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Showing posts with label SOP. Show all posts
Showing posts with label SOP. Show all posts
Thursday, April 30, 2020
April 2020 Newsletter: Quality Counts
Thursday, May 3, 2018
May 2018 eNewsletter: What We Can Learn from FDA Court Order
WHAT WE CAN LEARN
FROM FDA COURT ORDER
What Companies Can Learn From the Riddhi Vitamins' Cease and Desist Order*Riddhi USA is a wholesale dietary supplement manufacturing company. It manufactures products for label-owning marketing companies, like many of the Companies that receive the Vitamin Consultancy Newsletter.
After an inspection the violations were considered so egregious that a Federal Judge was asked to order Riddhi to stop all activities until it could meet GMP requirements. Needless to say, all of its customers, Companies like yours, are scrambling to find new manufacturers.
What are the lessons we need to take from this regulatory action?
Let's start by listing what FDA thought were the most serious violations:
"-[1] failing to establish product specificationsThese are nearly all Standard Operating Procedures violations.
-- for the identity, purity, strength and composition of the finished dietary supplements
-[2] inadequate master manufacturing and batch production records
-[3] lack of quality control procedures
-[4] lack of procedures to investigate product complaints
-[5] products’ labeling failed to declare dietary ingredients, allergens and place of business."
Either Riddhi did not have the written procedures or failed to implement them. That also means the customers of Riddhi failed to "be in a state of control" -- the requirement that applies to all label-owners.
Specifications. Records. Procedures...
You need to have them. You need to implement them. FDA publicized the Riddhi case as a warning to all companies that the agency can shut you down if you fail to adopt SOPs, train employees in their use, and actually implement them.
The Vitamin Consultancy provides up-to-day procedures and the OPS 4 SOPs system that enables you to implement the specifications, records and procedures required.
It is up to the Company's senior management to take the lead in careful implementation.
The SOP introduction indicates:
"The following Positions in the Company are listed in these SOPs: the CEO, COO, Quality Control Manager (QCM), Emergency Manager (EM), SOP & CCDS Manager, Customer Service Manager and Warehouse Manager. The COO or (where one is not designated) the CEO shall hold these Manager Positions unless the Positions are filled by appointment by the CEO..."
That is:
CEO/COOThe Vitamin Consultancy offers "refresher" training sessions where staff members assigned to the different positions mentioned in the SOPs can recommit to following the SOP procedures.
QCM
EM
SOP/CCDA Manger
Customer Service Manager
Warehouse Manager
More information here: http://vitaminconsultancycertification.weebly.com/ops-4-sops.html
* https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm603111.htm
===================================
Practice Note: Reading the FDA Regulation changing the way conventional food labels are configured. The new Regulation is being delayed until 2020 (good news!).
Yes, I was reading down the hundreds of Comments in the Regulation, and FDA's Responses. This one, #431, got a raised eyebrow, since it is contrary to what FDA has said elsewhere: "We agree there is a difference in biological activity between synthetic and naturally derived β-carotene. "
In the past FDA would object if any vitamin company said "natural" was better than "synthetic." Does that irrational rule still hold? If your naturally derived nutrient ingredient has been shown to be better than synthetic versions, it seems the old rule may no longer hold.
https://www.federalregister.gov/documents/2018/05/04/2018-09476/food-labeling-revision-of-the-nutrition-and-supplement-facts-labels-and-serving-sizes-of-foods-that
==================
Proposition 65 Coming at YOU!
www.ProfessionalSafetyDossier.com
------------------------
Need Transcription Services?
Try this: https://www.rev.com/
Proposition 65 Coming at YOU!
www.ProfessionalSafetyDossier.com
------------------------
Need Transcription Services?
Try this: https://www.rev.com/
Thursday, November 7, 2013
Investing in Regulatory Compliance RoI
Memorandum from Ralph Fucetola JD
Date: November 7,
2013
To: All Potential Natural Product Company Investors
This Memorandum is to acquaint
you with the benefits to your Company raising sufficient capital to comply
fully with FDA/FTC SOP/ GMP & Clinical Study Guidelines.
Good Studies lead to good claims; good claims lead to increased ROI!
Properly Structured Standard Operating Procedures and
Trained Employees lead to significant regulatory savings.
Good Studies lead to good claims; good claims lead to increased ROI!
Properly Structured Standard Operating Procedures and
Trained Employees lead to significant regulatory savings.
Getting Ready for the FDA & FTC -- www.VitaminIndustryCompliance.com
Even more evidence that the agencies are serious
about nutrient & natural product claims; this from the Natural Products
Association in March 2011:
“A new and completely different type of safety website is
now open for business. Almost anyone can post information on SaferProducts.gov about a
consumer product they believe might be dangerous or has already caused a safety
problem. Not only will this database of consumer comments be public, it also
will be searchable. "Through this database consumers will have open access
to product safety information that they’ve never seen before, and this
information will empower them to make safer choices," said Inez Tenenbaum,
chairman of the U.S. Consumer Product
Safety Commission.”
What
does that mean? It means your Company reputation
can be ruined by willful false posters; it means the govt will be trolling the
site to find companies to harass…
And consider these “data points” from the last two
editions of my Vitamin Lawyer Update
eMemo: the UK advertising agency, the ASA now states, according to
WINSH.org, “research on the ingredients was not the same as research on the
product itself…”
Let’s repeat the key phrase: “…research on the ingredients was not the same as
research on the product itself…” – and “research on the product itself” means a Clinical Trial, of course! The substantiation generated by the
Clinical Trial is the legal basis for making product claims.
The Natural Products Association (NPA) said in
February ‘11 – “Time's Up: FDA has begun real enforcement of dietary supplement
GMPs. Companies of all sizes are being inspected. Are you ready?”
Is
your Company ready? What does it take to be ready? See Below.
The above Red Letter warnings from
the NPA & ASA urgently restate what I’ve been telling my perceptive clients
regarding the vitamin or natural products companies. Are you ready for the FDA
inspectors? Below are the 4 essential
steps you must take with estimates of the investments these essential steps
require from your Company. You need to budget this investment now and start to
do what you can to be prepared; in this way you will outperform the competition
who will not be so prepared.
