In a highly followed litigation (CRN and NPA filed a number of amicus briefs), United States v. Bayer Corp (US District Court for New Jersey) the Department of Justice and the Federal Trade Commission sought an Order holding Bayer in contempt of Court alleging that Bayer had violated the terms of a consent decree that required that the company posses "competent and reliable scientific evidence to substantiate its dietary supplement claims".  This is the general standard that FTC requires for substantiation of all dietary supplement claims (see FTC Dietary Supplement Business Guide).

The contempt motion alleged that Bayer did not have adequate substantiation for the following claims being made for a probiotic supplement (Phillips Colon Health "PCH" consisting of: Lactobacillus gassieri KS-13, Bifidobacterium bifidum G9-1 and Bifidobacterium longum MM-2) "to Promote Overall Digestive Health" and "Helps Defend Against Occasional Constipation, Diarrhea, Gas and Bloating."

The decision, which I view as a "must read" for anyone in the dietary supplement industry responsible for  creating and substantiating structure/function claims, in denying the FTC's motion in its entirety, clearly explains what is meant by  "competent and reliable scientific  evidence." 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 stated in the opinion:

First, the FTC Guidance makes clear that this standard is not the drug standard. 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 "the 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), http://www.fda.gov/regulatoryinformation/guidances/ucm073200.htm

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 discussed how FTC had attempted to argue that Bayer had made implied "drug" claims.  Apparently, FTC's best argument for this allegation was the use of the phrase, “prevention of occasional digestive upsets” by Bayer in a single store advertisement.  Merely using the word "prevention" does not, however, automatically mean prevention of disease.  As the Court correctly noted:

Although the display uses the word “prevention,” it is not a disease claim. The use of the term “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 presented any clear and convincing evidence 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.

Furthermore, FTC's choice of an expert witness in its prosecution of Bayer was inexplicable because the person admitted to knowing absolutely nothing about dietary supplements.  As set forth in the opinion, the FTC Expert witness, Dr. Loren Laine:  

opined that competent and reliable scientific evidence for the PCH claims at issue requires a randomized controlled trial ("Laine-Level RCT") meeting 8 specific requirements: (1) randomized; (2) placebo-controlled; (3) double-blind; (4) human clinical trial; (5) done in the target population; (6) with the specific product at issue; (7) using appropriate statistical methods; and (8) designed with the desired outcome as the primary endpoint.

The Court stated further noted:

Dr. Laine testified that only the "highest quality evidence," "level one evidence," or an "excellent" study of his design,  would satisfy the "competent and reliable scientific evidence standard." Dr. Laine admitted, however, that he had: (1) "never written any articles, books, or clinical guideline on probiotics,"; (2) "never conducted a study of any kind on probiotics,"; and (3) is "not an expert in probiotics," Additionally, Dr. Laine does not "hold [himself] out as an expert on dietary supplements." Dr. Laine does not "know of any probiotic product that has a study meeting [his] design." In fact, he indicated that he does not "know of any dietary supplement at all" that has a study meeting his design.

Dr. Laine testified that his study design did not distinguish between drugs or supplements. Dr. Laine explained that his study design would apply equally to "drugs," "educational brochures," "surgical interventions," "supplements" and even "food."

(Internal citations omitted).

It is also stunning that neither FTC, nor its expert witness, seemed concern 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).

What is most important about this decision for industry is not only the rejection of the attempt to place pharmaceutical standards on dietary supplements, but also the recognition by the Court of the flexibility of what actually constitutes "competent and reliable science" for dietary supplement structure/function claims as set forth in the FTC and FDA guidance.

Also of interest is the discussion of the steps that Bayer took to ensure that its claims were both acceptable structure/function claims (not drug claims) and were adequately substantiated.  As described at some length in the decision, Bayer uses a process known as the Legal, Medical, Regulatory  (LMR) review.  As stated in the decision:

The  role of “legal” in the LMR process is “to look at any claims or messaging in the document” and make sure they “are not misleading and are supported by evidence.”  The role of “regulatory” is to ensure that “the claims . . . are acceptable structure function claims based on DSHEA.”  If regulatory determines that a claim “is a disease claim,” it rejects the promotional material and no one can override that determination. The role of “medical” in the LMR process is to “look at dietary supplements and the claims [to] ensure that [there is] competent and reliable scientific evidence.”  (Internal Citations omitted).

The decision continues with a discussion of the steps that Bayer undertakes in performing its scientific review.

In conclusion, FTC has probably not been rebuffed in an attempted regulatory overreach concerning dietary supplements to this extent since the late 1990s when it attempted to bar Metagenics from using the name “Bone Builder” for a calcium product. WF

Steven Shapiro is of counsel to Rivkin Radler, LLP, and a partner of Ullman, Shapiro & Ullman

His 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.

Posted 10/2/15