| |||
| |||
|
Wednesday, June 12, 2019
Hemp Rules Changing
Wednesday, May 15, 2019
Specifications, Testing and Samples Webinar
|
||||||||||||||
|
||||||||||||||
|
||||||||||||||
|
||||||||||||||
|
Friday, February 15, 2019
February Vitamin Consultancy Newsletter STS WEBINAR
[1] FDA Takes Action Against Products Claiming to Treat Disease
[2] NEW WEBINAR: When must you have batches of your product tested?
------------
[1] The journalists at Vitamin Retailer have been investigating FDA's latest actions and report "On Feb. 11, the U.S. Food and Drug Administration (FDA) posted 12 warning letters and 5 online advisory letters to foreign and domestic companies that are illegally selling more than 58 products, many that are sold as dietary supplements, which are unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer’s disease and a number of other serious diseases and health conditions." https://vitaminretailer.com/fda-takes-action-against-products-claiming-to-treat-disease-seeks-to-strengthen-oversight/
Looking more closely at the warning letters and actions, we find that they are mostly about the "claims" being made, not the ingredients (though some disreputable companies have adulterated their vitamin products with unapproved drugs). The lesson: be careful what you claim. Be very careful about the words you use to describe those claims! For example, one of the valid nutrient ingredients mentioned was Alpha GPC (L-Alpha glycerophosphocholine) --not because it is a "drug" -- but because the claims made were about treating cognitive impairment medical conditions.
The article reports that FDA Commissioner Scott Gottlieb, MD said, “Today’s actions are part of the FDA’s larger effort to address the booming growth of the dietary supplement industry through the implementation of modern regulatory initiatives that will enable the agency to preserve the balanced vision of the Dietary Supplement Health and Education Act (DSHEA), enacted by Congress 25 years ago. That law sought to achieve the right balance between preserving consumers’ access to lawful
supplements, promoting innovation in these products, while upholding our obligation to protect the public from unsafe and unlawful products and holding accountable those actors who are unable or unwilling to comply with the requirements of the law. Our newest policy efforts will seize the game-changing opportunity to further strengthen the regulatory framework overseeing dietary supplements and will hone in on important steps to both promote industry innovation while upholding the safety of these products as part of our overall commitment to protecting public health.”
Bottom Line: pay attention to the words you use to state your claims... and have the Vitamin Consultancy review them before you communicate to the public!
------
STS WEBINAR & EBOOK
[2] Here is a Practice Question I often receive from my Vitamin Consultancy clients.
Does FDA require that the Label Owner of a DSHEA Dietary Supplement have finished product batch-tested [in addition to verifying the ingredients]?
Yes. Here are the batch testing concerns from Subpart C of the GMP regulations:
1. That the product meets the specifications for the product in 6 specific areas - 21 CFR 111.75(a) through (g)
2. That an expiration date, if any, is scientifically valid [Such a date is not required by FDA, so I do not recommend expiration dates]
3. Specific types of tests required - 21 CFR 111.75(h)(2)
4. Must test for: identity, purity, strength, composition, and the limits on types of contamination that may adulterate - 21 CFR 111.75(c) & (d)
5. Every finished batch must be tested - 21 CFR 111.75(c)
6. There are certain exemptions - 21 CFR 111.75(d)
In addition to testing concerns, Part IX also addresses Specifications and Samples. You have to determine what your specifications are for 7 specific areas set forth in Subpart B and, under Subpart C, you have to determine whether your product meets the specifications in 6 specific areas listed there.
Comparison of Subpart B and C Specification Requirements:
B. Required to Establish
1. control point specifications
2. components
3. in-process
4. labels and packaging
5. finished batch
6. received for packaging and labeling
7. finished product packaging and labeling
C. Required to Determine Product Meets
1. components
2. in-process
3. finished batch
4. received for packaging and labeling
5. labels and packaging
6. finished product packaging and labeling
[Subpart A is about "General Requirements" and Subpart B is about Requirements to Establish Specifications; Subpart C is about testing. Subpart D* is about specifications and verification of dietary ingredients and Subpart E is about representative and reserve samples]
My new Specifications, Testing and Sampling (STS) Webinar and eBook cover these matters in greater detail with references to the specific regulations and standards required. Email me with "STS Webinar" in the subject line and we can arrange your access to the webinar and its accompanying ebook.
As always, of course, my monthly retainer clients will automatically receive access to this new Webinar and eBook as soon as they are posted.
Tuesday, January 22, 2019
It's a New Year - Time to Audit Your Compliance to Changing Regulations
It's a New Year - Time to Audit Your Compliance to Changing Regulations
Your Company MUST have a PCQI
New Food Safety Training Webinar
FDA's Food Safety Regulation requires a written plan and a trained PCQI - Preventative Controls Qualified Individual. I have you covered.