HHS Secretary Sibelius admitted a
couple years ago that she has a $16 Billion slush fund under Obamacare that can
be used to fund activities like the FDA’s 4,000 new inspectors… and FDA has
already dramatically increased inspections, without those new bureaucrats! SOP
Certification Training is what your company needs.
Says FDA -
"...documentation of employee
training is necessary to track which employees have been trained in which operations. Therefore, final Sec.
111.14(b)(2) requires you to keep documentation of
training, including the date of the training, the type of training, and the person(s)
trained." Federal Register, page 34811
What do you need to survive an FDA
inspection? Go here: www.VitaminIndustryCompliance.com
1. Standard
Operating Procedures – in
place and up-to-date. GMP compliant detailed SOP documentation not only
satisfies FDA & FTC, but also helps you organize your business!
2. Product
Substantiation Notebook –
in place and up-to-date; this Notebook is a MUST if you get inspected! The
Notebook should includs copies of the Structure and Function Claims Notices
companies are required to file with the FDA within 30 days of marketing any
claim.
3. Your
ROI can be strongly enhanced by copy-writers who know how to avoid Red Flag
claims & Illegal Testimonials!
4. A
Third-Party Clinical Trial of your product; you can no longer fully rely on
published science about isolated ingredients.
The Dietary Supplement and Natural
Remedies market is at a unique moment in its recent history.
The market has grown from
under a billion dollars when the Dietary Supplement Health and Education Act
(DSHEA) passed in 1994 (the first law allowing claims to be made for such
products) to about $50 billion in 2009. The current recession is only having a marginal effect on the nutrient market
and one survey shows that 51% of the purchasers would cut back on food
purchases rather than vitamin purchases. At the same time, significant
regulatory initiatives have occurred during the past years with potential
impact on the market. After 14 years, FDA finally issued Good Manufacturing
Practice (GMP) regulations for the industry during June, 2007 which became
completely effective in June 2009.
All of these factors contribute to a growing industry that
typically sees, after initial investment, a cost of goods, for start-ups, at
about 20 to 25% of retail, rapidly moving down to 10% as new companies are able
to order product runs in the hundreds of thousands of capsules.
Bottom line: savvy
investors, seeking reasonably assured ROI, will find in the natural products
market potential opportunity, if the
Company invests in in Regulatory Compliance!
The
Vitamin Lawyer.com Consultancy
Notary Public of the
State of New Jersey #2398815
Attorney at Law in NJ – 1971 - 2006 – All Rights Reserved.
Attorney at Law in NJ – 1971 - 2006 – All Rights Reserved.
Friday, November 23, 2012
11.23.12 - Vitamin Lawyer Certification Program
… Vitamin Lawyer.com Consultancy
Update eMemo –11.23.2012
COMING -- JANUARY, 2013!
THE VITAMIN LAWYER REGULATORY COMPLIANCE CERTIFICATION PROGRAM!
But you can get a head start on your competitors... read on!
Natural Products Association (NPA) Confirms
That FDA Inspections will Reach ALL Label-Holders!
Welcome to the Update eMemo... helping the natural products and services industry comply with lawful regulatory standards...
And as we approach the new year and its fiscal cliff, you need this information too: www.FundforNaturalSolutions.org
THE NATURAL PRODUCTS ASSOCIATION TELLS US WHAT
THE "HOT TOPICS" WILL BE THIS COMING YEAR!
"FDA Hot Topic: Developing compliant master manufacturing and batch production records. FDA Hot Topic: Qualifying your suppliers and other vendors and qualifying Certificates of Analyses (COAs) to allow for reduced testing of components. FDA Hot Topic: Conducting material reviews, appropriate handling of customer complaints, adequate documentation of related investigations, and resulting corrective actions. FDA Hot Topic: Establishing and confirming specifications, QC personnel responsibilities, laboratory operations, scientifically valid methods, raw materials and finished product testing requirements, and change control..." http://npa.informz.net/NPA/archives/archive_1815037.html
WHAT ARE WE GOING TO DO ABOUT THAT?
PROCEDURE - Standard Operating Procedures and Good Manufacturing/Marketing Practices.
CLAIMS - Claims control, definition and substantiation...
and the FDA required S & F Claims Notice.
TRAINING - It's not enough to have procedures says FDA:
YOU have to train you team and prove they are qualified.
[Name Redacted] Wellness Company CEO “Alice”
“The FDA Agents said they’d be at our company for at least 6 days.
We showed them the SOPs Counsel Ralph prepared for us
and they were gone in about 2 days… no threats!!”
The Pressure is on: "Dietary supplement manufacturers are facing a high level of regulatory scrutiny from the government as a result of the study released last week by the U.S. Dept. of Health & Human Services Office of the Inspector General. This study raises new concerns that structure/function claims are not accurate and misleading to consumers. A sample of 127 dietary supplements were reviewed and concluded 'Overall, substantiation documents for the sampled supplements were inconsistent with FDA guidance on competent and reliable scientific evidence.' Plus, another study by the HHS OIG reviewed labels for the required adverse event contact information and found that a shocking '20 percent of dietary supplement labels in our sample did not provide the required telephone numbers or addresses.'"Look for the Vitamin Lawyer Regulatory Compliance Certification Program...
http://npa.informz.net/NPA/archives/archive_1869633.html
Last issue of the Update eMemo told you about the FDA inspection last month of one of the Vitamin Lawyer Consultancy clients. I was on the phone with that client several times a day, over the course of the inspection. They were ready. Are YOU?
Now, the Natural Products Association confirms what I told you. In a special email broadcast, the NPA notified its members, which include all the largest vitamin companies --
FDA is Taking Inspections to the Next Level—Are You Ready?
FDA is concerned with the current lack of GMP compliance and is preparing to take a closer look during inspections. FDA has also said they are circling back to companies who have already been inspected. Dr. Daniel Fabricant, director of FDA's Division of Dietary Supplement Programs recently stated, “the majority of inspections [the FDA] have done have resulted in a non-compliance atmosphere, whether resulting in a warning letter or just observations on the 483s.”
There is no logical alternative to getting ready NOW.
