"In a case closely followed by all advertisers in general and the dietary supplement/natural products industry in particular, United States v. Bayer Corp., the United States District Court for New Jersey rebuffed an attempt by the Federal Trade Commission (FTC) to greatly increase the level of proof required for an advertiser to substantiate health related claims. The case, wherein the Department of Justice and the FTC sought an Order holding Bayer in contempt of Court for allegedly violating the terms of a consent decree that required that the company posses "competent and reliable scientific evidence to substantiate its dietary supplement claims", could have led to a significant stifling of advertising claims available to any company seeking to tout the health benefits of its products. Instead, the Court’s decision provides an invaluable roadmap for companies seeking to establish a compliance program to support all types of advertising claims.
Bayer and the FTC
The contempt motion claimed that Bayer violated a 2007 Consent Injunction which in turn arose from allegations that it violated a 1991 Administrative Order to cease and desist making unsubstantiated claims on behalf of One-A-Day vitamins, which was owned by Miles, Inc. Under that Order, Miles was directed to “cease and desist from making any representation, directly or by implication, concerning the need for or benefits to be derived from [One-A-Day vitamins] unless . . . at the time such representation is made [it] possesses and relies upon a reasonable basis consisting of competent and reliable scientific evidence to substantiate the representation” (emphasis added). Bayer subsequently acquired the One-A-Day brand and became subject to the terms of the 1991 Order. The 2007 Injunction resulted from charges that Bayer made unsubstantiated claims on behalf of its One-A-Day Weight Smart product. The 2007 Consent Injunction extended the strictures of the Administrative Order to all health related claims made by the company’s consumer products division.
In September, 2014 the Department of Justice, acting on behalf of the FTC, filed a motion seeking to hold Bayer in contempt of court for allegedly making unsubstantiated claims on behalf of its probiotic supplement Phillips Colon Health ("PCH"). PCH consists of: Lactobacillus gassieri KS-13, Bifidobacterium bifidum G9-1, and Bifidobacterium longum MM-2. The primary claims challenged by the FTC were that the product could be used to "Promote Overall Digestive Health" and "Help Defend Against Occasional Constipation, Diarrhea, Gas and Bloating." Both of these claims appear to be what the supplement industry would consider mainstream “structure/function claims” permitted for use on dietary supplements under the Dietary Supplement Health and Education Act of 1994. The Commission, however, argued that the opinion of its expert, Dr. Loren Laine of Yale Medical School, established that these claims could only be substantiated by “gold standard” (long term, double blinded, placebo controlled) clinical trials on the PCH product.
Clinical Studies Not Needed
In April 2001, the FTC published Dietary Supplements: An Advertising Guide for Industry setting out the Commission’s views on what constitutes “competent and reliable scientific evidence” deemed acceptable by “experts in the field”. No substantive revision to the Guide has been issued in the intervening 14 years, so it remains the definitive public notice of the level of substantiation that the Commission believes necessary to support health related claims made on behalf of dietary supplement products. By extension, it is also the most significant public statement of the Commission’s expectation of substantiation for any product making health related claims.
The Bayer decision, which is a "must read" for anyone responsible for creating or reviewing advertising in the dietary supplement and other health related products industries rebuffs the FTC’s effort to impose a requirement of two clinical trial as the expected level of evidence to meet the standard of "competent and reliable scientific evidence", while explaining in great detail what would actually be required by that standard. The Court notes, among other things, the flexibility of the standard and the fact that, for supplements, "this standard is not the drug standard".
As the Court cogently observed, the FTC Advertising Guide clearly establishes that the standard applied by FDA for the approval of drug products, two long term double blinded placebo controlled clinical trials, is not what is required to support claims for dietary supplements, rather:
"Randomized clinical trials are not required. FTC Guidance at 9-18. Instead, "competent and reliable scientific evidence" is a 'flexible" standard', and '[t]here is no fixed formula for the number or type of studies required.' Id. at 8-9. Although 'well-controlled human clinical studies are the most reliable form of evidence[,]' they are not necessary, and '[r]esults obtained in animal and in vitro studies will also be examined, particularly where they are widely considered to be acceptable substitutes for human research or where human research is infeasible.' Id. at 10. '[R]esearch explaining the biological mechanism underlying the claimed effect' will also be considered. Id. '[E]pidemiologic evidence may be an acceptable substitute for clinical data' in some circumstances. Id.
"Second, the FTC Guidance states that one should look to t'he totality of the evidence.' Id. at 14. 'The surrounding body of evidence will have a significant impact both on what type, amount and quality of evidence is required to substantiate a claim and on how that claim is presented.' Id.
"Third, studies on the precise formula used in the advertised product are not required. Rather, it can be 'appropriate to extrapolate from the research to the claimed effect,' even if there 'are significant discrepancies between the research conditions and the real life use being promoted.' Id. at 16.
