manufacturing Practices rule within 2 years.</p><p>3. Adverse Event Reporting, defining AER:</p><p>“death, a life-threatening experience, inpatient hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, infection, significant disfigurement (serious or persistent rashes, second or third degree burns, hair loss, or persistent or significant alteration of appearance), or an event which requires medical intervention to prevent the health outcomes listed above.”</p><p>4. FDA web page about MoCRA: <a href="https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022">https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022</a></p><p>5. FDA Cosmetic GMP Guidance: <a href="https://www.fda.gov/media/86366/download?attachment">https://www.fda.gov/media/86366/download?attachment</a></p><p data-pm-slice="1 1 []"><span style="font-size: 12px;">6. FDA MoCRA site: </span><a href="https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products" tabindex="-1" target="_blank"><span style="font-size: 12px;">https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products</span></a></p><p data-pm-slice="1 1 []">7. Small Business Exemptions: <a href="https://www.fda.gov/cosmetics/cosmetics-news-events/fda-issues-compliance-policy-cosmetic-product-facility-registration-and-cosmetic-product-listing">https://www.fda.gov/cosmetics/cosmetics-news-events/fda-issues-compliance-policy-cosmetic-product-facility-registration-and-cosmetic-product-listing</a></p><p style="background-color: white; box-sizing: border-box; color: #333333; font-family: Georgia, Times; font-size: 1rem; line-height: 1.5; margin: 0px 0px 1rem;"><strong style="box-sizing: border-box;"></strong></p><blockquote><p style="background-color: white; box-sizing: border-box; color: #333333; font-family: Georgia, Times; font-size: 1rem; line-height: 1.5; margin: 0px 0px 1rem;"><strong style="box-sizing: border-box;">Exemptions:</strong></p><p style="background-color: white; box-sizing: border-box; color: #333333; font-family: Georgia, Times; font-size: 1rem; line-height: 1.5; margin: 0px 0px 1rem;">MoCRA exempts certain small businesses from facility registration and product listing requirements.</p><p style="background-color: white; box-sizing: border-box; color: #333333; font-family: Georgia, Times; font-size: 1rem; line-height: 1.5; margin: 0px 0px 1rem;">However, such exemptions do not apply to facilities that manufacture or process, or responsible persons for, the following cosmetic products:</p><ul style="background-color: white; box-sizing: border-box; color: #333333; font-family: Georgia, Times; font-size: 1rem; line-height: 1.5; margin-bottom: 1rem; margin-top: 0px;"><li style="box-sizing: border-box;">Products that regularly come into contact with mucus membrane of the eye under customary or usual conditions of use.</li><li style="box-sizing: border-box; margin-bottom: 0px; margin-top: 0.5rem;">Products that are injected.</li><li style="box-sizing: border-box; margin-bottom: 0px; margin-top: 0.5rem;">Products that are intended for internal use.</li><li style="box-sizing: border-box; margin-bottom: 0px; margin-top: 0.5rem;">Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use.</li></ul></blockquote><p data-pm-slice="1 1 []"><br /></p><div><br /></div>Health Freedom of Choice Bloghttp://www.blogger.com/profile/15606420362458868870noreply@blogger.com0tag:blogger.com,1999:blog-1111124027441239439.post-43845730302742410232023-07-06T19:12:00.000-07:002023-07-06T19:12:32.217-07:00Private Business Plan<p> </p><p align="center" class="MsoNormal" style="mso-margin-bottom-alt: auto; text-align: center;"><a name="BodyTopicCoverPage"></a><a name="TopicCoverPage"><span style="mso-bookmark: BodyTopicCoverPage;"><span style="font-family: "Verdana","sans-serif"; font-size: 24.0pt; mso-bidi-font-family: Verdana; mso-bidi-font-size: 12.0pt; mso-fareast-font-family: Verdana; mso-no-proof: yes;"><v:shapetype coordsize="21600,21600" filled="f" id="_x0000_t75" o:preferrelative="t" o:spt="75" path="m@4@5l@4@11@9@11@9@5xe" stroked="f">
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<p align="center" class="MsoNormal" style="mso-margin-bottom-alt: auto; text-align: center;"><span style="mso-bookmark: TopicCoverPage;"><span style="mso-bookmark: BodyTopicCoverPage;"><span style="font-family: "Verdana","sans-serif"; font-size: 10.0pt; mso-bidi-font-family: Verdana; mso-bidi-font-size: 12.0pt; mso-fareast-font-family: Verdana;"> </span></span></span></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/a/AVvXsEhamE-RdtFyGrk3SuypxXPilTASY7WTLzJn-55KqsjPR_JPE3AwCyPgWGsHa0KCneSFDNbc5azxjcaEsS_MalW3EVMKD8AKOwV6yYyZWVaJBN3c70ZeothqpSn1YtaVctb_NwIYbfCyZ02QfQPy98u5u2HcNdAalNInerI4zyQzAJgoVxBRXD2LWgN9Ha0" style="margin-left: 1em; margin-right: 1em;"><img alt="" data-original-height="370" data-original-width="357" height="240" src="https://blogger.googleusercontent.com/img/a/AVvXsEhamE-RdtFyGrk3SuypxXPilTASY7WTLzJn-55KqsjPR_JPE3AwCyPgWGsHa0KCneSFDNbc5azxjcaEsS_MalW3EVMKD8AKOwV6yYyZWVaJBN3c70ZeothqpSn1YtaVctb_NwIYbfCyZ02QfQPy98u5u2HcNdAalNInerI4zyQzAJgoVxBRXD2LWgN9Ha0" width="232" /></a></div><br /><o:p></o:p><p></p>
<p align="center" class="MsoNormal" style="mso-margin-bottom-alt: auto; text-align: center;"><span style="font-size: large;"><span style="mso-bookmark: TopicCoverPage;"><span style="mso-bookmark: BodyTopicCoverPage;"><b style="mso-bidi-font-weight: normal;"><span style="font-family: Verdana, "sans-serif";">SYMPHONY CANNA
BRANDS, LLC</span></b></span></span><span style="mso-bookmark: TopicCoverPage;"><span style="mso-bookmark: BodyTopicCoverPage;"><span style="font-family: Verdana, "sans-serif";"><o:p></o:p></span></span></span></span></p>
<p align="center" class="MsoNormal" style="mso-margin-bottom-alt: auto; text-align: center;"><span style="font-size: large;"><span style="mso-bookmark: TopicCoverPage;"><span style="mso-bookmark: BodyTopicCoverPage;"><b style="mso-bidi-font-weight: normal;"><span style="font-family: Verdana, "sans-serif";">A New Jersey
Company</span></b></span></span></span><span style="font-family: Verdana, "sans-serif"; font-size: x-large;"> </span></p>
<p align="center" class="MsoNormal" style="mso-margin-bottom-alt: auto; text-align: center;"><span style="font-size: large;"><span style="mso-bookmark: TopicCoverPage;"><span style="mso-bookmark: BodyTopicCoverPage;"><b style="mso-bidi-font-weight: normal;"><span style="font-family: Verdana, "sans-serif";">Licensed Cannabis
Cultivation<br />
& Manufacturing Business Plan</span></b></span></span><span style="mso-bookmark: TopicCoverPage;"><span style="mso-bookmark: BodyTopicCoverPage;"><span style="font-family: Verdana, "sans-serif";"><o:p></o:p></span></span></span></span></p>
<p align="center" class="MsoNormal" style="mso-margin-bottom-alt: auto; text-align: center;"><span style="mso-bookmark: TopicCoverPage;"><span style="mso-bookmark: BodyTopicCoverPage;"><b style="mso-bidi-font-weight: normal;"><span style="font-family: Verdana, "sans-serif";"><span style="font-size: large;">FUNDING:
$5,000,000</span></span></b></span></span></p>
<p class="MsoNormal" style="mso-margin-bottom-alt: auto;"><span style="mso-bookmark: TopicCoverPage;"><span style="mso-bookmark: BodyTopicCoverPage;"><span style="font-family: "Verdana","sans-serif"; font-size: 10.0pt; mso-bidi-font-family: Verdana; mso-bidi-font-size: 12.0pt; mso-fareast-font-family: Verdana;"> <o:p></o:p></span></span></span></p>
<p class="MsoNormal" style="text-indent: 0in;"><span style="mso-bookmark: TopicCoverPage;"><span style="mso-bookmark: BodyTopicCoverPage;"><b style="mso-bidi-font-weight: normal;"><span style="font-size: 11.0pt; mso-fareast-font-family: Verdana;">Disclaimers and
Disclosures:</span></b></span></span><span style="mso-bookmark: TopicCoverPage;"><span style="mso-bookmark: BodyTopicCoverPage;"><span style="font-size: 11.0pt; mso-fareast-font-family: Verdana;"><span style="mso-spacerun: yes;"> </span> </span></span></span></p><p class="MsoNormal" style="text-indent: 0in;"><span style="mso-bookmark: TopicCoverPage;"><span style="mso-bookmark: BodyTopicCoverPage;"><span style="font-size: 11.0pt;">This Business Plan contains proprietary information
about <span style="color: black; mso-themecolor: text1;">Symphony Canna Brands </span>and
may not be reproduced, copied, disclosed, or utilized in any way in whole or in
part, without the prior written consent of <span style="color: black; mso-themecolor: text1;">Symphony Canna Brands.<span style="mso-spacerun: yes;"> </span></span></span></span></span></p><p class="MsoNormal" style="text-indent: 0in;"><span style="mso-bookmark: TopicCoverPage;"><span style="mso-bookmark: BodyTopicCoverPage;"><span style="font-size: 11.0pt;"><span style="color: black; mso-themecolor: text1;"><span style="mso-spacerun: yes;"></span></span></span></span></span><span style="mso-bookmark: TopicCoverPage;"><span style="mso-bookmark: BodyTopicCoverPage;"><span style="font-size: 11.0pt; mso-fareast-font-family: Verdana;">This is a business
plan. It does not imply an offering of securities. These estimates are based on
our experience, together with our good faith estimates for the development of
the business based upon due diligence research and communication with
wholesalers. </span></span></span></p><p class="MsoNormal" style="text-indent: 0in;"><span style="mso-bookmark: TopicCoverPage;"><span style="mso-bookmark: BodyTopicCoverPage;"><span style="font-size: 11.0pt; mso-fareast-font-family: Verdana;">This memorandum contains forward-looking statements that are based
on management's expectations, estimates, projections and assumptions. These
statements are not guarantees of future performance and involve certain risks
and uncertainties, which are difficult to predict. Therefore, actual future
results may vary.</span></span></span></p>
<p class="MsoNormal" style="mso-margin-bottom-alt: auto;"><span style="mso-bookmark: TopicCoverPage;"><span style="mso-bookmark: BodyTopicCoverPage;"><span style="font-family: Symbol; font-size: 10.0pt; mso-bidi-font-family: Symbol; mso-bidi-font-size: 12.0pt; mso-fareast-font-family: Symbol;">Ó</span></span></span><span style="mso-bookmark: TopicCoverPage;"><span style="mso-bookmark: BodyTopicCoverPage;"><span style="font-family: "Verdana","sans-serif"; font-size: 10.0pt; mso-bidi-font-family: Verdana; mso-bidi-font-size: 12.0pt; mso-fareast-font-family: Verdana;"> 2023</span></span></span></p>
<p class="CannaMasterApplicationHeader2"><a name="_Toc139289654">Table of
Contents</a><o:p></o:p></p>
<p class="MsoToc2" style="tab-stops: right dotted 467.5pt;"><!--[if supportFields]><span
style='font-size:14.0pt'><span style='mso-element:field-begin'></span><span
style='mso-spacerun:yes'> </span>TOC \o "1-3" \h \z \u <span
style='mso-element:field-separator'></span></span><![endif]--><a href="file:///C:/Users/Ralph/Documents/CannabisBiz/Symphony%20-%20Business%20and%20Financial%20Plan.2.docx#_Toc139289654"><span style="mso-fareast-font-family: Arial; mso-no-proof: yes;">Table of Contents</span><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;"><span style="mso-tab-count: 1 dotted;">. </span></span><!--[if supportFields]><span
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</xml><![endif]--></span><!--[if supportFields]><span style='color:windowtext;
display:none;mso-hide:screen;mso-no-proof:yes;text-decoration:none;text-underline:
none'><span style='mso-element:field-end'></span></span><![endif]--></a><span style="font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: "Times New Roman"; mso-fareast-theme-font: minor-fareast; mso-hansi-theme-font: minor-latin; mso-no-proof: yes;"><o:p></o:p></span></p>
<p class="MsoToc2" style="tab-stops: right dotted 467.5pt;"><a href="file:///C:/Users/Ralph/Documents/CannabisBiz/Symphony%20-%20Business%20and%20Financial%20Plan.2.docx#_Toc139289655"><span style="mso-fareast-font-family: Arial; mso-no-proof: yes;">Symphony Canna Brands,
LLC</span><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;"><span style="mso-tab-count: 1 dotted;">.. </span></span><!--[if supportFields]><span
style='color:windowtext;display:none;mso-hide:screen;mso-no-proof:yes;
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PAGEREF _Toc139289655 \h <span style='mso-element:field-separator'></span></span><![endif]--><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;">3<!--[if gte mso 9]><xml>
<w:data>08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E0000005F0054006F0063003100330039003200380039003600350035000000</w:data>
</xml><![endif]--></span><!--[if supportFields]><span style='color:windowtext;
display:none;mso-hide:screen;mso-no-proof:yes;text-decoration:none;text-underline:
none'><span style='mso-element:field-end'></span></span><![endif]--></a><span style="font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: "Times New Roman"; mso-fareast-theme-font: minor-fareast; mso-hansi-theme-font: minor-latin; mso-no-proof: yes;"><o:p></o:p></span></p>
<p class="MsoToc2" style="tab-stops: right dotted 467.5pt;"><a href="file:///C:/Users/Ralph/Documents/CannabisBiz/Symphony%20-%20Business%20and%20Financial%20Plan.2.docx#_Toc139289656"><span style="mso-fareast-font-family: Arial; mso-no-proof: yes;">Executive Summary</span><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;"><span style="mso-tab-count: 1 dotted;">. </span></span><!--[if supportFields]><span
style='color:windowtext;display:none;mso-hide:screen;mso-no-proof:yes;
text-decoration:none;text-underline:none'><span style='mso-element:field-begin'></span>
PAGEREF _Toc139289656 \h <span style='mso-element:field-separator'></span></span><![endif]--><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;">3<!--[if gte mso 9]><xml>
<w:data>08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E0000005F0054006F0063003100330039003200380039003600350036000000</w:data>
</xml><![endif]--></span><!--[if supportFields]><span style='color:windowtext;
display:none;mso-hide:screen;mso-no-proof:yes;text-decoration:none;text-underline:
none'><span style='mso-element:field-end'></span></span><![endif]--></a><span style="font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: "Times New Roman"; mso-fareast-theme-font: minor-fareast; mso-hansi-theme-font: minor-latin; mso-no-proof: yes;"><o:p></o:p></span></p>
<p class="MsoToc2" style="tab-stops: right dotted 467.5pt;"><a href="file:///C:/Users/Ralph/Documents/CannabisBiz/Symphony%20-%20Business%20and%20Financial%20Plan.2.docx#_Toc139289657"><span style="mso-fareast-font-family: Arial; mso-no-proof: yes;">The Company</span><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;"><span style="mso-tab-count: 1 dotted;">. </span></span><!--[if supportFields]><span
style='color:windowtext;display:none;mso-hide:screen;mso-no-proof:yes;
text-decoration:none;text-underline:none'><span style='mso-element:field-begin'></span>
PAGEREF _Toc139289657 \h <span style='mso-element:field-separator'></span></span><![endif]--><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;">3<!--[if gte mso 9]><xml>
<w:data>08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E0000005F0054006F0063003100330039003200380039003600350037000000</w:data>
</xml><![endif]--></span><!--[if supportFields]><span style='color:windowtext;
display:none;mso-hide:screen;mso-no-proof:yes;text-decoration:none;text-underline:
none'><span style='mso-element:field-end'></span></span><![endif]--></a><span style="font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: "Times New Roman"; mso-fareast-theme-font: minor-fareast; mso-hansi-theme-font: minor-latin; mso-no-proof: yes;"><o:p></o:p></span></p>
<p class="MsoToc2" style="tab-stops: right dotted 467.5pt;"><a href="file:///C:/Users/Ralph/Documents/CannabisBiz/Symphony%20-%20Business%20and%20Financial%20Plan.2.docx#_Toc139289659"><span style="background: white; mso-no-proof: yes;">Company Mission</span><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;"><span style="mso-tab-count: 1 dotted;">. </span></span><!--[if supportFields]><span
style='color:windowtext;display:none;mso-hide:screen;mso-no-proof:yes;
text-decoration:none;text-underline:none'><span style='mso-element:field-begin'></span>
PAGEREF _Toc139289659 \h <span style='mso-element:field-separator'></span></span><![endif]--><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;">4<!--[if gte mso 9]><xml>
<w:data>08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E0000005F0054006F0063003100330039003200380039003600350039000000</w:data>
</xml><![endif]--></span><!--[if supportFields]><span style='color:windowtext;
display:none;mso-hide:screen;mso-no-proof:yes;text-decoration:none;text-underline:
none'><span style='mso-element:field-end'></span></span><![endif]--></a><span style="font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: "Times New Roman"; mso-fareast-theme-font: minor-fareast; mso-hansi-theme-font: minor-latin; mso-no-proof: yes;"><o:p></o:p></span></p>
<p class="MsoToc2" style="tab-stops: right dotted 467.5pt;"><a href="file:///C:/Users/Ralph/Documents/CannabisBiz/Symphony%20-%20Business%20and%20Financial%20Plan.2.docx#_Toc139289660"><span style="background: white; mso-no-proof: yes;">Background of Team</span><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;"><span style="mso-tab-count: 1 dotted;">.. </span></span><!--[if supportFields]><span
style='color:windowtext;display:none;mso-hide:screen;mso-no-proof:yes;
text-decoration:none;text-underline:none'><span style='mso-element:field-begin'></span>
PAGEREF _Toc139289660 \h <span style='mso-element:field-separator'></span></span><![endif]--><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;">4<!--[if gte mso 9]><xml>
<w:data>08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E0000005F0054006F0063003100330039003200380039003600360030000000</w:data>
</xml><![endif]--></span><!--[if supportFields]><span style='color:windowtext;
display:none;mso-hide:screen;mso-no-proof:yes;text-decoration:none;text-underline:
none'><span style='mso-element:field-end'></span></span><![endif]--></a><span style="font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: "Times New Roman"; mso-fareast-theme-font: minor-fareast; mso-hansi-theme-font: minor-latin; mso-no-proof: yes;"><o:p></o:p></span></p>
<p class="MsoToc3" style="tab-stops: right dotted 467.5pt;"><a href="file:///C:/Users/Ralph/Documents/CannabisBiz/Symphony%20-%20Business%20and%20Financial%20Plan.2.docx#_Toc139289661"><span style="mso-fareast-font-family: Arial; mso-no-proof: yes;">Jonathan (Avi),
Wertenteil – Chief Executive Officer</span><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;"><span style="mso-tab-count: 1 dotted;"> </span></span><!--[if supportFields]><span
style='color:windowtext;display:none;mso-hide:screen;mso-no-proof:yes;
text-decoration:none;text-underline:none'><span style='mso-element:field-begin'></span>
PAGEREF _Toc139289661 \h <span style='mso-element:field-separator'></span></span><![endif]--><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;">4<!--[if gte mso 9]><xml>
<w:data>08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E0000005F0054006F0063003100330039003200380039003600360031000000</w:data>
</xml><![endif]--></span><!--[if supportFields]><span style='color:windowtext;
display:none;mso-hide:screen;mso-no-proof:yes;text-decoration:none;text-underline:
none'><span style='mso-element:field-end'></span></span><![endif]--></a><span style="font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: "Times New Roman"; mso-fareast-theme-font: minor-fareast; mso-hansi-theme-font: minor-latin; mso-no-proof: yes;"><o:p></o:p></span></p>
<p class="MsoToc3" style="tab-stops: right dotted 467.5pt;"><a href="file:///C:/Users/Ralph/Documents/CannabisBiz/Symphony%20-%20Business%20and%20Financial%20Plan.2.docx#_Toc139289662"><span style="mso-fareast-font-family: Arial; mso-no-proof: yes;">Bruce Cooper –Chief
Operating Officer</span><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;"><span style="mso-tab-count: 1 dotted;"> </span></span><!--[if supportFields]><span
style='color:windowtext;display:none;mso-hide:screen;mso-no-proof:yes;
text-decoration:none;text-underline:none'><span style='mso-element:field-begin'></span>
PAGEREF _Toc139289662 \h <span style='mso-element:field-separator'></span></span><![endif]--><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;">5<!--[if gte mso 9]><xml>
<w:data>08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E0000005F0054006F0063003100330039003200380039003600360032000000</w:data>
</xml><![endif]--></span><!--[if supportFields]><span style='color:windowtext;
display:none;mso-hide:screen;mso-no-proof:yes;text-decoration:none;text-underline:
none'><span style='mso-element:field-end'></span></span><![endif]--></a><span style="font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: "Times New Roman"; mso-fareast-theme-font: minor-fareast; mso-hansi-theme-font: minor-latin; mso-no-proof: yes;"><o:p></o:p></span></p>
<p class="MsoToc3" style="tab-stops: right dotted 467.5pt;"><a href="file:///C:/Users/Ralph/Documents/CannabisBiz/Symphony%20-%20Business%20and%20Financial%20Plan.2.docx#_Toc139289663"><span style="mso-fareast-font-family: Arial; mso-no-proof: yes;">Ralph, Fucetola JD –
Chief Compliance Officer</span><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;"><span style="mso-tab-count: 1 dotted;"> </span></span><!--[if supportFields]><span
style='color:windowtext;display:none;mso-hide:screen;mso-no-proof:yes;
text-decoration:none;text-underline:none'><span style='mso-element:field-begin'></span>
PAGEREF _Toc139289663 \h <span style='mso-element:field-separator'></span></span><![endif]--><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;">5<!--[if gte mso 9]><xml>
<w:data>08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E0000005F0054006F0063003100330039003200380039003600360033000000</w:data>
</xml><![endif]--></span><!--[if supportFields]><span style='color:windowtext;
display:none;mso-hide:screen;mso-no-proof:yes;text-decoration:none;text-underline:
none'><span style='mso-element:field-end'></span></span><![endif]--></a><span style="font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: "Times New Roman"; mso-fareast-theme-font: minor-fareast; mso-hansi-theme-font: minor-latin; mso-no-proof: yes;"><o:p></o:p></span></p>
<p class="MsoToc2" style="tab-stops: right dotted 467.5pt;"><a href="file:///C:/Users/Ralph/Documents/CannabisBiz/Symphony%20-%20Business%20and%20Financial%20Plan.2.docx#_Toc139289664"><span style="background: white; mso-no-proof: yes;">Business Development</span><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;"><span style="mso-tab-count: 1 dotted;"> </span></span><!--[if supportFields]><span
style='color:windowtext;display:none;mso-hide:screen;mso-no-proof:yes;
text-decoration:none;text-underline:none'><span style='mso-element:field-begin'></span>
PAGEREF _Toc139289664 \h <span style='mso-element:field-separator'></span></span><![endif]--><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;">5<!--[if gte mso 9]><xml>
<w:data>08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E0000005F0054006F0063003100330039003200380039003600360034000000</w:data>
</xml><![endif]--></span><!--[if supportFields]><span style='color:windowtext;
display:none;mso-hide:screen;mso-no-proof:yes;text-decoration:none;text-underline:
none'><span style='mso-element:field-end'></span></span><![endif]--></a><span style="font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: "Times New Roman"; mso-fareast-theme-font: minor-fareast; mso-hansi-theme-font: minor-latin; mso-no-proof: yes;"><o:p></o:p></span></p>
<p class="MsoToc2" style="tab-stops: right dotted 467.5pt;"><a href="file:///C:/Users/Ralph/Documents/CannabisBiz/Symphony%20-%20Business%20and%20Financial%20Plan.2.docx#_Toc139289665"><span style="background: white; mso-no-proof: yes;">Location, Facility, and Production
Overview for Phase One</span><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;"><span style="mso-tab-count: 1 dotted;">. </span></span><!--[if supportFields]><span
style='color:windowtext;display:none;mso-hide:screen;mso-no-proof:yes;
text-decoration:none;text-underline:none'><span style='mso-element:field-begin'></span>
PAGEREF _Toc139289665 \h <span style='mso-element:field-separator'></span></span><![endif]--><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;">6<!--[if gte mso 9]><xml>
<w:data>08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E0000005F0054006F0063003100330039003200380039003600360035000000</w:data>
</xml><![endif]--></span><!--[if supportFields]><span style='color:windowtext;
display:none;mso-hide:screen;mso-no-proof:yes;text-decoration:none;text-underline:
none'><span style='mso-element:field-end'></span></span><![endif]--></a><span style="font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: "Times New Roman"; mso-fareast-theme-font: minor-fareast; mso-hansi-theme-font: minor-latin; mso-no-proof: yes;"><o:p></o:p></span></p>
<p class="MsoToc3" style="tab-stops: right dotted 467.5pt;"><a href="file:///C:/Users/Ralph/Documents/CannabisBiz/Symphony%20-%20Business%20and%20Financial%20Plan.2.docx#_Toc139289666"><span style="background: white; mso-no-proof: yes;">Pro Forma Plans</span><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;"><span style="mso-tab-count: 1 dotted;">. </span></span><!--[if supportFields]><span
style='color:windowtext;display:none;mso-hide:screen;mso-no-proof:yes;
text-decoration:none;text-underline:none'><span style='mso-element:field-begin'></span>
PAGEREF _Toc139289666 \h <span style='mso-element:field-separator'></span></span><![endif]--><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;">8<!--[if gte mso 9]><xml>
<w:data>08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E0000005F0054006F0063003100330039003200380039003600360036000000</w:data>
</xml><![endif]--></span><!--[if supportFields]><span style='color:windowtext;
display:none;mso-hide:screen;mso-no-proof:yes;text-decoration:none;text-underline:
none'><span style='mso-element:field-end'></span></span><![endif]--></a><span style="font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: "Times New Roman"; mso-fareast-theme-font: minor-fareast; mso-hansi-theme-font: minor-latin; mso-no-proof: yes;"><o:p></o:p></span></p>
<p class="MsoToc3" style="tab-stops: right dotted 467.5pt;"><a href="file:///C:/Users/Ralph/Documents/CannabisBiz/Symphony%20-%20Business%20and%20Financial%20Plan.2.docx#_Toc139289667"><span style="mso-fareast-font-family: Arial; mso-no-proof: yes;">Business Start Up Cost</span><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;"><span style="mso-tab-count: 1 dotted;"> </span></span><!--[if supportFields]><span
style='color:windowtext;display:none;mso-hide:screen;mso-no-proof:yes;
text-decoration:none;text-underline:none'><span style='mso-element:field-begin'></span>
PAGEREF _Toc139289667 \h <span style='mso-element:field-separator'></span></span><![endif]--><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;">9<!--[if gte mso 9]><xml>
<w:data>08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E0000005F0054006F0063003100330039003200380039003600360037000000</w:data>
</xml><![endif]--></span><!--[if supportFields]><span style='color:windowtext;
display:none;mso-hide:screen;mso-no-proof:yes;text-decoration:none;text-underline:
none'><span style='mso-element:field-end'></span></span><![endif]--></a><span style="font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: "Times New Roman"; mso-fareast-theme-font: minor-fareast; mso-hansi-theme-font: minor-latin; mso-no-proof: yes;"><o:p></o:p></span></p>
<p class="MsoToc2" style="tab-stops: right dotted 467.5pt;"><a href="file:///C:/Users/Ralph/Documents/CannabisBiz/Symphony%20-%20Business%20and%20Financial%20Plan.2.docx#_Toc139289668"><span style="background: white; mso-fareast-font-family: Arial; mso-no-proof: yes;">Overview
for Phase Two</span><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;"><span style="mso-tab-count: 1 dotted;">. </span></span><!--[if supportFields]><span
style='color:windowtext;display:none;mso-hide:screen;mso-no-proof:yes;
text-decoration:none;text-underline:none'><span style='mso-element:field-begin'></span>
PAGEREF _Toc139289668 \h <span style='mso-element:field-separator'></span></span><![endif]--><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;">10<!--[if gte mso 9]><xml>
<w:data>08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E0000005F0054006F0063003100330039003200380039003600360038000000</w:data>
</xml><![endif]--></span><!--[if supportFields]><span style='color:windowtext;
display:none;mso-hide:screen;mso-no-proof:yes;text-decoration:none;text-underline:
none'><span style='mso-element:field-end'></span></span><![endif]--></a><span style="font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: "Times New Roman"; mso-fareast-theme-font: minor-fareast; mso-hansi-theme-font: minor-latin; mso-no-proof: yes;"><o:p></o:p></span></p>
<p class="MsoToc2" style="tab-stops: right dotted 467.5pt;"><a href="file:///C:/Users/Ralph/Documents/CannabisBiz/Symphony%20-%20Business%20and%20Financial%20Plan.2.docx#_Toc139289669"><span style="mso-fareast-font-family: Arial; mso-no-proof: yes;">Market Analysis</span><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;"><span style="mso-tab-count: 1 dotted;">. </span></span><!--[if supportFields]><span
style='color:windowtext;display:none;mso-hide:screen;mso-no-proof:yes;
text-decoration:none;text-underline:none'><span style='mso-element:field-begin'></span>
PAGEREF _Toc139289669 \h <span style='mso-element:field-separator'></span></span><![endif]--><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;">11<!--[if gte mso 9]><xml>
<w:data>08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E0000005F0054006F0063003100330039003200380039003600360039000000</w:data>
</xml><![endif]--></span><!--[if supportFields]><span style='color:windowtext;
display:none;mso-hide:screen;mso-no-proof:yes;text-decoration:none;text-underline:
none'><span style='mso-element:field-end'></span></span><![endif]--></a><span style="font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: "Times New Roman"; mso-fareast-theme-font: minor-fareast; mso-hansi-theme-font: minor-latin; mso-no-proof: yes;"><o:p></o:p></span></p>
<p class="MsoToc3" style="tab-stops: right dotted 467.5pt;"><a href="file:///C:/Users/Ralph/Documents/CannabisBiz/Symphony%20-%20Business%20and%20Financial%20Plan.2.docx#_Toc139289670"><span style="mso-fareast-font-family: Arial; mso-no-proof: yes;">Resolution from City of
Bridgeton</span><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;"><span style="mso-tab-count: 1 dotted;">. </span></span><!--[if supportFields]><span
style='color:windowtext;display:none;mso-hide:screen;mso-no-proof:yes;
text-decoration:none;text-underline:none'><span style='mso-element:field-begin'></span>
PAGEREF _Toc139289670 \h <span style='mso-element:field-separator'></span></span><![endif]--><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;">12<!--[if gte mso 9]><xml>
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</xml><![endif]--></span><!--[if supportFields]><span style='color:windowtext;
display:none;mso-hide:screen;mso-no-proof:yes;text-decoration:none;text-underline:
none'><span style='mso-element:field-end'></span></span><![endif]--></a><span style="font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: "Times New Roman"; mso-fareast-theme-font: minor-fareast; mso-hansi-theme-font: minor-latin; mso-no-proof: yes;"><o:p></o:p></span></p>
<p class="MsoToc3" style="tab-stops: right dotted 467.5pt;"><a href="file:///C:/Users/Ralph/Documents/CannabisBiz/Symphony%20-%20Business%20and%20Financial%20Plan.2.docx#_Toc139289671"><span style="mso-fareast-font-family: Arial; mso-no-proof: yes;">Letter of Support from
City of Bridgeton</span><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;"><span style="mso-tab-count: 1 dotted;">. </span></span><!--[if supportFields]><span
style='color:windowtext;display:none;mso-hide:screen;mso-no-proof:yes;
text-decoration:none;text-underline:none'><span style='mso-element:field-begin'></span>
