February Vitamin Consultancy Newsletter STS WEBINAR

[1] FDA Takes Action Against Products Claiming to Treat Disease

[2] NEW WEBINAR: When must you have batches of your product tested?

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[1] The journalists at Vitamin Retailer have been investigating FDA's latest actions and report "On Feb. 11, the U.S. Food and Drug Administration (FDA) posted 12 warning letters and 5 online advisory letters to foreign and domestic companies that are illegally selling more than 58 products, many that are sold as dietary supplements, which are unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer’s disease and a number of other serious diseases and health conditions." https://vitaminretailer.com/fda-takes-action-against-products-claiming-to-treat-disease-seeks-to-strengthen-oversight/

Looking more closely at the warning letters and actions, we find that they are mostly about the "claims" being made, not the ingredients (though some disreputable companies have adulterated their vitamin products with unapproved drugs).  The lesson:  be careful what you claim.  Be very careful about the words you use to describe those claims!  For example, one of the valid nutrient ingredients mentioned was Alpha GPC (L-Alpha glycerophosphocholine) --not because it is a "drug" -- but because the claims made were about treating cognitive impairment medical conditions.

The article reports that FDA Commissioner Scott Gottlieb, MD said, “Today’s actions are part of the FDA’s larger effort to address the booming growth of the dietary supplement industry through the implementation of modern regulatory initiatives that will enable the agency to preserve the balanced vision of the Dietary Supplement Health and Education Act (DSHEA), enacted by Congress 25 years ago. That law sought to achieve the right balance between preserving consumers’ access to lawful
supplements, promoting innovation in these products, while upholding our obligation to protect the public from unsafe and unlawful products and holding accountable those actors who are unable or unwilling to comply with the requirements of the law. Our newest policy efforts will seize the game-changing opportunity to further strengthen the regulatory framework overseeing dietary supplements and will hone in on important steps to both promote industry innovation while upholding the safety of these products as part of our overall commitment to protecting public health.”

Bottom Line:  pay attention to the words you use to state your claims... and have the Vitamin Consultancy review them before you communicate to the public!

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STS WEBINAR & EBOOK

[2] Here is a Practice Question I often receive from my Vitamin Consultancy clients.

Does FDA require that the Label Owner of a DSHEA Dietary Supplement have finished product batch-tested [in addition to verifying the ingredients]?

Yes.  Here are the batch testing concerns from Subpart C of the GMP regulations:

1.  That the product meets the specifications for the product in 6 specific areas - 21 CFR 111.75(a) through (g)
2.  That an expiration date, if any, is scientifically valid [Such a date is not required by FDA, so I do not recommend expiration dates]
3.  Specific types of tests required - 21 CFR 111.75(h)(2)
4.  Must test for: identity, purity, strength, composition, and the limits on types of contamination that may adulterate - 21 CFR 111.75(c) & (d)
5.  Every finished batch must be tested - 21 CFR 111.75(c)
6.  There are certain exemptions - 21 CFR 111.75(d)

In addition to testing concerns, Part IX also addresses Specifications and Samples. You have to determine what your specifications are for 7 specific areas set forth in Subpart B and, under Subpart C, you have to determine whether your product meets the specifications in 6 specific areas listed there.

Comparison of Subpart B and C Specification Requirements:

B.  Required to Establish

1. control point specifications
2. components
3. in-process
4. labels and packaging
5. finished batch
6. received for packaging and labeling
7. finished product packaging and labeling

C.  Required to Determine Product Meets

1. components
2. in-process
3. finished batch
4. received for packaging and labeling
5. labels and packaging
6. finished product packaging and labeling

[Subpart A is about "General Requirements" and Subpart B is about Requirements to Establish Specifications; Subpart C is about testing. Subpart D* is about specifications and verification of dietary ingredients and Subpart E is about representative and reserve samples]

My new Specifications, Testing and Sampling (STS) Webinar and eBook cover these matters in greater detail with references to the specific regulations and standards required.  Email me with "STS Webinar" in the subject line and we can arrange your access to the webinar and its accompanying ebook.

As always, of course, my monthly retainer clients will automatically receive access to this new Webinar and eBook as soon as they are posted.

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: www.SOPcertification.com. 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.

