Will December Bring New Proposals for the Dietary Supplement Industry?

Hello and Happy December!

FDA has been busy in the past few months, publishing several draft guidance documents and proposed rules for food safety—including a proposal that would ban partially hydrogenated oils in foods.  They also published updated guidance on cosmetic GMPs but have been relatively quiet about dietary supplements.  However, in September FDA’s Center for Food Safety and Applied Nutrition (CFSAN) published their “Plan for Program Priorities, 2013-2014” that included quite a list of goals for the dietary supplement program (http://tinyurl.com/nx6hsse). Since there are less than 30 days left in 2013, it will be interesting to see whether FDA will publish a flurry of proposed rules or miss their proposed deadline.

CFSAN’s overall plan for the dietary supplement industry is to “take steps to improve the safety and labeling of dietary supplements and the supply chain.”  It is interesting that the supply chain was mentioned since many dietary supplement manufacturers have complained that the dietary supplement GMPs do not extend to the suppliers, making it difficult for manufacturers to convince raw material suppliers of the importance of good documentation and record keeping that would help manufacturers comply with the GMPs (http://tinyurl.com/lj3z35f).

The CFSAN Plan for Program Priorities goes on to list 5 planned steps to address the safety and labeling of dietary supplements:

     1.       Modernize the postmarket surveillance system for regulating dietary supplements. This was a recommendation from the Department of Health & Human Services Inspector General’s 2012 report, “Dietary Supplements: Structure/Function Claims Fail To Meet Federal Requirements” (http://tinyurl.com/keq4b27). By the way, this document details a study in which the Inspector General’s Office reviewed label claims and the manufacturer’s substantiation dossiers for 72 dietary supplement products.

      2.       Develop and implement risk-based compliance and regulatory strategies to address dietary supplement safety issues.  FDA typically takes a risk-based approach in their oversight and regulatory enforcement actions in regulated industries.  In the past FDA had indicated that they were particularly interested in monitoring the marketplace for claims relating to cancer, diabetes and influenza H1N1; they also watch for supplements that claim to affect memory, sexual function and weight loss.  It is unclear whether FDA will publish their regulatory strategies but we will be watching for updates to their compliance policy and inspection manuals.

     3.      Publish revised draft guidance on new dietary ingredients (NDIs) to increase premarket oversight of dietary supplements.  This highly anticipated guidance could prove to be very interesting.  The first draft was published in July of 2011.  FDA received over 12,000 comments on this document that appeared to the dietary supplement industry to be a substantial overreach by the agency that in effect, would put into place a premarket approval process for dietary supplements; a proposal that appears to violate the enabling legislation of the dietary supplement regulations.  It is unlikely that publication of the revised draft guidance would be received as good wishes for a prosperous new year by industry.

    4.      Publish final guidance on new dietary ingredients (NDIs) to increase premarket oversight of dietary supplements.  While this step is set for 2014, the short timeline indicates that the agency does not expect as many comments as there were for the first draft.  Perhaps they have thoughtfully considered the industry’s previous comments and the document will be something that both industry and regulators will find workable.

    5.      Publish final guidance to help dietary supplement and beverage manufacturers and distributors determine whether a liquid food product (such as energy drinks) may be labeled and marketed as a dietary supplement.  In December of 2009 FDA published a guidance document on “Factors that Distinguish Liquid Dietary Supplements from Beverages…” (http://tinyurl.com/nxjuswg).  FDA issued the guidance at a time when many ‘functional beverages’ were making their way to store shelves.  The apparent aim was to rein in the industry; however the plethora of liquid products available that claim to be dietary supplements but look like beverages is testament to the fact that the 2009 guidance has been largely ignored.

If CFSAN does publish all those proposed documents, we will do our best to keep you up to date without inundating your inbox.  In the meantime, the associates at FDALabels.com and Bioscience Translation & Application are ready to help you ensure that your products are compliant with FDA regulations so that you can enjoy uninterrupted market success.

As always, we hope you find these occasional updates interesting. Please use this link http://eepurl.com/Imbjv to subscribe to our occasional email newsletters regarding FDA regulations and other topics of interest to FDA-regulated companies.  We send messages targeted to the dietary supplement, cosmetic, food, OTC drug and medical device industry sectors.  You may subscribe to one or all of the newsletters and you may unsubscribe at any time.

All the best to you!

Evelyn & Associates

www.FDALabels.com

www.BioTransApp.com

Alaskan Native Art, Structure Function Claims and the FTC

Late last summer while visiting the Alaska State Museum in Juneau,  a postcard with a photo of a decorated canoe caught my eye.  On the front it said, "Genuine Alaskan Native Art" and on the back was a blub about the Federal Trade Commission (FTC) and  FTC information on Alaskan Native Art. There are specific guidelines on when terms such as 'Alaska native' can be used.