PAGEREF _Toc139289671 \h <span style='mso-element:field-separator'></span></span><![endif]--><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;">13<!--[if gte mso 9]><xml>
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</xml><![endif]--></span><!--[if supportFields]><span style='color:windowtext;
display:none;mso-hide:screen;mso-no-proof:yes;text-decoration:none;text-underline:
none'><span style='mso-element:field-end'></span></span><![endif]--></a><span style="font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: "Times New Roman"; mso-fareast-theme-font: minor-fareast; mso-hansi-theme-font: minor-latin; mso-no-proof: yes;"><o:p></o:p></span></p>
<p class="MsoToc3" style="tab-stops: right dotted 467.5pt;"><a href="file:///C:/Users/Ralph/Documents/CannabisBiz/Symphony%20-%20Business%20and%20Financial%20Plan.2.docx#_Toc139289672"><span style="mso-fareast-font-family: Arial; mso-no-proof: yes;">Approval for Cultivation
License</span><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;"><span style="mso-tab-count: 1 dotted;">. </span></span><!--[if supportFields]><span
style='color:windowtext;display:none;mso-hide:screen;mso-no-proof:yes;
text-decoration:none;text-underline:none'><span style='mso-element:field-begin'></span>
PAGEREF _Toc139289672 \h <span style='mso-element:field-separator'></span></span><![endif]--><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;">14<!--[if gte mso 9]><xml>
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</xml><![endif]--></span><!--[if supportFields]><span style='color:windowtext;
display:none;mso-hide:screen;mso-no-proof:yes;text-decoration:none;text-underline:
none'><span style='mso-element:field-end'></span></span><![endif]--></a><span style="font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: "Times New Roman"; mso-fareast-theme-font: minor-fareast; mso-hansi-theme-font: minor-latin; mso-no-proof: yes;"><o:p></o:p></span></p>
<p class="MsoToc3" style="tab-stops: right dotted 467.5pt;"><a href="file:///C:/Users/Ralph/Documents/CannabisBiz/Symphony%20-%20Business%20and%20Financial%20Plan.2.docx#_Toc139289673"><span style="mso-fareast-font-family: Arial; mso-no-proof: yes;">Approval for
Manufacturing License</span><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;"><span style="mso-tab-count: 1 dotted;">. </span></span><!--[if supportFields]><span
style='color:windowtext;display:none;mso-hide:screen;mso-no-proof:yes;
text-decoration:none;text-underline:none'><span style='mso-element:field-begin'></span>
PAGEREF _Toc139289673 \h <span style='mso-element:field-separator'></span></span><![endif]--><span style="color: windowtext; display: none; mso-hide: screen; mso-no-proof: yes; text-decoration: none; text-underline: none;">15<!--[if gte mso 9]><xml>
<w:data>08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E0000005F0054006F0063003100330039003200380039003600370033000000</w:data>
</xml><![endif]--></span><!--[if supportFields]><span style='color:windowtext;
display:none;mso-hide:screen;mso-no-proof:yes;text-decoration:none;text-underline:
none'><span style='mso-element:field-end'></span></span><![endif]--></a><span style="font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: "Times New Roman"; mso-fareast-theme-font: minor-fareast; mso-hansi-theme-font: minor-latin; mso-no-proof: yes;"><o:p></o:p></span></p>
<p class="MsoToc3" style="tab-stops: right dotted 467.5pt;"><a href="file:///C:/Users/Ralph/Documents/CannabisBiz/Symphony%20-%20Business%20and%20Financial%20Plan.2.docx#_Toc139289674"><span style="mso-fareast-font-family: Arial; mso-no-proof: yes;">Pro Forma Balance Sheet</span></a></p>
<p align="center" class="MsoNormal" style="text-align: center;"><b style="mso-bidi-font-weight: normal;">New Jersey Annual Cultivation & MANUFACTURING LICENSE<o:p></o:p></b></p>
<p align="center" class="MsoNormal" style="text-align: center;"><b style="mso-bidi-font-weight: normal;">Business Plan</b></p>
<p class="CannaMasterApplicationHeader2"><a name="_Toc139289656"><b>Executive
Summary</b></a><o:p></o:p></p>
<p class="Normal0" style="line-height: normal;"><span style="color: black; mso-themecolor: text1;">Having legalized medicinal cannabis for use by registered
patients following legislative action in 2010, New Jersey is an older cannabis
market that saw the program’s implementation stall at its initial rollout and
in later licensing rounds. Since 2018, the state has witnessed exponential
growth in medicinal cannabis patient count and total sales, with total spending
for 2019 surpassing $107 million.</span><a href="file:///C:/Users/Ralph/Documents/CannabisBiz/Symphony%20-%20Business%20and%20Financial%20Plan.2.docx#_ftn1" name="_ftnref1" style="mso-footnote-id: ftn1;" title=""><span class="MsoFootnoteReference"><span style="color: black; mso-fareast-font-family: "Times New Roman"; mso-fareast-theme-font: major-fareast; mso-themecolor: text1;"><span style="mso-special-character: footnote;"><!--[if !supportFootnotes]--><span class="MsoFootnoteReference"><span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-US; mso-fareast-theme-font: major-fareast; mso-themecolor: text1;">[1]</span></span><!--[endif]--></span></span></span></a><span style="color: black; mso-themecolor: text1;"> In 2021 the state opened its doors to
the newly formed recreational market. Our team received Minimality approval and
submitted a full cultivation and manufacturing application to Cannabis
Regulatory Commission (CRC) in December 2021.</span></p>
<p class="Normal0" style="line-height: normal;"><span style="color: black; mso-themecolor: text1;">We aim to enter the market at the onset of adult-use
legalization, which is expected to generate over $1 billion in annual sales by
2024.</span><a href="file:///C:/Users/Ralph/Documents/CannabisBiz/Symphony%20-%20Business%20and%20Financial%20Plan.2.docx#_ftn2" name="_ftnref2" style="mso-footnote-id: ftn2;" title=""><span class="MsoFootnoteReference"><span style="color: black; mso-fareast-font-family: "Times New Roman"; mso-fareast-theme-font: major-fareast; mso-themecolor: text1;"><span style="mso-special-character: footnote;"><!--[if !supportFootnotes]--><span class="MsoFootnoteReference"><span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-US; mso-fareast-theme-font: major-fareast; mso-themecolor: text1;">[2]</span></span><!--[endif]--></span></span></span></a><span style="color: black; mso-themecolor: text1;"> Our business has thoroughly planned
and prepared for the challenges inherent in operating a cannabis cultivation
business, and we are thrilled to present this opportunity.</span></p>
<p class="Normal0" style="line-height: normal;"><span style="color: black; mso-themecolor: text1;">Symphony Canna Brands, LLC (Symphony Canna Brands) is a
New Jersey business founded by Jonathan (Avi) Wertenteil, Ralph Fucetola and Bruce
L. Cooper for the purpose of starting low-cost cannabis cultivation and
manufacturing in New Jersey. With a team of seasoned cannabis experts, we plan
to cultivate approximately 150,000 square feet of canopy area, along with a 10,000
Square feet processing, packaging, manufacturing, and distribution area. Our
plan is to utilize both the cultivation license and manufacturing licenses to
produce and distribute packaged products directly to retailers and delivery
services thought the state.</span></p>
<p class="CannaMasterApplicationHeader2"><a name="_Toc139289657"><b>The Company</b></a><o:p></o:p></p>
<p class="Normal0" style="line-height: normal;"><span style="color: black; mso-themecolor: text1;">Symphony Canna Brands LLC was created to capitalize on
the new and growing opportunity presented by the adult-use cannabis
legalization and upcoming licensing round in New Jersey. Our goal is to secure
a significant market share of the target state of New Jersey with high-quality
cannabis products. Symphony Canna Brands was awarded both cultivation and
manufacturing licenses in June 2023. <span style="mso-spacerun: yes;"> </span>Due
to these factors, Symphony Canna Brands is well positioned and well equipped to
seize the opportunity presented in the New Jersey adult use cannabis Market. Due
to our existing relationships, retailers around the state are ready to accept
products from our production facility.</span></p>
<p class="Normal0" style="line-height: normal;"><span style="color: black; mso-themecolor: text1;">Our vision is to cultivate, manufacture and distribute the
best cannabis products to retailers and delivery services thought the state
while maintaining low costs. During our discussions with the local
municipality, we floated the idea of hiring inmates from the state prison near
our facility and have received positive feedback from the municipality (see
letter of support from Bridgeton) We also have an agreement to provide
on-the-job training for qualified former inmates from the Nehemiah Group (Local
Halfway House). Although there is a well-known cycle of individuals with a
criminal history that, when released from prison, experience challenges
reintegrating into society and often return to similar habits that lead to
future incarceration, we have decided to work with former inmates. On-the-job
training reminds inmates that they do have value in society and inspires them
to pursue a life that does not require them to break laws. Furthermore, there
are other nearby businesses in the industrial zone where our property is
located that utilize cheap labor by hiring inmates in their facilities.</span></p>
<p class="Normal0" style="line-height: normal;"><span style="color: black; mso-themecolor: text1;">Our growers and operators have decades of experience in
the medicinal cannabis sector, and they will utilize their knowledge and
expertise to assist Symphony Canna Brands in all aspects of its business. Our
growers and operators have worked on large scale cannabis projects in both
indoor and outdoor settings. We believe this is a unique advantage that
Symphony Canna Brands will have. Symphony Canna Brands will produce high
quality cannabis products and will enhance the cannabis ecosystem that New
Jersey is nurturing to a profitable, statewide industry.</span></p>
<p class="CannaMasterApplicationHeader3" style="line-height: normal;"><a name="_Toc139289658"><span style="color: black; mso-themecolor: text1; text-decoration: none; text-underline: none;">Additionally, Symphony Canna Brands intends to
cultivate using only organic natural inputs including fertilizers and pest
management. This is a low-cost production model and has been proven in many
states. Symphony Canna Brands team members were one of the first to operate a
large-scale commercial cultivation operation in California where there is
rigorous testing for pesticides and other dangerous inputs. The operation
passed all inspections with high quality organic products. Symphony Canna
Brands intends on using automated irrigation and fertigation thereby maximizing
the quality of the organic inputs.</span></a></p>
<p class="CannaMasterApplicationHeader2"><a name="_Toc139289659"><span style="background: white; mso-fareast-font-family: "Times New Roman";"><b>Company
Mission</b></span></a><span style="background: white; mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></p>
<p class="Normal0" style="line-height: normal;"><span style="color: black; mso-themecolor: text1;">Our Mission is to provide superior quality cannabis
products for the New Jersey recreational cannabis market. We intend to
cultivate with only organic ingredients and plan on using low-cost production
methods without compromising the quality of the cannabis.</span></p>
<p class="CannaMasterApplicationHeader2"><a name="_Toc139289660"><span style="background: white; mso-fareast-font-family: "Times New Roman";"><b>Background
of Team</b></span></a><span style="background: white; mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></p>
<p class="Normal0" style="line-height: normal; text-indent: 0in;"><span style="color: black; mso-themecolor: text1;"><span style="mso-spacerun: yes;">
</span>Symphony Canna Brands has assembled a team of business leaders and
industry executives with ample experience and expertise to lead Symphony Canna
Brands to profitability in almost any scenario. Our business is led by Jonathan
(Avi) Wertenteil, Chief Executive Officer, Bruce Cooper, Chief Operating
Officer, and Ralph Fucetola, Chief Compliance Officer. Combining Bruce’s
leadership capabilities with Avi’s cannabis cultivation entrepreneurial
background and Ralph’s decades of legal experience, there is a strong
leadership foundation. In addition, Ralph’s three and a half decades of
pharmaceutical compliance experience will prove to be crucial in this very highly
regulated industry. Together, our leadership brings the experience and skills
required to be profitable in the cannabis space.<span style="mso-spacerun: yes;"> </span>The following is a detailed description of
everyone’s experience and skillset.</span></p>
<p align="center" class="CannaMasterApplicationHeader3" style="text-align: center;"><a name="_Toc139289661"><b>Jonathan (Avi), Wertenteil – Chief Executive Officer</b></a><o:p></o:p></p>
<p class="MsoNormal">Avi brings substantial experience in the cannabis industry
as the founder of Red Hill Organics, a leading cannabis cultivation company in
California that cultivated over 88,000 square feet of canopy grow space
supplying licensed dispensaries throughout California. Avi received a
bachelor’s degree in business administration and is proficient in navigating
regulatory compliance and worked closely with the California department of food
and agriculture to ensure that all local and state regulations were satisfied.
Additionally, Avi served in an elite paratrooper’s unit in the Israeli Defense
Force for three years.</p>
<p align="center" class="CannaMasterApplicationHeader3" style="text-align: center;"><a name="_Toc139289662"><b>Bruce Cooper – Chief Operating Officer</b></a> <o:p></o:p></p>
<p class="MsoNormal">Bruce brings over 20 years of varied, in-depth experience as
a senior police officer in the New Jersey State Human Service Police as well as
a caseworker for the Camden County Board of Social Services. Bruce received a bachelor’s
degree in Management Science from Kean University and served as a U.S. Navy
Third Class Petty Officer on the USS Belknap CG-26. Inspired to serve his
community, Bruce was elected as both the Millville City Commissioner and a
Member of the School Board and is a John Maxwell-Certified Life Coach, Speaker,
and Trainer. Collectively, Bruce’s roles in the highly regulated industries of
law enforcement, social services, and the Navy have provided him with a
knowledgeable, informed perspective, which translates to a multitude of
relevant, transferable skills such as leadership, organization, project
management, critical thinking, government regulations, public safety and
security, and problem solving. Bruce is equipped with the requisite business
acumen to apply his knowledge, skills, and experience to the highly regulated
cannabis industry.</p>
<p align="center" class="CannaMasterApplicationHeader3" style="text-align: center;"><a name="_Toc139289663"><b>Ralph, Fucetola JD – Chief Compliance Officer</b></a><o:p></o:p></p>
<p class="MsoNormal">Ralph is a preeminent leader in several highly regulated
industries including nutrients, vitamins, alternative health, and cannabis.
Ralph is known by the moniker of the “Vitamin Lawyer,” given his status as a renowned
author and educator, with dozens of his articles published in numerous journals
and websites. Ralph received a bachelor’s degree with Distinction and a Juris
Doctor from Rutgers University. He operates a consulting practice specializing
in systems process integration claims; advertising and label review; consulting
with marketers, consumers, advocates, and local attorneys regarding regulatory
issues and petitions and litigation. Ralph carefully applies the business
acumen, knowledge, experience, and skills from his roles in the nutrients,
alternative health, and vitamins industries to provide a competitive edge as an
advisor to the management and application teams for the New Jersey medical and
adult use cannabis licenses. Ralph’s knowledge, skills, and experience provide
a well-rounded perspective of many of the central issues, variables, and facets
affecting the cannabis industry.</p>
<p class="CannaMasterApplicationHeader2"><a name="_Toc139289664"><span style="background: white; mso-fareast-font-family: "Times New Roman";"><b>Business
Development</b></span></a><span style="background: white; mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></p>
<p class="Normal0" style="line-height: normal;"><span style="color: black; mso-themecolor: text1;">Business development is the heart of any successful
cannabis production, and we intend to implement detailed strategies to
facilitate development, including building a strong presence in the market,
achieving, and maintaining a positive cash flow, implementing a scalable
marketing strategy, and sustaining business growth over time. Achieving market
validation and building an initial distribution and customer base will be the
foundation of the business, from which we will expand to reach more and more
customers. The first challenge for our company will be to attract an initial
pool of customers, who will then spread the word about our brand as a result of
our extraordinary product quality and selection. We will also engage in
substantial marketing and advertising to the extent allowed by law, helping to
further develop our presence in the market and alert more licensed cannabis
businesses, especially distribution and dispensary businesses, to the existence
of our new cannabis cultivation facility. Additionally, as one of only a
handful of licensed cannabis businesses in New Jersey, we will essentially have
a captive market, as the state’s large customer base will be forced to choose
from only a small number of providers with whom they may lawfully do business.
As the business and its customer base expands, we will quickly achieve positive
cash flow, rapidly growing sales sufficient to generate a return on investment.
Finally, the business will sustain this growth by staying on the frontlines of
advancements in the industry, hiring and training quality employees, skilled
managers, and executives, and adapting to changes in the swiftly developing
market.</span></p>
<p class="CannaMasterApplicationHeader2"><a name="_Toc139289665"><span style="background: white; mso-fareast-font-family: "Times New Roman";"><b>Location, Facility,
and Production Overview for Phase One</b></span></a><span style="background: white; mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></p>
<p class="Normal0" style="line-height: normal;"><span style="color: black; mso-themecolor: text1;">The location of the facility is on a 4.5-acre property in
an industrial zoned park in the city of Bridgeton in Cumberland County, New
Jersey. The property has an existing 13,000 square foot building that was
constructed three years ago and is in excellent condition. The address is 5
South Industrial Drive, Bridgeton, New Jersey.<span style="mso-spacerun: yes;"> </span></span></p>
<p class="Normal0" style="line-height: normal;"><span style="color: black; mso-themecolor: text1;">In Phase One, our facility will have 4 indoor grow rooms
that total 3,000 square feet of indoor flowering canopy. Each room will be
harvested three times a year enabling us to stagger our harvests monthly
ensuring a constant supply. Additionally, we intend to build a 10,000 square
feet state of the art high tech greenhouses for low-cost year-round production
of low-cost cannabis flower.</span></p>
<p class="Normal0" style="line-height: normal;"><span style="color: black; mso-themecolor: text1;">In order to satisfy the demand for water, we plan to
install five 10,000-gallon water tanks. We will drill one or more
environmentally friendly wells on our property, as necessary, in order to
eliminate the use of municipal water. Instead of wasteful reverse osmosis water
cleaning systems, we will use high-powered filters that will achieve optimal
results for our purposes without producing excess wastewater. We plan to use
automated watering and fertigation systems such as Roots Talk and Dosatron that
will allow our facility to function more sustainably and predictably. We plan
on installing environmentally friendly LED lights such as Gavita.</span></p>
<p class="MsoNormal">Our indoor grow rooms will use a hydroponic system along
with a CO2 delivery system that will push air under the plants, increasing air
flow and decreasing stagnation that can foster contaminants. We intend to
follow standard industry practices and utilize dehumidifiers, carbon filters,
HVAC, and integrated controls to monitor the grow room environment and mitigate
odors.</p>
<p class="MsoNormal">Along with the 13,000 square foot cultivation canopy we plan
to build a state-of-the-art nursery to grow baby plants that can be transferred
to the flowering cultivation area. Additionally, we intend to build an
approximately 9,000 square foot manufacturing, processing, packaging, storage,
and distribution center where we will create specialty products such as
pre-rolls, infused pre-rolls, vapes, oils, topicals, infused foods, infused
drinks. All products will be packaged under our variety of in-house brands
which then be sold and distributed to retail outlets across the state. <o:p></o:p></p>
<p class="MsoNormal"><o:p> </o:p></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/a/AVvXsEjL6Dc-7-YTpAkcSfGToUbX2MvCBf6KABwoQhDzTW-dX1xacaZjQLQNb-zD-wZ7F37EEOx2SANXzjpy4hvUegM91LUnAGQ1tdzo4vgbJ-Fwu8fOuTGaOEF1UR_i0UlqzKbvohxO4ewSzqwjoHRKmo1BLrEH4eHPWXmEn3C-JJqUTupBJwA2_-G16bJFBk4" style="margin-left: 1em; margin-right: 1em;"><img alt="" data-original-height="603" data-original-width="641" height="240" src="https://blogger.googleusercontent.com/img/a/AVvXsEjL6Dc-7-YTpAkcSfGToUbX2MvCBf6KABwoQhDzTW-dX1xacaZjQLQNb-zD-wZ7F37EEOx2SANXzjpy4hvUegM91LUnAGQ1tdzo4vgbJ-Fwu8fOuTGaOEF1UR_i0UlqzKbvohxO4ewSzqwjoHRKmo1BLrEH4eHPWXmEn3C-JJqUTupBJwA2_-G16bJFBk4" width="255" /></a></div><p></p>
<p align="center" class="MsoNormal" style="text-align: center;"><span style="mso-bidi-font-weight: bold;">Site Map of 5 South Industrial Drive
Bridgeton NJ<o:p></o:p></span></p>
<p align="center" class="CannaMasterApplicationHeader3" style="text-align: center;"><span style="background: white; mso-fareast-font-family: "Times New Roman";"><o:p><span style="text-decoration: none;"> </span></o:p></span></p>
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 107%; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-US;"><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/a/AVvXsEgntcJpWxULo4anPnU2OSz4szRDglqdFYOhLk0CPKh0k_EnA0hHUHz1xCmLnKWQVCO0S6SRZurC4bHey0orZwNZkbdqeWefu5LcUT5BIJ7L0pWcRoFm4G5FVhLsrGJAhnmkf0QS8yYCS9z4DvXAlJB19wHb-6JDHmwCIG5LCbIXhlxDzL45-RtRhNbdQW4" style="margin-left: 1em; margin-right: 1em;"><img alt="" data-original-height="658" data-original-width="975" height="216" src="https://blogger.googleusercontent.com/img/a/AVvXsEgntcJpWxULo4anPnU2OSz4szRDglqdFYOhLk0CPKh0k_EnA0hHUHz1xCmLnKWQVCO0S6SRZurC4bHey0orZwNZkbdqeWefu5LcUT5BIJ7L0pWcRoFm4G5FVhLsrGJAhnmkf0QS8yYCS9z4DvXAlJB19wHb-6JDHmwCIG5LCbIXhlxDzL45-RtRhNbdQW4" width="320" /></a></div><br /><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/a/AVvXsEh3_VAfINId58e4bQnJh6FnWflbwGgetMtVpId1jzfHy0pQ-6k11_nbnrYRZ3dabnxJLc_UtX1nUEMRwb_MUxVcU3lPrjJlajehGxXNOWrijNFjNju0UWAWpkO7UATuVNt0-Vpi6ZTGwpc-ZpFkTjXKahWj4C0JNLHkOSZfDHlD3zkaNl47zOZMjOyXms8" style="margin-left: 1em; margin-right: 1em;"><img alt="" data-original-height="602" data-original-width="975" height="198" src="https://blogger.googleusercontent.com/img/a/AVvXsEh3_VAfINId58e4bQnJh6FnWflbwGgetMtVpId1jzfHy0pQ-6k11_nbnrYRZ3dabnxJLc_UtX1nUEMRwb_MUxVcU3lPrjJlajehGxXNOWrijNFjNju0UWAWpkO7UATuVNt0-Vpi6ZTGwpc-ZpFkTjXKahWj4C0JNLHkOSZfDHlD3zkaNl47zOZMjOyXms8" width="320" /></a></div></span>
<p align="center" class="CannaMasterApplicationHeader3" style="text-align: center;"><a name="_Toc139289666"><span style="background: white; mso-fareast-font-family: "Times New Roman";">Pro Forma Plans</span></a><span style="background: white;"><o:p></o:p></span></p>
<p class="MsoNormal"><o:p> </o:p></p>
<p class="MsoNormal"><a name="_Toc139013984"></a><a name="_Toc139013930"><span style="mso-bookmark: _Toc139013984;"><b style="mso-bidi-font-weight: normal;"><span style="background: white; font-size: 14.0pt; mso-no-proof: yes;"><v:shape id="Picture_x0020_6" o:spid="_x0000_i1034" style="height: 315.75pt; mso-wrap-style: square; visibility: visible; width: 468pt;" type="#_x0000_t75">
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</v:imagedata></v:shape></span></b></span></a><span style="mso-bookmark: _Toc139013984;"></span><span style="mso-bookmark: _Toc139013930;"></span><b><span style="background: white; font-size: 14.0pt;"><o:p></o:p></span></b></p>
<p class="MsoNormal"><a name="_Toc139013985"></a><a name="_Toc139013931"><span style="mso-bookmark: _Toc139013985;"><b style="mso-bidi-font-weight: normal;"><span style="background: white; font-size: 14.0pt; mso-no-proof: yes;"><v:shape id="Picture_x0020_7" o:spid="_x0000_i1033" style="height: 288.75pt; mso-wrap-style: square; visibility: visible; width: 468pt;" type="#_x0000_t75">
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</v:imagedata></v:shape></span></b></span></a><span style="mso-bookmark: _Toc139013985;"></span><span style="mso-bookmark: _Toc139013931;"></span><b><span style="background: white; font-size: 14.0pt;"><o:p></o:p></span></b></p>
<p align="center" class="CannaMasterApplicationHeader3" style="text-align: center;"><a name="_Toc139289667">Business Start Up Cost</a><o:p></o:p></p>
<p class="Normal0" style="line-height: normal; text-indent: 0in;"><span style="color: black; mso-themecolor: text1;"><o:p> </o:p></span></p>
<p align="center" class="Normal0" style="line-height: normal; text-align: center;"><span style="mso-no-proof: yes;"><v:shape id="_x0000_i1032" style="height: 414.75pt; mso-wrap-style: square; visibility: visible; width: 373.5pt;" type="#_x0000_t75">
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<p class="Normal0" style="line-height: normal;"><span style="color: black; mso-themecolor: text1;"><o:p> </o:p></span></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/a/AVvXsEhnK-uin0blQoXoXp6MOS8McPYPPCiW7v4TC8LOfWkXWH4A7-X-uOGtkuAcqem4GPv0k5laPf-ETBg4iNm7Rai3u_9Kt0CFxDocMiHhKmfLLXIxuaSas5plt3izWhryZyZFrw-fE3IQhT6MRCToAJ6rBuXrs1qYeTbkHfqquRRVKxHwJnFMPQN3kdoBuOA" style="margin-left: 1em; margin-right: 1em;"><img alt="" data-original-height="864" data-original-width="778" height="390" src="https://blogger.googleusercontent.com/img/a/AVvXsEhnK-uin0blQoXoXp6MOS8McPYPPCiW7v4TC8LOfWkXWH4A7-X-uOGtkuAcqem4GPv0k5laPf-ETBg4iNm7Rai3u_9Kt0CFxDocMiHhKmfLLXIxuaSas5plt3izWhryZyZFrw-fE3IQhT6MRCToAJ6rBuXrs1qYeTbkHfqquRRVKxHwJnFMPQN3kdoBuOA=w351-h390" width="351" /></a></div><p></p>
<p class="CannaMasterApplicationHeader2"><a name="_Toc139289668"><span style="background: white;"><b>Overview for Phase Two</b></span></a><span style="background: white;"><o:p></o:p></span></p>
<p class="MsoNormal">With proceeds from the operating business our team intends
on utilizing all 150,000 square feet of licensed cultivation canopy. An
additional 50,000 square feet of high-tech greenhouses will be installed on the
existing property. Additionally, we will expand to the property that we
acquired with initial startup funds in order to build 87,000 of outdoor
cultivation canopy, which be utilized for the creation of low-cost biomass for
specialty vape concentrates carts that will be sold by the gram.<span style="mso-spacerun: yes;"> </span>Below is an aerial image of 6 South
Industrial Drive where we intend to house the expansion. <o:p></o:p></p>
<p align="left" class="Normal0" style="line-height: normal; text-align: left;"><span style="background: white;"><o:p> </o:p></span></p><p align="left" class="Normal0" style="line-height: normal; text-align: left;"><span style="color: black; mso-themecolor: text1;"><o:p></o:p></span></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/a/AVvXsEi2bXBrG2Vbo1-o0lKevC3bTqwcGnIRU2s1nNllFwlMzmCzNYUFQl0Np2RrwtT3MVewbZytPHO0LaPPcTR46TFsxUc757sHf2dYYPsjiBSdeC3yRzU8bBO249Zpd0RmT4oRnme0SUfkF_w-JpYpPc3zRS5gs4LiTYS1DONWwFb7DDO6lXuqepmQ2E3ewRs" style="margin-left: 1em; margin-right: 1em;"><img alt="" data-original-height="459" data-original-width="255" height="240" src="https://blogger.googleusercontent.com/img/a/AVvXsEi2bXBrG2Vbo1-o0lKevC3bTqwcGnIRU2s1nNllFwlMzmCzNYUFQl0Np2RrwtT3MVewbZytPHO0LaPPcTR46TFsxUc757sHf2dYYPsjiBSdeC3yRzU8bBO249Zpd0RmT4oRnme0SUfkF_w-JpYpPc3zRS5gs4LiTYS1DONWwFb7DDO6lXuqepmQ2E3ewRs" width="133" /></a></div><p></p><p align="center" class="Normal0" style="line-height: normal; text-align: center;"><br /></p>
<p align="center" class="Normal0" style="line-height: normal; text-align: center;"><b><span style="color: black; font-size: 14.0pt; mso-themecolor: text1;"><o:p></o:p></span></b></p><div class="separator" style="clear: both; text-align: center;"><b><a href="https://blogger.googleusercontent.com/img/a/AVvXsEiiUTLy7KxRhe1s6oaLsuXS44bLcpLw8MNeLTSg6ccDnNRz6OTQPOeYP6BpkfA2935X6KZgZU14doG4vQp4fiXuFDP-Iw4D-0hNgFtmWFkVjkCxixrIWkuPnQ2WSNyJOhP4gmhDKTLOWIekyLTHmpESEpNZDbhgMz5C8Xp9Vp3CHLq0yj_yrLTswW7946s" style="margin-left: 1em; margin-right: 1em;"><img alt="" data-original-height="399" data-original-width="715" height="179" src="https://blogger.googleusercontent.com/img/a/AVvXsEiiUTLy7KxRhe1s6oaLsuXS44bLcpLw8MNeLTSg6ccDnNRz6OTQPOeYP6BpkfA2935X6KZgZU14doG4vQp4fiXuFDP-Iw4D-0hNgFtmWFkVjkCxixrIWkuPnQ2WSNyJOhP4gmhDKTLOWIekyLTHmpESEpNZDbhgMz5C8Xp9Vp3CHLq0yj_yrLTswW7946s" width="320" /></a></b></div><p></p><p align="left" class="MsoNormal" style="line-height: 107%; margin-bottom: 8.0pt; text-align: left; text-indent: 0in;"><br /></p>
<p class="CannaMasterApplicationHeader2"><a name="_Toc139289669"><b>Market Analysis</b></a><o:p></o:p></p>
<p class="CannaMasterApplicationHeader4" style="line-height: normal;"><span style="font-style: normal; mso-bidi-font-family: "Times New Roman"; mso-bidi-font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"><span style="mso-spacerun: yes;"> </span>The US cannabis industry grew by more than
23% in 2020, most of which was in adult-use markets. In the past few years, the
population of New Jersey has experienced rapid growth. We will capitalize on
both of these points by obtaining a cultivation license at the onset of
adult-use legalization, which is expected to generate over $1 billion in annual
revenue. The 2017 National Survey on Drug Use and Health, commissioned by a
branch of the US Department of Health and Human Services, found that 2.5% of
adult respondents were daily or almost daily cannabis users, nearly 8% had used
cannabis within the past month, and 15% had used cannabis within the past year.</span></p>
<p class="CannaMasterApplicationHeader4" style="line-height: normal;"><span style="font-style: normal; mso-bidi-font-family: "Times New Roman"; mso-bidi-font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">Assuming these
national figures hold true at the state level, New Jersey contains nearly 250
thousand daily cannabis users, 769 thousand additional monthly users, and over
1.3 million annual users (not inclusive of monthly and daily users). From the
analysis of survey data on the consumption habits of cannabis users, the most
recent studies indicate heavy non-medical users consume an average of 1.3-1.9
grams per day of cannabis flower. Our market analysis assumes a convergence to
a daily consumption rate significantly below this range in establishing an
eventual market size estimate.</span></p>
<p class="CannaMasterApplicationHeader4" style="line-height: normal;"><span style="font-style: normal; mso-bidi-font-family: "Times New Roman"; mso-bidi-font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">As the number of
cannabis users in the population increases, the number of infrequent consumers
will increase, which will lower the average demand per adult cannabis consumer.
