Saturday, December 31, 2016

2017 Health Freedom Assessment

Inspired by General Bert
Here is Our 2017
Health Freedom Assessment
Urgent Information for Your Future

I visited my friends and fellow trustees, Dr. Laibow and Gen. Stubblebine (at JFK Hospital, Edison, NJ) where Gen. Bert has been for the last 120 days a couple days ago.  Gen. Bert is improving and we had a chance to catch up about the election and other strategic health freedom-related issues. His take? 2016 was not a good year for health freedom. Except for our amazing court victory the week before Christmas in which a Judge of the NJ Superior Court confirmed once again the right of Informed Consent, even in hospitals! Bert lives. Nutritional therapy works, when hospitals allow it.

You can read the Assessment here:

Or watch the video version here:

Please share these links widely on social media.

May you and your have a prosperous, healthy and free new year

Monday, December 12, 2016

The Vitamin Importer's “Ace in the Hole”

The Vitamin Importer's “Ace in the Hole”
Automated Commercial Environment (ACE)
Import Data System

This Vitamin Consultancy Newsletter focuses on an important aspect of business for the natural nutrient products market -- using the new ACE system to comply with requirements for importing FDA regulated products.

The new system will make it easier for FDA to block what it considers contraband, but it will also largely take the risk out of importing: you should know in advance whether your shipment would be stopped if shipped, thereby avoiding the expenses of rejected and returned shipments.

What follows are excerpts from the FDA announcement of its new imported products data requirements * that must be met at the point of entry.  Use of the ACE - Automated Commercial Environment - data system will be required as of December 29, 2016. This applies to all FDA regulated products imported into the United States.

The regulation does not distinguish between Foods and Dietary Supplements, treating DSs as Foods.

Whenever you intend to import a food product, you are required to notify the FDA.

Key regulation points:

1. "The owner or consignee of an FDA-regulated product is now defined as the importer of record."
2. "FDA can reject an entry for failure to provide through ACE the complete and accurate information required by the rule..."
3. "FDA will continue to provide assistance to filers working to properly submit the required data."
4. Intended Use Code (IUC) ** required for ACE submittal.

Practice Guide: Use the email and phone contacts below to make successful import filings.  FDA will walk you through your first use of ACE.

Ralph Fucetola JD


From: Trade Alert: FDA Issues New Import Data Requirements
Posted on November 30, 2016 by FDA Voice by: Howard Sklamberg, J.D. (Deputy Commissioner for Global Regulatory Operations and Policy)

"One of FDA’s many responsibilities is to review imported products regulated by the agency to determine admissibility. This job has become increasingly challenging with growing volumes of imports of FDA-regulated products each year — from six million import entries in 2002 to 35 million in 2015."

"...A final rule published on November 29 in the Federal Register specifies certain data that must be submitted in ACE when an FDA-regulated product is offered for import into the United States..."

"The rule also includes technical revisions to certain sections of FDA regulations:

    "The owner or consignee of an FDA-regulated product is now defined as the importer of record. This brings FDA regulations up to date with previous revisions to customs laws. (21 CFR 1.83 and 21 CFR 1005.2)

    FDA will now directly provide a notice that an FDA-regulated product is to be sampled, rather than having to go through CBP to provide that notice. (21 CFR 1.90)

    FDA may now provide written notices electronically to the importer of record about FDA actions to refuse FDA-regulated products and/or subject certain drug products to administrative destruction. (21 CFR 1.94)

    The rule clarifies that FDA can reject an entry for failure to provide through ACE the complete and accurate information required by the rule."

----- Important Resources -----

"FDA will continue to provide assistance to filers working to properly submit the required data.

Some of the measures we have instituted:
  •     We are offering telephone meetings with importers, customs brokers, and other stakeholders, in real-time, while they are filing entries in ACE. Request a meeting by emailing
  •     An ACE Support Center is staffed 24/7. Reach FDA staff by email at or by phone at a domestic toll-free line (877-345-1101) or a local/international line (571-620-7320).
  •     Upon request, FDA will assist in a filer’s first ACE submission, or for filers who import various commodities, FDA will assist with every first submission of a particular commodity.
  •     Additional assistance for general import operations and policy questions, including FDA product codes and entry requirements, is available via email at or by calling 301-796-0356."