Most important, make sure that your Claims are all DSHEA-permitted Support for Normal Structure and Function Claims. I aim to review claims language within a day or two at most... so send me your Claims!

Ralph Fucetola JD

Citation: http://dietarysupplementexperts.com/fda-warning-letters-2015-summary/

Antioxidant Claims and FDA Regulation

VITAMIN CONSULTANCY UPDATE eMEMOApril 21, 2015

Memorandum from Ralph Fucetola JD To: Vitamin Consultancy Contact List: Keep May 1, 2015 open for an exciting Health Freedom Event: the Mayday! Marathon :  http://tinyurl.com/MaydayMarathon. [1] Many vitamin purveyors want to make Antioxidant Claims about their products. Free-radical quenching nutrients are of great significance in achieving and maintaining a healthy status... So it shouldn't surprise us that FDA has restrictive regulations on using the term "Antioxidant" -- restrictions of which very few in the industry are aware. Here is the central relevant regulation language [there are other requirements which I can discuss with you if you are interested]: "(g) Nutrient content claims using the term "antioxidant." A nutrient content claim that characterizes the level of antioxidant nutrients present in a food may be used on the label or in the labeling of that food when: (1) An RDI has been established for each of the nutrients; (2) The nutrients that are the subject of the claim have recognized antioxidant activity; that is, when there exists scientific evidence that, following absorption from the gastrointestinal tract, the substance participates in physiological, biochemical, or cellular processes that inactivate free radicals or prevent free radical-initiated chemical reactions..." Primarily, the restriction that often causes issues for herbal antioxidants and other nutrients is that they do not have a RDI -- Recommended Daily Intake -- and thus cannot qualify under the Regulation. So what is the work-around? Since the Vitamin Consultancy is here to make sure you have a way around bureaucratic restrictions, this is my suggestion for an alternative rubric to express your products' antioxidant claims if they do not qualify under the Regulation: "Supports Normal Antioxidant Function" -- SNAF. Of course, "the devil is in the details" and I'm here to work with you on those. Valid substantiation is required. Just let me know how I can help. [2]  If you are on this elist, you are most likely involved in the Natural Products market. And, if so, a number of you have, in addition to dietary supplement products, some cosmetic products. And... if so... have you considered marketing your natural cosmetic products in the European Union? There are special rules that easily  let you do just that! Rima Laibow, MD and Robert Goodman, PhD have teamed-up with me to provide the required third-party EU Cosmetic Dossier services for you. What is that? Take a look at the short slide presentation here: http://vitaminconsultancycertification.weebly.com/eu-cosmetic-dossiers.html  You will be pleasantly surprised. [3] And remember that my full SOP Training Webinar System is available for your use:www.SOPcertification.com . Does your manunfacturing facility need a Virtual Audit? More about that here:  www.RegulatoryComplianceNetwork.com.

11/02/07 - FDA Commissioner Warns Industry

 

... VLUeM – 11.02.07 - VITAMIN LAWYER UPDATE e-MEMO


Lots of ground to cover in this memo… important information…

1. Health Freedom Blog Update, Factoid & Client GMP Warning
2. Raising the RDA
3. Taking vitamins is good for you
4. Organic is better…
5. Warning from new FDA Commissioner to DS industry
6. SEO for small businesses

1. Vitamin Lawyer Health Freedom Blog –
New Posting - http://vitaminlawyerhealthfreedom.blogspot.com/

“In the past, over-conservative government-sponsored [maximum level] standards have encouraged dietary complacency…” - Vitamin Safety Review Panel

Client GMP Warning: This just in: one of the Vitamin Lawyer clients reports receiving a request from his production people: “In the very near future we are going to need a copy of your stability study which substantiates your Exp [expiration] date. FDA requires that this be on file and available for review.” This particular client is wisely having his contract manufacturer laboratory retain samples to test every six months so he will have the data.

Please note that the FDA does not currently require the use of “expiration” or “best if used by” dates.

The new GMP Rule comments state: “if you use an expiration date on a product, you should have data to support that date... We recommended that you have a written testing program designed to assess the stability characteristics of the dietary supplement, and that you use the results of the stability testing to determine appropriate storage conditions and expiration dates… the final rule does not require that you establish an expiration date, we decline to offer guidance on the type of data that are acceptable to support an expiration date, other than to repeat that any expiration date that you place on a product label (including a ‘best if used by’ date) should be supported by data.”