I prepared a 15 page Food Safety Plan that closely tracks the Regulation, 21 CFR 117.126. Then I prepared an 18 minute training webinar and eBook, along with a certification test. If you pass, you receive a PCQI Certification of Completion of the training.
The Certification Training Program is structured to introduce the trainee to a standard Food Safety Plan under FDA regulations. All registered food facilities are required to have a written Food Safety Plan in place and in operation. After completing the webinar and reviewing the Food Safety Plan Format and the eBook, contact me to receive the Certification Test, and upon completion and return of the test, the Preventative Controls Qualified Individual (PCQI) Certification will be provided.
Is your company required to register as a food facility [and is therefore required to have a Food Safety Plan]? If you handle food, yes.
This certification program, including the Food Safety Plan, eBook and webinar training, is priced at $600 -- but, for recipients of the Vitamin Consultancy Newsletter, I am offering a 50% Discount, if purchased during the month of January, 2019. Just email me at: ralph.fucetola@usa.net with "FSP" in the subject line.
Says the FDA: “The Food Safety Modernization Act of 2011 (FSMA) directs the Food and Drug Administration (FDA) as the food regulatory agency of the U.S. Department of Health and Human Services to better protect public health by, among other things, adopting a modern, preventive, and risk-based approach to food safety regulation. On September 17, 2015, FDA published the final rule Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (PCHF rule) (80 FR 55907). This final rule became effective on November 16, 2015. It creates new requirements for the production of human food by registered food facilities... The intent of this guide is to inform domestic and foreign food facilities about the PCHF regulation and enable them to better understand the requirements of the rule. The rule is binding and has the full force and effect of law.”
The Regulation provides that the Plan shall contain the following Contents:
(1) The written hazard analysis as required by § 117.130(a)(2);The Plan has 22 separate sections. The PCQI must be a manager of the company and must be trained, with proof of training.
(2) The written preventive controls as required by § 117.135(b);
(3) The written supply-chain program as required by subpart G of this part;
(4) The written recall plan as required by § 117.139(a);
(5) The written procedures for monitoring the implementation of the preventive controls as required by § 117.145(a)(1);
(6) The written corrective action procedures as required by § 117.150(a)(1); and
(7) The written verification procedures as required by § 117.165(b).
-----------------------
Horizon v Jonuzi et al.
Last month the case survived a Summary Judgment Motion.
This may be the most important lawsuit pending in the USA regarding Insurance Industry reimbursement for holistic and integrative treatments and therapies... including dietary supplements as Medical Foods. This pending litigation can construe the Affordable Care Act to forbid insurance carrier discrimination against holistic and integrative practitioners, permitting proper insurance coding for such therapies.
From the standpoint of the Mission of the Institute, this change would facilitate retrospective research into holistic and integrative modalities (through coding statistics). That's why the Institute for Health Research is sponsoring crowdfunding support for the litigation. [Note: I am not the attorney of record on this case.]
Read more here: https://vitaminlawyerhealthfreedom.blogspot.com/2018/12/provider-nondiscrimination-case.html
Please read about it, and help our crowdfunding effort. This case is quite important!
Donate here: https://fundly.com/support-natural-therapies
And while you are at it... remember the Institute is now sponsoring a holistic and integrative IRB program for all you researchers. www.inhere.org/institutional-review-board/
Monday, December 3, 2018
Year End 2018 Newsletter
Note: notice, notification: private and confidential . . . . . .
Year-End Round-Up: More Happenings That Impacts Your Business.
From Conscience to Miracles... the Vitamin Consultancy has News for You.
-----
Here Are Some
News Items of Interest
-----
Update on my experience with Dr. Wolf's "Divine Wellness" ethically harvested ovine placenta, CBD and Nano Gold supplement.
The apparent lesion on my chest continues to heal and the new skin that's grown back over seems normal. This is an "off label" topical use of a DSHEA supplement product.
Here is the link to this product: https://www.divinewellnessclub.com/idevaffiliate/idevaffiliate.php?id=103
You can see the original note in last month's email here: http://vitaminlawyerarchives.blogspot.com/2018/11/keeping-up-with-agency-regulations.html [article 4.1]
BTW, Dr. Wolf is coming out with a version of the product without CBD or hemp oil.
-----
Philanthropic Credit Grants --
May Be Considered
May Be Considered
A Private Barter Facilitation System
Sponsored by a private sovran church association, PCs may be the private currency of the future. For a limited time the organization is granting 5,000 units to each individual, just for signing up.