There are various other requirements that may delay importation, or add costs to it, *** but food importation notices through ACE have the potential to simplify importation red tape.
* The Data Requirements are set forth in the Federal Register:

** Intended Use Codes (IUC):  --

"Base Code 230.000 - For Consumer Use as Human Food - A human food product intended for distribution in the general public supply chain or military commissaries in its present form with or without repackaging or with minimal processing such as cooking, slicing, or peeling. Examples include packaged food products, pre-packed salads, fresh chopped or cut vegetables and fruits, bulk fruits for consumer packaging, and convenience foods." [Dietary Supplements, as "packaged food products..." are included in Base Code 230.00.]

*** The General Enforcement regulations are at:  - Subpart E relates to imports and exports.
05 December 2016

Monday, November 21, 2016

Food Safety Summary for DSHEA Products

Food Safety Summary for DSHEA Products

Company Action Alert:  Biennial Food Facility Registrations Due Dec 2016

This memorandum is paraphrased from a number of sources and is intended as a private communication to the regular clients of The Vitamin Consultancy.


The Food Safety Modernization Act was signed in 2011 (with some protection for DSHEA products that I fought hard to have included) and with it, notably tougher government and retailer food safety standards.

Demands on companies to demonstrate regulatory compliance and due diligence will continue to escalate, yet just one failed performance verification audit or one product recall can significantly damage your business -- even if you have written Standard Operating Procedures in place.

In these litigious times, lawyers and consumers alike will seize on any opportunity to take legal action against manufacturers in the event of finding any issue with the product purchased. Food manufacturers supplying retail organizations understand the need to ensure the highest product quality.

It is therefore in the best interests of manufacturers marketers to take steps to ensure systems and procedures are in place to minimize the risk of harm to the public and consequent litigation. In the event of such an instance, the company must have the necessary documentary evidence that the company has been duly diligent in the manufacturing process.

The FDA states that the Label Owner for the product is ultimately responsible for assuring that the ingredient providers, manufacturers, packers, shippers and all persons involved in the process adhere to all food safety regulations.

The Primary Food Safety Regulations include:

[1] The Food Facility RegistrationBiennial renewals are due Oct – Dec 2016 (and 2018, 2020, etc) --

[Practice Note: you must confirm the registration receipt email by return email within 30 days or the registration is not valid.]

[2] Good Manufacturing Processes (GMPs) which vary depending on whether the product is an OTC drug, a cosmetic, or a food or dietary supplement (by the way, in DSHEA, the Dietary Supplement Health and Education Act of 1994, Congress directed FDA to model the Dietary Supplement GMPs after Food GMPs, not Drug GMPs.

[3] The 2011 Food Safety Law which gave enhanced powers to FDA, but, in section 1011 of the Act preserved our grandfathered DSHEA ingredients from those enhanced powers.

[Practice Note: this means the battle has shifted to exactly what ingredients are “grandfathered.”]

Additionally there are local (city, county) and state regulations that apply to the handling of foods.

Some of the overall concerns that arise are included in the following “Black Letter Law” overview:

Duty of Care

Under the common law we each have a Duty of Care which requires that we conform to a standard of reasonable care regarding any acts or omissions that could foreseeably harm others. The Standard of Care is the standard degree of watchfulness, attentiveness, prudence and caution of a reasonable individual who is under a Duty of Care.

In manufacturing the Standard of Care is determined by the cGMPs as implemented by a reasonably prudent manufacturer of a product.

Failure to meet the Standard of Care will likely be regarded as negligence, and any proximately caused, foreseeable damages may be claimed by an injured party.