"The Food and Drug Administration (FDA) agrees in its guidance, recognizing that randomized, controlled clinical trials for dietary supplements may not be "possible, practical, or ethical." See FDA, Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act (Dec. 2008).
Based on these statements in the Advertising Guide and the FDA’s Guidance on the same subject, the Court concluded that "The Government failed to establish, by clear and convincing evidence, that Bayer violated the 2007 Order issued by this Court. The United States did not carry its burden of proving that Bayer failed to possess and rely upon 'competent and reliable scientific evidence" to substantiate its specific claims about PCH's efficacy for constipation, diarrhea, and gas and bloating.' "
The Court also rejected the FTC’s attempted to argue that the use of the phrase, “prevention of occasional digestive upsets” in a single store advertisement was a "disease" claim, justifying the requirement of clinical trials as substantiation. The Court stated that merely using the word "prevention" does not automatically mean prevention of disease. As the Court correctly noted, the FDA’s Guidance on Structure Function Claims states:
Although the display uses the word “prevention,” it is not a disease claim. The use of the terms “occasional” as well as the described symptom, “digestive upsets,” do not indicate a disease state; rather, this is a structure-function claim. See 65 Fed. Reg. 1000, 1006 (promotes digestion “does not refer explicitly or implicitly to an effect on a disease state”)
Thus, because the FTC presented no consumer survey data, no customer impression testimony, and no expert marketing testimony of any kind, the Court found that FTC had not proven by clear and convincing evidence (the standard applicable on Contempt applications) that Bayer made implied claims of any kind, let alone implied disease claims rather than a structure / function claim of the type acknowledged as valid by FDA.
Supplements, not Drugs
The Court further noted that neither FTC, nor its expert witness, seemed concerned about the lack of knowledge regarding dietary supplements:
“The FTC did not provide Dr. Laine with a copy of the FTC Guidance for Industry regarding the substantiation necessary for dietary supplement claims. Therefore, Dr. Laine testified that he ‘did not rely on [the FTC Guidance] or look at it when [he] made [his] original report.’ Dr. Laine also was not familiar with DSHEA, which regulates dietary supplements and categorizes supplements differently from drugs. Dr. Laine ‘had not heard of the statute’ at ‘the time that [he] provided [his] report.’ Dr. Laine also ‘did not review [ ] or consider . . . FDA regulations in any way’ in formulating his expert opinion. Nor was Dr. Laine informed of the regulatory distinction between "structure function" claims and disease claims.
“Although Dr. Laine did ‘know in a general sense there has been a different interpretation [between the substantiation standards for dietary supplements and drugs]’ he was ‘not up on the legal and regulatory issues as an expert.’ Dr. Laine admitted he was ‘not paying attention to the law or regulations about the difference between dietary supplements and drugs.’ (Internal citations omitted).
“Dr. Laine testified that his study design did not distinguish between drugs or supplements. Dr. Laine explained that his [standards] would apply equally to ‘drugs,’ ‘educational brochures,’ ‘surgical interventions,’ ‘supplements’ and even ‘food.’ " (Internal citations omitted).
Putting aside both the inexplicable position of the FTC's expert and the Commission's decision to pursue this case on that basis, what is most important about this decision to industry is recognition by the Court of the flexibility of what actually constitutes "competent and reliable science" as set forth in the FTC and FDA guidance.
A Quick Lesson on Advertising Reviews
Companies would do well take note of the steps that Bayer took to ensure that its claims were both acceptable structure/function claims (not drug/disease claims) and were adequately substantiated, which seem to be a model that should be emulated by all. In particular, the Court noted that, as part of its Standard Operating Procedure for the release of advertising and promotional materials, Bayer conducted an “LMR review”. This process involved representatives of the Company’s legal, medical and regulatory departments. Unanimous approval of the LMR group was required before any such material could be published; if any member of the review group did not agree that the piece of promotional material under consideration was compliant with all legal, medical and regulatory obligations, it would not be used. Critical to the process is the fact that marketing is not part of this review process.
The Court’s rejection of the FTC’s efforts to require “drug” level substantiation for mundane structure/function claims constitutes a significant victory for the supplement industry as it can continue to rely on the standards for ensuring what constitutes "competent and reliable scientific evidence" that have been articulated by the FTC and FDA in its guidance documents without having to rely on “gold standard” clinical trials. The decision also provides comfort for other companies making health related claims and the Court flatly rejected the Commission’s expert’s call for clinical trials in support of virtually any type of health related claim.
To date, since no appeal of the decision has been filed by the FTC it technically has effect only in the District of New Jersey. Given the difficulties with the Commission’s case that were so clearly highlighted by this decision, it would seem extremely unlikely that there will be an appeal or another effort to press such an extreme view of the requirements for substantiation any time soon."
Steven Shapiro and Marc Ullman are Of Counsel to Rivkin Radler, LLP . Their practice focuses on the dietary supplement/natural products industry with a particular emphasis on FDA and FTC compliance issues including labels, labeling and advertising claims.