YOUR PAPERS MUST BE IN ORDER.
I can provide you with the formats needed to meet the new standards and guide you to “tweak” and implement them. This includes -
[1] the all-important, updated SOPs format for you to "tweak" for your company,
[2] the critical clauses to include in your Manufacturer’s standard contract form and
[3] the Structure and Function Claims Notice format.
ONCE YOUR PAPERS ARE IN ORDER,
I CAN CONDUCT A TRAINING WEBINAR
FOR YOUR COMPANY AND CERTIFY
YOUR COMPLIANCE FOR FDA REGULATION.
FOR YOUR COMPANY AND CERTIFY
YOUR COMPLIANCE FOR FDA REGULATION.
(Extra Charge for Webianr.)
eMAIL ME AT; ralph.fucetola@usa.net
WITH 'SOP' IN THE SUBJECT LINE!
WITH 'SOP' IN THE SUBJECT LINE!
TO SET UP YOUR SPECIAL DISCOUNT TIME!
Vitamin Lawyer Connections
Yes, you do need clinical trials! Further Services You Need!
A Third-Party Clinical Trial of your product; you can no longer fully rely on published science about isolated ingredients – This can cost up to several hundred thousand dollars. NCT offers a Minimal Clinical Trial from $25,000.
www.NaturalClinicalTrials.net
WHAT SHOULD YOU DO? Contact me NOW! 973.300.4594
The longer you put off addressing any of the above issues,
the more at-risk is your company!
Special Service for EU Cosmetics Dossiers: You can sell in the EU without prior governmental approval, if you have a Dossier from NCT! Please take a look at our new Webinar linked from this web page: http://www.naturalclinicaltrials.com/NCT-EU-Cosmetics.php.
Vitamin Lawyer Connections…
Do you Skype? If so, free Skype.com is one of the easiest ways to contact me, no matter where I may be.My Skype handle is: vitaminlawyer
Do you have an affiliation program? We’d like to list it.
If you don’t have an affiliate program… I have Affiliate Program SOPs & Rules …
And good advice… for you.
“One on One with the Vitamin Lawyer” from Power Pictures Inc.
Trailer: www.youtube.com/watch?v=wWPvzpn0YgA www.powerpicturesllc.com –
Airing on: www.telostv.com
Follow me on Twitter - www.twitter.com/healthfreedomus
THESE UPDATE MEMOS NOW ARCHIVED AT:
http://vitaminlawyerarchives.blogspot.com/
ralph …
Ralph Fucetola JDwww.FundforNaturalSolutions.org
www.NaturalHealthOptions.net www.vitaminlawyer.com http://vitaminlawyerarchives.blogspot.com http://vitaminlawyerhealthfreedom.blogspot.com
www.HealthFreedomPortal.org
I had to rebuild my Vitamin Lawyer email list and have taken every precaution
to include only people who I believe want to opt-in. If you did not want to receive this emai,
please just email me at ralph.fucetola@usa.net with "delete from list" in the subject line.
I apologize for any inconvenience.
Friday, January 18, 2008
01/18/08 - SOPs and FDA Regulations
… VLUeM – 01.18.08 - VITAMIN LAWYER WEEKLY UPDATE e-MEMO
PRIVATE MESSAGE: The purpose of the VLUeM e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and client list. Private, privileged & confidential...
This issue: saving your company from costly new FDA regulations…
_______________________________________________
1. Health Freedom Blog update
2. News Target targets FDA attacks on supplements… are your SOPs ready?
3. Food niche with potential
4. VL Memo Archives Blog - improved format for this Update eMemo!
______________________________________________
1. Vitamin Lawyer Health Freedom Blog & Factoids
New Postings - http://vitaminlawyerhealthfreedom.blogspot.com/
Factoid: FDA just decided not to define the word “Natural” although petitioned to do so. Functional Nutrition Magazine also tells us that “Natural” was the favorite word last year for launching new food products, appearing on almost 2,500 of them. See: http://www.functionalingredientsmag.com/fimag/articleDisplay.asp?strArticleId=1553&strSite=FFNSite
The OneLook.com meta-dictionary defines “Natural” as: “adjective: existing in or produced by nature; not artificial or imitation… (used especially of commodities) in the natural unprocessed condition…”
eAlerts – STOP FORCED VACCINATION! A powerful new tool to stopped forced vaccination has been established by the Natural Solutions Foundation. You can join this open Yahoo!Group at: http://groups.yahoo.com/group/no-forced-vaccination/join
If you will be in the NYC area on January 26th and would like to meet with Gen. Stubblebine, Dr. Laibow and myself about ending forced drugging and vaccinations (they have a six hour stop over at JFK on their way to a Codex meeting in Africa) let me know; it will be a brunch or lunch meeting near the airport. And you can always join the Health Freedom eAlert list at: www.globalhealthfreedom.org .
This eMemo is being sent through my “back-up” Earthlink email address since AOL is still blocking my usa.net emails; however, please email me at ralph.fucetola@usa.net as I monitor that email all the time. If you have an AOL email address, please add my usa.net address to your permitted list.
______________________________________________
2. News Target targets FDA attacks on supplements – see SOP Alert! below.
“FDA Announces Plan to Eliminate Vitamin Companies by Byron Richards
“(January 15 - NewsTarget) The FDA, emboldened by its transformation into a drug company, has embarked upon an anti-American plan of interfering with business and intentionally eliminating various dietary supplement companies from the market. The FDA announcement came on Friday, June 22, 2007 under the guise of a final rule for dietary supplement good manufacturing practices (CGMPs). Within this 800 page rule the FDA states, "We find that this final rule will have a significant economic impact on a substantial number of small entities... Establishments with above average costs, and even establishments with average costs, could be hard pressed to continue to operate. Some of these may decide it is too costly and either change product lines or go out of business... very small …and …small dietary supplement manufacturers … will be at risk of going out of business... costs per establishment are proportionally higher for very small than for large establishments... The regulatory costs of this final rule will also discourage new small businesses from entering the industry." (http://www.cfsan.fda.gov/%7Elrd/fr07625a.html)
”This FDA rule will directly raise the price of dietary supplements for all consumers. The FDA acknowledges this and says "We expect that the majority of these costs will be borne by consumers of dietary supplements, who will likely respond to the increase in prices by reducing consumption." Thus, the FDA is intentionally seeking to shrink the size of the dietary supplement industry and reduce the influence of safe and effective options to improve the dreadful trend in the health of Americans. The goal is to leave toxic drugs as the primary health option.