Due Diligence

That the company engaged in Due Diligence to determine the Duty and Standard of Care can be a defense for to manufacturers accused of violating food safety regulations (but, of course, the regulations have to be implemented going forward). This defense asserts that the accused took all reasonable practicable steps to avoid the harm. It is a sufficient defense for the person charged to prove that:

• All reasonable precautions were taken, with
• All due diligence to avoid the occurrence, whether personally or through any person under their control.

“Taking all reasonable precautions” includes setting up systems of control which are appropriate to the risk. What is reasonable is determined by the size and resources of the business. “Exercising all due diligence” involves having procedures in place which review and audit the system to ensure it is operating effectively.

Whether or not a defense will be successful depends on the circumstances surrounding each case.

Hazards Analysis Critical Control Points

In food production cGMPs call for a Hazards Analysis Critical Control Points (HACCP) based system to support the procedures to identify where hazards might occur. The HACCP structure is then used to put into place procedures to mitigate the risk of the hazard from occurring in the first place. The HACCP process strictly monitors and controls each manufacturing step, to reduce the probability for hazards to occur.  This is similar to the section in my standard SOPs on CAPA (Section 20).

HACCP is based on 7 core principles:

• Conduct a food safety hazard analysis
• Identify the Critical Control Points (CCPs) (point at which a hazard is optimally controlled)
• Establish critical limits for each CCP
• Establish CCP monitoring requirements
• Establish corrective actions when monitoring indicates that a particular CCP is not under control
• Establish record keeping procedures
• Establish procedures to verify system is working as intended


We have briefly looked at the Black Letter law concepts of Duty and Standard of Care, and Due Diligence and have listed the three primary areas of FDA food safety control.

Having Standard Operating Procedures (SOPs) that track the appropriate GMPs for the type of regulated product manufacturing is an important first step in meeting regulatory requirements.

The second step is to fully implementing them.

However, even if “all your papers are in order” your ingredients or claims may run afoul of FDA food safety regulatory actions. Only close attention to changes in the enforcement climate will keep you ahead of the pack of competitors.

The Vitamin Consultancy aims to keep you informed so you can continue to develop and market your dietary supplement products in relative freedom.


Thursday, October 27, 2016

Agenda 2020 - Foresight, Not Hindsight

Agenda 2020 - Foresight, Not Hindsight

Re: The Institute for Health Research and the Vitamin Consultancy's Business Collaborative

The natural product industry in the United States has been growing rapidly for the past half century.  As a participant in that business, you want to know where it is going next. The next big thing? The next regulatory assault? You need foresight, not hindsight. That's what this private memo is about.

To paraphrase, "An industry divided will not stand."  I have been closely observing the direction the government is taking with regard to supplements and I don't like it! Back in the '70s and '80s there were far fewer supplement companies, and they were small by today's standards. But those that existed pulled together, understanding that there was safety in numbers, and by the mid-'90s we were able to cajole Congress into giving DSHEA (the Dietary Supplement Health and Education Act) unanimous approval.

The industry that grew from that push back is now maturing and its participants need to pay attention to the threats, and opportunities, on the horizon.

Since you are on my Vitamin Consultancy email list you probably know that I practiced law for 36 years, becoming known as The Vitamin Lawyer. Today I continue my work through my Vitamin Consultancy and as Vice President of Natural Solutions and President of the Institute for Health Research --

A plan is developing for the next few years that involves you and your company. The plan is called Agenda 2020 as it is envisioned to be fully implemented over the next four years -- our "20-20" vision for the future.

The plan includes continued enhancements to the Vitamin Consultancy, bringing additional professionals into the Consultancy. An example is the Cosmetic Dossier Service Dr. R. Goodman and I provide.

Our core VC services will continue to be upgraded:

1. Label, literature and claims consulting
2. General vitamin industry consulting
3. SOP and GMP compliance
4. The Cosmetic Dossier
5. The Vitamin Consultancy Webinar Training System
6. GMP physical and virtual audits

These services are funded through client fees and are self-supporting.