An examination of Colorado’s relatively mature adult-use statistics for
baseline market measurements is enlightening. In 2017, with a population of
5,700,000, Colorado realized sales of 55,437 pounds of cannabis per month. This
translates to a per capita consumption level of 1.867 ounces per year, or 0.156
ounces per month. In order to be conservative, we have estimated New Jersey's
consumption levels to be half of this rate, i.e., t0.0778 ounces per capita per
month (less than one tenth of one gram per day). As the market matures, we
assume that per capita demand per month will increase significantly. This
implies a monthly statewide demand of 777,689 ounces by the end of the first
year of the program.</span></p>
<p class="CannaMasterApplicationHeader4" style="line-height: normal;"><span style="font-style: normal; mso-bidi-font-family: "Times New Roman"; mso-bidi-font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">With the initial
licensing of only 37 cultivation centers, we expect to produce at least 21,000
ounces of cannabis annually to meet state needs. Even while building in
conservative practices at multiple levels of our market analysis, these estimates
suggest an extremely healthy market outlook for our proposed cultivation
business. We believe that the demand for adult-use cannabis in New Jersey will
support a competitive market for many years to come. Many adult-use states like
Colorado and California rely heavily on national and international tourism to
provide a consistent source of revenue. Additionally, our state welcomes an
average of 100 million tourist annually, according to the New Jersey Economist
Division.</span></p>
<p align="left" class="MsoNormal" style="text-align: left;"><b>Company Documents:</b><span style="text-align: center;"> </span></p>
<p align="center" class="CannaMasterApplicationHeader3" style="text-align: center;"><a name="_Toc139289670">Resolution from City of Bridgeton</a></p><p class="CannaMasterApplicationHeader4" style="line-height: normal;"><span style="font-style: normal; mso-bidi-font-family: "Times New Roman"; mso-bidi-font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/a/AVvXsEgZhOSXkuHqz0WzKoCeqiDCRh2AEwFGky126zmLsL57if6jXYEkJd5qyo46eI_Cmnx5sB4thO7VSr14L3gofA4XEbVv9W8axU0fJrOwGbb48sA5cy6gjP2fVo2w9nN2h519xUIPQcj1r0-Bft6jjAtR96lGSOe_85dQYS0_eySYUOluBql4SY2N-_1RRXU" style="margin-left: 1em; margin-right: 1em;"><img alt="" data-original-height="1037" data-original-width="945" height="552" src="https://blogger.googleusercontent.com/img/a/AVvXsEgZhOSXkuHqz0WzKoCeqiDCRh2AEwFGky126zmLsL57if6jXYEkJd5qyo46eI_Cmnx5sB4thO7VSr14L3gofA4XEbVv9W8axU0fJrOwGbb48sA5cy6gjP2fVo2w9nN2h519xUIPQcj1r0-Bft6jjAtR96lGSOe_85dQYS0_eySYUOluBql4SY2N-_1RRXU=w504-h552" width="504" /></a></div><p></p>
<p align="center" class="CannaMasterApplicationHeader3" style="text-align: center;"><a name="_Toc139289671">Letter of Support from City of Bridgeton</a></p>
<p align="center" class="MsoNormal" style="text-align: center;"><b><span style="font-size: 14.0pt;"><span style="mso-spacerun: yes;"></span></span></b></p><div class="separator" style="clear: both; text-align: center;"><b><a href="https://blogger.googleusercontent.com/img/a/AVvXsEjFeHAnN7gL-Dd0vTsaDUBktukiIdLM3VCCUwAzlDMSYrBrTIRHxj-ItUJRxvQYIjMj8rg7jyMS8qLxEwyESuXnSpoAgwgh-UdEK-zKFbmWXCyXRJLgl0IQM4Ss2VAVyVB7Co5TCUJfC-PSIhwStfO-CMxDQ1qZdjKYIL-E4Vnw3F6qE8nlp1qvvtFnHKA" style="margin-left: 1em; margin-right: 1em;"><img alt="" data-original-height="1015" data-original-width="975" height="511" src="https://blogger.googleusercontent.com/img/a/AVvXsEjFeHAnN7gL-Dd0vTsaDUBktukiIdLM3VCCUwAzlDMSYrBrTIRHxj-ItUJRxvQYIjMj8rg7jyMS8qLxEwyESuXnSpoAgwgh-UdEK-zKFbmWXCyXRJLgl0IQM4Ss2VAVyVB7Co5TCUJfC-PSIhwStfO-CMxDQ1qZdjKYIL-E4Vnw3F6qE8nlp1qvvtFnHKA=w491-h511" width="491" /></a></b></div><p></p>
<p align="center" class="CannaMasterApplicationHeader3" style="text-align: center;"><a name="_Toc139289672">Approval for Cultivation License</a><o:p></o:p></p>
<p align="center" class="MsoNormal" style="text-align: center;"><b><span style="font-size: 14.0pt;"><o:p> </o:p></span></b><a href="https://blogger.googleusercontent.com/img/a/AVvXsEgLzC_R6IVQjqRYr4v5MePktjgmRX9HoIgj4ySAKy_FsFI0c8PTwOh4hFmu3pMwvXYoQ3UmGI3p88i0Hwm4Qfsu7cMVr1rSq6OTa23b1JteivzioZ7PdW_9T2qDT_46pvEnc5swWIkCSmJfR85YLvlabIUl_1bkEadAEZO8lRNz43JTPFlEInRExrJjHok" style="font-size: 14pt; font-weight: bold; margin-left: 1em; margin-right: 1em;"><img alt="" data-original-height="938" data-original-width="911" height="375" src="https://blogger.googleusercontent.com/img/a/AVvXsEgLzC_R6IVQjqRYr4v5MePktjgmRX9HoIgj4ySAKy_FsFI0c8PTwOh4hFmu3pMwvXYoQ3UmGI3p88i0Hwm4Qfsu7cMVr1rSq6OTa23b1JteivzioZ7PdW_9T2qDT_46pvEnc5swWIkCSmJfR85YLvlabIUl_1bkEadAEZO8lRNz43JTPFlEInRExrJjHok=w364-h375" width="364" /></a></p>
<p align="center" class="CannaMasterApplicationHeader3" style="text-align: center;"><a name="_Toc139289673">Approval for Manufacturing License</a></p>
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<p align="center" class="MsoNormal" style="text-align: center;"><b><span style="font-size: 14.0pt;"><o:p></o:p></span></b></p><div class="separator" style="clear: both; text-align: center;"><b><a href="https://blogger.googleusercontent.com/img/a/AVvXsEjsWeZIAIRaweEOZ6cS6OI73vOxIZOKNquYtIovJrAozK4LK8uj8jOGTgYOsXIJoCyH-YVU4TCYbPTfzD8thbpDhh363Bey_vGpDeHByzd2exZIxhPCAj7IeRc-MeEhIiHO1uBc-mXYLEJBeZRO0tupAUjOim8SXEQOP3coIe7z6G7huFYECRFBzv3rDHw" style="margin-left: 1em; margin-right: 1em;"><img alt="" data-original-height="938" data-original-width="909" height="402" src="https://blogger.googleusercontent.com/img/a/AVvXsEjsWeZIAIRaweEOZ6cS6OI73vOxIZOKNquYtIovJrAozK4LK8uj8jOGTgYOsXIJoCyH-YVU4TCYbPTfzD8thbpDhh363Bey_vGpDeHByzd2exZIxhPCAj7IeRc-MeEhIiHO1uBc-mXYLEJBeZRO0tupAUjOim8SXEQOP3coIe7z6G7huFYECRFBzv3rDHw=w390-h402" width="390" /></a></b></div><br /><p></p>
<p align="center" class="CannaMasterApplicationHeader3" style="text-align: center;"><a name="_Toc139289674">Pro Forma Balance Sheet</a></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/a/AVvXsEhqMa1NfipQAAwHFaUjmeFaNNGBt1cJccuUTMuWl9EEskXWaAQnNFGLosrutCxht6qHKkLR9ymdys3HrY9lluDf96AZTkbMgGwkexfAdqCaaYiayU8gLSlhwte7OYleukD4UwzOoYn8G2w7uTeW-K3Tp3bxg-IePZCpiQFx5xfTKwdSiaEwfadRpZs0EK8" style="margin-left: 1em; margin-right: 1em;"><img alt="" data-original-height="735" data-original-width="975" height="358" src="https://blogger.googleusercontent.com/img/a/AVvXsEhqMa1NfipQAAwHFaUjmeFaNNGBt1cJccuUTMuWl9EEskXWaAQnNFGLosrutCxht6qHKkLR9ymdys3HrY9lluDf96AZTkbMgGwkexfAdqCaaYiayU8gLSlhwte7OYleukD4UwzOoYn8G2w7uTeW-K3Tp3bxg-IePZCpiQFx5xfTKwdSiaEwfadRpZs0EK8=w475-h358" width="475" /></a></div><br /><p></p>
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<div style="mso-element: footnote-list;"><!--[if !supportFootnotes]--><br clear="all" />
<hr align="left" size="1" width="33%" />
<!--[endif]-->
<div id="ftn1" style="mso-element: footnote;">
<p class="MsoFootnoteText"><a href="file:///C:/Users/Ralph/Documents/CannabisBiz/Symphony%20-%20Business%20and%20Financial%20Plan.2.docx#_ftnref1" name="_ftn1" style="mso-footnote-id: ftn1;" title=""><span class="MsoFootnoteReference"><span style="mso-special-character: footnote;"><!--[if !supportFootnotes]--><span class="MsoFootnoteReference"><span style="font-family: "Times New Roman","serif"; font-size: 10.0pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US; mso-fareast-theme-font: minor-latin;">[1]</span></span><!--[endif]--></span></span></a>
Arcview Market Research/BDS Analytics, <i>The State of Legal Cannabis Markets</i>,
6<sup>th</sup> Edition (2019 Update).<o:p></o:p></p>
</div>
<div id="ftn2" style="mso-element: footnote;">
<p class="MsoFootnoteText"><a href="file:///C:/Users/Ralph/Documents/CannabisBiz/Symphony%20-%20Business%20and%20Financial%20Plan.2.docx#_ftnref2" name="_ftn2" style="mso-footnote-id: ftn2;" title=""><span class="MsoFootnoteReference"><span style="mso-special-character: footnote;"><!--[if !supportFootnotes]--><span class="MsoFootnoteReference"><span style="font-family: "Times New Roman","serif"; font-size: 10.0pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US; mso-fareast-theme-font: minor-latin;">[2]</span></span><!--[endif]--></span></span></a>
Arcview Market Research/BDSA, <i>The State of Legal Cannabis Markets</i>, 8<sup>th</sup>
Edition (2020 Update).<o:p></o:p></p>
<p class="MsoFootnoteText"><o:p> </o:p></p>
</div>
</div>Health Freedom of Choice Bloghttp://www.blogger.com/profile/15606420362458868870noreply@blogger.comtag:blogger.com,1999:blog-1111124027441239439.post-80428575662441639832022-11-11T07:29:00.001-08:002022-11-11T07:43:17.443-08:00November 2022 Newsletter: Free Export Guidance<p> </p><table border="0" cellpadding="0" cellspacing="0" role="presentation" style="border-collapse: collapse; color: black; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td align="center" class="mceSpacing-24" style="padding: 12px 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><img alt="Logo" src="https://dim.mcusercontent.com/cs/b90078d41a788bb042d5af1db/images/02a6819f-4583-4c74-8f34-5d5e0c4f6c05.jpg?w=453&dpr=2" style="border: 0px; display: block; height: auto; max-width: 100%; outline: none; width: 453.219px;" width="453.21945137157104" /></td></tr><tr><td class="mceSpacing-24" style="padding: 12px 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div class="mceText" style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; width: 612px;"><h1 style="font-size: 31px; margin: 0px 0px 24px; padding: 0px;"><span style="color: #ff0909;">FDA Free Export Guidance</span></h1><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong><span style="font-size: 12px;">The FDA has provided a formal Guidance on the exporting of products not approved for use in the USA. That Guidance begins:</span></strong></p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><span style="font-size: 11px;">“This guidance document summarizes and explains the basic requirements and procedures under the FDA Export Reform and Enhancement Act of 1996 (Public Law 104-134, as amended by Public Law 104-180) for exporting human drugs, animal drugs, biological products, devices, food, food additives, color additives, and dietary supplements that may not be sold or distributed in the United States.”</span></p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><span style="font-size: 12px;">A Review of the Guidance strongly suggests that FDA allows the broadest export authority without prior FDA approval. The Summary Chart provides for export under Section 801(e)(1).</span></p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><span style="font-size: 12px;">Page 18 of the Guidance sets out the 801 requirements:</span></p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><span style="font-size: 11px;">“Section 801(e)(1) of the Act states that a food, drug, device, or cosmetic intended for export shall not be deemed to be adulterated or misbranded if the article: • Accords to the specifications of the foreign purchaser; • Is not in conflict with the laws of the country to which it is intended for export; • Is labeled on the outside of the shipping package that it is intended for export; and • Is not sold or offered for sale in domestic commerce.”</span></p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong><span style="font-size: 12px;">Conclusion: A company relying on 801 has to maintain records of the transaction showing compliance with the above provisions and provide the records to the FDA in the event of an inspection. There is no pre-export filing required.</span></strong></p><p class="last-child" style="margin: 0px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><span style="font-size: 11px;">https://www.fda.gov/media/138075/download</span></p></div></td></tr><tr><td class="mceSpacing-24" style="padding: 20px 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><table border="0" cellpadding="0" cellspacing="0" role="presentation" style="border-collapse: collapse; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td style="border-top: 2px solid rgb(0, 0, 0); min-width: 100%; text-size-adjust: 100%; word-break: break-word;" valign="top"></td></tr></tbody></table></td></tr><tr><td class="mceSpacing-24" style="padding: 12px 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div class="mceText" style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; width: 612px;"><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong><span style="color: #fe0606;"><span style="font-size: 20px;">CHRONO CREATIONS</span></span></strong></p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">MY SON DREW FUCETOLA IS TAKING ON A FEW NEW CLIENTS FOR HIS COMPUTER CONTROL SYSTEM CONSULTING FIRM. FREE ANALYSIS OF YOUR PROCESSING SYSTEMS. GET THE MOST UPDATED APPS AVAILABLE!</p><p class="last-child" style="margin: 0px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">Contact me at ralph.fucetola@gmail.com with ‘Chrono’ in the subject line.</p></div></td></tr><tr><td class="mceSpacing-24" style="padding: 20px 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><table border="0" cellpadding="0" cellspacing="0" role="presentation" style="border-collapse: collapse; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td style="border-top: 2px solid rgb(0, 0, 0); min-width: 100%; text-size-adjust: 100%; word-break: break-word;" valign="top"></td></tr></tbody></table></td></tr><tr><td class="mceSpacing-24" style="padding: 12px 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div class="mceText" style="width: 612px;"><p style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong><span style="color: #f80707;"><span style="font-size: 22px;">ERC: EMPLOYEE RETENTION CREDIT</span></span></strong></p><p style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>Have you seen the TV ads for this multi-billion dollar program? Get some of your taxes back…</strong></p><p style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">How to Apply for the Employee Retention Credit (ERC) Under the CARES Act</p><p style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">[These 70% Retention Credits are in addition to any PPP loans and are a free grant, no payback. Available to small businesses up to 499 employees.]</p><p style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">1) Watch the 5 minute ERC video with this link:</p><p style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><a href="https://www.jornscpa.com/snap/?refid=11450617" style="color: black; text-size-adjust: 100%; word-break: break-word;" target="_blank">https://www.jornscpa.com/snap/?refid=11450617</a></p><p style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">2) Click on "See If You Qualify" to submit contact info to the Accounting Firm.</p><p style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">3) If qualified and if Company wants to apply, sign the Engagement Letter.</p><p class="last-child" style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; margin: 0px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">4) If you have further questions, I can set up a call with the Jorns Firm to get questions answered before sign up.</p><p class="last-child" style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; margin: 0px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><br /></p><p class="last-child" style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; margin: 0px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">-------------------------------------</p><p class="last-child" style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; margin: 0px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">Vitamin Consultancy Archive Link:</p><p class="last-child" style="margin: 0px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><span style="font-family: Helvetica Neue, Helvetica, Arial, Verdana, sans-serif;"><a href="https://us14.campaign-archive.com/home/?u=b90078d41a788bb042d5af1db&id=5487712bce">https://us14.campaign-archive.com/home/?u=b90078d41a788bb042d5af1db&id=5487712bce</a></span></p></div></td></tr></tbody></table>Health Freedom of Choice Bloghttp://www.blogger.com/profile/15606420362458868870noreply@blogger.com0tag:blogger.com,1999:blog-1111124027441239439.post-51351416152870763842022-06-08T07:31:00.006-07:002022-11-11T07:35:54.937-08:00Durbin Bill and DSHEA<p> </p><table border="0" cellpadding="0" cellspacing="0" role="presentation" style="border-collapse: collapse; color: black; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td class="mceSpacing-24" style="padding: 12px 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div class="mceText" style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; text-align: center; width: 612px;"><p class="last-child" style="margin: 0px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><a href="https://mailchi.mp/b1ae4a8ae7de/new-threat-to-dshea?e=[UNIQID]" style="color: black; text-size-adjust: 100%; word-break: break-word;">View this email in your browser</a></p></div></td></tr><tr><td align="center" class="mceSpacing-24" style="padding: 12px 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><img alt="Logo" src="https://dim.mcusercontent.com/cs/b90078d41a788bb042d5af1db/images/02a6819f-4583-4c74-8f34-5d5e0c4f6c05.jpg?w=262&dpr=2" style="border: 0px; display: block; height: auto; max-width: 100%; outline: none; width: 262.219px;" width="262.2194513715711" /></td></tr><tr><td class="mceSpacing-24" style="padding: 12px 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div class="mceText" style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; width: 612px;"><h1 style="font-size: 31.248px; margin: 0px 0px 24px; padding: 0px;"><span style="font-size: 21px;">Durbin and Braun Bill<br />Seeks to Register All DSHEA Products<br />DIETARY SUPPLEMENT FALSE ‘TRANSPARENCY’ BILL<br />ACT HERE NOW: </span><a href="https://inhere.salsalabs.org/DurbinDSBill" style="color: black; text-size-adjust: 100%; word-break: break-word;" target="_blank"><span style="color: #686868;"><span style="font-size: 21px;">https://inhere.salsalabs.org/DurbinDSBill</span></span></a></h1><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>Senators Durbin and Braun have issued a Media Release proposing further legislative restrictions on the availability of dietary supplements.</strong></p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">The bill has the innocuous sounding title of <em>The Dietary Supplement Listing Act of 2022</em>. Since Sen. Durbin is the current Majority Whip the bill stands a good chance of passing before the upcoming congressional election.</p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">In the Release Sen. Durbin admitted, “Seventy percent of people in America take a dietary supplement including me.”</p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">The proposal is to have all dietary supplements ‘registered’ with the Food and Drug Administration (FDA) because, the Senators imply, since Congress unanimously passed the <em>Dietary Supplement Health and Education Act of 1994</em> (DSHEA) the number of dietary supplement products available to the public has increased from about 4,000 to an estimated 80,000.</p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>We reject the authoritarian notion that, because Americans want nutrients and therefore nutrient companies are successful, they ought to be further regulated and restricted.</strong></p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">Unlike pharmaceutical drugs which, even when used according to prescription, may kill over 500,000 Americans annually there are virtually no adverse reactions reported for dietary supplements. There is no public health reason to register nutrients which are foods deemed safe when used as directed.</p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">If there were to be a serious adverse reaction to a nutrient the current law requires notification to FDA. Additionally dietary supplement marketers are already required to notify FDA regarding each claim made for each dietary supplement within 30 days of making the claim. Further, all manufacturers of dietary supplements must register with FDA as food processing facilities.</p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>The Senators are wrong to imply that FDA needs additional power to “regulate” supplements.</strong></p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">Since there is no compelling reason to add another layer of registration and notification above those that already exist, and such registration will be an additional burden on especially smaller companies, the Durbin/Braun proposal should be rejected.</p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>The Bill is just another power grab to limit access to the market and availability of affordable nutrients.</strong></p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">We have initiated a campaign to educate supplement users regarding the Durbin/Braun proposal, providing the public with an easy “Action Item” through the system that operates the Natural Solution email list. The goal is for the Action Item to ‘go viral and flood the White House and each individual’s Senators and Member of Congress with our concerns.</p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>HERE IS THE LINK TO THE ACTION ITEM</strong><br /><a href="https://inhere.salsalabs.org/DurbinDSBill" style="color: black; text-size-adjust: 100%; word-break: break-word;" target="_blank"><span style="color: #686868;">https://inhere.salsalabs.org/DurbinDSBill</span></a></p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>Share with all your circles of influence and act now or </strong><em><strong>your</strong></em><strong> access to nutrients will be at risk.</strong></p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">Share with this link: <a href="http://www.opensourcetruth.com/stop-durbin-braun-vitamin-registration-bill/" style="color: black; text-size-adjust: 100%; word-break: break-word;" target="_blank"><span style="color: #686868;">http://www.opensourcetruth.com/stop-durbin-braun-vitamin-registration-bill/</span></a></p><p class="last-child" style="margin: 0px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">Support this campaign here: <a href="https://fundly.com/support-natural-therapies" style="color: black; text-size-adjust: 100%; word-break: break-word;" target="_blank"><span style="color: #686868;">https://fundly.com/support-natural-therapies</span></a></p></div></td></tr></tbody></table>Health Freedom of Choice Bloghttp://www.blogger.com/profile/15606420362458868870noreply@blogger.com0tag:blogger.com,1999:blog-1111124027441239439.post-65944797795444125002022-03-25T07:34:00.003-07:002022-11-11T07:35:35.503-08:00March 2022 Newsletter: Useful Links<p> </p><table border="0" cellpadding="0" cellspacing="0" role="presentation" style="border-collapse: collapse; color: black; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td class="mceSpacing-24" id="mceColumnContainer" style="padding: 12px 48px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div class="mceText" style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; text-align: center; width: 564px;"><p class="last-child" style="margin: 0px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><a href="https://mailchi.mp/381070c12675/vitamin-consultancy-updates?e=[UNIQID]" style="color: black; text-size-adjust: 100%; word-break: break-word;">View this email in your browser</a></p></div></td></tr><tr><td align="center" class="mceSpacing-24" id="mceColumnContainer" style="padding: 32px 48px; text-size-adjust: 100%; word-break: break-word;" valign="top"><img alt="Logo" src="https://dim.mcusercontent.com/cs/b90078d41a788bb042d5af1db/images/02a6819f-4583-4c74-8f34-5d5e0c4f6c05.jpg?w=262&dpr=2" style="border: 0px; display: block; height: auto; max-width: 100%; outline: none; width: 262.219px;" width="262.2194513715711" /></td></tr><tr><td class="mceSpacing-24" id="mceColumnContainer" style="padding: 12px 48px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div class="mceText" style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; text-align: center; width: 564px;"><h1 style="font-size: 31.248px; margin: 0px 0px 24px; padding: 0px;">The Vitamin Consultancy Newsletter</h1><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>This is my first newsletter since December 2021, so I’m sending you some important links with information to impact your bottom line.</strong></p><p class="last-child" style="margin: 0px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><em>Regards, Ralph…</em></p></div></td></tr><tr><td class="mceSpacing-24" id="mceColumnContainer" style="padding: 12px 48px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div class="mceText" style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; width: 564px;"><p class="last-child" style="margin: 0px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">I continue to offer consulting services through <a href="http://www.vitaminconsultancy.com/" style="color: black; text-size-adjust: 100%; word-break: break-word;">www.VitaminConsultancy.com </a>and <a href="http://www.systemsprocessingintegration.com/" style="color: black; text-size-adjust: 100%; word-break: break-word;">www.SystemsProcessingIntegration.com</a> — Mention the Vitamin Consultancy Newsletter and I’ll give you ten percent off any invoice during April, the month when I am acknowledging my 77th birthday.</p></div></td></tr><tr><td class="mceSpacing-24" id="mceColumnContainer" style="padding: 12px 48px; text-size-adjust: 100%; word-break: break-word;" valign="top"><table border="0" cellpadding="0" cellspacing="0" role="presentation" style="border-collapse: collapse; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td style="border-top: 2px solid rgb(0, 0, 0); min-width: 100%; text-size-adjust: 100%; word-break: break-word;" valign="top"></td></tr></tbody></table></td></tr><tr><td class="mceSpacing-24" id="mceColumnContainer" style="padding: 12px 48px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div class="mceText" style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; width: 564px;"><p class="last-child" style="margin: 0px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">Ann and Bill Chaisson, with whom I have worked since the late 1960s have a new web site for their beautiful .925 silver Sons and Daughters of Liberty medallions. I proudly wear my SoL medallion, which only gains value over time. <a href="https://www.libertyhillpatriots.com/productss" style="color: black; text-size-adjust: 100%; word-break: break-word;">https://www.libertyhillpatriots.com/productss</a></p></div></td></tr><tr><td align="center" class="mceSpacing-24" id="mceColumnContainer" style="padding: 12px 48px; text-size-adjust: 100%; word-break: break-word;" valign="top"><img alt="" role="presentation" src="https://dim.mcusercontent.com/cs/b90078d41a788bb042d5af1db/images/3a208944-28be-1c50-355d-fe395e35222b.jpg?w=564&dpr=2" style="border: 0px; display: block; height: auto; max-width: 100%; outline: none; width: 564px;" width="564" /></td></tr><tr><td align="center" class="mceSpacing-24" id="mceColumnContainer" style="padding: 12px 48px; text-size-adjust: 100%; word-break: break-word;" valign="top"><table align="center" border="0" cellpadding="0" cellspacing="0" role="presentation" style="border-collapse: collapse; text-size-adjust: 100%;"><tbody><tr><td class="mceButton" style="background-color: #bf1717; border-radius: 50px; text-align: center; text-size-adjust: 100%; word-break: break-word;" valign="top"><a href="https://www.libertyhillpatriots.com/productss" style="border-radius: 50px; border: 2px solid rgb(191, 23, 23); color: white; display: inline-block; font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; min-width: 30px; padding: 16px 28px; text-decoration-line: none; text-size-adjust: 100%; word-break: break-word;" target="_blank">Shop Here</a></td></tr></tbody></table></td></tr><tr><td class="mceSpacing-24" id="mceColumnContainer" style="padding: 12px 48px; text-size-adjust: 100%; word-break: break-word;" valign="top"><table border="0" cellpadding="0" cellspacing="0" role="presentation" style="border-collapse: collapse; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td style="border-top: 2px solid rgb(0, 0, 0); min-width: 100%; text-size-adjust: 100%; word-break: break-word;" valign="top"></td></tr></tbody></table></td></tr><tr><td align="center" class="mceSpacing-24" id="mceColumnContainer" style="padding: 12px 0px; text-size-adjust: 100%; word-break: break-word;" valign="top"><img alt="" role="presentation" src="https://dim.mcusercontent.com/cs/b90078d41a788bb042d5af1db/images/d2a9399c-92e9-9766-9080-34acd2cb84bb.jpg?w=223&dpr=2" style="border: 0px; display: block; height: auto; max-width: 100%; outline: none; width: 223px;" width="223" /></td></tr><tr><td class="mceSpacing-24" id="mceColumnContainer" style="padding: 12px 48px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div class="mceText" style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; width: 564px;"><h1 style="font-size: 31.248px; margin: 0px 0px 24px; padding: 0px;"><span style="font-size: 29px;">You Need Drew’s IT Networking Skills!</span></h1><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">My son Drew, after three years running the IT network for an expanding Dallas warehouse distribution system (now about one million square feet), is working with his wife Sophie as office manager, to establish his own consulting practice, <a href="https://www.chronocreation.com/" style="color: black; text-size-adjust: 100%; word-break: break-word;">www.ChronoCreation.com</a></p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>Chrono Creation Systems is </strong><em><strong>the company that creates time for you</strong></em><strong>… and, time is money, so your bottom line </strong><em><strong>always</strong></em><strong> benefits more from Drew and Sophie’s services than you pay.