”Independent analysis of this FDA rule has placed cost of compliance at 10 fold what the FDA estimates with as many as 50% of small companies unable to comply.”
To read more: http://www.newstarget.com/022499.html
SOP ALERT FOR COMPANIES: Now more than ever, “your papers must be in order…” – The Vitamin Lawyer Consultancy has prepared formats for Standard Operating Procedures to allow small companies to comply with the new rules, including the new AER law, by maintaining the necessary records. Our SOP format is relatively short (about 20 pages) but does cover all the areas needed:
A. Refund, Delivery & Returns Policies
B. Standard Disclaimers; Site Use Statement
C. Standard Testimonial Waiver
D. Email Privacy Policy
E. Document Retention Policy
F. Quality Control Procedures - Standards, Complaints and Policy Coordination
G. Order Processing Procedure
H. Bookkeeping and Account Management
I. Order Record Keeping and Retrieval; AER Reporting
J. Emergency Planning and Crisis Management
You can find out more at: http://tinyurl.com/2eu6yj
If you need the format, please email me at ralph.fucetola@usa.net and put “SOP” in the subject line. Typically, it takes an hour or two of my time to fine tune the format for you.
______________________________________________
3. Food niche with potential
Report pinpoints functional food niche with most potential - By Lorraine Heller
January 16, 2008 - Foods and drinks developed to address the specific health needs of consumers are expected to exceed category growth in the US functional food segment, according to a new report. Published by TSG, the study estimates that 'targeted foods', which currently make up 12 percent of the $60bn functional food segment, could grow to take a massive 25-35 percent share in 2012. This could bring up the total value of the sub-segment to between $55bn and $77bn over the next 13 years. Functional foods as a whole are projected to have a market value of $219bn by 2012.
TSG defines targeted foods are those functional foods that are designed to address specific health or disease conditions; specific physical or mental states; or specific age or gender needs. These, says the study, will grow "exponentially" as the functional foods markets continues its ascent into the mainstream.
"They will be the evolution of functional foods," TSG CEO Panna Sharma told NutraIngredients-USA.com.
Foods and beverages in this category include products that address: Digestive health, Celiac disease, Arthritis, Cancer prevention, Heart health
[Note from Vitamin Lawyer: some of these claims would not be allowed as Dietary Supplement claims.]
…[Other of these] products address: * Sports performance, * Beauty, * Skin care, * Libido, * Brain function
…TSG states: "Beverages will continue to drive innovation and early consumer adoption which will drive tighter alignment between functional ingredients and nutraceutical companies and the beverage community."
…"Global food and beverage giants will aggressively enter the market through acquisitions, alliances and select investments," said TSG.
For more –
http://www.nutraingredients-usa.com/news/ng.asp?n=82599&m=1NIU116&c=jegwylrviswtnqa
______________________________________________
4. Upgrading the VL Update eMemo!
I’m getting closer to the new version of the Update eMemo. I’ve begun to post earlier memos on a blogspot.com Blog. You can see it at: http://vitaminlawyerarchives.blogspot.com
In the future, you’ll receive a shorter weekly update email with links to Blog articles that will be posted as the information becomes available… more timely information better indexed!
______________________________________________
You got on this e-list by opting in or becoming a client of the Vitamin Lawyer.com Consultancy. If you want to be taken off the list, please “reply” to this email with the word “remove” in the subject line. On the other hand, you are welcomed to forward this to your own eList…
And do remember to check out the VLUeM Online Archives: http://tinyurl.com/rkneb
Online Seminar compilation of briefs and white papers: http://tinyurl.com/ua9lq
For an outline of typical cGMP SOP docs: http://tinyurl.com/2eu6yj
Vitamin Lawyer Oversight Seal: http://tinyurl.com/2cfoyb
For the latest on Adverse Event Reporting: http://www.aer-consultants.com
Vitamin Lawyer Health Freedom Blog: http://vitaminlawyerhealthfreedom.blogspot.com
For Health Freedom Issues: http://www.globalhealthfreedom.org - Please consider donating to Natural Solutions Foundation - your help is needed to protect the natural products market from bureaucratic interference...
Ralph Fucetola, JD - The Vitamin Lawyer.com Consultancy
http://www.vitaminlawyer.com – ralph.fucetola@usa.net
All Rights Reserved © 2008 . . .
PRIVATE MESSAGE: The purpose of the VLUeM e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and client list. Private, privileged & confidential...
This issue: saving your company from costly new FDA regulations…
_______________________________________________
1. Health Freedom Blog update
2. News Target targets FDA attacks on supplements… are your SOPs ready?
3. Food niche with potential
4. VL Memo Archives Blog - improved format for this Update eMemo!
______________________________________________
1. Vitamin Lawyer Health Freedom Blog & Factoids
New Postings - http://vitaminlawyerhealthfreedom.blogspot.com/
Factoid: FDA just decided not to define the word “Natural” although petitioned to do so. Functional Nutrition Magazine also tells us that “Natural” was the favorite word last year for launching new food products, appearing on almost 2,500 of them. See: http://www.functionalingredientsmag.com/fimag/articleDisplay.asp?strArticleId=1553&strSite=FFNSite
The OneLook.com meta-dictionary defines “Natural” as: “adjective: existing in or produced by nature; not artificial or imitation… (used especially of commodities) in the natural unprocessed condition…”
eAlerts – STOP FORCED VACCINATION! A powerful new tool to stopped forced vaccination has been established by the Natural Solutions Foundation. You can join this open Yahoo!Group at: http://groups.yahoo.com/group/no-forced-vaccination/join
If you will be in the NYC area on January 26th and would like to meet with Gen. Stubblebine, Dr. Laibow and myself about ending forced drugging and vaccinations (they have a six hour stop over at JFK on their way to a Codex meeting in Africa) let me know; it will be a brunch or lunch meeting near the airport. And you can always join the Health Freedom eAlert list at: www.globalhealthfreedom.org .