The FTC has recently gotten the attention of the food and dietary supplement industries by requiring two clinical trials for support of structure function claims.  No where in FDA regulations is this required.  Companies must have data supporting the claims they make as discussed in this FDA guidance but there is no stipulation that 2 clinical trials are required. FDA Law Blog has written very good pieces about the conflict between POM Wonderful and the FTC.

Today FDA published an announcement in the Federal Register  that the Office of Management and Budget had approved the agency's request to collect information from industry on substantiation of structure function claims.  It will be important for industry to respond with realistic information about the time and effort proper vetting of claims takes.

The associates at  FDALabels.com can review your claims and supporting data to help you determine if you have proper substantiation. 

FTC and Two Well-controlled Clinical Studies

In their settlement with Dannon over claims on DanActive and Activia, the FTC again evoked its standard of “two well-control clinical trials” to support structure function claims.  This standard was previously applied to Nestlé’s Boost® Kids Essentials drink and POM Wonderful Pomegranate Juice (POM is challenging FTC’s 2 clinical trial standard but the courts have yet to weigh in). 

FDA has written an extensive guidance document on claim substantiation without providing a definitive number of studies and instead relying on the interpretation of ‘adequate’ studies to support the claims.  FDA and FTC cooperate on cases involving claims on foods and supplements with FTC taking the lead in most cases.  Does this mean that FTC’s ‘two well-controlled clinical studies” will be the standard? Would ‘two well-controlled clinical studies’ prove to be a safe harbor for companies making structure function claims that do not directly or indirectly discuss disease states?  There’s just no telling but stay tuned.

The use of structure function claims on food products has been increasing and FDA is watching closely and cracking down on companies making claims with help from the FTC.  As a review, food products may include claims about the levels of nutrients that have an established RDI or DV as long as the levels of fat and sodium do not exceed set limits. They may also make certain health claims that link nutrients to disease prevention and ‘qualified’ health claims that have weaker support (see http://www.fda.gov/Food/LabelingNutrition/LabelClaims/HealthClaimsMeetingSignificantScientificAgreementSSA/default.htm)

and http://www.fda.gov/food/labelingnutrition/labelclaims/qualifiedhealthclaims/default.htm, respectively).

Food companies are getting into trouble when trying to make structure function claims. These claims discuss how the product or ingredients in it affect the normal, healthy structure or normal, healthy function of the body or its systems and do not discuss any drug-like properties or imply that the product in any way may prevent, treat, or cure any disease.  It is possible to craft claims that discuss the effects of the product on ‘normal’ conditions that are occasional, mild, temporary and self limiting such as occasional sleeplessness, occasional irregularity, and occasional indigestion.  All claims must be truthful, not misleading and backed by scientific evidence.

We at Bioscience Translation & Application stand ready to review your claims and supporting data and to help you craft appropriate claims and we welcome your inquires on these and other topics relating to food regulations. Learn more atwww.BioTransApp.com

Warning Letter & Draft Guidance on Clinical Trials

Hello!

The FDA has been busy lately, issuing many guidance documents and warning letters.  Two that are of particular interest to the dietary supplement industry are a series of warning letters to companies marketing chelation/detoxification products (see http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm229320.htm) and a new guidance on when FDA permission is required to conduct a clinical study (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM229175.pdf)

The FDA press release about the warning letters on chelation products cites examples that were clearly marketed inappropriately due to claims being made about autism and heavy metal poisoning.  Other products were marketed as dietary supplements but were not made to be ingested.  FDA’s press release also provides insight into the agency’s objection to the term ‘detoxification’.  Many of the chelation products talk about removing heavy metals and pollutants and it is clear that FDA views any detoxification as a disease prevention or treatment process.  While these letters address chelation, anyone wishing to market product for colon health should also avoid the term ‘detoxification’.

The guidance document on clinical studies is also very relevant for dietary supplement companies.  All claims made about dietary supplement products must be substantiated with scientific studies. Traditionally, the industry has relied upon a collection of studies on individual ingredients to support claims made on a product consisting of many ingredients.  Recent FDA and FTC enforcement actions indicate that regulators from these agencies believe that studies should be conducted on the final product in order to make claims.  Recent findings from the National Advertising Division of the Better Business Bureau, which reviews food and dietary supplement product claims, support this view. 