But that is not all that we do here. Natural Solutions Foundation and the Institute for Health Research have a significant portion of my attention, my time and advise. Their activities need to be self-supporting too. This memo focuses on the Institute.

But be aware there are some exciting changes coming to Natural Solutions -- to be covered in a future memo.

The Institute for Health Research was established in 1998 by Green Turtle Bay Vitamins founder Karen Horbatt and Dr. Richard Podell, a well-known Jersey physician and teacher. I am the third trustee. Today Ms Horbatt remains our Chairwoman Emeritus, I am President of the Institute and several health professionals, including Rima Laibow MD have joined the Board.

We have begun to publish a professional Journal and seek leading-edge health, natural approach research papers. Our focus is providing actionable information for people in the natural products arena. You can read the first published articles, by luminaries such as Gary Null, ND, Sharry Edwards, MEd and Rima Laibow, MD, at

US tax law allows your company to donate up to 5% of its gross profits to charitable activities, and gain a significant tax break. The Institute is authorized to accept such donations and issue the appropriate tax receipt. We have a PayPal donation button on the main page and are also happy to receive checks or money orders made out to the Institute c/o Ralph Fucetola, 58 Plotts Rd, Newton, NJ 07860.

How much of your company's gross profits are you ready to allocate toward protecting your Commercial Health Freedom? This is the time of year when it is prudent to make those allocations.

Here is the monthly Institute budget I need your help to meet:

1. Office space, overhead and supplies: $1500
2. Web Master / Site & Journal Maintenance: $1,000
3. EList maintenance: $700
4. Educate Decision Makers system: $700
5. Social Media Intern: $750

There are other expenses. For example, we need to develop a PR budget, including adequate funds for at least quarterly trips to venues such as Washington, DC or trade meetings.
Bottom line: what can funding the Institute office do for you?

The Vitamin Consultancy will be able to continue to provide you with a very high level of professional consulting for modest hourly fees, along with the Webinar System and other special services.

But, as the Institute becomes properly funded, in cooperation with the Consultancy, I will also be able to provide Sustaining Members early alerts critical to operating in an increasingly complex regulatory climate.

The first Alert from the Institute that I am preparing is a Special Report: Food Safety Regulation -- Action List. These will include summaries of the private alerts I provide  privately to my Monthly Retainer Consultancy Clients. Biannual registration renewals are due.

Another powerful business's tool we are developing is the Nutrient Companies' Business Collaborative -- a private information exchange that brings best practices to the fore, keeping the Sustaining Members at the leading edge.

The goal of the Collaborative is to introduce its members to each other, to share their special capacities for mutual benefit, and clout. "Push Back Works" and pushing back together works even better.

As a Sustaining Member your company will be among the first to hear about new technologies and leading edge approaches, such as using frequency in the testing and processing of food products. Here I am thinking of the pioneering frequency matrix work of Sharry Edwards or the recent frequency analysis article by Mike Adams.

How does your company become a Sustaining Member?

Set up a recurring donation through our PayPal donation button at or send a check or money order for one year (min. $1200). We will provide appropriate tax receipts. If it is convenient for you, I can arrange to have the Institute send you a monthly invoice from its PayPal account.

Whether a clear vision for Agenda 2020 comes into sight will depend on you seeing that vision benefiting the future success of your business. IMHO, it's time foresee where we are going.

Call me if you have any questions, or just to let me know that you are in...

Ralph Fucetola JD

Tuesday, October 18, 2016

Merchant Accounts for Nutrients

Merchant Account for Nutrients

One of the challenges facing dietary supplement companies is where to find merchant services, such as the ability to accept credit and debit cards for your product sales.  For leading-edge products this can be quite a challenge. For example, PayPal is well-known for cutting-off companies that sell products such as CBDs and the like.

Dan Fucetola of Winning Business Solutions has sourced a merchant account company that specializes in nutrient products.

You can find out more here:

Just click on "G.E.T. Merchant Account: START HERE."