</strong></p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><em><strong>Imagine that!</strong></em><strong></strong></p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">Contact them at: <a href="https://www.chronocreation.com/chronocreation/contact-us" style="color: black; text-size-adjust: 100%; word-break: break-word;">https://www.chronocreation.com/chronocreation/contact-us</a></p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">Here is what they do:</p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>Produce</strong> advanced integrative software to automate systems within your business, getting your systems to ‘talk’ to each other efficiently, to:</p><ul class="last-child" style="margin-bottom: 0px;"><li style="text-size-adjust: 100%;"><p style="margin-bottom: 0px; margin-left: 0px !important; margin-right: 0px !important; margin-top: 0px !important; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>Reduce</strong> employee workload and therefore employee time.</p></li><li style="text-size-adjust: 100%;"><p style="margin-bottom: 0px; margin-left: 0px !important; margin-right: 0px !important; margin-top: 0px !important; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>Create</strong> time for efficient productivity.</p></li><li style="text-size-adjust: 100%;"><p style="margin-bottom: 0px; margin-left: 0px !important; margin-right: 0px !important; margin-top: 0px !important; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>Provide</strong> satisfactory and personal customer support.</p></li><li style="text-size-adjust: 100%;"><p style="margin-bottom: 0px; margin-left: 0px !important; margin-right: 0px !important; margin-top: 0px !important; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>Unique</strong> software built specifically for your business needs.</p></li><li style="text-size-adjust: 100%;"><p style="margin-bottom: 0px; margin-left: 0px !important; margin-right: 0px !important; margin-top: 0px !important; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>Improve</strong> your bottom line.</p></li></ul></div></td></tr></tbody></table>Health Freedom of Choice Bloghttp://www.blogger.com/profile/15606420362458868870noreply@blogger.com0tag:blogger.com,1999:blog-1111124027441239439.post-28108784234950139472021-05-26T07:37:00.001-07:002022-11-11T07:39:15.838-08:00May 2021 Newsletter: Defining 'Healthy'<p> </p><table border="0" cellpadding="0" cellspacing="0" style="color: black; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td class="mceSpacing-24" style="padding-left: 48px; padding-right: 48px; padding-top: 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div class="mceText" style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; text-align: center; width: 564px;"><p class="last-child" style="margin: 0px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>Vitamin Consultancy May 2021 Newsletter</strong></p></div></td></tr><tr><td align="center" class="mceSpacing-24" style="padding-left: 48px; padding-right: 48px; padding-top: 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><img alt="Logo" src="https://dim.mcusercontent.com/cs/b90078d41a788bb042d5af1db/images/02a6819f-4583-4c74-8f34-5d5e0c4f6c05.jpg?w=262&dpr=2" style="border: 0px; height: auto; max-width: 100%; outline: none; width: 262.219px;" width="262.2194513715711" /></td></tr><tr><td class="mceSpacing-24" style="padding-left: 48px; padding-right: 48px; padding-top: 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div class="mceText" style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; width: 564px;"><h1 style="font-size: 31.248px; margin: 0px 0px 24px; padding: 0px;">Are Your Products “Healthy”?</h1><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>FDA posted the following Notice earlier this month.</strong></p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">The U.S. Food and Drug Administration is issuing a procedural notice on the preliminary quantitative consumer research it plans to conduct on symbols that could be used in the future to convey the nutrient content claim “healthy.” As part of the Paperwork Reduction Act, Federal agencies are required to publish notice in the Federal Register on each proposed information collection and to give the public the opportunity to comment.<br /><br />The FDA is conducting the research in conjunction with the development of a proposed rule the FDA intends to later publish that would update when manufacturers may use the “healthy’ nutrient content claim on food packages. The symbol would be a stylized representation of the nutrient content claim.<br /><br />The update to the definition and creation of a symbol for the “healthy” nutrient content claim are part of the FDA’s Nutrition Innovation Strategy (NIS). The NIS is intended to reduce the burden of nutrition-related chronic diseases, which are experienced at a disproportionately higher rate by communities of color. One of the elements of the NIS is to modernize claims, which serve as quick signals for consumers about what benefits a food or beverage they choose might have. Claims and symbols can also help consumers better understand nutrition information and can encourage companies to reformulate products to improve their nutritional value.<br /><br />The FDA is seeking comment on ways to enhance the quality, usefulness, and clarity of the information to be collected. Comments on the notice are due 60 days following publication in the <em>Federal Register</em>. Submit comments electronically to <a href="https://www.regulations.gov/" style="color: black; text-size-adjust: 100%; word-break: break-word;"><span style="color: #007cba;">https://www.regulations.gov</span></a>. Written comments should be addressed to: Dockets Management Staff (HFA-305) / Food and Drug Administration / 5630 Fishers Lane, Rm. 1061 - Rockville, MD 20852</p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">Please consider filing your suggestions with the FDA at the indicated link.</p><p class="last-child" style="margin: 0px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">Source: <a href="https://www.fda.gov/food/cfsan-constituent-updates/fda-issues-procedural-notice-consumer-research-healthy-symbol" style="color: black; text-size-adjust: 100%; word-break: break-word;">https://www.fda.gov/food/cfsan-constituent-updates/fda-issues-procedural-notice-consumer-research-healthy-symbol</a></p></div></td></tr><tr><td class="mceSpacing-24" style="padding-top: 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><table border="0" cellpadding="0" cellspacing="0" style="border-top: 20px solid transparent; margin-bottom: 0px; margin-top: 0px; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td style="min-width: 100%; text-size-adjust: 100%; word-break: break-word;" valign="top"></td></tr></tbody></table></td></tr><tr><td class="mceSpacing-24" style="padding-left: 48px; padding-right: 48px; padding-top: 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div class="mceText" style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; text-align: center; width: 564px;"><h1 style="font-size: 31.248px; margin: 0px 0px 24px; padding: 0px;">Vitamin Consultancy Services</h1><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>As your business gets ready for the end of the lockdowns you need to review your regulatory status. There are new rules… I am available to work with your company to make sure your SOPs and other procedures are up-to-date. Just give me a call! 973.300.4594</strong></p><p class="last-child" style="margin: 0px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>SPECIAL REOPENING RATES!<br /></strong><a href="http://www.systemsprocessingintegration.com/" style="color: black; text-size-adjust: 100%; word-break: break-word;"><strong>www.SystemsProcessingIntegration.com</strong></a></p></div></td></tr></tbody></table>Health Freedom of Choice Bloghttp://www.blogger.com/profile/15606420362458868870noreply@blogger.com0tag:blogger.com,1999:blog-1111124027441239439.post-5435115681629844832021-03-12T07:40:00.001-08:002022-11-11T07:42:04.239-08:00March 2021 Newsletter: Commercial Freedom Of Speech<p> </p><br /><p></p><table border="0" cellpadding="0" cellspacing="0" style="color: black; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td class="mceSpacing-24" style="padding-left: 48px; padding-right: 48px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div class="mceText" style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; text-align: center; width: 564px;"><p class="last-child" style="margin: 0px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"></p></div></td><td align="center" class="mceSpacing-24" style="padding-left: 48px; padding-right: 48px; text-size-adjust: 100%; word-break: break-word;" valign="top"><a href="http://systemsprocessingintegration.com/" style="display: inline-block; text-size-adjust: 100%; word-break: break-word;" target="_blank"><img alt="Systems Processing Integration" src="https://dim.mcusercontent.com/cs/b90078d41a788bb042d5af1db/images/02a6819f-4583-4c74-8f34-5d5e0c4f6c05.jpg?w=466&dpr=2" style="border: 0px; height: auto; max-width: 100%; outline: none; text-decoration-line: none; width: 466.219px;" width="466.21945137157104" /></a></td></tr><tr><td class="mceSpacing-24" style="padding-top: 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><table align="center" border="0" cellpadding="0" cellspacing="0" style="text-size-adjust: 100%; width: 100%px;"><tbody><tr><td class="mceSection" style="background-position: center center; background-repeat: no-repeat; background-size: cover; text-size-adjust: 100%; word-break: break-word;" valign="top"><table border="0" cellpadding="0" cellspacing="0" style="table-layout: fixed; text-size-adjust: 100%; width: 100%px;"><colgroup><col span="1"></col><col span="1"></col><col span="1"></col><col span="1"></col><col span="1"></col><col span="1"></col><col span="1"></col><col span="1"></col><col span="1"></col><col span="1"></col><col span="1"></col><col span="1"></col></colgroup><tbody><tr><td class="mceColumn" colspan="12" style="background-color: #e6e9f2; background-position: center center; background-repeat: no-repeat; background-size: cover; padding-bottom: 12px; padding-top: 12px; text-size-adjust: 100%; word-break: break-word;" valign="top" width="100%"><table border="0" cellpadding="0" cellspacing="0" style="text-size-adjust: 100%; width: 100%px;"><tbody><tr></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table></td></tr><tr><td class="mceSpacing-24" style="padding-left: 48px; padding-right: 48px; padding-top: 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div class="mceText" style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; text-align: center; width: 564px;"><h1 style="font-size: 31.248px; margin: 0px 0px 24px; padding: 0px;">Vitamin Consultancy Newsletter<br /><a href="http://www.vitaminconsultancy.com/" style="color: black; text-size-adjust: 100%; word-break: break-word;">www.VitaminConsultancy.com</a></h1><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>12 March 2021 — The Federal Appeals Court that serves the West Coast made a decision that supports commercial freedom of speech regarding dietary supplements. Reuters reports:</strong><br /><br /><em>A class action lawsuit accusing big box retailer Target Corp and nutritional supplement makers International Vitamin Corp and Perrigo Co of falsely marketing biotin, a nutritional supplement, as promoting healthy hair and skin is preempted by federal law, a federal appeals court has ruled.</em></p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><em>A unanimous panel of the 9th U.S. Circuit Court of Appeals held …that the claims made on the supplement’s label were protected by the federal Food, Drug and Cosmetic Act (FDCA) as general claims about the structure and function of biotin, and that the product included appropriate disclaimers, affirming a lower court order dismissing the case.</em></p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>What this means is that States like California cannot impose stricter “false advertising” rules than the Federal Government imposes.</strong> It means there is a national standard for claims. When general structure and function claims are made — with appropriate disclaimers — Federal law protects the claims.<br /><br />Isn’t it time for us to review your claims and make sure your disclaimers are in order? Just email me: <a href="mailto:ralph.fucetola@gmail.com" style="color: black; text-size-adjust: 100%; word-break: break-word;">ralph.fucetola@gmail.com</a> with “Review” in the subject line. Ten percent off my regular rates if you email your questions.</p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>While claims are the </strong><em><strong>key</strong></em><strong> for marketing natural products, including dietary supplements, careful consideration of claims is </strong><em><strong>not</strong></em><strong> enough to keep you in business.</strong></p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>Your processing system must be “in order” and, as FDA says, you “</strong><em><strong>must be in a state of control</strong></em><strong>” at all times.</strong></p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>My </strong><em><strong>SPI</strong></em><strong> System allows you to meet the state-of-the-market requirements for transparency and traceability. Please check out my </strong><a href="http://www.systemsprocessingintegration.com/" style="color: black; text-size-adjust: 100%; word-break: break-word;"><strong>www.SystemsProcessingIntegration.com</strong></a><strong> web site and let’s talk about what parts of the SPI System you can start to implement first.</strong></p><h3 class="last-child" style="font-size: 20px; margin: 0px; padding: 0px;">The sooner, the better… 973.300.4594</h3></div></td></tr><tr><td align="center" class="mceSpacing-24" style="padding-left: 48px; padding-right: 48px; padding-top: 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><a href="http://www.vitaminconsultancy.com/" style="display: inline-block; text-size-adjust: 100%; word-break: break-word;" target="_blank"><img alt="Notary Seal" src="https://dim.mcusercontent.com/cs/b90078d41a788bb042d5af1db/images/4375569b-9a95-42d4-93cb-0fc254a13850.jpg?w=269&dpr=2" style="border: 0px; height: auto; max-width: 100%; outline: none; text-decoration-line: none; width: 269px;" width="269" /></a></td></tr><tr><td class="mceSpacing-24" style="padding-top: 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><table border="0" cellpadding="0" cellspacing="0" style="border-top: 20px solid transparent; margin-bottom: 0px; margin-top: 0px; text-size-adjust: 100%; width: 100%px;"><tbody><tr></tr></tbody></table></td></tr></tbody></table>Health Freedom of Choice Bloghttp://www.blogger.com/profile/15606420362458868870noreply@blogger.com0tag:blogger.com,1999:blog-1111124027441239439.post-32777841121259269342021-01-20T09:29:00.001-08:002021-01-20T09:29:51.916-08:00January 20, 2021 Newsletter<p><br /></p><table border="0" cellpadding="0" cellspacing="0" style="color: black; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td class="mceSpacing-24" style="padding-left: 48px; padding-right: 48px; padding-top: 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div class="mceText" style="font-family: Arial, "Helvetica Neue", Helvetica, sans-serif; font-size: 16px; text-align: center; width: 564px;"><h2 class="last-child" style="font-family: "Playfair Display", Georgia, "Times New Roman", serif; font-size: 25.008px; margin: 0px; padding: 0px;">Vitamin Consultancy Newsletter<br /><a href="http://www.vitaminconsultancy.com/" style="color: #006c73; text-size-adjust: 100%; word-break: break-word;">www.VitaminConsultancy.com</a></h2></div></td></tr><tr><td align="center" class="mceSpacing-24" style="padding-left: 48px; padding-right: 48px; padding-top: 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><a href="http://www.systemsprocessingintegration.com/" style="display: inline-block; text-size-adjust: 100%; word-break: break-word;" target="_blank"><img alt="Logo" src="https://dim.mcusercontent.com/cs/b90078d41a788bb042d5af1db/images/02a6819f-4583-4c74-8f34-5d5e0c4f6c05.jpg?w=416&dpr=2" style="border: 0px; height: auto; max-width: 100%; outline: none; text-decoration-line: none; width: 416.219px;" width="416.2194513715711" /></a></td></tr><tr><td class="mceSpacing-24" style="padding-left: 48px; padding-right: 48px; padding-top: 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div class="mceText" style="font-family: Arial, "Helvetica Neue", Helvetica, sans-serif; font-size: 16px; width: 564px;"><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">While the declared “pandemic” has slowed bureaucracy to a crawl, one appeals court recently made a decision that supports commercial freedom of speech regarding dietary supplements. Reuters reports:<br /><br /><em>A class action lawsuit accusing big box retailer Target Corp and nutritional supplement makers International Vitamin Corp and Perrigo Co of falsely marketing biotin, a nutritional supplement, as promoting healthy hair and skin is preempted by federal law, a federal appeals court has ruled.</em></p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><em>A unanimous panel of the 9th U.S. Circuit Court of Appeals held Wednesday that the claims made on the supplement’s label were protected by the federal Food, Drug and Cosmetic Act (FDCA) as general claims about the structure and function of biotin, and that the product included appropriate disclaimers, affirming a lower court order dismissing the case.</em><br /></p><p class="last-child" style="margin: 0px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">What this means is that States like California cannot impose stricter “false advertising” rules than the Federal Government imposes. It means there is a national standard for claims. When general structure and function claims are made — with appropriate disclaimers — Federal law protects the claims.<br /><br /><strong>Isn’t it time for us to review your claims and make sure your disclaimers are in order? Just email me: ralph.fucetola@usa.net with “Review” in the subject line. Ten percent off my regular rates if you email your questions.</strong><br /></p></div></td></tr><tr><td align="center" class="mceSpacing-24" style="padding-left: 48px; padding-right: 48px; padding-top: 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><img alt="" role="presentation" src="https://dim.mcusercontent.com/cs/b90078d41a788bb042d5af1db/images/a8443988-8dce-44da-91bb-cc6c324ba84e.jpg?w=291&dpr=2" style="border: 0px; height: auto; max-width: 100%; outline: none; width: 291px;" width="291" /></td></tr><tr><td class="mceSpacing-24" style="padding-left: 48px; padding-right: 48px; padding-top: 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div class="mceText" style="font-family: Arial, "Helvetica Neue", Helvetica, sans-serif; font-size: 16px; text-align: center; width: 564px;"><h1 class="last-child" style="font-family: "Playfair Display", Georgia, "Times New Roman", serif; font-size: 31.248px; margin: 0px; padding: 0px;">Time to Try Some Crypto</h1></div></td></tr><tr><td class="mceSpacing-24" style="padding-left: 48px; padding-right: 48px; padding-top: 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div class="mceText" style="font-family: Arial, "Helvetica Neue", Helvetica, sans-serif; font-size: 16px; width: 564px;"><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">"The times they are a changing..." Never thought I'd see the Banana Republic spectacle of the new regime being installed in Washington, DC by 25,000 soldiers carefully vetted by the deep state, contrary to the actual electoral will of the people. Sad days coming -- the promised "dark winter."</p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>One thing for certain, the US dollar will evaporate as the artificial COVID boom pops. The Fed Debt is about to accelerate as the new regime tries to "stimulate" itself out of the disaster. Where to go for protection? Maybe now's the time to put a toe into crypto.</strong></p><p class="last-child" style="margin: 0px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">I've joined HoneyMiner which is an easy way to begin to experience Bitcoin. The system is a small program that runs in the background on your computer whenever it is on. It uses your excess processing capacity to mine crypto with you and the company sharing the crypto.<br /><br /><strong>Start with 1,000 Satoshis free.</strong><br /><br /><b>More here: <a href="https://honeyminer.com/referred/5tviv" style="color: #006c73; text-size-adjust: 100%; word-break: break-word;">https://honeyminer.com/referred/5tviv</a></b></p></div></td></tr></tbody></table>Health Freedom of Choice Bloghttp://www.blogger.com/profile/15606420362458868870noreply@blogger.com0tag:blogger.com,1999:blog-1111124027441239439.post-91042081352077761162020-12-11T09:33:00.001-08:002021-01-20T09:34:08.363-08:00December 2020 Newsletter<p> </p><table border="0" cellpadding="0" cellspacing="0" style="color: black; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td class="mceSpacing-24" style="padding-left: 40px; padding-right: 40px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div class="mceText" style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; text-align: center; width: 580px;"><h3 class="last-child" style="font-size: 20px; margin: 0px; padding: 0px;">The Vitamin Consultancy Newsletter<br />11 December 2020<br />Ralph Fucetola JD</h3></div></td></tr><tr><td class="mceSpacing-24" style="padding-left: 40px; padding-right: 40px; padding-top: 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><table align="center" border="0" cellpadding="0" cellspacing="0" style="text-size-adjust: 100%; width: 100%px;"><tbody><tr><td class="mceSection" style="background-position: center center; background-repeat: no-repeat; background-size: cover; text-size-adjust: 100%; word-break: break-word;" valign="top"><table border="0" cellpadding="0" cellspacing="0" style="table-layout: fixed; text-size-adjust: 100%; width: 100%px;"><colgroup><col span="1"></col><col span="1"></col><col span="1"></col><col span="1"></col><col span="1"></col><col span="1"></col><col span="1"></col><col span="1"></col><col span="1"></col><col span="1"></col><col span="1"></col><col span="1"></col></colgroup><tbody><tr><td class="mceColumn" colspan="12" style="background-color: #476584; background-position: center center; background-repeat: no-repeat; background-size: cover; padding-bottom: 24px; padding-top: 24px; text-size-adjust: 100%; word-break: break-word;" valign="top" width="100%"><table border="0" cellpadding="0" cellspacing="0" style="text-size-adjust: 100%; width: 100%px;"><tbody><tr><td align="center" class="mceSpacing-24" style="padding-left: 24px; padding-right: 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><a href="http://www.systemsprocessingintegration.com/" style="display: inline-block; text-size-adjust: 100%; word-break: break-word;" target="_blank"><img alt="Systems Processing Integration" src="https://dim.mcusercontent.com/cs/b90078d41a788bb042d5af1db/images/2eaf7cd7-7475-47aa-9000-f70b3c3cf801.jpg?w=612&dpr=2" style="border: 0px; height: auto; max-width: 100%; outline: none; text-decoration-line: none; width: 612px;" width="611.9999999999999" /></a></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table></td></tr><tr><td class="mceSpacing-24" style="padding-left: 40px; padding-right: 40px; padding-top: 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div class="mceText" style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; text-align: center; width: 580px;"><h1 style="font-size: 31.248px; margin: 0px 0px 24px; padding: 0px;">It's Time to Get Ready for What’s Next</h1><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>GETTING READY FOR THE NEW YEAR AND NEW REGIME</strong><br /><strong><span style="color: #ed0909;">Now more than ever “your papers must be in order.”</span></strong></p><h2 style="font-size: 25.008px; margin: 0px 0px 24px; padding: 0px;">But First… Are You Interested<br />in Cryptocurrency?<br /><em><span style="color: #ee0e0e;">OF COURSE YOU ARE!</span></em></h2><h2 style="font-size: 25.008px; margin: 0px 0px 24px; padding: 0px;">Join <em>Honey Miner</em></h2><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">It is a no-cost (except the cost of your computer time) BTC miner that uses your excess CPUs to generate crypto even while you are not using your computer. </p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">I've already earned a couple dozen Satori (a Satori is 1/1,000,000 BTC) in the four hours I've been a member. This program was recommended by my nephew Jeff Giles who is very savvy about crypto. </p><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">You can put all your computers on the system and the program will keep track of your Satori rewards. Easy download and set-up.</p><h3 style="font-size: 20px; margin: 0px 0px 24px; padding: 0px;">Join now and get 1,000 Satoris to start. </h3><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;">You can earn more crypto by asking others to join. Once your HM Wallet is set up you can receive and send BTC to others... in other words, you are part of the crypto revolution!