This eMemo is being sent through my “back-up” Earthlink email address since AOL is still blocking my usa.net emails; however, please email me at ralph.fucetola@usa.net as I monitor that email all the time. If you have an AOL email address, please add my usa.net address to your permitted list.
______________________________________________
2. News Target targets FDA attacks on supplements – see SOP Alert! below.
“FDA Announces Plan to Eliminate Vitamin Companies by Byron Richards
“(January 15 - NewsTarget) The FDA, emboldened by its transformation into a drug company, has embarked upon an anti-American plan of interfering with business and intentionally eliminating various dietary supplement companies from the market. The FDA announcement came on Friday, June 22, 2007 under the guise of a final rule for dietary supplement good manufacturing practices (CGMPs). Within this 800 page rule the FDA states, "We find that this final rule will have a significant economic impact on a substantial number of small entities... Establishments with above average costs, and even establishments with average costs, could be hard pressed to continue to operate. Some of these may decide it is too costly and either change product lines or go out of business... very small …and …small dietary supplement manufacturers … will be at risk of going out of business... costs per establishment are proportionally higher for very small than for large establishments... The regulatory costs of this final rule will also discourage new small businesses from entering the industry." (http://www.cfsan.fda.gov/%7Elrd/fr07625a.html)
”This FDA rule will directly raise the price of dietary supplements for all consumers. The FDA acknowledges this and says "We expect that the majority of these costs will be borne by consumers of dietary supplements, who will likely respond to the increase in prices by reducing consumption." Thus, the FDA is intentionally seeking to shrink the size of the dietary supplement industry and reduce the influence of safe and effective options to improve the dreadful trend in the health of Americans. The goal is to leave toxic drugs as the primary health option.
”Independent analysis of this FDA rule has placed cost of compliance at 10 fold what the FDA estimates with as many as 50% of small companies unable to comply.”
To read more: http://www.newstarget.com/022499.html
SOP ALERT FOR COMPANIES: Now more than ever, “your papers must be in order…” – The Vitamin Lawyer Consultancy has prepared formats for Standard Operating Procedures to allow small companies to comply with the new rules, including the new AER law, by maintaining the necessary records. Our SOP format is relatively short (about 20 pages) but does cover all the areas needed:
A. Refund, Delivery & Returns Policies
B. Standard Disclaimers; Site Use Statement
C. Standard Testimonial Waiver
D. Email Privacy Policy
E. Document Retention Policy
F. Quality Control Procedures - Standards, Complaints and Policy Coordination
G. Order Processing Procedure
H. Bookkeeping and Account Management
I. Order Record Keeping and Retrieval; AER Reporting
J. Emergency Planning and Crisis Management
You can find out more at: http://tinyurl.com/2eu6yj
If you need the format, please email me at ralph.fucetola@usa.net and put “SOP” in the subject line. Typically, it takes an hour or two of my time to fine tune the format for you.
______________________________________________
3. Food niche with potential
Report pinpoints functional food niche with most potential - By Lorraine Heller
January 16, 2008 - Foods and drinks developed to address the specific health needs of consumers are expected to exceed category growth in the US functional food segment, according to a new report. Published by TSG, the study estimates that 'targeted foods', which currently make up 12 percent of the $60bn functional food segment, could grow to take a massive 25-35 percent share in 2012. This could bring up the total value of the sub-segment to between $55bn and $77bn over the next 13 years. Functional foods as a whole are projected to have a market value of $219bn by 2012.
TSG defines targeted foods are those functional foods that are designed to address specific health or disease conditions; specific physical or mental states; or specific age or gender needs. These, says the study, will grow "exponentially" as the functional foods markets continues its ascent into the mainstream.
"They will be the evolution of functional foods," TSG CEO Panna Sharma told NutraIngredients-USA.com.
Foods and beverages in this category include products that address: Digestive health, Celiac disease, Arthritis, Cancer prevention, Heart health
[Note from Vitamin Lawyer: some of these claims would not be allowed as Dietary Supplement claims.]
…[Other of these] products address: * Sports performance, * Beauty, * Skin care, * Libido, * Brain function
…TSG states: "Beverages will continue to drive innovation and early consumer adoption which will drive tighter alignment between functional ingredients and nutraceutical companies and the beverage community."
…"Global food and beverage giants will aggressively enter the market through acquisitions, alliances and select investments," said TSG.
For more –
http://www.nutraingredients-usa.com/news/ng.asp?n=82599&m=1NIU116&c=jegwylrviswtnqa
______________________________________________
4. Upgrading the VL Update eMemo!
I’m getting closer to the new version of the Update eMemo. I’ve begun to post earlier memos on a blogspot.com Blog. You can see it at: http://vitaminlawyerarchives.blogspot.com
In the future, you’ll receive a shorter weekly update email with links to Blog articles that will be posted as the information becomes available… more timely information better indexed!
______________________________________________
You got on this e-list by opting in or becoming a client of the Vitamin Lawyer.com Consultancy. If you want to be taken off the list, please “reply” to this email with the word “remove” in the subject line. On the other hand, you are welcomed to forward this to your own eList…
And do remember to check out the VLUeM Online Archives: http://tinyurl.com/rkneb
Online Seminar compilation of briefs and white papers: http://tinyurl.com/ua9lq
For an outline of typical cGMP SOP docs: http://tinyurl.com/2eu6yj
Vitamin Lawyer Oversight Seal: http://tinyurl.com/2cfoyb
For the latest on Adverse Event Reporting: http://www.aer-consultants.com
Vitamin Lawyer Health Freedom Blog: http://vitaminlawyerhealthfreedom.blogspot.com
For Health Freedom Issues: http://www.globalhealthfreedom.org - Please consider donating to Natural Solutions Foundation - your help is needed to protect the natural products market from bureaucratic interference...
Ralph Fucetola, JD - The Vitamin Lawyer.com Consultancy
http://www.vitaminlawyer.com – ralph.fucetola@usa.net
All Rights Reserved © 2008 . . .