Back to the new guidance:  A quandary for the industry is presented by the newly published guidance which notes that if a study has an endpoint that looks at the effect of the dietary supplement on a disease condition, then FDA requires submission of an Investigational New Drug (IND) application.  However, it seems to me that submission of an IND would in effect mean that the company conducting the study has declared that their product is a drug and not a dietary supplement.  The net effect is that studies must be carefully designed and the subject population carefully screened to avoid running afoul of dietary supplement regulations. 

The good news is that the guidance is a draft and FDA is seeking public comments. It will be very important for dietary supplement manufacturers to pay attention to this issue and support efforts by trade groups to fight back.  Otherwise, this guidance could be a small step that could dramatically effect what dietary supplement products will remain in the marketplace. 

I plan to discuss this guidance with two attorneys who will be speaking on Dietary Supplement Claim Substantiation at the Regulatory Affairs Professionals Society conference sessions I am chairing next week in San Jose, CA.  http://s36.a2zinc.net/clients/raps/annual10/public/SessionDetails.aspx?SessionID=26 

If any of you will be at the conference or in the area, please let me know so that we can meet.

FTC Issues Letters on Omega-3 Fatty Acid Claims

The Federal Trade Commission in conjunction with the Food and Drug Administration has announced that they have issued warning letters to several companies who are making claims regarding omega 3 fatty acids and brain and vision function.  The agencies are seeking information regarding the substantiation of these claims. 

Recently, Northwest Natural Products successfully responded to a similar warning letter with the result that FTC issued a closeout letter stating that no enforcement action would be taken. In the letter, the FTC stated,

“Upon careful review of the matter, including non-public information submitted to staff, we have determined not to recommend enforcement action at this time. The factors we considered in making this determination include the very limited duration of the print advertising campaign containing the claims at issue and NNP's swift and voluntary action to modify all marketing materials for these products, including product packaging and labeling, to ensure compliance with the FTC Act. Specifically, we understand that NNP has destroyed all remaining product labels containing the claims at issue and is in the process of distributing new labels”

The letter further stated that the FTC staff “appreciates NNP' s significant cooperation in the prompt resolution of this matter.”  This example clearly shows how having appropriate documentation of all claims as well as displaying good faith by being cooperative and working to address any regulatory issues can prevent enforcement actions that could result in product seizure and severe disruptions in business. 

At Bioscience Translation & Application, we often provide our clients with information as to what risks various claims may pose.  We also remind our clients that all claims must be truthful, not misleading and substantiated by scientific data.  We at Bioscience Translation & Application are ready to evaluate your product claims and to help you gather the information required to substantiate your product claims to ensure your success  We also stand ready to help you respond to FDA letters and actions, should the need ever arise. Visit us at www.BioTransApp.com

For further information on this topic, you may view the FTC news release at http://www.ftc.gov/opa/2010/02/omega.shtm  and a discussion of it at http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2010/02/ftc-hones-in-on-omega3-claims-among-others.html

See the Northwest Natural Products closeout letter at http://www.ftc.gov/os/closings/091030northwestclosingletter.pdf

Court Rules Against FTC in Supplement Claims Case

Hello!

You may find the story from FoodNavigation.com that is pasted below interesting.  It involves LaneLabs, a supplement company that is under a consent decree due to making false claims on dietary supplement products.  The FTC brought a suit against them due to new claims they were making stating that these claims violated the consent decree; however, the court ruled that the company indeed had data to substantiate the claims they were making and further stated that the company had made efforts to ensure compliance by conducting studies and hiring a compliance officer.  It is also important to note that the court found that FTC did not bring evidence that consumers had complained about the products or had been harmed.  The court also stated that the FTC and LaneLabs had a difference of opinion when it came to interpreting the data supporting the claims.

It is very rare for FTC to lose this type of case and demonstrates a point we often discuss with our clients:  It is possible for experts to disagree when interpreting claims, regulations and scientific studies but good faith efforts to be compliant have value.  Remember to always have a file of data regarding the structure function claims you make about your food or dietary supplement products. This file should include both supporting and contradictory studies and an analysis of the strength of the overall data.  This data will help you craft claims that are compliant and be ready to answer any questions FDA or FTC may raise.  I have worked on only one case where the FDA disagreed with our interpretation of the science supporting claims that were being made.  Because the company involved had a data file on claim substantiation, we were able to respond to the FDA warning letter very quickly.  We sent them a number of articles and never received a follow up complaint or regulatory action.

At Bioscience Translation & Application we are always ready to help you evaluate your marketing materials for regulatory compliance. We also offer claim substantiation services.  While we hope you never need it, we are also able to provide support in the event FDA or FTC takes issue with your claims. Learn more at www.BioTransApp.com