</p><p class="last-child" style="margin: 0px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>Join through me here: <span style="color: #476584;"> </span></strong><a href="https://honeyminer.com/referred/5tviv" style="color: black; text-size-adjust: 100%; word-break: break-word;"><strong><span style="color: #0da5eb;">https://honeyminer.com/referred/5tviv</span></strong></a></p></div></td></tr><tr><td align="center" class="mceSpacing-24" style="padding-left: 40px; padding-right: 40px; padding-top: 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><a href="https://honeyminer.com/referred/5tviv" style="display: inline-block; text-size-adjust: 100%; word-break: break-word;" target="_blank"><img alt="" role="presentation" src="https://dim.mcusercontent.com/cs/b90078d41a788bb042d5af1db/images/f936518c-4ab5-427d-a194-5326a58c2c07.jpg?w=416&dpr=2" style="border: 0px; height: auto; max-width: 100%; outline: none; text-decoration-line: none; width: 416px;" width="415.99999999999994" /></a></td></tr><tr><td class="mceSpacing-24" style="padding-left: 40px; padding-right: 40px; padding-top: 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div class="mceText" style="font-family: "Helvetica Neue", Helvetica, Arial, Verdana, sans-serif; font-size: 16px; text-align: center; width: 580px;"><p style="margin: 0px 0px 24px; padding: 0px; text-size-adjust: 100%; word-break: break-word;"><strong>Some Useful Links:</strong><span style="color: #202020;"><br /></span><a href="http://vitaminlawyerarchives.blogspot.com/" style="color: black; text-size-adjust: 100%; word-break: break-word;" target="_blank"><span style="color: #2baadf;">http://vitaminlawyerarchives.blogspot.com/</span></a><span style="color: #202020;"><br /></span><a href="https://vitaminlawyerhealthfreedom.blogspot.com/" style="color: black; text-size-adjust: 100%; word-break: break-word;" target="_blank"><span style="color: #2baadf;">https://vitaminlawyerhealthfreedom.blogspot.com/</span></a><span style="color: #202020;"><br /></span><a href="https://www.minds.com/groups/profile/1171655581270441984/feed" style="color: black; text-size-adjust: 100%; word-break: break-word;" target="_blank"><span style="color: #2baadf;">https://www.minds.com/groups/profile/1171655581270441984/feed</span></a></p><h3 class="last-child" style="font-size: 20px; margin: 0px; padding: 0px;"><span style="color: #f50c0c;">GETTING READY FOR 2021</span><br />My Systems Processing Integration <br />Will Give Your Company Peace of Mind<br /><a href="http://www.systemsprocessingintegration.com/" style="color: black; text-size-adjust: 100%; word-break: break-word;"><span style="color: #1977e3;">www.SystemsProcessingIntegration.com</span></a></h3></div></td></tr><tr><td align="center" class="mceSpacing-24" style="padding-left: 40px; padding-right: 40px; padding-top: 24px; text-size-adjust: 100%; word-break: break-word;" valign="top"><a href="http://www.systemsprocessingintegration.com/" style="display: inline-block; text-size-adjust: 100%; word-break: break-word;" target="_blank"><img alt="" role="presentation" src="https://dim.mcusercontent.com/cs/b90078d41a788bb042d5af1db/images/30a67684-9440-412e-8b28-7ffaa4d58243.jpg?w=489&dpr=2" style="border: 0px; height: auto; max-width: 100%; outline: none; text-decoration-line: none; width: 489px;" width="488.99999999999994" /></a></td></tr></tbody></table>Health Freedom of Choice Bloghttp://www.blogger.com/profile/15606420362458868870noreply@blogger.com0tag:blogger.com,1999:blog-1111124027441239439.post-21306544029039435802020-10-14T16:16:00.004-07:002020-10-14T16:19:47.786-07:00October 2020: Rounding Rules<p> </p><table border="0" cellpadding="0" cellspacing="0" class="templateContainer" style="background-color: #fafafa; border-collapse: collapse; border: 0px; color: black; max-width: 600px !important; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td id="templatePreheader" style="background-attachment: initial; background-clip: initial; background-image: none; background-origin: initial; background-position: center center; background-repeat: no-repeat; background-size: cover; border-bottom: 0px; border-top: 0px; padding-bottom: 9px; padding-top: 9px; text-size-adjust: 100%;" valign="top"><table border="0" cellpadding="0" cellspacing="0" class="mcnTextBlock" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%px;"><tbody class="mcnTextBlockOuter"><tr><td class="mcnTextBlockInner" style="padding-top: 9px; text-size-adjust: 100%;" valign="top"><table align="left" border="0" cellpadding="0" cellspacing="0" class="mcnTextContentContainer" style="border-collapse: collapse; max-width: 390px; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td class="mcnTextContent" style="color: #656565; font-family: Helvetica; font-size: 12px; line-height: 18px; padding: 0px 18px 9px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div style="text-align: center;"><strong>The Vitamin Consultancy eLetter</strong><br /><a href="http://vitaminlawyerarchives.blogspot.com/" style="color: #656565; text-size-adjust: 100%;" target="_blank">Link to Newsletter Archives</a></div></td></tr></tbody></table><table align="left" border="0" cellpadding="0" cellspacing="0" class="mcnTextContentContainer" style="border-collapse: collapse; max-width: 210px; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td class="mcnTextContent" style="color: #656565; font-family: Helvetica; font-size: 12px; line-height: 18px; padding: 0px 18px 9px; text-size-adjust: 100%; word-break: break-word;" valign="top"><a href="https://mailchi.mp/117984862262/vitamin-consultancy-newsletter-sodium-rules-and-scotus-petition?e=[UNIQID]" style="color: #656565; text-size-adjust: 100%;" target="_blank">View this email in your browser</a></td></tr></tbody></table></td></tr></tbody></table></td></tr><tr><td id="templateHeader" style="background: none center center / cover no-repeat rgb(255, 255, 255); border-bottom: 0px; border-top: 0px; padding-bottom: 0px; padding-top: 0px; text-size-adjust: 100%;" valign="top"><table border="0" cellpadding="0" cellspacing="0" class="mcnImageBlock" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%px;"><tbody class="mcnImageBlockOuter"><tr><td class="mcnImageBlockInner" style="padding: 9px; text-size-adjust: 100%;" valign="top"><table align="left" border="0" cellpadding="0" cellspacing="0" class="mcnImageContentContainer" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td class="mcnImageContent" style="padding: 0px 9px; text-align: center; text-size-adjust: 100%;" valign="top"><img align="center" alt="" class="mcnImage" src="https://gallery.mailchimp.com/b90078d41a788bb042d5af1db/images/f0c21da0-c751-4a09-a581-1dfe43061a57.jpg" style="border: 0px; display: inline !important; height: auto; max-width: 535px; outline: none; padding-bottom: 0px; vertical-align: bottom;" width="535" /></td></tr></tbody></table></td></tr></tbody></table></td></tr><tr><td style="text-size-adjust: 100%;" valign="top"><table align="center" border="0" cellpadding="0" cellspacing="0" id="templateColumns" style="background-color: white; border-bottom: 0px; border-collapse: collapse; border-top: 0px; padding-bottom: 9px; padding-top: 0px; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td style="text-size-adjust: 100%;" valign="top"><table align="left" border="0" cellpadding="0" cellspacing="0" id="templateBody" style="border-bottom: 0px; border-collapse: collapse; border-top: 0px; padding-bottom: 9px; padding-top: 0px; text-size-adjust: 100%; width: 400px;"><tbody><tr><td style="text-size-adjust: 100%;"><table border="0" cellpadding="0" cellspacing="0" class="mcnTextBlock" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%px;"><tbody class="mcnTextBlockOuter"><tr><td class="mcnTextBlockInner" style="padding-top: 9px; text-size-adjust: 100%;" valign="top"><table align="left" border="0" cellpadding="0" cellspacing="0" class="mcnTextContentContainer" style="border-collapse: collapse; max-width: 100%; min-width: 100%; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td class="mcnTextContent" style="color: #202020; font-family: Helvetica; font-size: 16px; line-height: 24px; padding: 0px 18px 9px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div style="text-align: center;"><span style="font-size: 24px;"><strong><span style="color: red;">Sodium and the DSHEA Label</span><br />Listing Sodium in the Supplement Facts Box</strong></span></div><br /> <strong>Sodium Chloride -- table salt </strong>-- is listed as Generally Recognized As Safe (GRAS) as are a number of other forms of sodium.[1] <br /><br /> <strong>Sodium as a nutrient must be shown</strong> on the Nutrition Facts label [2]<br /><br /> <strong>Sodium, like other nutrients, has a Daily Value</strong> -- the DV is under 2300 mg/day. The regulations require you to disclose the level of sodium in the product. You regularly see sodium disclosed on the Nutrient Facts Label for ordinary foods.<br /><br /> <strong>For a DSHEA product</strong> Supplement Facts Label there is a list of what must be included at 21 CFR 101.36(b)(2)(i)(B). This requirement includes disclosing Sodium <em>if present</em>.<br /><br /> <strong>However,</strong> whether something is <em>present</em> may depend on how it is measured and how the measurement is rounded. There are rounding-down rules for the SF label. [3] <br /><br /> <strong>So, if the product has less than <em>5 mg per daily serving</em></strong> (which is about 1/3 of 1% of the DV) the percent can be rounded down to zero and does not need to be included. (pg 129)<br /><br /> <strong>How much sodium is in a serving of your product? That is the question. </strong>I can help you figure that out. -- for sodium or any other ingredient. For my regular retainer clients I am adding an SOP section on rounding rules...<br /><br />---------------------<br /><span style="font-size: 10px;">[1] https://www.fda.gov/food/food-additives-petitions/food-additive-status-list<br />[2] https://www.fda.gov/media/84261/download<br />[3] https://www.fda.gov/media/81606/download / 21 CFR 101.9(c)</span></td></tr></tbody></table></td></tr></tbody></table><table border="0" cellpadding="0" cellspacing="0" class="mcnDividerBlock" style="border-collapse: collapse; min-width: 100%; table-layout: fixed !important; text-size-adjust: 100%; width: 100%px;"><tbody class="mcnDividerBlockOuter"><tr><td class="mcnDividerBlockInner" style="min-width: 100%; padding: 18px; text-size-adjust: 100%;"><table border="0" cellpadding="0" cellspacing="0" class="mcnDividerContent" style="border-collapse: collapse; border-top: 2px solid rgb(234, 234, 234); min-width: 100%; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td style="text-size-adjust: 100%;"></td></tr></tbody></table></td></tr></tbody></table><table border="0" cellpadding="0" cellspacing="0" class="mcnBoxedTextBlock" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%px;"><tbody class="mcnBoxedTextBlockOuter"><tr><td class="mcnBoxedTextBlockInner" style="text-size-adjust: 100%;" valign="top"><table align="left" border="0" cellpadding="0" cellspacing="0" class="mcnBoxedTextContentContainer" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td style="padding: 9px 18px; text-size-adjust: 100%;"><table border="0" cellspacing="0" class="mcnTextContentContainer" style="background-color: #0e09a6; border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td class="mcnTextContent" style="color: #f2f2f2; font-family: Helvetica; font-size: 14px; line-height: 21px; padding: 18px; text-align: center; text-size-adjust: 100%; word-break: break-word;" valign="top"><strong>Patricia Finn, Esq.</strong> filed the SCOTUS vaccine mandate Petition last week. This is the first time in a century that this issue has come squarely before the Court. Read more about this landmark case: <br /><a href="http://www.opensourcetruth.com/will-scotus-decide-to-hear-vaccine-mandate-case-this-year/" style="color: #2baadf; text-size-adjust: 100%;" target="_blank">http://www.opensourcetruth.com/will-scotus-decide-to-hear-vaccine-mandate-case-this-year/</a><br /><br /><strong>YOUR URGENT SUPPORT FOR THIS CASE WILL MAKE A POWERFUL DIFFERENCE!</strong></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table><table border="0" cellpadding="0" cellspacing="0" class="mcnImageBlock" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%px;"><tbody class="mcnImageBlockOuter"><tr><td class="mcnImageBlockInner" style="padding: 9px; text-size-adjust: 100%;" valign="top"><table align="left" border="0" cellpadding="0" cellspacing="0" class="mcnImageContentContainer" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td class="mcnImageContent" style="padding: 0px 9px; text-align: center; text-size-adjust: 100%;" valign="top"><img align="center" alt="" class="mcnImage" src="https://mcusercontent.com/b90078d41a788bb042d5af1db/images/82629766-5f4c-45dc-81b6-2a3808b55f69.jpg" style="border: 0px; display: inline !important; height: auto; max-width: 688px; outline: none; padding-bottom: 0px; vertical-align: bottom;" width="305.76" /></td></tr></tbody></table></td></tr></tbody></table><table border="0" cellpadding="0" cellspacing="0" class="mcnTextBlock" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%px;"><tbody class="mcnTextBlockOuter"><tr><td class="mcnTextBlockInner" style="padding-top: 9px; text-size-adjust: 100%;" valign="top"><table align="left" border="0" cellpadding="0" cellspacing="0" class="mcnTextContentContainer" style="border-collapse: collapse; max-width: 100%; min-width: 100%; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td class="mcnTextContent" style="color: #202020; font-family: Helvetica; font-size: 16px; line-height: 24px; padding: 0px 18px 9px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div style="text-align: center;"><strong><span style="font-size: 18px;"><a href="https://fundly.com/support-natural-therapies" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;" target="_blank">https://fundly.com/support-natural-therapies</a></span></strong></div></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table><table align="left" border="0" cellpadding="0" cellspacing="0" id="templateSidebar" style="border-bottom: 0px; border-collapse: collapse; border-top: 0px; padding-bottom: 9px; padding-top: 0px; text-size-adjust: 100%; width: 200px;"><tbody><tr><td style="text-size-adjust: 100%;" valign="top"><table border="0" cellpadding="0" cellspacing="0" class="mcnCaptionBlock" style="border-collapse: collapse; text-size-adjust: 100%; width: 100%px;"><tbody class="mcnCaptionBlockOuter"><tr><td class="mcnCaptionBlockInner" style="padding: 9px; text-size-adjust: 100%;" valign="top"><table align="left" border="0" cellpadding="0" cellspacing="0" class="mcnCaptionBottomContent" style="border-collapse: collapse; text-size-adjust: 100%;"><tbody><tr><td align="center" class="mcnCaptionBottomImageContent" style="padding: 0px 9px 9px; text-size-adjust: 100%;" valign="top"><img alt="" class="mcnImage" src="https://gallery.mailchimp.com/b90078d41a788bb042d5af1db/images/0eea2c09-1be4-4ce9-9529-79c47d4b9381.jpg" style="border: 0px; height: auto; max-width: 269px; outline: none; vertical-align: bottom;" width="164" /></td></tr><tr><td class="mcnTextContent" style="color: #656565; font-family: Helvetica; font-size: 12px; line-height: 18px; padding: 0px 9px; text-size-adjust: 100%; word-break: break-word;" valign="top" width="164">My experience will strengthen your company! I provide private and confidential, competent electronic professional consulting to my Dietary Supplement and advanced healthcare ("CAM") modality clients, for the purpose of compliance with International, State and Federal (including FTC and FDA) standards for communicating about the advertising and sale of dietary supplements (including medical foods) and/or providing of health care services and information. You should consider my SOP / cGMP Certification Course, allowing start-up and established vitamin companies and practitioners who own their own private labeled products to meet with new FDA procedural regulations. <div style="text-align: center;"><strong><a href="http://www.vitaminconsultancy.com/" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;" target="_blank">www.VitaminConsultancy.com</a></strong></div></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table></td></tr><tr><td id="templateFooter" style="background-attachment: initial; background-clip: initial; background-image: none; background-origin: initial; background-position: center center; background-repeat: no-repeat; background-size: cover; border-bottom: 0px; border-top: 2px solid rgb(234, 234, 234); padding-bottom: 9px; padding-top: 9px; text-size-adjust: 100%;" valign="top"><table border="0" cellpadding="0" cellspacing="0" class="mcnFollowBlock" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%px;"><tbody class="mcnFollowBlockOuter"><tr><td align="center" class="mcnFollowBlockInner" style="padding: 9px; text-size-adjust: 100%;" valign="top"><table border="0" cellpadding="0" cellspacing="0" class="mcnFollowContentContainer" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td align="center" style="padding-left: 9px; padding-right: 9px; text-size-adjust: 100%;"><table border="0" cellpadding="0" cellspacing="0" class="mcnFollowContent" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td align="center" style="padding-left: 9px; padding-right: 9px; padding-top: 9px; text-size-adjust: 100%;" valign="top"></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table>Health Freedom of Choice Bloghttp://www.blogger.com/profile/15606420362458868870noreply@blogger.com0tag:blogger.com,1999:blog-1111124027441239439.post-69543547583343489152020-09-02T16:18:00.009-07:002020-10-14T16:23:42.482-07:00September 2020: The Woodlands Lunch Forum<p> </p><table border="0" cellpadding="0" cellspacing="0" class="templateContainer" style="background-color: #fafafa; border-collapse: collapse; border: 0px; color: black; max-width: 600px; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td id="templatePreheader" style="background-attachment: initial; background-clip: initial; background-image: none; background-origin: initial; background-position: 50% 50%; background-repeat: no-repeat; background-size: cover; border-bottom: 0px; border-top: 0px; padding-bottom: 9px; padding-top: 9px; text-size-adjust: 100%;" valign="top"><table border="0" cellpadding="0" cellspacing="0" class="mcnTextBlock" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%px;"><tbody class="mcnTextBlockOuter"><tr><td class="mcnTextBlockInner" style="padding-top: 9px; text-size-adjust: 100%;" valign="top"><table align="left" border="0" cellpadding="0" cellspacing="0" class="mcnTextContentContainer" style="border-collapse: collapse; max-width: 390px; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td class="mcnTextContent" style="color: #656565; font-family: Helvetica; font-size: 12px; line-height: 18px; padding: 0px 18px 9px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div style="text-align: center;"><strong>The Vitamin Consultancy eLetter</strong><br /><a href="http://vitaminlawyerarchives.blogspot.com/" style="color: #656565; text-size-adjust: 100%;" target="_blank">Link to Newsletter Archives</a></div></td></tr></tbody></table><table align="left" border="0" cellpadding="0" cellspacing="0" class="mcnTextContentContainer" style="border-collapse: collapse; max-width: 210px; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td class="mcnTextContent" style="color: #656565; font-family: Helvetica; font-size: 12px; line-height: 18px; padding: 0px 18px 9px; text-size-adjust: 100%; word-break: break-word;" valign="top"><a href="https://mailchi.mp/1a9d274f1366/livestream-thursday-lunch-texas-meeting-counsel-ralph-and-dr-rima?e=[UNIQID]" style="color: #656565; text-size-adjust: 100%;" target="_blank">View this email in your browser</a></td></tr></tbody></table></td></tr></tbody></table></td></tr><tr><td id="templateHeader" style="background: none 50% 50% / cover no-repeat rgb(255, 255, 255); border-bottom: 0px; border-top: 0px; padding-bottom: 0px; padding-top: 0px; text-size-adjust: 100%;" valign="top"><table border="0" cellpadding="0" cellspacing="0" class="mcnImageBlock" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%px;"><tbody class="mcnImageBlockOuter"><tr><td class="mcnImageBlockInner" style="padding: 9px; text-size-adjust: 100%;" valign="top"><table align="left" border="0" cellpadding="0" cellspacing="0" class="mcnImageContentContainer" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td class="mcnImageContent" style="padding: 0px 9px; text-align: center; text-size-adjust: 100%;" valign="top"><img align="center" alt="" class="mcnImage" src="https://gallery.mailchimp.com/b90078d41a788bb042d5af1db/images/f0c21da0-c751-4a09-a581-1dfe43061a57.jpg" style="border: 0px; display: inline; height: auto; max-width: 535px; outline: none; padding-bottom: 0px; vertical-align: bottom;" width="411.95" /></td></tr></tbody></table></td></tr></tbody></table><table border="0" cellpadding="0" cellspacing="0" class="mcnImageBlock" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%px;"><tbody class="mcnImageBlockOuter"><tr><td class="mcnImageBlockInner" style="padding: 9px; text-size-adjust: 100%;" valign="top"><table align="left" border="0" cellpadding="0" cellspacing="0" class="mcnImageContentContainer" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td class="mcnImageContent" style="padding: 0px 9px; text-align: center; text-size-adjust: 100%;" valign="top"><b><span style="color: red; font-size: large;">UPDATE</span></b><br /><b style="box-sizing: inherit; color: #444444; font-family: "Pontano Sans", sans-serif; text-align: start;"><span style="box-sizing: inherit; color: red;"><strong style="box-sizing: inherit;">September 10th Live Stream ARCHIVE Link<br style="box-sizing: inherit;" /><strong style="box-sizing: inherit;"><a href="https://facebook.com/WoodlandsOnline/videos/3230794120372858/" style="background-color: transparent; box-sizing: inherit; color: #1f3ac4; text-decoration-line: none; transition: all 0.3s ease 0s;">https://facebook.com/WoodlandsOnline/videos/3230794120372858/</a></strong></strong></span></b><br /><img align="center" alt="" class="mcnImage" src="https://mcusercontent.com/b90078d41a788bb042d5af1db/images/8e49637a-7a3e-43fd-9485-ef53480c0e9d.jpg" style="border: 0px; display: inline; height: auto; max-width: 640px; outline: none; padding-bottom: 0px; vertical-align: bottom;" width="360.96" /></td></tr></tbody></table></td></tr></tbody></table></td></tr><tr><td style="text-size-adjust: 100%;" valign="top"><table align="center" border="0" cellpadding="0" cellspacing="0" id="templateColumns" style="background-color: white; border-bottom: 0px; border-collapse: collapse; border-top: 0px; padding-bottom: 9px; padding-top: 0px; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td style="text-size-adjust: 100%;" valign="top"><table align="left" border="0" cellpadding="0" cellspacing="0" id="templateBody" style="border-bottom: 0px; border-collapse: collapse; border-top: 0px; padding-bottom: 9px; padding-top: 0px; text-size-adjust: 100%; width: 400px;"><tbody><tr><td style="text-size-adjust: 100%;"><table border="0" cellpadding="0" cellspacing="0" class="mcnTextBlock" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%px;"><tbody class="mcnTextBlockOuter"><tr><td class="mcnTextBlockInner" style="padding-top: 9px; text-size-adjust: 100%;" valign="top"><table align="left" border="0" cellpadding="0" cellspacing="0" class="mcnTextContentContainer" style="border-collapse: collapse; max-width: 100%; min-width: 100%; text-size-adjust: 100%; width: 100%px;"><tbody><tr><td class="mcnTextContent" style="color: #202020; font-family: Helvetica; font-size: 16px; line-height: 24px; padding: 0px 18px 9px; text-size-adjust: 100%; word-break: break-word;" valign="top"><h1 style="font-size: 26px; line-height: 32.5px; margin: 0px; padding: 0px; text-align: center;"><br /></h1><h1 style="font-size: 26px; line-height: 32.5px; margin: 0px; padding: 0px; text-align: center;">THE WOODLANDS<br />LUNCH FORUM</h1><h4 class="null" style="font-size: 18px; line-height: 22.5px; margin: 0px; padding: 0px; text-align: center;"><span style="font-size: 16px;">Dr. Rima and I are speaking in Texas this<br />Thursday (me in person; her by Skype) at<br /><strong>The Woodlands Lunch Forum</strong> <br />(my trip delayed from February)<br /><strong>We will be livestreamed</strong><br />Thursday - September 10, 2020<br />at 11:30 AM CDT <br />Live Stream here:<br /><a href="http://www.woodlandsonline.com/vmps/videolisting.cfm?vdoid=4248" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;" target="_blank">http://www.woodlandsonline.com/vmps/videolisting.cfm?vdoid=4248</a><br />Event:<br /><a href="http://www.inhere.org/the-woodlands-lunch-forum/" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;" target="_blank">http://www.inhere.org/the-woodlands-lunch-forum/</a></span></h4><div style="text-align: center;"><em>Calendar it and Join Us There!</em><br />PLEASE SHARE THIS MESSAGE</div></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table>Health Freedom of Choice Bloghttp://www.blogger.com/profile/15606420362458868870noreply@blogger.com0tag:blogger.com,1999:blog-1111124027441239439.post-75830482281055918062020-08-12T19:20:00.002-07:002020-09-13T07:38:43.965-07:00August 2020 - Unique Facility Identifier<p> </p><table border="0" cellpadding="0" cellspacing="0" class="templateContainer" style="background-color: #fafafa; border-collapse: collapse; border: 0px; color: black; max-width: 600px; text-size-adjust: 100%; width: 100%;"><tbody><tr><td id="templatePreheader" style="background-attachment: initial; background-clip: initial; background-image: none; background-origin: initial; background-position: 50% 50%; background-repeat: no-repeat; background-size: cover; border-bottom: 0px; border-top: 0px; padding-bottom: 9px; padding-top: 9px; text-size-adjust: 100%;" valign="top"><table border="0" cellpadding="0" cellspacing="0" class="mcnTextBlock" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%;"><tbody class="mcnTextBlockOuter"><tr><td class="mcnTextBlockInner" style="padding-top: 9px; text-size-adjust: 100%;" valign="top"><table align="left" border="0" cellpadding="0" cellspacing="0" class="mcnTextContentContainer" style="border-collapse: collapse; max-width: 390px; text-size-adjust: 100%; width: 100%;"><tbody><tr><td class="mcnTextContent" style="color: #656565; font-family: helvetica; font-size: 12px; line-height: 18px; padding: 0px 18px 9px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div style="text-align: center;"><strong>The Vitamin Consultancy eLetter</strong><br /><a href="http://vitaminlawyerarchives.blogspot.com/" style="color: #656565; text-size-adjust: 100%;" target="_blank">Link to Newsletter Archives</a></div></td></tr></tbody></table><table align="left" border="0" cellpadding="0" cellspacing="0" class="mcnTextContentContainer" style="border-collapse: collapse; max-width: 210px; text-size-adjust: 100%; width: 100%;"><tbody><tr><td class="mcnTextContent" style="color: #656565; font-family: helvetica; font-size: 12px; line-height: 18px; padding: 0px 18px 9px; text-size-adjust: 100%; word-break: break-word;" valign="top"><a href="https://mailchi.mp/0a439cb1fab5/new-fda-requirements-and-i-will-be-in-houston-on-10-september?e=[UNIQID]" style="color: #656565; text-size-adjust: 100%;" target="_blank">View this email in your browser</a></td></tr></tbody></table></td></tr></tbody></table></td></tr><tr><td id="templateHeader" style="background: none 50% 50% / cover no-repeat rgb(255, 255, 255); border-bottom: 0px; border-top: 0px; padding-bottom: 0px; padding-top: 0px; text-size-adjust: 100%;" valign="top"><table border="0" cellpadding="0" cellspacing="0" class="mcnImageBlock" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%;"><tbody class="mcnImageBlockOuter"><tr><td class="mcnImageBlockInner" style="padding: 9px; text-size-adjust: 100%;" valign="top"><table align="left" border="0" cellpadding="0" cellspacing="0" class="mcnImageContentContainer" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%;"><tbody><tr><td class="mcnImageContent" style="padding: 0px 9px; text-align: center; text-size-adjust: 100%;" valign="top"><img align="center" alt="" class="mcnImage" src="https://gallery.mailchimp.com/b90078d41a788bb042d5af1db/images/f0c21da0-c751-4a09-a581-1dfe43061a57.jpg" style="border: 0px; display: inline; height: auto; max-width: 535px; outline: none; padding-bottom: 0px; vertical-align: bottom;" width="535" /></td></tr></tbody></table></td></tr></tbody></table></td></tr><tr><td style="text-size-adjust: 100%;" valign="top"><table align="center" border="0" cellpadding="0" cellspacing="0" id="templateColumns" style="background-color: white; border-bottom: 0px; border-collapse: collapse; border-top: 0px; padding-bottom: 9px; padding-top: 0px; text-size-adjust: 100%; width: 100%;"><tbody><tr><td style="text-size-adjust: 100%;" valign="top"><table align="left" border="0" cellpadding="0" cellspacing="0" id="templateBody" style="border-bottom: 0px; border-collapse: collapse; border-top: 0px; padding-bottom: 9px; padding-top: 0px; text-size-adjust: 100%; width: 400px;"><tbody><tr><td style="text-size-adjust: 100%;"><table border="0" cellpadding="0" cellspacing="0" class="mcnBoxedTextBlock" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%;"><tbody class="mcnBoxedTextBlockOuter"><tr><td class="mcnBoxedTextBlockInner" style="text-size-adjust: 100%;" valign="top"><table align="left" border="0" cellpadding="0" cellspacing="0" class="mcnBoxedTextContentContainer" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%;"><tbody><tr><td style="padding: 9px 18px; text-size-adjust: 100%;"><table border="0" cellspacing="0" class="mcnTextContentContainer" style="background-color: #404040; border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%;"><tbody><tr><td class="mcnTextContent" style="color: #f2f2f2; font-family: helvetica; line-height: 21px; padding: 18px; text-align: center; text-size-adjust: 100%; word-break: break-word;" valign="top"><div style="font-size: 14px;"><span style="font-size: 25px;"><strong>At The Woodlands<br />Lunch Forum<br />Thursday<br />September 10, 2020<br /><span style="color: red;">I'd Love to See YOU in Texas!</span></strong></span></div><div style="font-size: 14px;"><span style="font-size: 16px;"><strong>Here are the Details</strong></span><br /><strong> <a href="http://www.inhere.org/the-woodlands-lunch-forum/" rel="noopener noreferrer" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;" target="_Blank">http://www.inhere.org/the-woodlands-lunch-forum/</a></strong></div><div><span style="font-size: 14px;"><b>VIDEO ARCHIVE LINK</b></span><br /><strong style="background-color: white; box-sizing: inherit; color: #444444; font-family: "Pontano Sans", sans-serif; text-align: left;"><a href="https://facebook.com/WoodlandsOnline/videos/3230794120372858/" rel="noopener noreferrer" style="background-color: transparent; box-sizing: inherit; color: #1f3ac4; text-decoration-line: none; transition: all 0.3s ease 0s;" target="_blank">https://facebook.com/WoodlandsOnline/videos/3230794120372858/</a></strong></div></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table><table border="0" cellpadding="0" cellspacing="0" class="mcnImageBlock" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%;"><tbody class="mcnImageBlockOuter"><tr><td class="mcnImageBlockInner" style="padding: 9px; text-size-adjust: 100%;" valign="top"><table align="left" border="0" cellpadding="0" cellspacing="0" class="mcnImageContentContainer" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%;"><tbody><tr><td class="mcnImageContent" style="padding: 0px 9px; text-align: center; text-size-adjust: 100%;" valign="top"><img align="center" alt="" class="mcnImage" src="https://mcusercontent.com/b90078d41a788bb042d5af1db/images/599174d4-3833-4e89-8ca4-edc251e07bfd.jpg" style="border: 0px; display: inline; height: auto; max-width: 300px; outline: none; padding-bottom: 0px; vertical-align: bottom;" width="300" /></td></tr></tbody></table></td></tr></tbody></table><table border="0" cellpadding="0" cellspacing="0" class="mcnTextBlock" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%;"><tbody class="mcnTextBlockOuter"><tr><td class="mcnTextBlockInner" style="padding-top: 9px; text-size-adjust: 100%;" valign="top"><table align="left" border="0" cellpadding="0" cellspacing="0" class="mcnTextContentContainer" style="border-collapse: collapse; max-width: 100%; min-width: 100%; text-size-adjust: 100%; width: 100%;"><tbody><tr><td class="mcnTextContent" style="color: #202020; font-family: helvetica; line-height: 24px; padding: 0px 18px 9px; text-size-adjust: 100%; word-break: break-word;" valign="top"><h1 style="line-height: 32.5px; margin: 0px; padding: 0px; text-align: center;"><span style="color: red;"><span style="font-size: x-large;">UFI</span></span><br /><span style="font-size: 20px;">UNIQUE FACILITY IDENTIFIER</span></h1><p style="font-size: 16px; line-height: 24px; margin: 10px 0px; padding: 0px; text-size-adjust: 100%;"><span style="font-size: 14px;">Every other year all food processing facilities must renew their registration (between October and December). This year, 2020, is one of those years. This time, though, there will be an added twist: you will need to obtain a "UFI" -- a Unique Facility Identifier number. However, FDA has not yet set up the system to generate the number. Bureaucracy at work! So I asked FDA about this new requirement. Here is the communication. I will let all the clients of The Vitamin Consultancy know how to meet the requirements. Remember, if you handle any food product, such as dietary supplements or herbs, you must be registered.