Saturday, March 31, 2007
03/31/07 - Your FDA Compliance Notebooks, Affiliate Marketing
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1. Your SoP & Substantiation Notebooks & FDA Inspections
2. Grow Your Online Affiliation Program!
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1. Your SoP & Substantiation Notebooks & FDA Inspections
Updated here: www.VitaminIndustryCompliance.com
I’ve been asked what a Dietary Supplement marketer ought to have available for an FDA visit, in the event of a surprise agency inspection.
Ideally, you ought to have a couple loose leaf note books, (a) one entitled "Standard Operating Procedures Notebook" (or “SoP Notebook”) and (b) the other entitled “Substantiation Notebook.”
(A) The first Notebook should contain your:
(1) Operations Manual/SoPs and Employee Manual
(2) Formula sheets
(3) Label copies (with dates as to when they were in use)
(4) Literature copies (likewise dated)
(5) Copies of your Structure and Function Notices
(6) Insurance Policy binder page
(7) Certificate of Incorporation (or LLC Certificate of Formation)
(8) EIN and Bank Account number information
(B) The second Notebook contains information that substantiates the claims you are making. This Notebook should have a section for each product and each claim for the product, by ingredient.
(1) Abstract pages of scientific journal articles regarding the ingredients
(2) Clinical study reports about the ingredients and combinations of them
(3) Ethnographic reports on traditional uses
(4) Expert opinion letters
If you are ever visited by FDA, for one of their famous "surprise visits" having this stuff together so you can give them a copy would make them very happy.
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2. Grow Your Affiliate Program
The Vitamin Lawyer Consultancy does provide Affiliate Program Rules. Let me know if you want to establish an Affiliation Program.
Besides the right Rules, of course, you need the right software. One good program that I can recommend is the program used by BiomagScience.com for its online biomagnet sales program. It is a two step program, so, typically, you will see two banners from it on Affiliate web sites. One is for retail sales of biomagnets (for which you receive a sales commission), and the other is a “Become a Biomagscience Affiliate” banner, where another web site can join as an Affiliate, and your site earns an override on all retail sales through that site. If you go to the following page, you can see that banner: http://home.earthlink.net/~lifespirit23/support-lifespirit.htm .
But that’s just the start. After you have your web site and your affiliation program, you need to market it! If you do it right, you can expect very significant sales growth!
Here are excerpts from a piece through Add Me Newsletter about being an affiliate marketer.
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www.addme.com
How To Immediately Boost Your Affiliate Marketing Sa'les
By Titus Hoskins
Affiliate marketing is a very competitive field. Savvy affiliate marketers use every tactic they know to get the upper hand over their competition. It can mean the difference of whether or not they get that all important sa'le.
One of the best ways to boost your affiliate sa'les is to take full advantage of brand name recognition. … Popular brand names with popular trendy products sell the best.
If you're an affiliate marketer you must choose the products you promote with the utmost care; in many cases this is where you will determine the outcome of your marketing efforts…
As an affiliate marketer you can promote anything, why not choose the most popular brands and products. Just look for popular trends and join the bandwagon. Sure, the competition might be stiffer but the demand for these products will also be greater.
If you join affiliate networks like Commission Junction [or, for another example, eAffiliatez.com – rf] they will show you the companies with the highest sa'les volume in their system. Study this sa'les data before you pick your affiliate companies or products.
You can even use Google Trends to tell which products are popular and in which countries. Do some market research first and pick the most popular products to promote.
Many marketers keep an eye on their PPC (Pay Per Click) keywords for any surges in searches or impressions. A big jump could mean an increase in popularity for that product or company.
* Be Aware of “The Buzz” Factor …Certain brand names and products have buzz. …
* Can It Only Be Bought Online? … One of my most successful tactics has been to pick products or offers that are only available online. Dell products come quickly to mind. … Online coupons and exclusive deals also increases your affiliate sa'les. Look for these and display them along with your popular brands for they will increase your sa'les. Everybody loves a deal!
* Use Brand Names In Your Site Copy and PPC Advertising … You must always check with your affiliate company what rules they have about displaying brand names and trademarks on your site copy. Most companies will supply their affiliates with web content they can use for promotion.
Most Companies have strict rules prohibiting affiliates from using certain brand name keywords in their PPC advertising. Each company is different, so check before you proceed with any PPC campaigns.
However, one of the most effective ways for PPC advertising is to use the particular brand name and product name in your PPC ads. Savvy affiliate marketers have figured this one out long ago, it mainly has to do with finding the buyer at the right stage in their buying process. If they're looking a particular product ; they may already have their minds made up and are ready to buy…
* A Rose Is A Rose Is A Sa'le! … In conclusion… Keep your eyes peeled for popular trends and shifts in the marketplace so you can adjust your marketing to meet these new demands….
About the Author - The author is a full-time online marketer. For the latest and most effective web marketing tools try: Internet Marketing Tools - http://www.titushoskins.com/ © 2007 Titus Hoskins.
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Well, that’s all for now.
Ralph Fucetola, JD
The Vitamin Lawyer.com Consultancy
http://www.vitaminlawyer.com
All Rights Reserved
Friday, March 16, 2007
03/16/07 - Making Claims, SoP Outline, Health Freedom Site attacked
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1. Making Claims & New Dietary Supplements
2. Record Keeping SoP and Employee Manual – Online Outlines Available
3. Health Freedom Site Attacked
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1. MAKING CLAIMS & NEW DIETARY INGREDIENTS
Say your company needs a "DSHEA compliance" letter from The VitaminLawyer.com Consultancy about a new product. The threshold issue is whether the product is a "new dietary ingredient". We start by noting whether the product is found in the IBIDS data base. Then we check to see if similar products are found in the general FDA data base and look for references indicating whether FDA treats the product as a new dietary ingredient.
Journal abstracts showing the product being studied prior to the DSHEA "grandfathering" date of June, 1994 can be useful. Such information could show that the product was part of the food supply before the grandfathering date. This will negate the new dietary ingredient issue (which would have required prior FDA approval before marketing -- with proof of safety).
