In a much anticipated opinion for the dietary supplement industry and for products making health benefit statements, the District of New Jersey in US v. Bayer has found in favor of Bayer in holding that the government failed to establish Bayer was in contempt of a 2007 FTC consent decree.
In so holding, the court rejected the government’s proposed substantiation standard that would require randomized clinical trials (RCTs) to substantiate health benefit statements, including structure function claims, on dietary supplements. The decision adds to the body of government guidances, industry opinions and case law that the appropriate scientific substantiation standard for dietary supplements is the totality of the evidence.
The court’s opinion in US v. Bayer Corp., issued on September 24, 2015, rejects the government’s position that Bayer was in violation of a 2007 consent decree it entered into with the FTC. That consent decree, involving Bayer’s advertising of WeightSmart vitamins, reflects a settlement in which Bayer, among other things, was enjoined from making any express or implied claims about the benefits, performance or efficacy of any dietary supplement it markets or sells unless, at the time the representation is made, Bayer “possesses and relies upon competent and reliable scientific evidence that substantiates the representation.”
Notably, as with similar FTC consent decrees, the 2007 Bayer consent decree defined “competent and reliable scientific evidence” as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”
The FTC’s challenge in the 2015 case related to structure function claims made for Bayer’s Phillip’s Colon Health (PHC) product, a dietary supplement containing a proprietary blend of three specific strains of bacteria: Lactobacillus gassieri KS-13, Bifidobacterium bifidum G9-1 and Bifidobacterium longum MM-2. In 2011, the FTC began investigating whether Bayer possessed competent and reliable scientific substantiation for its claims regarding PCH; Bayer produced a vast body of scientific evidence in support of its claims. FTC then transferred the case to the Department of Justice for enforcement, and the DOJ filed a motion for an order to show cause in September 2014 as to why Bayer should not be held in civil contempt for violating the 2007 consent decree provision that Bayer must “possess and rely on competent and reliable scientific evidence that substantiates” its dietary supplement claims. Following a contempt hearing in June 2015, the court held that the government did not prove by clear and convincing evidence that Bayer violated the 2007 consent order. The court also provided detailed analysis of its finding that Bayer’s structure function claims were not implied disease claims and that the appropriate scientific substantiation standard for structure function claims does not require RCTs.
CLAIMS AT ISSUE
The PCH claims challenged include:
- “To Promote Overall Digestive Health” and
- “Helps Defend Against Occasional Constipation, Diarrhea, Gas and Bloating”
The court noted that FTC witnesses explicitly agreed that the two bulleted claims are effectively the same, in that the two claims amount to the “singular claim of promoting overall digestive health” by “defend[ing] against the occasional constipation, diarrhea, gas and bloating that an individual or patient may have.” The court also went into great detail, citing FDA’s Final Rule on structure function claims, in providing a list of appropriate digestive health structure function claims, and affirming that PCH’s claims are also appropriate structure function claims – not disease claims.
The government also argued that the PCH claims “are clearly euphemisms for ‘treat, cure and prevent.’” However, the court found that the government’s suggestion was irrelevant because it had not argued that Bayer made disease claims and presented no evidence (such as consumer surveys, consumer testimony or marketing data) that Bayer made any implied claims. In fact, all PCH products contained the mandatory Dietary Supplement Health and Education Act statement that PCH is “not intended to diagnose, treat, cure or prevent any disease.” Thus, the court found it could not conclude by clear and convincing evidence that Bayer made any implied disease claims.
Also notable is the court’s discussion of potential implied claims involving terminology such as “prevent, treat, or cure” that are not linked to a disease state. According to the court, even if Bayer made implied claims regarding prevention, treatment or cure in the context of PCH products, such claims would not be disease claims because the health conditions referenced on PCH products (constipation, diarrhea, gas and bloating) “are not diseases, but rather variations of the normal state of health.” While “prevent, treat and cure” often signal disease claims and remain risky claims for dietary supplements, the court’s opinion appears to provide some leeway when such terms are used in the context of “normal states of health,” as opposed to diseases, particularly where the full context of the claim indicates a non-disease state. Distinguishing between disease and non-disease states may not always be clear and the implication of this approach beyond digestive health claims will remain to be seen.
“COMPETENT AND RELIABLE EVIDENCE”
The government’s expert, Dr. Loren Laine, opined that competent and reliable scientific evidence for the structure function claims at issue, as well as any drug, educational brochure, surgical intervention, or food, would require an 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. However, this definition differs from the plain language of the 2007 consent decree, meaning Bayer was never put on notice that such a standard was required. Furthermore, Dr. Laine’s standard contradicts FTC guidance, FDA guidance, and industry expert opinions that do not require RCTs for structure function claims, nor has such a standard ever been applied to any other probiotic product or dietary supplement. As the RCT standard is referenced nowhere “in the four corners” of the 2007 consent decree, the court held that the government cannot create a new standard through expert testimony that was not known to the industry prior to the contempt motion, nor does any evidence indicate such a substantiation standard would be appropriate. As an aside, the outcome could be different for companies that have entered into consent decrees where the FTC did define “competent and reliable evidence” as mandating RCTs for the products or claims in question, given those companies would be on notice of FTC’s expected substantiation standard in the isolated context of that particular company.
In addition to holding that competent and reliable scientific evidence does not require RCTs absent a specific mandate from FTC, the opinion also provides helpful guidance to manufacturers regarding substantiation expectations by quoting FTC and FDA guidances and affirming a more flexible standard based on the totality of the evidence. Specifically, the court noted, and quoted from FTC guidance, that “[t]here is no fixed formula for the number or type of studies required”, “[t]here is no set protocol for how to conduct research that will be acceptable under the FTC substantiation doctrine,” companies can appropriately rely on studies of a “similar formulation” and extrapolate between populations, and neutral studies do not necessarily undercut a body of supporting evidence. Finally, in terms of expectations for “possessing” a substantiation file, the court held that a company need not print and file every document relied on as part of its substantiation dossier, and reliance on studies provided by suppliers is an appropriate data point in the body of evidence.
The opinion is a significant win for Bayer and the dietary supplement industry as a whole, while also providing helpful guidance to dietary supplement manufacturers regarding digestive health structure function claims, scientific substantiation standards, and maintaining substantiation files – areas that manufacturers are well aware of in light of false advertising class actions.
Some key takeaways moving forward:
- Competent and reliable scientific evidence for substantiating dietary supplement structure function claims does not automatically require RCTs
- Companies with existing FTC consent decrees that have specific substantiation requirements, such as those mandating RCTs, for products or claims must still comply with their operative Consent Decrees
- The totality of the evidence can include a variety of scientific evidence, including animal and in-vitro studies, epidemiological evidence, studies on mechanisms of action, and substantiation from suppliers
- Companies must be able to produce substantiation for claims, but companies need not print and retain every study or record assessed during the substantiation process where the company maintains regular and easy access to such files
- Specifically as to digestive health structure function claims, constipation, diarrhea, gas and bloating are not considered diseases, but states of health
- Use of the terms “prevent, cure, or treat” does not automatically trigger disease claims if made in the context of a general state of health or non-disease state
Importantly, dietary supplement manufacturers must ensure claims are truthful and not misleading.
Find out more about this significant ruling by contacting the authors.
See the court’s ruling here.