To get on to the Global Health Freedom eblast list, please go to: http://www.globalhealthfreedom.org


2. Raising the RDA

“The US Recommended Daily Allowance/Daily Reference Intakes are too low and most should be raised immediately, says an independent panel of physicians, academics and researchers. In a statement this week, the Independent Vitamin Safety Review Panel said: “Government-sponsored nutrient recommendations, such as the US RDA/DRIs, are not keeping pace with recent progress in nutrition research… In the past, over-conservative government-sponsored standards have encouraged dietary complacency. People have been led to believe that they can get all the nutrients they need from a 'balanced diet' of processed foods. That is not true. For adequate vitamin and mineral intake, a diet of unprocessed, whole foods, along with the intelligent use of nutritional supplements, is more than just a good idea: it is essential.”

orthomolecular.org/resources/omns/v03n10.shtml


3. Taking vitamins is good for you…

Knowledge of Heath, Inc. - nutritionj.com/content/pdf/1475-2891-6-30.pdf
Special Report: Dietary Supplement Fanatics Healthiest Of All - By Bill Sardi © 2007

“They may not be laughing at vitamin supplement fanatics much longer. According to an authoritative study just published in The Nutrition Journal, avid dietary supplement users who, on average, take 17 different supplements daily, were judged to be far healthier than adults who just take a single supplement such as a common multivitamin, or who don't take dietary supplements at all.…While more than half of U.S. adults take dietary supplements, nearly
half of these supplement consumers take only one type of supplement, most commonly an inexpensive multivitamin…Risk for disease was far lower among the multi-supplement users compared to non-users. Risk for diabetes was 73% less, coronary heart disease 52% less, and self-determined health status (report health status was rated as "good or excellent") 74% more often, compared to non-supplement users.

This study may dispel a common belief that a low-dose multivitamin may be sufficient to address essential nutrient shortages. Source: Gladys Block, et al, Usage patterns, health, and nutritional status of long-term multiple dietary supplement users: a cross-sectional study. The Nutrition Journal, 6: 30, 2007


4. Organic is better…

“The biggest study into organic food has found that it is more nutritious than ordinary produce and may help to lengthen people's lives. The evidence from the £12m four-year project will end years of debate and is likely to overturn government advice that eating organic food is no more than a lifestyle choice. The study found that organic fruit and vegetables contained as much as 40% more antioxidants, which scientists believe can cut the risk of cancer and heart disease, Britain’s biggest killers. They also had higher levels of beneficial minerals such as iron and zinc.”

timesonline.co.uk/tol/news/uk/health/article2753446.ece


5. Warning from new FDA Commissioner to DS industry

Speaking before the American Society for Pharmacology and Experimental Therapeutics (ASPET) and the American Society for Nutritional Sciences, Dr. Lester M. Crawford, Acting Commissioner of the Food and Drug Administration (FDA), outlined what the agency claims is its science-based approach to regulating dietary supplements

"FDA is absolutely committed to protecting consumers from misleading claims and unsafe products," said Dr. Crawford. "Unlike most foods, some dietary supplements are pharmacologically active. And we have
seen over the last 10 years a huge growth in the dietary supplements industry, including the introduction of products that seem far removed from the vitamins and minerals of the pre-DSHEA days. We have become increasingly aware of the potential health problems some of these products pose."

In the last 6 months, FDA has inspected 180 domestic dietary supplement manufacturers; sent 119 warning letters to dietary supplement distributors; refused entry to 1,171 foreign shipments of dietary supplements; and seized or supervised voluntary destruction of almost $18 million worth of mislabeled or adulterated products. "We will continue to aggressively enforce DSHEA against unsafe or mislabeled products," Crawford said.