The other part of the DSHEA compliance issue has to do with the claims to be made for the product. If there are no claims being made, other than "a good source of [ingredient]" or "advanced bioavailable form of [ingredient]" (with substantiation for these claims, of course) then there would be no claim issues. Simple general “support of normal structure and function” claims are allowed. Even “immune system support” claims could be allowed:
"A “claim that a product "supports the immune system" is not specific enough to imply prevention of disease because the immune system has both structure/function and disease fighting roles. A general claim of this type doesn’t specifically focus the intended use of the product on the disease aspect of the system’s function."
Here is access to the FDA guidance: http://www.fda.gov/ohrms/dockets/98fr/98n-0044_gdl0001.pdf. Once these threshold issues are resolved, it becomes possible to provide a DSHEA compliance letter for use with potential distributors, online affiliates and joint venturers.
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2. RECORD KEEPING SoP AND EMPLOYEE MANUAL
SoP – Standard Operating Procedures – are an important part of cGMPs (current Good Manufacturing (Marketing) Practices. I’ve created a new web page with outlines of the contents of the SoP and EM documents - http://tinyurl.com/2eu6yj
A primary concern of small, leading edge dietary supplement purveyors is how to deal with the new wave of regulation that seems to be sweeping the industry. The first rule of bureaucracy is, “Are your papers in order?” Well, are they? In the context of current Good Manufacturing/Marketing Practices (cGMPs) your “papers” are the documentation of your business activities, from buying your products, through advertising, selling and shipping them. And then, dealing with customer issues, refunds, recalls, adverse event claims, etc., etc.
To make it as simple as possible, I’ve developed a shorter and simpler “Record Keeping SoP” version of my Standard Operating Procedures/Employee Handbook (SoP/EMs) that is made for smaller, Internet oriented dietary supplement and alternative therapy companies. For a bit over an hour of my time, I can customize the Record Keeping SoP format for your company, so you will know what documents you need to keep and for how long. Just email me at ralph.fucetola@usa.net with “Record SoP” in the subject line and I’ll let you know what information I need and how you can reserve the time for your SoP.
You can now also take a look at the Tables of Contents of the Record Keeping SoP (actual document: 5 pages), the Standard SoP Manual (16 pages) and the Employee Manual (22 single-spaced pages) that I’ve posted at: http://tinyurl.com/2eu6yj
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3. HEALTH FREEDOM SITE ATTACKED ON 03/12:
The websites of the Natural Solutions Foundation - www.globalhealthfreedom.org and www.healthfreedomusa.org – disappeared from the Internet within hours of the site exposing the genocidal agenda “the illness industry.” The sites are online again, but with a number of images and other information still missing. You can read the original article and the Internet attack at: http://www.healthfreedomusa.org/index.php?page_id=219
Here is what Dr. Laibow had to say in an email blast while the sites were down: “…our hosting company… locked our site with no reason given, no warning and no explanation. When I called to talk to someone about this I was told that the supervisor was "on leave," the manager was "not here," probably would not call me back when he got there, and that there was no one to talk to about the fact that my site was locked for no apparent reason at all. All this after 19 minutes and 45 seconds of international phone call holding. Why is our site blocked? Because, according to the technical services person, the site was locked in the computer with no explanation and can not be unlocked until I talk with the right person. Who is that? He does not know… The War on Freedom IS a War on Health Freedom… I wrote about the genocidal intent of the illness industry called Big Pharma in my latest email to you. Funny, immediately after that our site is mysteriously locked for no reason. Hmmmmm. Could it be that the Power Beast does not want you to know about these realities? Looks like it, doesn't it…”
As of today, the two parts of the site that still do not work, curiously, are the email sign-up and the Organics 4 U Shop. So no one can join or help support NSF*. Curious and curiouser… If you’ve chosen to be in this industry, you need to acknowledge its realities.
Ralph Fucetola JD
http://www.vitaminlawyer.com
* The Foundation can receive donations through PayPal, however.
You can PayPal to naturalsolution@optonline.net and the donation will go directly to the Foundation.
Also, do see Nutricide, now on YouTube at: http://video.google.com/videoplay?docid=-5266884912495233634&q=Nutricide
Monday, October 23, 2006
10/23/06 - More on SoPs and SEO
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Here’s what I cover in this memo:
1. SoPs – More on Operating Procedures
2. Top Ten SEO Factors – from Entire Web
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1. SoPs - More on Standard Operating Procedures
I know I’ve been telling you quite a bit over the past couple months on Standard Operating Procedures. There is an important business reason for that: bit by bit the FDA is coming out with more requirements that apply to dietary supplement companies, enforcing a provision in the 1994 DSHEA law giving FDA authority to codify current Good Manufacturing/Marketing Practices in the industry.
In comments to one member of Congress, discussing a meeting on SoPs, FDA stated: “The agenda included topics regarding the small business entities' manufacturing practices and standard operating procedures for: (1) personnel; (2) buildings and facilities; (3) equipment; (4) laboratory operations; (5) production and process controls; and (6)
warehousing, distribution and post-distribution of' raw, intermediate and final products . The meeting included a discussion about the verification of the identity, purity and composition of dietary supplements and dietary supplement ingredients.”
http://www.fda.gov/ohrms/dockets/dockets/96n0417/96n-0417-c000098-vol3.pdf
There has been continuing controversy regarding SoPs for the industry. GNC made its position clear in 2003, “FDA asserts that “dietary supplements have their own set of unique requirements as a result of the characteristics and hazards due to their ‘hybrid’ nature, e.g., dietary supplements can be considered as falling somewhere along the continuum between conventional foods on the one hand and drugs on the other.” Dietary supplements in fact fall within the food category and were treated as a food item for their entire history. DSHEA in 1994 confirmed the food status of dietary supplements and provided an expanded definition of the category.”
http://www.fda.gov/ohrms/dockets/dailys/03/Aug03/081803/96N-0417_emc-000197-01.doc
As a result, the original intention of FDA to have formal cGMP in place several years ago has been delayed. Now the agency seems to be imposing the regulations in a more piecemeal strategy. I’ve recently been reading FDA warning letters that cite a lack of an SoP as a concern of the agency.