I URGE YOU TO SIGN UP NOW: https://www.philanthropicbank.info/
Go to "Register" at upper right corner.
-----
VICTORY IN PROVIDER DISCRIMINATION CASE!
I am one of the experts working with the defense in the NJ case of Horizon v Jonuzi et al. Horizon (BlueCross/Blue Shield) sued Atlantic Integrative Medical Center for "fraud" although not one client of the center complained. These insurance fraud cases usually end with capitulation by the provider, or by way of a Summary Judgment Motion, in favor of the insurer. Horizon brought the SJM -- and last week, lost the motion! Defendants' lawyer said he cannot remember another case where the defense survived this type of attack!
What this means is that this case may be a proper vehicle to test the extent of the Affordable Care Act's "provider nondiscrimination" clause -- this case may set a precedent forcing insurers to cover holistic and integrative care!
We need your help to effectively present this defense and counterclaim. Donate here: https://fundly.com/support-natural-therapies/
-----
New HHS Guidance
Says the Acting HHS Secretary: "For too long too many of these healthcare practitioners have been bullied and discriminated against because of their religious beliefs and moral convictions leaving many of them to wonder whether they have a future in our healthcare system. When faithful Americans are bullied out of the public square and out of public service, when bigotry is allowed to flourish, we all lose."
This article covers the story: https://explainlife.com/trump-lays-groundwork-to-ban-mandatory-vaccinations-across-u-s-2730/
And here is the new Disclosure Statement any company, hospital, or agency that gets Federal Funding needs to give to its employees:
DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 88
[Docket No.: HHS–OCR–2018–0002]
RIN 0945–ZA03
Protecting Statutory Conscience Rights in Health Care; Delegations of Authority
AGENCY: Office for Civil Rights (OCR), Office of the Secretary, HHS.
https://www.gpo.gov/fdsys/pkg/FR-2018-01-26/pdf/2018-01226.pdf
Appendix A to Part 88—Notice Concerning Federal Health Care Conscience and Associated AntiDiscrimination Protections
[Name of recipient, the Department, or Department component] complies with Federal health care conscience and associated anti-discrimination laws and does not exclude, treat adversely, coerce, or otherwise discriminate against persons or entities on the basis of their religious beliefs or moral convictions. You have the right to decline to participate in, refer for, undergo, or pay for certain health care-related treatments, research, or services (such as abortion or assisted suicide, among others) which violate your conscience, religious beliefs, or moral convictions under Federal law.
If you believe that [Name of recipient, the Department, or Department component] has failed to accommodate your conscientious, religious, or moral objection, or has unlawfully discriminated against you on those grounds, you can file a conscience and religious freedom complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf or by mail or phone at: U.S. Department of Health and Human Services, 200 Independence Avenue SW, Room 509F, HHH Building, Washington, DC 20201, 1–800–368–1019, 800–537–7697 (TDD).
Complaint forms and more information about Federal health care conscience and associated anti-discrimination laws are available at http://www.hhs.gov/conscience.
Dated: January 18, 2018.
Eric D. Hargan,
Acting Secretary, Department of Health and
Human Services.
[FR Doc. 2018–01226 Filed 1–19–18; 11:15 am]
-----
TIME RAN OUT
More information on how Dr. Goodman and I can help: www.ProfessionalSafetyDossier.com
Here is my article about all this, posted at Open Source Truth: http://www.opensourcetruth.com/proposition-65-california-ratchets-up-cancer-repro-harm-warning-rules/
Systems Processing Integration
Check out my new web site for my OPS 4 SOPs System. This is the site you need to organize your basic Branding and Regulatory documents. www.SystemsProcessingIntegration.com
Sunday, November 11, 2018
Keeping Up with Agency Regulations
Keeping Up with Changing Regulations
[1] FDA on "Natural"
https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm456090.htm
"Although the FDA has not engaged in rulemaking to establish a formal definition for the term "natural," we do have a longstanding policy concerning the use of "natural" in human food labeling. The FDA has considered the term "natural" to mean that nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in that food. However, this policy was not intended to address food production methods, such as the use of pesticides, nor did it explicitly address food processing or manufacturing methods, such as thermal technologies, pasteurization, or irradiation. The FDA also did not consider whether the term "natural" should describe any nutritional or other health benefit."
--------------------------
[2] FDA GMPs -- TEN YEARS OLD
The Natural Products Association is engaging in a tenth year review of the FDA dietary supplement GMPs. Some valuable information is being developed. One bottom-line point: there is a new FDA emphasis on adequate Quality Assurance, which means specific staff members tasked with that role. QA must sign off on all product batches and the person signing off must not be the person overseeing the production. This applies to both manufacturers and to the label-owner who is expected to "be in a state of control."