The article continues: When DSHEA was passed a decade ago, there were about 4,000 supplements on the market, including vitamins, minerals, amino acids, and herbs and other botanicals. Congress determined that these products were more like foods than drugs, which cannot be put on the market unless a high threshold of evidence about their safety and efficacy is met, and that, like foods, such dietary supplements should in general be given the benefit of the doubt as to safety. A recent Institute of Medicine report, sponsored by FDA, estimated that American consumers spend $18 billion annually on dietary supplements and that there are about 29,000 such products on the market, with another 1,000 new products introduced each year.

altmedicine.about.com/cs/govtregulation/a/FDAPlan.htm

Are your papers in order? http://tinyurl.com/2eu6yj


6. Search Engine Optimization for Small Business Owners

Entireweb Newsletter * November 1, 2007 * ISSUE #384

Small business owners are often limited by small marketing budgets and manpower. But that doesn't mean they can't compete against larger businesses or websites when focused on search engine optimization. SEO is a basic marketing tool that everyone should use regardless of size...

What makes a keyword competitive? One way to determine the competitiveness of a search term is to simply type that search term into Google and notice the number of web pages that contain that search term. This number appears in the upper right-hand corner of the search results page and appears as, "Results 1 - 10 of about 228,000,000 for [your search term here]." ...From my perspective, when this number is less than 3 or 4 million, the particular search term would not be all that competitive in and of itself.

Determining just how competitive the search term is. There are a variety of methods to determine true keyword effectiveness (KEI, etc.)... In addition to the number of sites that contain your keyword, how well optimized are the top 3 sites that appear on the search result. You can determine this by:

1. Visiting the site and determining the Google PR of the page. This information is available by downloading the Google toolbar and looking in your browser. You will see a green bar and ranking (ex: PR5), which tells you how Google ranks this page/website with regard to popularity. Any site with a Google PR6 or better is well established and will be difficult to outrank in the near term.

2. Visit Google and type , "link:www.competitorwebsite.com". Be sure to replace 'competitorwebsite' with the website name you are researching... This will tell you how many sites are linking to this particular website. The larger the number the more difficult it will be to outrank.

3. Look at the website code. Simply visit the competitor's website and go to "View", "View Source". Look for the meta tags of "Title", "Description", and "Keywords"...

Using the above will give you a good sense of whether of not you can compete for given keywords...

About the Author: Michael Fleischner is an Internet marketing expert with more than 12 years of marketing experience... webmastersbookofsecrets.com

entireweb.com/newsletter/archive/2007/PRINT384.html

09/15/06 - "promotes and markets... for serious disease conditions"

09/15/06 - VITAMIN LAWYER UPDATE e-MEMO

VLN - http://www.vitaminlawyernews.com http://vitaminlawyerhealthfreedom.blogspot.com/

The FDA issued the following press release last week: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01446.html

Excerpts:

"At the request of ...(FDA), on September 5, 2006, U.S. Marshals seized quantities of Ellagimax capsules, Coral Max capsules, Coral Max without Iron capsules, and Advanced Arthritis Support capsules... valued at approximately $55,000.00."

[Note the following claim that the NEW drug and misbranding provisions apply to dietary supplements as well as to drugs, when the DS is being promoted, in FDA's opinion, as a "drug."]

"The products are alleged to be in violation of the new drug and misbranding provisions of the Federal Food, Drug and Cosmetic Act."

"Although these products are labeled as "dietary supplements," they are being promoted with claims typically associated with drug products. These claims are evident in the products' labeling, including various promotional literature, an audio cassette tape, and two Internet Web sites owned and used by the firm. ..."

"[Company's] labeling promotes and markets these products for serious disease conditions, including but not limited to cancer, arthritis, fibromyalgia and seizures."

[And now, what to expect.]

"Following an investigation of the firm's marketing practices, FDA advised Advantage Nutraceuticals that the claims related to prevention or treatment of diseases in many of its products' labeling make these products subject to regulation as drugs. Despite FDA's warnings, the firm failed to take sufficient steps to come into compliance with the Act. During subsequent inspections, FDA inspectors found that the offending claims were still being made."

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Note that "sufficient steps to come into compliance..." was the issue. This case appears to be another example of "guilty until proven innocent" in that no independent third party determined that the steps the company took were "sufficient." The companies that will survive in what is becoming a much stricter regulatory climate are those that are ready to react quickly. Oh, and if you are one of those companies trying to take "sufficient steps," not keeping a large inventory in your main plant is probably a good idea too.

You need to pay attention to your site claims on a continuing basis, and that is what the Vitamin Lawyer Oversight Seal program is all about. See: http://www.vitmainlawyer.com for details.