</span></p></td></tr></tbody></table></td></tr></tbody></table><table border="0" cellpadding="0" cellspacing="0" class="mcnImageBlock" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%;"><tbody class="mcnImageBlockOuter"><tr><td class="mcnImageBlockInner" style="padding: 9px; text-size-adjust: 100%;" valign="top"><table align="left" border="0" cellpadding="0" cellspacing="0" class="mcnImageContentContainer" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%;"><tbody><tr><td class="mcnImageContent" style="padding: 0px 9px; text-align: center; text-size-adjust: 100%;" valign="top"><img align="center" alt="" class="mcnImage" src="https://mcusercontent.com/b90078d41a788bb042d5af1db/images/854937e9-c785-4cde-abfb-4ba7da1a1a94.jpg" style="border: 0px; display: inline; height: auto; max-width: 718px; outline: none; padding-bottom: 0px; vertical-align: bottom;" width="364" /></td></tr></tbody></table></td></tr></tbody></table><table border="0" cellpadding="0" cellspacing="0" class="mcnTextBlock" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%;"><tbody class="mcnTextBlockOuter"><tr><td class="mcnTextBlockInner" style="padding-top: 9px; text-size-adjust: 100%;" valign="top"><table align="left" border="0" cellpadding="0" cellspacing="0" class="mcnTextContentContainer" style="border-collapse: collapse; max-width: 100%; min-width: 100%; text-size-adjust: 100%; width: 100%;"><tbody><tr><td class="mcnTextContent" style="color: #202020; font-family: helvetica; font-size: 16px; line-height: 24px; padding: 0px 18px 9px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div style="text-align: center;"><span style="font-size: 14px;"><strong>YOUR DONATION WILL MAKE A DIFFERENCE!</strong></span><br /><span style="font-size: 12px;"><strong><a href="http://www.inhere.org/2020/07/06/support-scotus-vaccine-rights-petition/" rel="noopener noreferrer" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;" target="_blank">http://www.inhere.org/2020/07/06/support-scotus-vaccine-rights-petition/</a></strong></span></div></td></tr></tbody></table></td></tr></tbody></table><table border="0" cellpadding="0" cellspacing="0" class="mcnImageBlock" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%;"><tbody class="mcnImageBlockOuter"><tr><td class="mcnImageBlockInner" style="padding: 9px; text-size-adjust: 100%;" valign="top"><table align="left" border="0" cellpadding="0" cellspacing="0" class="mcnImageContentContainer" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%;"><tbody><tr><td class="mcnImageContent" style="padding: 0px 9px; text-align: center; text-size-adjust: 100%;" valign="top"><img align="center" alt="" class="mcnImage" src="https://mcusercontent.com/b90078d41a788bb042d5af1db/images/82629766-5f4c-45dc-81b6-2a3808b55f69.jpg" style="border: 0px; display: inline; height: auto; max-width: 688px; outline: none; padding-bottom: 0px; vertical-align: bottom;" width="356.71999999999997" /></td></tr></tbody></table></td></tr></tbody></table><table border="0" cellpadding="0" cellspacing="0" class="mcnTextBlock" style="border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%;"><tbody class="mcnTextBlockOuter"><tr><td class="mcnTextBlockInner" style="padding-top: 9px; text-size-adjust: 100%;" valign="top"><table align="left" border="0" cellpadding="0" cellspacing="0" class="mcnTextContentContainer" style="border-collapse: collapse; max-width: 100%; min-width: 100%; text-size-adjust: 100%; width: 100%;"><tbody><tr><td class="mcnTextContent" style="color: #202020; font-family: helvetica; font-size: 16px; line-height: 24px; padding: 0px 18px 9px; text-size-adjust: 100%; word-break: break-word;" valign="top"><div style="text-align: center;"><strong><span style="font-size: 18px;"><a href="https://fundly.com/support-natural-therapies" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;" target="_blank">https://fundly.com/support-natural-therapies</a></span></strong></div></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table><table align="left" border="0" cellpadding="0" cellspacing="0" id="templateSidebar" style="border-bottom: 0px; border-collapse: collapse; border-top: 0px; padding-bottom: 9px; padding-top: 0px; text-size-adjust: 100%; width: 200px;"><tbody><tr><td style="text-size-adjust: 100%;" valign="top"><table border="0" cellpadding="0" cellspacing="0" class="mcnCaptionBlock" style="border-collapse: collapse; text-size-adjust: 100%; width: 100%;"><tbody class="mcnCaptionBlockOuter"><tr><td class="mcnCaptionBlockInner" style="padding: 9px; text-size-adjust: 100%;" valign="top"><table align="left" border="0" cellpadding="0" cellspacing="0" class="mcnCaptionBottomContent" style="border-collapse: collapse; text-size-adjust: 100%;"><tbody><tr><td align="center" class="mcnCaptionBottomImageContent" style="padding: 0px 9px 9px; text-size-adjust: 100%;" valign="top"><img alt="" class="mcnImage" src="https://gallery.mailchimp.com/b90078d41a788bb042d5af1db/images/0eea2c09-1be4-4ce9-9529-79c47d4b9381.jpg" style="border: 0px; height: auto; max-width: 269px; outline: none; vertical-align: bottom;" width="164" /></td></tr><tr><td class="mcnTextContent" style="color: #656565; font-family: helvetica; font-size: 12px; line-height: 18px; padding: 0px 9px; text-size-adjust: 100%; word-break: break-word;" valign="top" width="164">My experience will strengthen your company! I provide private and confidential, competent electronic professional consulting to my Dietary Supplement and advanced healthcare ("CAM") modality clients, for the purpose of compliance with International, State and Federal (including FTC and FDA) standards for communicating about the advertising and sale of dietary supplements (including medical foods) and/or providing of health care services and information. You should consider my SOP / cGMP Certification Course, allowing start-up and established vitamin companies and practitioners who own their own private labeled products to meet with new FDA procedural regulations. <div style="text-align: center;"><strong><a href="http://www.vitaminconsultancy.com/" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;" target="_blank">www.VitaminConsultancy.com</a></strong></div></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table></td></tr><tr></tr></tbody></table><br />Health Freedom of Choice Bloghttp://www.blogger.com/profile/15606420362458868870noreply@blogger.com0tag:blogger.com,1999:blog-1111124027441239439.post-79304133202585572962020-07-21T20:01:00.006-07:002020-09-12T15:26:23.235-07:00July 2020 - Contemporaneous Log and Texas Trip<table border="0" cellpadding="0" cellspacing="0" class="templateContainer" style="background-color: #fafafa; border-collapse: collapse; border: 0px; color: black; max-width: 600px; text-size-adjust: 100%; width: 100%;"><tbody>
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<strong>The Vitamin Consultancy eLetter</strong><br />
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<tr><td style="padding: 9px 18px; text-size-adjust: 100%;"><table border="0" cellspacing="0" class="mcnTextContentContainer" style="background-color: #404040; border-collapse: collapse; min-width: 100%; text-size-adjust: 100%; width: 100%;"><tbody>
<tr><td class="mcnTextContent" style="color: #f2f2f2; font-family: helvetica; font-size: 14px; line-height: 21px; padding: 18px; text-align: center; text-size-adjust: 100%; word-break: break-word;" valign="top"><strong><span style="font-size: 15px;"><span style="background-color: firebrick;">COVID willing, my trip to Texas to speak at The Woodlands Lunch Forum to inaugurate the Texas office of the Institute for Health Research is now scheduled for September 10th. This is the third postponement since February, but I do hope to see my Texas friends then. Tickets available through <a href="http://inhere.org/" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;" target="_blank">www.InHeRe.org</a><br /><br />Archive Link:<br /></span></span></strong><span style="background-color: white; box-sizing: inherit; color: #191e23; font-family: "Noto Serif"; font-size: 16px; font-weight: 600; text-align: start; white-space: pre-wrap;"><span style="box-sizing: inherit; color: red;"><span style="box-sizing: inherit;"><a href="http://www.woodlandsonline.com/vmps/videolisting.cfm?vdoid=4248" rel="noreferrer noopener" style="box-sizing: inherit; color: #007fac; outline: 0px; transition-duration: 0.05s; transition-property: border, background, color; transition-timing-function: ease-in-out;" target="_blank"><span data-rich-text-format-boundary="true" style="background-color: rgba(0, 160, 210, 0.2); border-radius: 2px; box-sizing: inherit;">https://facebook.com/WoodlandsOnline/videos/3230794120372858/</span></a></span></span></span></td></tr>
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<span style="color: red;">KEEPING A CONTEMPORANEOUS LOG</span><br /><strong><span style="font-size: 18px;">MEETING FDA RECORD KEEPING REQUIREMENTS</span></strong></h1>
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<span style="font-size: 14px;"><strong>The most important step that a small or start-up natural product / dietary supplement company can take to meet regulatory requirements is to keep a Contemporaneous Log of all activities relating to the receiving, handling and shipping of its products. Follow-up records, such as computer inventory systems or even my OPS for SOPs (Operating Procedures System for Standard Operating Procedures) with its private, password protected regulatory compliance web site -- <a href="http://www.systemsprocessingintegration.com/" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;" target="_blank">www.SystemsProcessingIntegration.com</a> -- are <em>after-the-fact</em> records.</strong><br /><br />What FDA tells us is that the product Label Owner<strong> "must be in a state of control"</strong> of all processes, whether contracted or handled in-house. Further the Agency tells us that, <strong>"if it is recorded that is how it happened; if it is not recorded it did not happen..."</strong><br /><br /><strong>This means that a contemporaneous, handwritten, initialed Receiving, Handling and Shipping Log is exactly what you need to start off right.</strong> Below is the format for the Log, but there are more sophisticated Log formats that I have available and am providing to my regular retainer clients. Those documents are part of the SOP system developed by The Vitamin Consultancy. Let me know if you need more specifics.<br /><br /><strong>The Log:</strong></span></div>
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Health Freedom of Choice Bloghttp://www.blogger.com/profile/15606420362458868870noreply@blogger.com0tag:blogger.com,1999:blog-1111124027441239439.post-66471139358509987622020-06-18T08:03:00.001-07:002020-09-12T15:27:20.938-07:00June 2020 - Trip to Texas - Labeling and Packaging Specifications Webinar & eBook<br />
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<strong>The Vitamin Consultancy eLetter</strong><br />
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<span style="color: red;">IN TEXAS <strike>JULY 8 - 12</strike></span></h1>
<h1 style="font-size: 26px; line-height: 32.5px; margin: 0px; padding: 0px; text-align: center;">ARCHIVE<br /><span style="box-sizing: inherit; color: #191e23; font-family: "Noto Serif"; font-size: 16px; text-align: start; white-space: pre-wrap;"><span style="box-sizing: inherit; color: red;"><span style="box-sizing: inherit;"><span data-rich-text-format-boundary="true" style="background-color: rgba(0, 160, 210, 0.2); border-radius: 2px; box-sizing: inherit; color: #007fac; outline: 0px; transition-duration: 0.05s; transition-property: border, background, color; transition-timing-function: ease-in-out;"><a href="http://www.woodlandsonline.com/vmps/videolisting.cfm?vdoid=4248" rel="noreferrer noopener" style="box-sizing: inherit; color: #007fac; outline: 0px; transition-duration: 0.05s; transition-property: border, background, color; transition-timing-function: ease-in-out;" target="_blank">https://facebook.com/WoodlandsOnline/videos/3230794120372858/</a></span></span></span></span></h1><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEibwYhjSjBrXlMhqIxasYuVoDQJ6Ux91hDlOclXlSJXcLekjR0YeatXPtlp6DAzC6NWRTOnbYaVSYtiIkzKXCjRBK6S-CTwc-v8nhGqhYCM2Jbtg8q6ZUP_Sm2IC2Bs2i0D2fQIJSehKCM/s640/Woodlands-final-banner.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="336" data-original-width="640" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEibwYhjSjBrXlMhqIxasYuVoDQJ6Ux91hDlOclXlSJXcLekjR0YeatXPtlp6DAzC6NWRTOnbYaVSYtiIkzKXCjRBK6S-CTwc-v8nhGqhYCM2Jbtg8q6ZUP_Sm2IC2Bs2i0D2fQIJSehKCM/s320/Woodlands-final-banner.jpg" width="320" /></a></div><br /><h1 style="font-size: 26px; line-height: 32.5px; margin: 0px; padding: 0px; text-align: center;"><br /><a href="http://www.inhere.org/the-woodlands-lunch-forum/" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;" target="_blank"><img data-file-id="2248342" height="320" src="https://mcusercontent.com/b90078d41a788bb042d5af1db/images/1a1ab073-e640-451c-bb0d-19c2a57fd5e4.jpg" style="border: 0px; height: 474px; margin: 0px; outline: none; text-decoration-line: none; width: 400px;" width="270" /></a></h1>
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<strong><span style="font-size: 18px;">RESERVE A SEAT HERE:<br /><a href="http://www.inhere.org/the-woodlands-lunch-forum/" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;" target="_blank">http://www.inhere.org/the-woodlands-lunch-forum/</a></span></strong></div>
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<span style="font-size: 14px;">I will be visiting Dallas, Austin and Houston. The sponsor of <em>The Woodlands Lunch Forum</em>, Larry Deckerhoff had this to say:</span></div>
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<span style="font-size: 14px;">"<em>Meet You After the Pandemic Reopening -- </em><strong>The theme of this Lunch Forum is Advanced Health for the New Millennium, Immunotherapy and Rejuvenation – Focus on Supercharged Immune Systems During Troubled Times. Among our featured speakers will be Ralph Fucetola JD, President of The Woodlands’ own Institute for Health Research. He will be joined by two experts in rejuvenation and immunotherapies. The short presentations will leave plenty of time to reconnect and enjoy the extraordinary cuisine at Amerigo’s Grille.”</strong></span></div>
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<span style="font-size: 18px;"><strong>Please contact Stephen with questions:<br /><a href="mailto:stephen.contreras1@hotmail.com" rel="noreferrer noopener" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;" target="_blank">stephen.contreras1@hotmail.com</a></strong></span></div>
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<span style="font-size: 18px;"><strong><span style="color: red;">LABELING AND PACKAGING SPECIFICATIONS</span></strong></span><br />
<span style="font-size: 14px;"><strong>New Vitamin Consultancy Webinar and eBook<br />Special Newsletter Price: $99.00</strong></span><br />
Contact: ralph.fucetola@gmail.com</div>
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<a href="http://www.vitaminconsultancy.com/webinars.php" style="color: #2baadf; text-size-adjust: 100%;" target="_blank"><img data-file-id="2248346" height="242" src="https://mcusercontent.com/b90078d41a788bb042d5af1db/images/e426fb36-9b33-433e-9114-9af742f5c6dc.jpg" style="border: 0px; height: 455px; margin: 0px; outline: none; text-decoration-line: none; width: 600px;" width="320" /></a></div>
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Health Freedom of Choice Bloghttp://www.blogger.com/profile/15606420362458868870noreply@blogger.com0tag:blogger.com,1999:blog-1111124027441239439.post-90042742534096645792020-05-27T07:14:00.000-07:002020-05-27T07:15:13.144-07:00May 2020 Newsletter: Reopening the Natural Economy<table border="0" cellpadding="0" cellspacing="0" class="templateContainer" style="background-color: #fafafa; border-collapse: collapse; border: 0px; color: black; max-width: 600px !important; text-size-adjust: 100%; width: 100%px;"><tbody>
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<strong>The Vitamin Consultancy eLetter</strong><br />
<a href="http://vitaminlawyerarchives.blogspot.com/" style="color: #656565; text-size-adjust: 100%;" target="_blank">Link to Newsletter Archives</a></div>
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<span style="color: red;">Although the Declared "Pandemic" is Ending...</span><br /><strong><span style="font-size: 18px;">EMERGENCY PLANNING SOP & RESTARTING</span></strong></h1>
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<span style="font-size: 14px;"><strong>A couple bits of news...</strong><br /><br /><strong>1. My trip to Texas to announce the opening of The Woodlands office of the Institute for Health Research - <a href="http://www.inhere.org/" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;" target="_blank">www.InHeRe.org</a> - originally scheduled for February, is now tentatively scheduled for late summer.</strong><br /><br /><strong>2. The Trump Admin says it is relieving the regulatory burden on businesses to let us get back to work quicker. My experience has been that FDA has backed-off physical inspections but has continued to push for compliance with previously issued </strong><strong>Observation</strong><strong> Reports. Use the time you have before the bureaucracy is back to work (well, what they consider "work") and get ready!</strong><br /><br /><strong>3. I AM AVAILABLE TO CONSULT WITH YOU AS YOU REOPEN. SPECIAL CONSULTING RATES FOR MAY.<span style="color: firebrick;"> </span> LET ME KNOW -- ralph.fucetola@gmail.com with Consulting in subject line.</strong><br /><br /><strong>No doubt future inspections will put more emphasis on company Emergency Planning.</strong><br /><br />I have updated my Standard Operating Procedures (SOP) format to add <strong>Working Remotely</strong> to SOP #13, Emergency Planning.<br /><br />My regular retainer clients received a copy of the revised SOP last month and those retainer companies that are part of my OPS for SOPs -- my on-line facility for Systems Processing Integration -- <a href="http://www.systemsprocessingintegration.com/" style="color: #2baadf; text-size-adjust: 100%;" target="_blank">www.SystemsProcessingIntegration.com</a> -- are having their SOPs automatically updated by me.<br /><br /><strong>Remember the OPS (Operating Procedures System) is a password-protected online page which houses copies of your SOPs and other primary regulatory documentation... just what you need during an emergency! CONTACT ME ABOUT SETTING-UP YOUR OPS 4 SOPs PAGE TODAY!</strong><br /><br /><span style="color: firebrick;"><strong>If you want a copy of SOP #13, the cost is now just $69 -- email me and I'll send you a PayPal money request.</strong></span></span></div>
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<span style="font-size: 14px;">I also included one additional duty to the general duties of your Emergency Manager (Section 1 of the SOP): "Maintain a list of staff members and their cell phones for text messaging and conference calling; this list should be maintained on a password-protected Internet Page which is part of the Company online OPS."<br /><br />Please let me know how I can help your company as the emergency ends.<br /><br /><strong>Dr. Laibow and I are maintaining a COVID information aggregation site here: <a href="http://www.truthaboutcoronavirus.com/" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;" target="_blank">www.TruthAboutCoronavirus.com</a><br /><br />We also held a COVID Emergency Health Summit (over 6 hours of podcasting with a half dozen experts) - more information here: <a href="http://www.inhere.org/2020/03/07/covid-19-emergency-health-summit/" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;">http://www.inhere.org/2020/03/07/covid-19-emergency-health-summit/</a></strong></span></div>
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<span style="font-size: 14px;"><strong>HERE IS WHAT AN OPS FOR SOPS PAGE CAN INCLUDE:</strong></span></div>
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<span style="font-size: 14px;"><strong><a href="http://www.systemsprocessingintegration.com/" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;" target="_blank"><img align="center" data-file-id="1986176" height="538" src="https://gallery.mailchimp.com/b90078d41a788bb042d5af1db/images/30a67684-9440-412e-8b28-7ffaa4d58243.jpg" style="border: 0px; height: 538px; margin: 5px; outline: none; text-decoration-line: none; width: 400px;" width="400" /></a></strong></span></div>
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Health Freedom of Choice Bloghttp://www.blogger.com/profile/15606420362458868870noreply@blogger.com0tag:blogger.com,1999:blog-1111124027441239439.post-71255837524501877862020-04-30T07:37:00.000-07:002020-05-27T07:16:59.635-07:00April 2020 Newsletter: Quality Counts<table border="0" cellpadding="0" cellspacing="0" class="templateContainer" style="background-color: #fafafa; border-collapse: collapse; border: 0px; color: black; max-width: 600px !important; text-size-adjust: 100%; width: 100%px;"><tbody>
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<span style="color: red;">SPECIAL BONUS eBOOK!<br />Labeling and Packaging Specs<br />-----</span></h1>
<h1 style="line-height: 32.5px; margin: 0px; padding: 0px;">
<span style="font-size: small;">Here is the <a href="http://www.vitaminconsultancy.com/Labeling-%26-Packaging-Specifications.pdf" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;" target="_blank" title="Labeling & Packaging Specifications eBook"><strong>LINK</strong></a> where you can download my latest eBook which explains how to keep a Labeling and Packaging Log in conformity with GMPs -- as provided in SOP #25 of the Vitamin Consultancy standard SOP format.</span></h1>
<a href="http://www.vitaminconsultancy.com/Labeling-%26-Packaging-Specifications.pdf" style="color: #2baadf; font-size: 16px; text-size-adjust: 100%;">http://www.vitaminconsultancy.com/Labeling-%26-Packaging-Specifications.pdf</a><br />
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<span style="color: red;">QUALITY COUNTS!</span><br /><span style="font-size: 18px;">And Increases Your Bottom Line</span><br /><strong><span style="font-size: 18px;">Nutrient Sales Surge During Declared Pandemic</span></strong></h1>
<center style="font-size: 16px;">
<strong><span style="font-size: 14px;"><a href="http://www.systemsprocessingintegration.com/" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;" target="_blank"><img data-file-id="2172628" height="450" src="https://mcusercontent.com/b90078d41a788bb042d5af1db/images/0e1fb631-0ec7-4c4f-9aa2-eca9b8679d43.jpg" style="border: 0px; height: 450px; margin: 0px; outline: none; text-decoration-line: none; width: 400px;" width="400" /></a></span></strong></center>
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<strong><span style="font-size: 18px;">Quality Counts!</span></strong></div>
<div style="font-size: 16px; line-height: 24px; margin-bottom: 10px; margin-top: 10px; padding: 0px; text-size-adjust: 100%;">
<strong><span style="font-size: 14px;">New ETQ Survey shows: "An important shift is happening. Organizations now treat quality as a strategic initiative. Survey data shows 66% of organizations categorize quality as a strategic growth investment. Treating quality as a strategic business initiative is paying off as organizations see an average return of 23% on their investments."</span></strong><br />
<br />
<span style="font-size: 14px;">Since Quality Counts, Quality Control must be a central concern. Under FDA's GMP there is no question that quality counts and that the product label owner is the responsible party for quality control. Your company needs to have Quality Control built into its Standard Operating Procedures (SOPs) and you need to have a designated Quality Control Manager.</span><br />
<br />
<span style="font-size: 14px;">The Vitamin Consultancy's standard SOPs include strong quality control provisions. In the vitamin industry, according to numerous FDA Form 483 Inspection Observations that means controlling "identity, purety, strength and composition" of the DSHEA product.<br /><br />Here is what the SOP says about the QC Manager: "The QC Manager shall review and evaluate with the company managers at least annually complaints, recalls, returned or salvaged products and internal investigations conducted for each."<br /><br />QC Goals include:</span></div>
<ul style="font-size: 16px;">
<li style="text-size-adjust: 100%;"><strong><span style="font-size: 14px;">Qualifying the Contract Manufacturer as capable meeting quality, strength, purity and identity standards</span></strong></li>
<li style="text-size-adjust: 100%;"><strong><span style="font-size: 14px;">Approving (or rejecting) products manufactured, processed, packed or held under contract by another company</span></strong></li>
<li style="text-size-adjust: 100%;"><strong><span style="font-size: 14px;">Approving (or rejecting) procedures and specifications impacting identity, strength, quality and purity</span></strong></li>
<li style="text-size-adjust: 100%;"><strong><span style="font-size: 14px;">Approving (or rejecting) packaging, labeling and product containers</span></strong></li>
<li style="text-size-adjust: 100%;"><strong><span style="font-size: 14px;">Reviewing and investigating consumer complaints.</span></strong></li>
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<strong><span style="font-size: 14px;">Contact me at ralph.fucetola@gmail.com and let's talk about brining your SOPs up-to-date. During this enforced period of self-shielding is a perfect time for you to get ready to get back to work! </span></strong></div>
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<strong><span style="font-size: 14px;">Learn more about my Systems Processing Integration!<br />I make being organized easy!<br /><a href="http://%20www.systemsprocessingintegration.com/" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;" target="_blank"> www.SystemsProcessingIntegration.com</a></span></strong></div>
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<span style="font-size: 14px;"><em>Stay safe</em> and for the latest from Dr. Rima and me on COVID-19 check <a href="http://www.truthaboutcoronavirus.com/" style="color: #2baadf; text-size-adjust: 100%;" target="_blank">www.TruthAboutCoronavirus.com</a> (if your browser says the site is "dangerous" it is right, but not a danger to <em>you</em>); alternatively, check <a href="http://www.opensourcetruth.com/" style="color: #2baadf; text-size-adjust: 100%;" target="_blank">www.OpenSourceTruth.com</a></span></div>
<center style="font-size: 16px;">
<strong><span style="font-size: 14px;"><a href="http://www.opensourcetruth.com/covid-second-wave/" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;"><img data-file-id="2215894" height="306" src="https://mcusercontent.com/b90078d41a788bb042d5af1db/images/4f1893a4-4495-411c-b077-2bfdba694d60.jpg" style="border: 0px; height: 306px; margin: 0px; outline: none; text-decoration-line: none; width: 500px;" width="500" /></a><br /><a href="http://www.opensourcetruth.com/covid-second-wave/" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;" target="_blank">http://www.opensourcetruth.com/covid-second-wave/</a></span></strong></center>
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Health Freedom of Choice Bloghttp://www.blogger.com/profile/15606420362458868870noreply@blogger.com0tag:blogger.com,1999:blog-1111124027441239439.post-58953453427687177262020-03-27T20:36:00.000-07:002020-03-27T20:36:17.709-07:00<table border="0" cellpadding="0" cellspacing="0" class="templateContainer" style="background-color: #fafafa; border-collapse: collapse; border: 0px; color: black; max-width: 600px !important; text-size-adjust: 100%; width: 100%px;"><tbody>
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<b>March 2020 Newsletter #2</b></div>
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<span style="font-size: 11px;">This Issue:<br />Pandemic Protective Masks<br />My Latest OST Article<br />Planning for After the Pandemic</span></h4>
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<span style="color: red;">PANDEMIC!</span><br /><strong><span style="font-size: 18px;">Dr. Rima: We Have Bulk Protective Masks</span></strong></h1>
<div style="line-height: 24px; margin-bottom: 10px; margin-top: 10px; padding: 0px; text-size-adjust: 100%;">
<strong>Everyone is worried about COVID-19 and every company is impacted by it. <em>And we all want to help. </em> Dr. Rima has sourced bulk amounts of protective masks. If you know institutional buyers, now is the time to let them know.</strong><br /><br />Here is the link:<br /><a href="http://drrimatruthreports.com/save-health-workers-lives-today/" style="color: #2baadf; text-size-adjust: 100%;" target="_blank">http://drrimatruthreports.com/save-health-workers-lives-today/</a><br /><br />The web page includes a product brochure with full details.<br /><br />And this link to my earlier March newsletter with an important article about Emergency SOP with Working Remotely provision:<br /><a href="http://vitaminlawyerarchives.blogspot.com/2020/03/march-2020-pandemic-newsletter.html" style="color: #2baadf; text-size-adjust: 100%;">http://vitaminlawyerarchives.blogspot.com/2020/03/march-2020-pandemic-newsletter.html</a><br /> </div>
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<div style="line-height: 24px; margin-bottom: 10px; margin-top: 10px; padding: 0px; text-align: center; text-size-adjust: 100%;">
<span style="font-size: 18px;"><strong>My latest article on Open Source Truth:<br /><a href="http://www.opensourcetruth.com/has-the-covid-curve-peaked/" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;">http://www.opensourcetruth.com/has-the-covid-curve-peaked/</a></strong></span><br /> </div>