For example, a recent warning letter to a label owner which was sent to me for review cited two violations of QA
"1. Your quality control operations did not include determining whether each finished batch conforms to established product specifications.Remember, these points were raised directly with the label-owner, not the manufacturer. Bottom line: Do you have Product Specifications? Do you have a person responsible for QA? Is QA included in your SOPs.
2. Your quality control operations did not include approving and releasing, or rejecting, each finished batch for distribution."
My retainer clients are compliant. Are you? www.SystemsProcessingIntegration.com
----------------------------------
[3] FDA Mandatory Food Recall Authority
November 5, 2018 - The U.S. Food and Drug Administration has released a final guidance regarding the agency’s mandatory recall authority under the FDA Food Safety Modernization Act (FSMA).
"The 2011 food safety law gave FDA mandatory recall authority for foods if there is a reasonable probability that the food is adulterated or misbranded under certain FDA authorities, and that the food could cause serious illnesses or death. FDA must give the responsible party an opportunity to conduct a voluntary recall before ordering a mandatory recall. Prior to the enactment of FSMA, FDA could only rely on manufacturers to voluntarily recall certain potentially harmful food products.
https://www.federalregister.gov/documents/2018/11/06/2018-24247/guidance-questions-and-answers-regarding-mandatory-food-recalls
Comment: you may recall that Dr. Laibow and I fought hard in 2010 and 2011 to preserve Section 1011 of the food "safety" bill, a section that exempted DSHEA dietary supplements from the "enhanced" authority of the law. We were denigrated when we worked through one late-nights weekend to get over 150,000 emails to the congressional conference committee, assuring that the exemption clause would stay in the law. Now we see the results: "mandatory" recalls based on mere "reasonable probability..." will become the norm for most foods, but not for DSHEA products!
----------------------------------
[4] TWO IMPORTANT STORIES YOU WON'T SEE ANYWHERE ELSE!
[1] What Happened to that Sore on My Chest?
I love to tell my list about success stories in the natural products market. Dr. Walter Wolf is one of those geniuses that I've had the privilege to know. He is an alchemist and naturopath. His new product, Divine Wellness, is amazing!
Ethically harvested ovine placenta, CBD hemp oil and Nano Gold. This is an immune boosting rejuvinater nutrient combination.
But I want to tell you about an "off label" use of the product. A few months ago I noticed a "beauty mark" on my chest had begun to enlarge and become lesion-like. That was concerning so I started putting a varying combination of CBD hemp oil, apricot seed extract, tea tree oil and nano silver on it. The growth stopped, but it remained. Then, a few days ago, I begin putting Divine Wellness on the spot.
As the series of images show, it quickly puffed-up, became quite dark, and is now flaking-off.
Amazing! Learn more about this natural product as a dietary supplement here: https://www.divinewellnessclub.com/idevaffiliate/idevaffiliate.php?id=103 -- yes, you can join the affiliate program.
[2] Horizon v Jonuzi et al. This may be the most important lawsuit pending in the USA regarding Insurance Industry reimbursement for holistic and integrative treatments and therapies... including dietary supplements as Medical Foods. This pending litigation can construe the Affordable Care Act to forbid insurance carrier discrimination against holistic and integrative practitioners, permitting proper insurance coding for such therapies.
From the standpoint of the Mission of the Institute, this change would facilitate retrospective research into holistic and integrative modalities (through coding statistics). That's why I've helped to set up a crowdfunding effort.
Read more here: http://www.inhere.org/2018/11/06/making-health-insurers-follow-the-rules/
Please read about it, and help our crowdfunding effort. This case is quite important!
Donate here: https://fundly.com/support-natural-therapies
------------------------
And while you are at it... remember the Institute is now sponsoring a holistic and integrative IRB program for all you researchers. http://www.inhere.org/institutional-review-board/
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.
TIME RAN OUT
If you think you have enough time to get ready for California's new, tougher, Proposition 65 warning rules, you are wrong. The new rules 2 months ago. If you think your product does not get into California, think again. If you think no one will notice, remember that Prop 65 is enforced by a hoard of private lawyers looking to grab fees and penalties from your company.
More information on how Dr. Goodman and I can help: www.ProfessionalSafetyDossier.com
Here is my article about all this, posted at Open Source Truth: http://www.opensourcetruth.com/proposition-65-california-ratchets-up-cancer-repro-harm-warning-rules/
Sunday, September 30, 2018
Your Food Safety Plan - September 2018 Newsletter
| ||||||||||||
|
Subscribe to:
Posts (Atom)