"We are proud to partner with Global Electronic Technology, Inc. for Merchant Services. Yes, they do handle dietary supplement products and anything else you can sell. Start by sending us a message to the special contact form below. Our GET account manager Luis will contact you directly. Please include your phone and email."

Ralph ...
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.          

Saturday, October 1, 2016

Vitamin Consultancy September 2016 Newsletter

Mail Chimp Version
CDC dangerous quarantine and treat/vax regulation
FDA offers 102 page NDI guidance
From: Ralph Fucetola JD

Welcome to the September 2016

Vitamin Consultancy eNewsletter.

The banner above, featuring yours truly and my co-trustees at Natural Solutions Foundation, Rima Laibow MD and Maj Gen Bert Stubblebine (US Army, Ret.) points to a very important and urgent matter.

The CDC has proposed a draconian quarantine and forced treatment/vaccination regulation, giving the public until October 19th to file comments. Under the Administrative Procedures Act, this is a necessary step for agency action, or for litigation testing the validity of the new rules. What does the rule say about Informed Consent? It says your consent "shall not be considered as a prerequisite..."

“§70.18 – Agreements. CDC may enter into an agreement with an individual, upon such terms as the CDC considers to be reasonably necessary, indicating that the individual consents to any of the public health measures authorized under this part, including quarantine, isolation, conditional release, medical examination, hospitalization, vaccination, and treatment; provided that the individual’s consent shall not be considered as a prerequisite to the exercise of any authority under this part.”

The FDA's guidelines for what is a New Dietary Ingredient (NDI) were issued in 2011. Last month an updating was proposed as FDA continues to implement a policy of making Dietary Supplement rules more like Pharmaceutical Rules rather than the food-standard regulation that Congress determined to be public policy in the Dietary Supplement Health and Education Act of 1994 (DSHEA).

The new document is 102 pages. The Devil, as they say, is in the Details. As is the deviltry...

This note is just to acquaint you with the fact that the rules are being made tougher. Bottom line: [1] what is an NDI and [2] how much harder will it be to have one approved by FDA?

[1] The definition, set by statute has not changed. The FDA now phrases it this way:

"On October 25, 1994, the Dietary Supplement Health and Education Act of 1994 (DSHEA) (Pub.L. 103-417) was signed into law. DSHEA amended the FD&C Act by adding, among other provisions, (1) section 201(ff) (21 U.S.C. 321(ff)), which defines the term “dietary supplement”; and (2) section 413 (21 U.S.C. 350b), which defines the term “new dietary ingredient” and requires the manufacturer or distributor of an NDI, or of the dietary supplement that contains the NDI, to submit a premarket notification to FDA at least 75 days before introducing the product into interstate commerce or delivering it for introduction into interstate commerce, unless the NDI and any other dietary ingredients in the dietary supplement “have been present in the food supply as an article used for food in a form in which the food has not been chemically altered” (21 U.S.C. 350b(a)(1))."

[2] How much harder? That of course translates into, how expensive?

The more restrictions, the more expense. Being "grandfathered" and thus exempt from the NDI process is not easy, for example:

"A notification is not required when the NDI and all other dietary ingredients in the dietary supplement have been present in the food supply as articles used for food in a form in which the food has not been chemically altered. ... FDA interprets the phrase “present in the food supply” to refer to the conventional food supply. Accordingly, we interpret a dietary ingredient that has been “present in the food supply as an article used for food” to mean a conventional food or conventional food ingredient. We do not consider prior use in dietary supplements to constitute presence in the food supply."

More directly impacting cost is what are the requirements to prove the safety of the NDI?

"That standard provides that a dietary supplement containing the NDI is adulterated unless there is adequate information to provide reasonable assurance that the ingredient does not present a significant or unreasonable risk of illness or injury."

What evidence is sufficient to meet this standard?

"A notification should provide evidence of a history of safe use; other evidence of safety, including clinical testing, animal testing, or both; or some combination of history of use and other evidence of safety. The submitted data should provide the basis for a conclusion that there is a reasonable expectation of safety under the proposed conditions of use of the dietary supplement containing the NDI."