To anticipate these developments, I’ve created a standard Operations Manual for my Vitamin Lawyer Consultancy clients. As the SoP is developed, it will cover all the areas cited by the FDA above. The most recent addition to the SoP is a page of instructions about reviewing Advertising Claims, whether on labels, literature or web sites. Those clients who are on a regular monthly retainer agreement with me have received that additional page already.
As an “added value” to my extended client base, I would be happy to provide a copy of this SoP page upon request. Of course the best way to be kept up to date is to be a regular monthly retainer client. And, you receive two added bonuses: a lower hourly rate and the use of my Vitamin Lawyer Oversight Seal. Drop me an email if you’d like more details.
See also [includes outline of SoP]: 07/05/06
See also [Crisis SoP]: 11/16/06
Updates: www.VitaminIndustryCompliance.com
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2. Some more good SEO advice from Entire Web -
"Entireweb Newsletter - October 24, 2006 - ISSUE #277
www.entireweb.com
Top Ten SEO Factors
These are what I believe to be the top 10 most important things (not necessarily in order) that you need, in order to get your website found in the search engines.
There are many other factors as well, but if you follow these guidelines, you'll stand a much better chance, and you'll be off to a good start.
1. Title Meta Tags
The title tag is what displays as the headline in the SERPs (Search Engine Results Pages). It's also what displays in the top blue band of Internet Explorer when your site is displayed
Your title tag of your website should be easy to read and designed to bring in traffic. By that, I mean that your main keyword phrase should be used toward the beginning of the tag. True there are websites being found now that do not use the phrase in the title, but the vast majority still do as of this writing.
Don't make the mistake of putting your company name first, unless you are already a household name, like Nascar or HBO. People are likely searching for what you have to offer, not your name.
Your title tag should be written with a capital letter starting the tag, and followed by all lowercase letters, unless you're using proper nouns. Some people prefer to capitalize every word, too.
2. Description Meta Tag
The description tag is the paragraph that people will see when your page comes up in the search results.
Your description tag should be captivating and designed to attract business. It should be easy to read, and compel the reader to act right now and follow your link. Without a description tag, search engines will frequently display the first text on your page. Is yours appropriate as a description of the page?
A proper description tag is what people will see below your title. You should make proper use of punctuation, and with readability, use your subject and geographical references.
3. Keywords Meta Tag
The importance of Meta keyword tags fluctuates from month to month among different search engines. There is a debate in the SEO community as to whether or not they help at all on certain search engines. In fact, in the summer of 2004 it appeared as if they were losing importance altogether.
However, you'll NEVER be penalized on any search engines for using relevant targeted keywords in moderation, and they can only help you with most, especially Yahoo.
Avoid stuffing your keyword metatags with too many keywords. Just use relevant tags that apply directly to the content of that particular page, and don't overdo it.
4. Alt Tags
The small yellow box that comes up when your mouse cursor is placed over an image is called the ALT tag. Every relevant image should have an alt tag with your key words or phrases mentioned in the tag.
A proper ALT tag goes after the file name, and before the Align indicator. * - The ALT tag is no longer being considered for ranking purposes by some search engines. That said, it still cannot HURT you, and will still help you with some engines. My recommendation is to continue to use them, but be sure to avoid keyword stuffing. Besides, who knows when the pendulum will swing back the other way?
5. Header Tags
The text of each page is given more weight by the search engines if you make use of header tags and then use descriptive body text below those headers. Bullet points work well too. It is not enough to merely BOLD or enlarge your text headlines.
6. Link Text
Search engine spiders cannot follow image links. In addition to having image links or buttons on your web pages, you should have text links at the bottom or elsewhere. The text that the user sees when looking at the link is called the link text. A link that displays products does not carry as much weight to the search engines as a link called oregon widgets. Link text is very important, and is actually one of the most frequently overlooked aspects of web design that I've seen.
7. Site Map
Using a site map not only makes it easy for your users to see the entire structure of your website, but it also makes it easier for the search engines to spider your site. When the search engine spiders come to visit, they will follow all of the text links from your main index page. If one of those links is to a site map, then the spiders will go right to the sitemap, and consequently visit every page you have text linked to from that site map. On the site map page, try to have a sentence or two describing each page, and not just a page of links.
8. Relevant Inbound Links
By relevant, I mean similar industry or subject related sites. Right now, no single strategy can get your site ranked higher faster than being linked to by dozens of other relevant websites. It used to be that the quantity of incoming links mattered most, but today, it's much better to have three highly relevant links to you from other popular related websites than 30 links from unrelated low ranked sites. If there are other businesses in your industry that you can trade links with, it will help your site enormously. Link to others, and have them link to you. It's proven, and it works. To see who's linking to you, in Google type the following... links: yourdomain.com
9. Your Content
Not to be forgotten of course, is the actual content of your webpage. It must be relevant helpful information that people want to read. These days, each webpage should be laser focused on one specific product or subject, in order to rank highly for that search phrase. The days of writing one webpage to appeal to dozens of search terms are long gone. Ideally, each page should have between 400 to 650 words on it. Too few, and the search engines won't consider it to be relevant enough. Too many words and the search engine spiders may have a hard time determining the actual subject or focus of the page.
Use your keywords or phrases often, and use them at the beginning of your paragraphs wherever possible. Don't overuse them and make the page sound phony, but don't write a page about a certain subject, and not mention that subject repeatedly either. Reading it out loud to yourself is a great way to judge how natural your text sounds.
Concentrate on writing quality pages that actually appeal to the human reader. Write pages that provide the reader with exactly what they are looking for; that is, information about the exact search phrase they've entered.
10. Avoid Cheating
With all of these tidbits of information, it's tempting to think that you can stuff 100 keywords into your title, or create a page with the phrase oregon widget company being used 100 times in headers, text links, ALT tags, bullet points etc. but that cannot help you. In fact, it can penalize you, and get your website banned from certain search engines.
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About the Author: Scott Hendison is an internet consultant that specializes in search engine optimization and internet marketing. He has written over 100 articles that are available on his website. He has also developed a tutorial area for beginning search engine optimization, at 'SEO101'."
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That’s all for now – I hope you find this information useful!
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