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<strong style="color: red; font-size: 24px;">PLANNING YOUR BUSINESS REBOOT AFTER THE PANDEMIC</strong></div>
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<strong>While you are working from home it's time to plan your post-pandemic come-back. It may help your planning if you consider your dietary supplement consumer's expressed interests.</strong><br /><br /><span style="font-size: 11px;">https://www.nutraingredients-usa.com/Article/2020/03/25/Worldwide-supplement-survey-highlights-key-consumer-trends</span><br /><br /><strong><span style="font-size: 14px;">2019 Worldwide supplement survey highlights key consumer trends - </span></strong><span style="font-size: 12px;">25-Mar-2020 By Danielle Masterson</span><br /><br /><span style="font-size: 14px;">Glanbia Nutritionals surveyed users from across the globe to better </span><span style="font-size: 14px;">understand consumer motive, usage, and knowledge gaps. </span><span style="font-size: 14px;">US, UK and China consumers who used vitamins regularly.</span><br /><br /><strong><span style="font-size: 14px;">US users listed top reasons to purchase:</span><br /><br /><span style="font-size: 14px;">55% - General Health</span><br /><span style="font-size: 14px;">37% - Heart Health</span><br /><span style="font-size: 14px;">32% - Healthy Aging</span><br /><span style="font-size: 14px;">23% - Mental Health</span></strong><br /><br /><span style="font-size: 14px;">In the 18 - 34 age demographic brain/cognitive health a top concern; </span><span style="font-size: 14px;">55 - 70 group: healthy aging and sleep support</span><br /><br /><span style="font-size: 14px;">Top vitamins used worldwide: C, D and Calcium; </span><span style="font-size: 14px;">Q10, K2, choline and biotin had high consumer interest</span><br /><br /><strong><span style="font-size: 18px;">Now that's some food for thought... or thoughts about nutrient foods. <em>You get it. </em> Plan from data.</span></strong></div>
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Health Freedom of Choice Bloghttp://www.blogger.com/profile/15606420362458868870noreply@blogger.com0tag:blogger.com,1999:blog-1111124027441239439.post-38864031420599494872020-03-13T08:39:00.001-07:002020-03-13T08:39:47.966-07:00March 2020 Pandemic Newsletter<div class="separator" style="clear: both; text-align: center;">
<a href="http://www.truthaboutcoronavirus.com/" target="_blank"><img border="0" data-original-height="383" data-original-width="783" height="156" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjR-pxK271JtDMdyn1JszXNwZC1ha3ZBZXkDFHDbZeV14dXJsyCiMLZ7y9ZCKeX7e6mGwyNQXMJT4vAJlxWJMuIoj5BJQFZ4b7GEMoTFTdR8JGqc-J45iTshsUbWz_EyzOYnHWUc5WR9w0/s320/COVID-summit-banner1.jpg" width="320" /></a></div>
<h1 style="background-color: white; color: #202020; font-family: Helvetica; font-size: 26px; line-height: 32.5px; margin: 0px; padding: 0px; text-align: center;">
<span style="color: red;">PANDEMIC!</span><span style="font-size: 18px;"><br /></span></h1>
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<span style="font-size: 18px;">EMERGENCY PLANNING SOP</span></h1>
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<strong>Everyone is worried about COVID-19 and every company is impacted by it.</strong><br /><br />I have updated my Standard Operating Procedures (SOP) format to add <strong>Working Remotely</strong> to SOP #13, Emergency Planning.<br /><br />My regular retainer clients are receiving a copy of the revised SOP and those retainer companies that are part of my OPS for SOPs -- my on-line facility for Systems Processing Integration -- <a href="http://www.systemsprocessingintegration.com/" style="color: #2baadf; text-size-adjust: 100%;" target="_blank">www.SystemsProcessingIntegration.com</a> -- are having their SOPs automatically updated by me.<br /><br />Remember the OPS (Operating Procedures System) is a password-protected online page which houses copies of your SOPs and other primary regulatory documentation... just what you need during an emergency!<br /><br />If you want a copy of SOP #13, the cost is just $99 -- email me and I'll send you a PayPal money request.<br /><br />But during this emergency, I want everyone to have the information they need to protect their company. So here is the new section of SOP #13, so you can get ready for remote working if you find your company under lock-down.<br />---------------------------------------<br /><br /><strong>[2] Working Remotely - It may be necessary for some or all staff to work remotely during an emergency. In advance of such contingency the Emergency Manager should:</strong></div>
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<li style="text-size-adjust: 100%;"><strong>Establish an Online Communication System, such as (1) Skype or Zoom, instructing all staff to have access to the system via cell phone and home computer; (2) a Conference Call Bridge number should also be established and (3) a Push Notice System can be established to text group messages to staff member cell phones.</strong><br /> </li>
<li style="text-size-adjust: 100%;"><strong>Designate staff members who are essential to operations and who should, if possible, work from the facility.</strong><br /> </li>
<li style="text-size-adjust: 100%;"><strong>Designate staff members who can continue their work remotely.</strong><br /> </li>
<li style="text-size-adjust: 100%;"><strong>Designate times and circumstances where staff members should call the Conference Call Bridge for instructions or text instructions to staff members’ cell phones.</strong></li>
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I also included one additional duty to the general duties of your Emergency Manager (Section 1 of the SOP): "Maintain a list of staff members and their cell phones for text messaging and conference calling; this list should be maintained on a password-protected Internet Page which is part of the Company online OPS."<br /><br />Please let me know how I can help your company during this emergency.<br /><br /><strong>Dr. Laibow and I are maintaining a COVID information aggregation site here: <a href="http://www.truthaboutcoronavirus.com/" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;" target="_blank">www.TruthAboutCoronavirus.com</a><br /><br />We are planning a COVID Emergency Health Summit; more information here: <a href="http://www.inhere.org/2020/03/07/covid-19-emergency-health-summit/" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;">http://www.inhere.org/2020/03/07/covid-19-emergency-health-summit/</a></strong></div>
Health Freedom of Choice Bloghttp://www.blogger.com/profile/15606420362458868870noreply@blogger.com0tag:blogger.com,1999:blog-1111124027441239439.post-89529218599935313982020-02-14T11:12:00.000-08:002020-02-19T18:50:46.938-08:00Cost Segregation and Your Business<table border="0" cellpadding="0" cellspacing="0" class="templateContainer" style="background-color: #fafafa; border-collapse: collapse; border: 0px; color: black; max-width: 600px !important; text-size-adjust: 100%; width: 100%px;"><tbody>
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<span style="font-size: 14px;"><strong>The Vitamin Consultancy eLetter</strong></span><br />
February Texas Trip, Cost Segregation<br />
Systems Processing Integration</div>
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<span style="color: red;">COVID-19 DELAYS TRIP<br /><strike>I'LL BE IN TEXAS</strike><br /><strike>LATER THIS MONTH</strike></span></h1>
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<span style="color: #202020;">My February Trip to Texas is </span><span style="color: red;">NOT</span><span style="color: #202020;"> going ahead as planned. Instead, COVID-19 permitting, I'll be in the Lone Star State from 5 May through 9 May 2020 -- traveling from Dallas through Austin to Houston where I am the featured speaker at The Woodlands Lunch Forum on Friday, May 8th. More about that event here: </span><a href="https://www.woodlandsonline.com/npps/story.cfm?nppage=65447" style="color: #2baadf;">https://www.woodlandsonline.com/npps/story.cfm?nppage=65447</a><span style="color: #202020;"> -- if you are going to be in the area, I'd love to see you!</span></div>
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<strong><span style="font-size: large;">Do you want to save money on your business <nobr style="font-size: inherit;"><a class="pxInta" href="https://us14.campaign-archive.com/?e=&u=b90078d41a788bb042d5af1db&id=ce024281a1#" id="PXLINK_3_0_3" style="background-color: transparent !important; border-bottom-color: rgb(28, 125, 255) !important; border-bottom-style: solid !important; border-image: initial !important; border-left-color: initial !important; border-left-style: initial !important; border-right-color: initial !important; border-right-style: initial !important; border-top-color: initial !important; border-top-style: initial !important; border-width: 0px 0px 1px !important; color: #2baadf; display: inline !important; font-size: inherit !important; font-weight: normal; padding-bottom: 1px !important; text-size-adjust: 100%;">Income Taxes</a></nobr>?</span> </strong><br />
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<strong><span style="color: #8d2424; font-size: large;">OF COURSE YOU DO!</span></strong></div>
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<span style="font-size: 12px;"><strong>Our Financial Services can help you accelerate your real estate depreciation through an engineered Cost Segregation (Cost<br />Seg) Study allowing you to expense <em>10% to 50% </em>of the cost of your building in the <em>FIRST YEAR</em>! </strong><br /><span style="color: #2a2a2a;"> </span><br /><strong>The TAX saving is guaranteed by <em>Urb Financials</em> to be </strong>ten<strong> times the cost of the study! </strong><br /><span style="color: #2a2a2a;"> </span><br /><strong>What is Cost Seg? </strong><strong><a href="http://winningbusinesssolutions.weebly.com/costseg-general.html" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;">CLICK HERE</a></strong><br /><br /><strong>How does Cost Seg benefit you? <a href="http://winningbusinesssolutions.weebly.com/costseg-general.html" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;">CLICK HERE</a></strong><br /><span style="color: #2a2a2a;"> </span><br /><strong>What is the IRS’ position on Cost Seg? <a href="http://winningbusinesssolutions.weebly.com/costseg-general.html" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;">CLICK HERE</a> </strong><br /><br /><span style="color: white;">"Some taxpayers are reluctant to use cost segregation, equating it with a high-risk tax shelter. In truth, this reluctance is misplaced. If the cost of the components in the engineering report is well- documented, the cost segregation technique is no more aggressive than using a permissible depreciation method under the Internal Revenue Code." </span><em>Journal of Accountancy</em><br /><span style="color: #2a2a2a;"> </span><br /><strong>Advanced Strategies and FAQs? <a href="http://winningbusinesssolutions.weebly.com/costseg-faqs.html" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;">CLICK HERE</a> </strong></span><br />
<br />
<strong><span style="font-size: large;"><span style="color: #8d2424;">THE PRELIMINARY COST SEGREGATION ANALYSIS IS FREE.</span><br /><span style="color: #2a2a2a;"> <a href="http://winningbusinesssolutions.weebly.com/costseg-questionnaire.html" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;">CLICK HERE FOR ESTIMATE APPLICATION</a></span></span></strong><br />
<br />
<strong><span style="color: white;">Once completed, please return Estimate </span><a href="http://winningbusinesssolutions.weebly.com/costseg.html#" id="PXLINK_0_0_0" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;"><span style="color: white;">Application Formn</span></a><span style="color: white;"> to <em>GET </em>at </span><a href="mailto:dannyfucetola@gmail.com" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;"><span style="color: white;">dannyfucetola@gmail.com</span></a><span style="color: white;"> and typically within ten business days of receipt of your completed form, we will provide you with a FREE Preliminary Analysis containing the estimate of the income tax benefits and projected cost of a Cost Segregation Study.</span></strong></td></tr>
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<strong><span style="color: red;">SYSTEMS PROCESSING INTEGRATION<br />DEFINING REGULATORY COMPLIANCE!</span></strong></div>
My experience will strengthen your company! I provide private and confidential, competent electronic professional consulting to my Dietary Supplement and advanced healthcare ("CAM") modality clients, for the purpose of compliance with International, State and Federal (including FTC and FDA) standards for communicating about dietary supplements (including medical foods) and/or providing health care services and information. You should consider my SOP / cGMP Certification Course, allowing start-up and established vitamin companies and practitioners who own their own private labeled products to meet FDA procedural regulations.<br />
<div style="text-align: center;">
<span style="font-size: 10px;"><strong><a href="http://www.vitaminconsultancy.com/" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;" target="_blank">VitaminConsultancy.com</a><br /><a href="http://www.systemsprocessingintegration.com/" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;" target="_blank">SystemsProcessingIntegration.com</a><br /><a href="http://www.professionalsafetydossier.com/" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;" target="_blank">ProfessionalSafetyDossier.com</a></strong></span></div>
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Health Freedom of Choice Bloghttp://www.blogger.com/profile/15606420362458868870noreply@blogger.com0tag:blogger.com,1999:blog-1111124027441239439.post-66851024507821522332020-01-29T11:16:00.000-08:002020-02-19T18:51:26.199-08:00Announcing: SPI Associates<table border="0" cellpadding="0" cellspacing="0" style="background-color: #fafafa; border-collapse: collapse; color: #222222; font-family: Roboto, RobotoDraft, Helvetica, Arial, sans-serif; font-size: small; width: 100%px;"><tbody>
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<span style="font-size: 18px;"><strong><br />January 2020 Second Issue:<br />INTRODUCING <em>SPI ASSOCIATES</em><br />SYSTEMS PROCESSING INTEGRATION<br /><a href="http://www.systemsprocessingintegration.com/">www.SystemsProcessingIntegration.com</a></strong></span></div>
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The Vitamin Consultancy</h1>
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<strong>SPI ASSOCIATES</strong></h2>
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<strong>Systems Processing Integration<br />Meeting FDA/FTC Natural Product<br />Regulatory Requirements<br /><a href="http://www.systemsprocessingintegration.com/">www.SystemsProcessingIntegration.com</a></strong></div>
<br />
<em>Systems Processing Integration Associates</em> is a project of The Vitamin Consultancy. It includes Ralph Fucetola JD, Robert Goodman, PhD and other professionally qualified associates who collaborate to meet natural product company Operating Procedure System needs.<br />
<br />
The dietary supplement, natural remedy, natural personal care markets are exceeding one hundred billion dollars annually, in the USA alone. [1] As the market has grown the original natural product pioneers are being succeeded by entrepreneurs and managers who are committed to protecting their companies’ Intellectual Property by organizing their processing systems in conformity with regulatory requirements.<br />
<br />
At the same time the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) are ratcheting-up enforcement and regulations. Although Congress told the FDA, when the Dietary Supplement Health and Education Act (DSHA) was adopted in 1994, that dietary supplement regulations should be like food regulations, the agency has consistently pushed for regulations that are much more like the highly restrictive requirements that apply to drug companies.<br />
<br />
FDA says that if your company owns the Label, as the Label Owner, your company must be “in a state of control” over the entire process of producing, storing, shipping and customer service. You can contract out each of these steps, but you must remain in control of them, by having carefully constructed Standard Operating Procedures (SOPs), by training your staff in operating the company under formal SOPs, and by being able to prove that your staff has been so trained.<br />
<br />
With recent FDA inspection emphasis on Quality Control (requiring a Quality Control Manager), Preventive Controls Qualified Individual (requiring a certified PCQI manager to sign-off on all new product runs) and renewed interest in seeing your company’s Specifications and Product Testing records, making sense of your process controls and organizing your systems, what I call <em>Systems Processing Integration</em>, must take a top priority to effectively manage your business.<br />
<br />
Our goal is to bring my half century of experience in the natural products industry, and that of my associates, to bear on the question of integrating and coordinating the various systems that you need in place to control your business, minimize control expenses, and enhance your capacity to compete in a tough market.<br />
<br />
<strong style="text-align: center;"><a href="http://www.systemsprocessingintegration.com/">www.SystemsProcessingIntegration.com</a></strong><br />
<div style="text-align: left;">
<br /></div>
We do this by integrating several services that support your business structure.<br />
<br />
<strong>[1] Standard Operating Procedures.</strong> This document tracks FDA concerns and includes 43 pages of procedures, formats and forms. Included:<br />
<br />
<span style="font-size: 10px;"> 1. Introduction / Index<br /> 2. Refund, Delivery & Returns Policies<br /> 3. Standard Disclaimers; Site Use Statement<br /> 4. Standard Waivers<br /> 5. Email Privacy Policy<br /> 6. Document Retention Policy<br /> 7. Quality Control / Claims / Complaints / Food Safety<br /> 8. Contract Manufacturer Agreement<br /> 9. Password and Internet/Program Access Controls<br /> 10. Order Processing Procedure<br /> 11. Bookkeeping and Account Management<br /> 12. Order Record and Retrieval; AER Reporting<br /> 13. Emergency Planning and Crisis Management<br /> 14. Payment Card Industry Data Security System<br /> 15. Private Labeling / Labels<br /> 16. Receiving, Handling, Shipping & Storage<br /> 17. Recalls<br /> 18. Complaint Form<br /> 19. Change Controls / New SOPs<br /> 20. CAPA<br /> 21. OPS (Operations Procedure System) / CCDS<br /> 22. New Employee Qualification and Training<br /> 23. Official Inspections: Procedures<br /> 24. New Product Development; Product Retirement<br /> 25. Labeling and Packaging Specifications</span><br />
<br />
Addenda:<br />
<br />
<span style="font-size: 10px;">Site Use Statement<br />Waivers<br />Complaint Form<br />CCDS Form<br />Contract Terms<br />Social Media Schedule<br />Program Access<br />Safety Contract<br />Food Safety Plan<br />Label & Packaging Specifications</span><br />
<br />
Within the structure of the SOPs are provisions for the Food Safety Plan, an increasing concern of Federal Regulators.<br />
<br />
The staff positions contemplated by recent FDA inspections include:<br />
<br />
<span style="font-size: 10px;">CEO<br />COO<br />Quality Control Manager (QCM)<br />Preventive Controls Qualified Individual (PCQI)<br />Emergency Manager (EM)<br />SOP & CCDS Manager<br />Customer Service Manager<br />Warehouse Manager</span><br />
<br />
<strong>[2] Webinar Training Program.</strong> With two dozen webinars, we cover a range of training necessary to implement an integrated processing system. The SOP training webinars cover the documents and the records which companies are required to keep.<br />
<br />
Current webinars include:<br />
<br />
<span style="font-size: 10px;">CAM Cautions<br />Cosmetic Safety Dossier Introduction<br />DS & Medical Foods for Physicians<br />Food Safety Plan - PCQI Training<br />Health Claims<br />Lawful Copy Writing<br />Minister CAM Practices<br />NGO Formation<br />OPS 4 SOPs<br />Quality Control<br />Record Keeping for GMPs<br />Second Opinion Wellness Coaching<br />SOP1: Introduction<br />SOP2: Section 1<br />SOP3: Section 2<br />SOP4: Conclusion<br />SOPs Certification Test<br />SOPs Certification Test for HCPs<br />SOPs for Health Care Practitioners<br />STS: Specifications, Tests, Samples</span><br />
<br />
Successful completion of training programs results in issuance of Certificates of Completion.<br />
<br />
<strong>[3] Third Party Certifications and Dossiers. </strong> Federal and State Regulators have a number of other regulatory concerns, some of which can be met through the services of third party certifiers which we coordinate. These include:<br />
<br />
<ol>
<li style="margin-left: 15px;"><strong>Proposition 65 Safety Dossiers. <a data-saferedirecturl="https://www.google.com/url?q=http://www.ProfessionalSafetyDossier.com&source=gmail&ust=1580400289660000&usg=AFQjCNEnElKtCIJMYGuQrirTHlP0yyR87w" href="http://www.professionalsafetydossier.com/" style="color: #6dc6dd; font-weight: normal;" target="_blank">www.ProfessionalSafetyDossier.<wbr></wbr>com</a></strong><br /><br />California increased its “Prop 65” program requiring stricter warnings for potentially toxic or cancer-causing substances in the marketplace. New York and New Jersey have just adopted similar regulations. The regulation allows companies to rely upon third party safety research and certifications.<br /> </li>
<li style="margin-left: 15px;"><strong>Cosmetic Product Safety Dossiers</strong> (for both USA and EU regulations).<br /><br />In the USA cosmetic labels must carry a “not safety tested” warning unless the product was safety tested or a qualified third party certifies that the ingredients are safe. The EU has a similar requirement. <a data-saferedirecturl="https://www.google.com/url?q=http://www.CosmeticSafetyDossier.com&source=gmail&ust=1580400289660000&usg=AFQjCNFxUTAP55Zx32uKcu9b9FY-qyBeGA" href="http://www.cosmeticsafetydossier.com/" style="color: #6dc6dd;" target="_blank">www.CosmeticSafetyDossier.com</a><br /> </li>
<li style="margin-left: 15px;"><strong>Safety Data Sheets.</strong><br /><br />While not yet formally required by FDA, Amazon now wants to see a formal Safety Data Sheet for many personal use products. Third Party Certified data sheets meet the requirement.</li>
</ol>
<br />
<strong>[4] Systems Processing Integration.</strong> <a data-saferedirecturl="https://www.google.com/url?q=http://www.SystemsProcessingIntegration.com&source=gmail&ust=1580400289660000&usg=AFQjCNHCRsDN9QfHSVinuTWAR49US7bIFg" href="http://www.systemsprocessingintegration.com/" style="color: #6dc6dd;" target="_blank">www.<wbr></wbr>SystemsProcessingIntegration.<wbr></wbr>com</a><br />
<br />
Bringing all the above data together, in one protected online location, ready for the inevitable FDA inspection, is the goal of Systems Processing Integration.<br />
<br />
Your private, password-protected SPI site includes copies of:<br />
<br />
SOPs<br />
CCDS (Company Core Data Sheet) for each product<br />
FDA-required Structure and Function Claim Post-Market Notices<br />
Commonly-used SOP forms<br />
Safety Dossiers<br />
Mission Statement and Branding Dossier<br />
Food Safety Plan<br />
FDA Food Facility Registration<br />
Key Manager Certifications (QCM, PCQI, etc.)<br />
<br />
<strong>SPI Associates, in cooperation with <em>The Vitamin Consultancy</em>, oversees and maintains your SPI site and its contents. There is a modest set-up fee and an annual or monthly maintenance fee.</strong><br />
<br />
<strong>Contact:</strong> <a href="mailto:ralph.fucetola@gmail.com" style="color: #6dc6dd;" target="_blank">ralph.fucetola@gmail.com</a> for further information and fees.<br />
<br />
<b>IRB SERVICES</b><br />
<br />
An allied service which can further support product claim substantiation is the Institute for Health Research's IRB service.<br />
<br />
A clinical trial is the best evidence supporting claims, but the trial must start with a formal Protocol that meets IRB (Institutional Review Board) Informed Consent standards, or the results may not be eligible for publication and may be rejected as substantiation.<br />
<br />
Dr. Goodman and I provide, through the Institute, assistance in preparing a Protocol which will comply with IRB standards, designing the trial with the Principle Investigator (PI).<br />
<br />
Unless you ask the right questions at the start the clinical trial will most likely not provide the data you need for legal substantiation. For more about the IRB services go to <a href="http://www.inhere.org/">www.InHeRe.org</a> and search the IRB drop-down tab.<br />
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<span style="font-size: 10px;">[1] <a data-saferedirecturl="https://www.google.com/url?q=https://www.grandviewresearch.com/industry-analysis/dietary-supplements-market&source=gmail&ust=1580400289660000&usg=AFQjCNEJkvgeyrb11z3ltnWpWFwsBE3DGQ" href="https://www.grandviewresearch.com/industry-analysis/dietary-supplements-market" style="color: #6dc6dd;" target="_blank">https://www.grandviewresearch.<wbr></wbr>com/industry-analysis/dietary-<wbr></wbr>supplements-market</a></span></td></tr>
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<span style="background: 0px 0px; border: 0px; color: black; font-family: "times new roman", times, serif; font-size: x-small; font-style: italic; font-weight: bold; letter-spacing: 0.05em; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">SPI Associates</span><span style="background-color: initial; color: black; font-family: "times new roman", times, serif; font-size: x-small; font-weight: bold; letter-spacing: 0.05em;"> -- Providing Specialist Support to Your Organization and its Integrated </span><span style="background: 0px 0px; border: 0px; color: black; font-family: "times new roman", times, serif; font-size: x-small; font-style: italic; font-weight: bold; letter-spacing: 0.05em; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">Standard Operating Procedures</span><span style="background-color: initial; color: black; font-family: "times new roman", times, serif; font-size: x-small; font-weight: bold; letter-spacing: 0.05em;"> [SOPs], Operating Procedures Systems [OPS], Mission and Branding Policies.</span></div>
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<span style="background: 0px 0px; border: 0px; font-family: "times new roman" , "times" , serif; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;"><span style="background: 0px 0px; border: 0px; color: black; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;"><span style="background: 0px 0px; border: 0px; font-weight: bold; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;"><span style="background: 0px 0px; border: 0px; letter-spacing: 0.05em; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">We develop and maintain a private, password protected, OPS for SOPs web site for your Company. Just when you need access to your documentation the most urgently [for example, during a storm or a <span style="background: 0px 0px; border: 0px; font-style: italic; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">surprise FDA inspection</span>] you will be <span style="background: 0px 0px; border: 0px; font-style: italic; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">very</span> happy your Company worked with Systems Processing Integration to establish your Private Site. When you need your regulatory compliance documentation available it will probably be too late to benefit from this program. Act now. Contact us here: </span></span></span><span style="background: 0px 0px; border: 0px; color: #008afc; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;"><span style="background: 0px 0px; border: 0px; font-weight: bold; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;"><span style="background: 0px 0px; border: 0px; letter-spacing: 0.05em; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;"><span style="background: 0px 0px; border: 0px; margin: 0px; outline: 0px; padding: 0px; text-decoration-line: underline; vertical-align: baseline;"><a href="https://ralphfucetola.wixsite.com/mysite/04-contact" style="background: 0px 0px; border: 0px; cursor: pointer; margin: 0px; outline: 0px; padding: 0px; text-decoration-line: none; vertical-align: baseline;" target="_blank">CONTACT</a></span></span></span></span></span></div>
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My experience will strengthen your company! I provide private and confidential, competent electronic professional consulting to my Dietary Supplement and advanced healthcare ("CAM") modality clients, for the purpose of compliance with International, State and Federal (including FTC and FDA) standards for communicating about the advertising and sale of dietary supplements (including medical foods) and/or providing of health care services and information. You should consider my SOP / cGMP Certification Course, allowing start-up and established vitamin companies and practitioners who own their own private labeled products to meet with new FDA procedural regulations.</div>
<div style="font-size: 15px; text-align: center;">