And, to the wise this interesting hint:
"FDA expects that when history of use evidence alone is adequate to support the safety of the NDI in the supplement, notifiers will prefer to use that route. Compared to the cost and time needed to conduct clinical or animal toxicology studies, it is generally less expensive and faster to gather historical information and to conduct chemistry studies to establish the identity of the historically used materials."

So, as your vitamin business moves ahead, you will need guidance in dealing with New Dietary Ingredients.

The Vitamin Consultancy is here to help with all aspects of new product development, from concept through testing, labeling, claim writing and the rest of your product presentation needs.
Standard Operating Procedures
Dietary Supplement and Natural Products
Development, Training & Deployment


...documentation of employee training is necessary

This web site, provides access to my Standard Operating Procedures certification program, specially designed for the industry, with special emphasis on small and start-up companies, but any company that has its own labels needs this program! You need my 36 years’ experience as The Vitamin Lawyer and half-century in the nutrient industry!

I can save your company hundreds of thousands of dollars in regulatory costs! Just embrace my three simple steps to regulatory compliance:

[1] PROCEDURE – I work with your CEO to tweak my Standard Operating Procedures and Good Manufacturing/Marketing Practices for your company

[2] CLAIMS – I work with your company for proper claims control, definition & substantiation... and the FDA required S&F Claims Notice.

[3] TRAINING - It's not enough to have procedures, says FDA: train your team and prove they are qualified - through my Three Step Program: Presenting, Training, Certifying.

That third step is what this Certification program is designed to accomplish: meeting FDA training requirements.

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 The Gold Standard - Vitamin Lawyer Consultancy Certification Program!

Tuesday, September 27, 2016

The DHEA Cases

You can read about the 1995 DHEA Cases that I handled for Life Extension Foundation here:

The cases stand for the proposition that Government cannot make a normal bodily substance (in these cases, DHEA, a male hormone found naturally in the body) into Contraband.

Here is the Life Extension article on the cases:

Sunday, August 28, 2016

Welcome to the New Vitamin Consultancy eLetter

New eLetter Archive here:

This newsletter copy:

The August 2016 eLetter

Welcome to the New Vitamin Consultancy eLetter

If you've received this email you are on my personal list. Since I imported this list from the email system my new MailChimp account replaces, I may have accidentally included emails of people who do not want to be on this list. If that is the case, please accept my apologies and just Reply to this email with "Remove" in the subject line.

My intent is to send out about one newsletter monthly, focusing on information that may be of special value to start-up companies in the natural product market.

Here is the archive covering nearly a decade of my newsletters:

But let's start with a blog posting from earlier this month, entitled "Vitamin War Stories." We all have our war stories. I hope you find these informative, or at least entertaining.

"[Recently traded some "Vitamin War" stories with some Vitamin Pioneers and it was suggested that I write out some of my stories, so, here are a few...]
I was 24 in 1969, in the middle of law school (I had graduated from Rutgers College, BA with Distinction and was then attending Rutgers Law School, earning my JD). 
That’s when I met future best-selling authors Durk Pearson and Sandy Shaw (the 1980s Life Extension books). My future wife Kathy Greene and I became part of Pearson/Shaw’s informal nutrient experiment group..."

Here is the link:

Have a great Labor Day holiday. I'll be here when you start your Fall/Winter marketing...


Ralph ...

Tuesday, July 26, 2016

FDA Food Registration Rule Change


Earlier this month the FDA Food Safety Center finalized the rule regarding the registration of food-handling facilities, making some changes in details. Generally, any facility that handles food must be registered with the FDA, and therefore, subject to FDA inspection (in addition to state and local food safety inspections).  The full update is at:

The registration requirement was part of the 2010 Food Safety Modernization Act (FSMA).

The Amendments to Registration of Food Facilities final rule updates FDA’s food facility registration requirements by requiring additional registration information for the food facility registration database for facilities both in the United States and abroad.