<strong><a data-saferedirecturl="https://www.google.com/url?q=http://www.vitaminconsultancy.com&source=gmail&ust=1580400289661000&usg=AFQjCNHEf-yc5tlk99wCu-OAZGtkK67i_g" href="http://www.vitaminconsultancy.com/" style="color: #6dc6dd; font-weight: normal;" target="_blank">www.VitaminConsultancy.com</a></strong></div>
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<strong>SAMPLE PRIVATE SITE ENTRY</strong></div>
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Health Freedom of Choice Bloghttp://www.blogger.com/profile/15606420362458868870noreply@blogger.com0tag:blogger.com,1999:blog-1111124027441239439.post-65347007580461213422020-01-23T12:01:00.000-08:002020-01-23T12:01:03.767-08:00January 2020 -- Useful Links for the New Year<table border="0" cellpadding="0" cellspacing="0" class="mcnTextBlock" style="background-color: white; border-collapse: collapse; color: black; min-width: 100%; text-size-adjust: 100%; width: 100%px;"><tbody class="mcnTextBlockOuter">
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiVf24cHJY-qdXeHVNuvsxRN3omIYLjMt6RM-9FaenuPEeLvY7TflVc9M9ayY_FobMs43BNtHeNTK1f0Dm4gDNRTkqwqCR4zxX0W29mG8sN_ZQJBX-OW6bA1sC-DwcWf7QhIvv0-J-V24E/s1600/RF.newVC.banner.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="391" data-original-width="1192" height="104" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiVf24cHJY-qdXeHVNuvsxRN3omIYLjMt6RM-9FaenuPEeLvY7TflVc9M9ayY_FobMs43BNtHeNTK1f0Dm4gDNRTkqwqCR4zxX0W29mG8sN_ZQJBX-OW6bA1sC-DwcWf7QhIvv0-J-V24E/s320/RF.newVC.banner.jpg" width="320" /></a></div>
<h1 style="line-height: 32.5px; margin: 0px; padding: 0px; text-align: center;">
<span style="color: #444444; font-size: small; font-weight: normal;">January 2020 Newsletter</span></h1>
<h1 style="color: #202020; font-size: 26px; line-height: 32.5px; margin: 0px; padding: 0px; text-align: center;">
<span style="color: red;">New Year Ideas for<br />You and Your Business</span></h1>
<div style="color: #202020; font-size: 16px; line-height: 24px; margin-bottom: 10px; margin-top: 10px; padding: 0px; text-align: center; text-size-adjust: 100%;">
<strong>MY USEFUL LINKS</strong><br /><strong><span style="font-size: 14px;"><em>Is this the Year YOU will Get Organized?</em><br /><a href="http://www.systemsprocessingintegration.com/" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;" target="_blank">www.SystemsProcessingIntegration.com</a></span></strong></div>
<div style="color: #202020; font-size: 16px; line-height: 24px; margin-bottom: 10px; margin-top: 10px; padding: 0px; text-align: center; text-size-adjust: 100%;">
<span style="font-size: 14px;"><strong>Prop 65 / Cosmetic / Amazon Safety Dossier<br /><a href="http://www.professionalsafetydossier.com/" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;" target="_blank">www.ProfessionalSafetyDossier.com</a></strong></span><br />New York now has its own Prop 65 Law<br />And New Jersey is about to follow.</div>
<hr style="color: #202020; font-size: 16px;" />
<div style="color: #202020; font-size: 16px; line-height: 24px; margin-bottom: 10px; margin-top: 10px; padding: 0px; text-align: center; text-size-adjust: 100%;">
<strong>AND THESE USEFUL LINKS FROM THE FDA</strong></div>
<div style="color: #202020; font-size: 16px; line-height: 24px; margin-bottom: 10px; margin-top: 10px; padding: 0px; text-size-adjust: 100%;">
<span style="font-size: 18px;"><strong>Food Facilities Registration:</strong></span><br />https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions<br /><br /><span style="font-size: 14px;"><strong>FDA Search Databases:</strong></span><br />https://www.fda.gov/industry/fda-basics-industry/search-databases<br /><br /><span style="font-size: 14px;"><strong>Medical Device Search:</strong></span><br />https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm<br /><br />"Many organizations that manufacture devices and products for distribution and use in the United States are required to register with the U.S. Food and Drug Administration on an annual basis. Some of this registration information is available to the public – but not all. For example, although food manufacturers are required to register with the FDA, the public is not entitled to their registration information." -- https://legalbeagle.com/5835541-manufacturers-fda-registration-number.html</div>
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<tr><td class="mcnTextContent" style="color: #f2f2f2; font-family: Helvetica; font-size: 14px; line-height: 21px; padding: 18px; text-align: center; text-size-adjust: 100%; word-break: break-word;" valign="top"><span style="font-size: 18px;"><strong>Cost Segregation -- COST SEG</strong></span><br /><strong>Can Save Your Company Taxes</strong><br /><strong>You don't want to pay more taxes<br />than you have to... right?</strong><br /><a href="http://www.winning-business-solutions.com/" style="color: #2baadf; text-size-adjust: 100%;" target="_blank"><strong>www.Winning-Business-Solutions.com</strong></a></td></tr>
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<tr><td class="mcnTextBlockInner" style="padding-top: 9px; text-size-adjust: 100%;" valign="top"><table align="left" border="0" cellpadding="0" cellspacing="0" class="mcnTextContentContainer" style="border-collapse: collapse; max-width: 100%; min-width: 100%; text-size-adjust: 100%; width: 100%px;"><tbody>
<tr><td class="mcnTextContent" style="color: #202020; font-family: Helvetica; font-size: 16px; line-height: 24px; padding: 0px 18px 9px; text-size-adjust: 100%; word-break: break-word;" valign="top"><strong>Winning Business Solutions can help you accelerate your real estate depreciation through an engineered Cost Segregation Study allowing you to expense <em>10% to 50% </em>of the cost of your building in the FIRST YEAR! </strong><br /><br /><strong>The tax savings is guaranteed to be ten times the cost of the study! </strong><br /><br /><strong><em>What is Cost Segregation?</em> </strong><br /><br />Currently, the IRS sees your building as one entity, depreciated using straight line depreciation over 27.5 or 39 years, or, in our analogy, a Big Mac. After an engineered Cost Segregation Study, the IRS will see the components of your building, e.g., decorative lighting or outdoor landscaping, much like we view a Big Mac as two all-beef patties, special sauce, lettuce, cheese, pickles, onions on a sesame seed bun.<br /><br />An engineered Cost Segregation Study allows some components to be moved into 5, 7 or 15-year property depreciation categories – lettuce might be in the 5-year category and the sesame seed bun might be in the 15-year category, just like decorative lighting is 5-year property and landscaping is 15-year property with an engineered Cost Segregation Study.<br /><br />Under the new tax bill, 5-year property, typically where the bulk of the reclassified components go, can be entirely expensed in the first year!<br /><br />Which means, depending on the type of building, 10% to 50% of your building can now be written off in the first year!<br /> <div style="text-align: center;">
<strong>How do you start your Cost Seg benefits?<br />Go to <a href="http://www.winning-business-solutions.com/" style="color: #2baadf; font-weight: normal; text-size-adjust: 100%;" target="_blank">www.Winning-Business-Solutions.com</a></strong><br />Complete the Contact Form</div>
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<span style="font-size: 24px;"><strong>CBD NEWS</strong></span></div>
<br />USDA Approves First State and Tribal Hemp Production Plans<br />Nicholas Saraceno | January 2, 2020<br /><br />The U.S. Department of Agriculture (USDA) has approved the first set of plans submitted by states and Indian tribes for the domestic production of hemp under the U.S. Domestic Hemp Production Program. The plans were submitted by the states of Louisiana, New Jersey and Ohio, and the Flandreau Santee Sioux, Santa Rosa Cahuilla, and La Jolla Band of Luiseño Indian Tribes.<br /><br />The Agriculture Improvement Act of 2018 (2018 Farm Bill) directed USDA to develop a regulatory oversight program for hemp and include provisions for USDA to approve hemp production plans submitted by states and Indian tribes. Accordingly, on Oct.31, 2019, USDA issued an interim final rule establishing the U.S. Domestic Hemp Production Program and the provisions for USDA to approve submitted plans. State and tribal plans provide details on practices and procedures that enable hemp producers in their jurisdictions to operate according to their individual plans and in compliance with federal laws.<br /><br />To produce hemp, growers must be licensed or authorized under a state, tribe or USDA production program. The program a grower is licensed under depends on the location of the hemp growing facility. If a state or tribe has an approved plan or is in the process of developing a plan, growers must apply and be licensed or authorized under its hemp program. If a state or tribe does not have a plan and does not intend to have a plan, growers can apply for a license from USDA.<br /><br />https://vitaminretailer.com/usda-approves-first-state-and-tribal-hemp-production-plans/<br /><br />-----------------<br /><br />https://vitaminretailer.com/congress-punts-on-regulating-cbd-in-year-end-spending-bill/<br /><br />Congress Punts on Regulating CBD in Year-End Spending Bill<br />Nicholas Saraceno | January 2, 2020<br /><br />On Dec. 16, Congress punted on legislation to regulate the growing CBD industry and set a safe level of daily consumption. The conference report directs funding for research, policy evaluation, market surveillance and enforcement discretion related to CBD and hemp. Unlike legislation, the conference report does not have the force of law.<br /><br />The Natural Products Association (NPA) supports legislation introduced by Congressman Jerry McNerney (D-CA) that would appropriate $100,000 for the FDA (U.S. Food and Drug Administration) to perform a Health Hazard Evaluation (HHE) and set a safe level of CBD for consumers to use each day. The legislation passed the House of Representatives in June of this year and follows the same precedent as red yeast rice, which allows a natural product to contain a level of a drug ingredient that the FDA has determined to be safe.<br /><br />“While providing funding for testing is a positive first step, unfortunately, today’s action falls short of what is needed to protect consumers. The future of the U.S. hemp industry and the farmers and producers who provide it are directly tied to smart regulations for CBD, which includes FDA establishing a safe level of consumption so consumers are protected,” said Daniel Fabricant, PhD, president and CEO of NPA. “We are concerned that if Congress fails to act next year then we could see another vaping-like public health crisis. While we are proud to be the only association to work on real legislation to regulate the CBD market, we are disappointed that Congress ultimately decided not to act. We appreciate the leadership of Congressman McNerney and look forward to working next year on a way to ensure consumers are protected.”<br /><br />For more information, visit www.npanational.org.</td></tr>
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Health Freedom of Choice Bloghttp://www.blogger.com/profile/15606420362458868870noreply@blogger.com0tag:blogger.com,1999:blog-1111124027441239439.post-69945981640067542482019-12-16T12:03:00.000-08:002020-01-23T12:05:25.575-08:00Marketing During the Trump Boom<h1 style="background-color: white; font-family: Helvetica; line-height: 32.5px; margin: 0px; padding: 0px; text-align: center;">
<span style="color: red; font-size: 26px;">MARKETING DURING THE TRUMP BOOM</span></h1>
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<span style="color: #444444; font-size: small; font-weight: normal;">December 2019 Newsletter</span></h1>
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<span style="color: black;"><strong><span style="font-size: 18px;">Natural Product companies marketing regulated products during the Trump Boom require focus on <em>your </em>Brand and <em>your</em> Systems Integration.</span></strong></span><br /><br /><span style="font-size: 14px;">The stock-market is reaching extraordinary heights (maybe even moving from Boom to Bubble... to the inevitable Bust?) while Trump Tariffs are about to double the cost of products such as wines made in the EU. New trade deals, while not Free Trade, at least offer the promise of more trade. The economy, bolstered by low interest rates and by the regulatory reforms which are unleashing the spirit of enterprise, continues to grow.<br /><br /><strong><span style="color: black;">So how do regulated Natural Product Companies prepare themselves for the coming year's continuing boom?</span></strong><br /><br />One important step is to be aware of the trends in regulation. I've analysed the FDA's Warning Letters for 2019 and summarized them in a previous newsletter. You can review that here: <a href="http://vitaminlawyerarchives.blogspot.com/2019/11/fda-warning-letters-specifications.html" style="color: #2baadf; text-size-adjust: 100%;">http://vitaminlawyerarchives.blogspot.com/2019/11/fda-warning-letters-specifications.html</a> -- FDA, like all bureaucracies, acts in waves of interest and disinterest. This past year both warning letters and comments during inspections suggest the written Specifications are a key to the agency's actions. I've prepared a webinar about Specifications. If you haven't seen it, I'll provide it to you at super discount. For just $50 -- email me at ralph.fucetola@gmail.com with Specifications in the subject line.</span><br /><br /><span style="font-size: 14px;"><strong><span style="color: black;">Really benefiting from the Trump Boom requires going beyond being aware of regulation to being proactive in marketing.</span></strong></span></div>
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<span style="font-size: 14px;"><strong><span style="color: black;">I strongly recommend using the holiday season "down time" to prepare for the coming year by taking two powerful steps: </span></strong><br /><br /><span style="color: black;"><strong>1. GET YOUR BRAND IN ORDER!</strong> Your Brand is an asset! It is your chief Intellectual Property. A proper Company Branding Profile adds value to your company. Let me work with you to secure this asset.<br /><br /><strong>2. INTEGRATE YOUR CONTROL SYSTEMS! </strong>-- <a href="http://www.systemsprocessingintegration.com/" style="color: #2baadf; text-size-adjust: 100%;" target="_blank">http://www.systemsprocessingintegration.com</a> </span></span><br /><br /><span style="font-size: 14px;"><strong>How do you do these essential tasks? You contact me at ralph.fucetola@gmail.com </strong></span><br /><br /><span style="font-size: 14px;">Happy New Year!<br /><br />Ralph</span></div>
Health Freedom of Choice Bloghttp://www.blogger.com/profile/15606420362458868870noreply@blogger.com0tag:blogger.com,1999:blog-1111124027441239439.post-69900276275734092712019-11-05T16:09:00.003-08:002019-11-05T16:10:34.831-08:00Vitamin Consultancy Services - Discounted<div class="separator" style="clear: both; text-align: center;">
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<a href="http://www.systemsprocessingintegration.com/" target="_blank">http://www.SystemsProcessingIntegration.com</a><br />
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<span style="font-size: 18px;"><strong>ALL THE VITAMIN CONSULTANCY SERVICES <em>YOU</em> NEED</strong><br /><span style="color: red;"><strong>DISCOUNTED 1/3 FOR THE 2019 'SELLING SEASON'</strong></span></span></h1>
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<b style="text-align: center;"><span style="font-size: xx-small;"> </span><br />GETTING READY FOR THE HOLIDAY SELLING SEASON?</b><br />
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<b style="text-align: center;">Vitamin Consultancy Services - 2019</b></div>
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<b style="text-align: center;">ALL PRICES REDUCED 33%</b></div>
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<b style="text-align: center;">Some of These Services are with Third Parties</b><br />
<b style="text-align: center;"><br /></b>
<b>1. <a href="http://www.vitaminconsultancy.com/">www.VitaminConsultancy.com</a></b><br />
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A. New Product Development Checklist<br />
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B. DSHEA, Medical Food and Cosmetic Labels Review<br />
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C. Sales Copy Review<br />
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D. GMP (Good Manufacturing Procedures) Manufacturer Audit<br />
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E. Standard Operating Procedures (SOPs) & Forms<br />
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(1) - SOP Format (41 Pages)<br />
(2) - Specifications for Master Manufacturing Record Checklist<br />
(3) - Food Safety Plan Format<br />
(4) - Site Use Statement Format<br />
(5) - Waivers (Testimonial, Model, Clinical Trial)<br />
(6) - Complaint Form<br />
(7) - CCDS (Company Core Data Sheet) Form<br />
(8) - Manufacturer Contract Terms<br />
(9) - Standard Quality Control Contract, Manufacturer<br />
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<b>2. <a href="http://www.professionalsafetydossier.com/">www.ProfessionalSafetyDossier.com</a> </b>[with Robert Goodman, PhD]<br />
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A. Safety Data Sheet (SDS) Dossier<br />
B. Cosmetic Safety Dossier<br />
C. California Prop 65 Safety Dossier<br />
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<b>3. <a href="http://www.systemsprocessingintegration.com/">www.SystemsProcessingIntegration.com</a></b><br />
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A. Operating Procedures Systems (OPS) -- SOP Documentation Private Website<br />
B. Mission and Branding Dossier<br />
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<b>4. <a href="http://www.inhere.org/">www.InHeRe.org</a></b><br />
Institute for Health Research [with Robert Goodman, PhD]<br />
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A. Institutional Review Board (IRB) Services for Clinical Trials<br />
B. Protocol Development for Clinical and Research Studies, and Clinical Trials<br />
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<b>5. <a href="http://www.tinyurl.com/SOPcertification">www.tinyurl.com/SOPcertification</a></b><br />
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A. SOP Certifications<br />
B. GMP Certifications<br />
C. PCQI (Preventive Controls Qualified Individual) Certifications<br />
D. The Vitamin Consultancy Webinars<br />
-- CAM Cautions<br />
-- Cosmetic Safety Dossier Introduction<br />
-- DS & Medical Foods for Physicians<br />
-- Food Safety Plan - PCQI Training<br />
-- Health Claims<br />
-- Lawful Copy Writing<br />
-- Minister CAM Practices<br />
-- NGO Formation<br />
-- OPS 4 SOPs<br />
-- Quality Control<br />
-- Record Keeping for GMPs<br />
-- Second Opinion Wellness Coaching<br />
-- SOP1: Introduction<br />
-- SOP2: Section 1<br />
-- SOP3: Section 2<br />
-- SOP4: Conclusion<br />
-- SOPs Certification Test<br />
-- SOPs Certification Test for HCPs<br />
-- SOPs for Health Care Practitioners<br />
-- STS: Specifications, Tests, Samples<br />
-- Terms of Use<br />
-- Testamonials<br />
-- Therapy is Not Treatment<br />
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<b>MY PLEDGE</b></div>
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<b>ONE-THIRD OFF REGULAR PRICES</b></div>
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<b>Until the End of 2019</b></div>
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<div style="text-align: center;">
The Vitamin Consultancy Archive Link</div>
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<a href="http://vitaminlawyerarchives.blogspot.com/">http://vitaminlawyerarchives.blogspot.com/</a></div>
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Health Freedom of Choice Bloghttp://www.blogger.com/profile/15606420362458868870noreply@blogger.com0tag:blogger.com,1999:blog-1111124027441239439.post-63938401438461733902019-11-04T18:28:00.000-08:002019-11-06T18:31:08.158-08:00FDA Warning Letters: Specifications<br />
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<span style="color: black;"><span style="font-size: 20px;"><strong>Sample 2019 FDA<br />Warning Letters.<br />It's About Specifications!</strong></span></span></div>
<br /><span style="color: black;">As we prepare for the end of the year, it's always good to look back at what issues have been hot button issues for FDA Warning Letters. Knowing is the first step toward being prepared.<br /><br />There were over three thousand warning letters so far this year. Many, if not most, are about tobacco or vapping. But, DSHEA products were, as always, represented. So were a few cosmetic products, but, I did not notice any warnings involving Medical Foods. I've picked out just a few DSHEA examples which appear typical to me.<br /><br /><span style="font-size: 14px;"><strong>This year's themes include Specifications, not just for the Product but also for the Components and Label. Yes, I've developed a new SOP (#25) covering Specifications for Labeling and Packaging.</strong></span><br /><br />Also, have you seen my<span> </span><em>Specifications -- Testing -- Samples</em><span> </span>Webinar? <span style="font-size: x-small;"> </span></span><a href="http://www.vitaminconsultancy.com/webinars.php" style="color: #6dc6dd; font-weight: normal; text-decoration: underline; text-size-adjust: 100%;"><span style="font-size: x-small;">http://www.vitaminconsultancy.com/webinars.php</span></a><br /><br /><span style="color: black;">The sample Warnings are below.<br /><br />After taking a look, review the services The Vitamin Consultancy offers and remember that we are running a 1/3-off year's end sale for all our services. The services list is here: <a href="https://vitaminlawyerarchives.blogspot.com/2019/11/vitamin-consultancy-services-discounted.html" style="color: #6dc6dd; font-weight: normal; text-decoration: underline; text-size-adjust: 100%;" target="_blank"><span style="font-size: x-small;">https://vitaminlawyerarchives.blogspot.com/2019/11/vitamin-consultancy-services-discounted.html</span></a><br /><br /><strong>Do you have all of the Specifications the FDA expects to see? If not, it's time to talk to me... Call: 973.300.4594 or email me at ralph.fucetola@gmail.com</strong><br /><br />Here are the Warning Samples (<strong>bold</strong><span> </span>added)<br /><br /><span style="font-size: x-small;"><strong>Revital U International, LLC</strong><br />Office of Human and Animal Food Operations West Division 3<br />CGMP/Dietary Supplement/Adulterated<br /><br />https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/revital-u-international-llc-585256-10162019<br /><br />The inspection of your facility revealed serious violations of FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements... These violations cause your dietary supplement products to be adulterated ... in that they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.<br /><br /><span><strong>You failed to establish specifications for each dietary supplement for the identity, purity, strength, and composition of the finished batch</strong></span><span> </span>of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement...<br /><br />-------<br /><br /><strong>Paisley Farms, LLC dba Paisley Farm & Crafts</strong><br />Division of Human and Animal Food Operations East V<br />CGMP/Dietary Supplement/Adulterated/Misbranded <br /><br />https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/paisley-farms-llc-dba-paisley-farm-crafts-575934-06042019<br /><br />The United States Food and Drug Administration (FDA) inspected your facility ... During the inspection we collected product labels for your Moringa Oleifera Leaf Powder and Moringa Oleifera Seed Powder products. Following the inspection... we reviewed your website ...r and your Facebook page... Your website links directly to your Facebook page, and your Facebook page also links directly to your website, where you take orders for the products ... The claims on your Facebook page establish that the products are drugs ... because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.<br /><br />Additionally, the product labels for your Moringa Oleifera Leaf Powder and Moringa Oleifera Seed Powder do not bear a statement of identity as a dietary supplement, a Supplement Facts panel, or other information suggesting that the product is intended to supplement the diet.<br /><br />-------------<br /><br /><strong>Herbal Healer Academy, Inc.</strong><br />Division of Human and Animal Food Operations West III<br />Unapproved New Drugs/Misbranded <br /><br />https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/herbal-healer-academy-inc-570957-09122019<br /><br />FDA reviewed your website ...and has determined that you take orders there for the products HHA CMO (Cetyl Myristoleate), HHA Colloidal Silver, HHA 4-Herb Tea Bulk, HHA 4-Herb Concentrate, Apricot Kernels, HHA Olive Leaf Liquid, HHA 5-HTP, HHA Herbalgesic, HHA CoQ10 with Hawthorn Berry, HHA Glucosamine & Chondroitin, Angiostop, HHA Beta Glucans, HHA Prostate Support and The Healing Formula Wound Care. In addition, FDA reviewed your product catalog following an inspection of your facility .... The claims on your website and within your product catalog establish that ... products are drugs ... because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.<br /><br />“Many people have reported relief from crippling arthritis in just 30 days using this product…”<br /><br />“Colloidal Silver has successfully controlled: … blood parasites, boils, candida, chronic fatigue syndrome (CFS), colitis, herpes, lupus, malaria, viral and fungal infections, rheumatoid arthritis, ringworm, shingles, yeast infections…”<br /><br />----------<br /><br /><strong>Ibitta Enterprises, Inc.</strong><br />Division of Human and Animal Food Operations West V<br />CGMP/Dietary Supplement/Adulterated/Misbranded<br /><br />https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ibitta-enterprises-inc-584337-09272019<br /><br />The significant violations documented during the inspection include, but are not limited to, the following:<br /><br /><strong>1. You failed to establish specifications for each dietary supplement that you manufacture for the identity, purity, strength and composition of the finished batch</strong><span> </span>of dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplements...<span> </span><span><strong>Specifically, you have not established such specifications for the dietary supplements you manufacture.</strong></span><br /><br />Once you have established the required finished product specifications, you must verify that the specifications are met ..., and you must make and keep records of such specifications and the verification thereof ...<br /><br />2.<span> </span><span><strong>You failed to establish specifications for each component that you use in the manufacture of a dietary supplement</strong></span>, including identity specifications and specifications necessary to ensure the purity, strength, and composition of dietary supplements manufactured using the components...<span> </span><span><strong>Specifically, you failed to establish identity specifications</strong></span><span> </span>for most of the components you use in your dietary supplements, and<span> </span><span><strong>you have not established any written specifications</strong></span><span> </span>to ensure the purity, strength, and composition of your dietary supplements manufactured using the components.<br /><br />3.<span> </span><span><strong>You failed to establish specifications for the dietary supplement labels (label specifications)</strong></span><span>...</span><span> </span>Specifically, you have no written label specifications for your finished dietary supplement products.<br /><br />-----------<br /><br /><strong>Alternative Laboratories</strong><br />Office of Human and Animal Food Operations East Division IV<br />Dietary Supplement/Adulterated <br /><br />https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/alternative-laboratories-586947-09182019<br /><br />Our review of your product labels revealed that you declared the ingredient 2-amino-5 methylheptane and Octodrine as a dietary ingredient in several of the dietary supplements you manufacture, including Elevate Smart Coffee, Choclevate, Elevate Nitro, Revital U Smart Coffee, Valentus SlimRoast Optimum Dark Roast Coffee, and Valentus SlimRoast Optimum Cocoa. The ingredients 2-amino-5 methylheptane and Octodrine are also called, among other names, 1,5-DMHA, 2-amino-6-methylheptane, 2-aminoisoheptane, 1,5-Dimethylhexylamine, 6- Amino-2-methylheptane, Amidrine, 2-Metil-6-amino-eptano, and 2-Isooctyl amine, and will be referred to hereinafter as DMHA.<br /><br />The term “dietary supplement” is defined in section 201(ff) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(ff)]. Given that you have declared DMHA as a dietary ingredient in the labeling of your products, we assume you have a basis to conclude that DMHA is a “dietary ingredient” under section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)]. If you have a basis to conclude that DMHA is a “dietary ingredient,” it would also be a “new dietary ingredient” (i.e., a dietary ingredient not marketed in the United States before October 15, 1994) under section 413(d) of the Act [21 U.S.C. § 350b(d)].</span></span></td></tr>
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Health Freedom of Choice Bloghttp://www.blogger.com/profile/15606420362458868870noreply@blogger.com0