Food facilities that manufacture/process, pack or hold food for consumption in the United States are required to register with the FDA, and this final rule adds new provisions to the current regulations to codify certain provisions of FSMA that were self-implementing and effective upon enactment of FSMA.

Those provisions include the requirement of an email address for registration, required renewal of registration every two years, and that all food facility registrations must contain an assurance that the FDA will be permitted to inspect the facility at the times and in the manner permitted by the Federal Food, Drug and Cosmetic Act.

In addition, the final rule adds certain new technical requirements for the facility registration system. All food facility registrations are required to be submitted to the FDA electronically, although this requirement does not take effect until January 4, 2020.

Registrations are now required to contain the type of activity conducted at the facility for each food product category. This is required as of the date of the final rule, July 14, 2016, which is prior to the October-December 2016 registration renewal period. Finally, beginning October 1, 2020, food facilities will need to provide a unique facility identifier (UFI) as part of the registration process.

The final rule also amends the definition of a retail food establishment in a way that expands the number of establishments that are considered retail food establishments, and that are therefore not required to register with the FDA as food facilities. The FDA states, "However, all food establishments, including retail food establishments, continue to have a responsibility to ensure their food is safe."

Tuesday, April 26, 2016

2015 FDA Warning Letter Analysis

2015 FDA Warning Letter Analysis

FDA was busy last year with a spat of warning letters to dietary supplement companies that I summarize here. A Warning Letter is more serious than the standard FDA inspection Observation Report.

1. While the number of warning letters is relatively low, under a hundred a year in an industry that has several thousand label-owners, the number has been growing: 67 in '13, 71 in '14 and 80 last year.

That means companies need to pay attention and get ready for FDA inspections and warnings. The best way to prepare? Make sure that your SOPs are up-to-date: Your papers must be in order.

2. One area of notable increase is in the number of citations for products adulterated with substances that are not dietary ingredients.

3. The major warning included in the letters related to labeling issues; of the 80 2015 letters, 60 included label issue citations. Website concerns were the second highest, with 43 and facility issues third with 35. Social media was a distant forth with 8.

4. Companies in California, Utah and Florida had the most warning letters.

5. Looking at the 80 letters from the viewpoint of the violations cited we find these:

40 Disease Claims
28 Adulteration, Non-dietary
27 cGMP Violations
23 Label Issues
07 Social Media
05 Caffeine, Powdered
04 Adulteration, Drug
01 Ad Not Substantiated

[My observation: most if not nearly all advertisement non-substantiation issues are raised by FTC, not FDA. Social media is becoming a regulatory concern but the effort to enforce is just starting.]

6. There were a number of disease claims warnings, with the claim being found in different places. In 8 cases, in the product name; in 8 on Facebook; 7 in testimonials; 6 in brochures and 5 in scientific references. One or two also cited meta-tags, YouTube, Pinterest, Tumblr, LinkedIn, eBooks and even printed books.

7. Disease claims on social media sites were primarily limited to Facebook (8) with the other social media sites (LinkedIn, Twitter, Tumblr, Pnterest and YouTube having one each).

8. The disease claims cited most included:

24 Arthritis
24 Inflammation
22 Antimicrobial
22 Cancer
21 Diabetes
18 Blood Pressure
16 Cholesterol
16 Pain

9. Among label violations specifically, the Supplement Fact Panel had the most citations.

10. Label errors such as serving size, statement of identity and incorrect amounts were among those most cited.

11. The most cited GMP violation was for Part E, Production and Process Controls with Quality Control, QC, a close second.

I conclude from this analysis that we can expect a continued increase in the number of inspections and, consequently, in the number of warning letters. Remember that an Inspection Report is a less formal response from the FDA and will be the usual Agency action after an inspection.

A Warning Letter can be avoided if, in advance of the inevitable inspection, your SOPs are set-up and being implemented, so that the various items listed above do not apply to your operations.

Ralph Fucetola JD