At the recent ACI/CRN dietary supplements conference, a panel on claim substantiation sparked debate over whether dietary supplement claims require clinical studies.  One of the main points of contention was exactly what U.S. v. Bayer held on that point.

Industry representatives contended that the case held that clinical testing is not required.  A representative from the FTC countered that the case was not about the need for clinical testing and, in fact, held only that Bayer was not required to possess strain-specific testing.  Let’s take a look back at the case.

The FTC alleged that Bayer had violated a prior FTC order by disseminating unsubstantiated claims for its probiotic supplement, Phillips Colon Health.  The prior order required Bayer to possess “competent and reliable scientific evidence” for dietary supplement claims.  In promoting Phillips Colon Health, Bayer had used claims, such as, “Helps defend against occasional constipation, diarrhea, gas and bloating.”

In support of its allegations that the Phillips Colon Health claims were unsubstantiated, the FTC offered “an expert in gastroenterology and clinical research.”  He opined that “competent and reliable scientific evidence,” as specified in the prior order, required a “human clinical study” that is randomized, double-blind, and placebo-controlled; “done in the target population” for the product, using “the specific product at issue”; and “designed with the desired outcome as the primary endpoint” and with “appropriate statistical methods.”  This expert was, self-admittedly, not expert in probiotics, was “not paying attention to the law or regulations about the difference between dietary supplements and drugs” in forming his opinion, and had not reviewed the FTC’s guidance specifically on substantiation for dietary supplement claims.

In support of its claims, Bayer offered nearly 100 studies, including at least seven “strain-specific randomized controlled trials” showing the effects of the probiotics in Phillips Colon Health on GI symptoms in various populations.  Because these studies did not meet his specific criteria – including not being on the full product formulation – the FTC’s expert opined that Bayer’s claims lacked adequate support.

Two experts who testified for Bayer were both experienced physicians and researchers with expertise in probiotics and the conduct of clinical studies.  Each expert had “understood and relied upon the FTC [dietary supplement] Guidance and the distinction it draws between supplements and drugs.”  The two experts concluded that Bayer’s claims were properly supported.

The court sided with Bayer and found that by offering “one expert who seems to require a higher-level RCT,” the FTC had not met its burden to prove an order violation.  The court further observed that two prior dietary supplement cases, FTC v. Garden of Life and Basic Res. v. FTC, “held [that] competent and reliable scientific evidence does not require drug-level clinical trials.”  The court stated that the “Government cannot try to reinvent this standard through expert testimony.”  The court, likewise, noted that the FTC’s dietary supplement guidance “specifically refutes the standard the Government seeks to impose.”  The court quoted the passage in the guidance stating that “[t]here is no fixed formula for the number or type of studies required.”

Takeaway 1: There is no mistaking that the Bayer court rejected any categorical determination that dietary supplement claims require a fixed number or type of studies.  Given the fact-driven nature of advertising cases, the Bayer decision could not – and has not – stopped the FTC from continuing to argue that particular supplements and claims require controlled trials.  However, post-Bayer, the FTC carries a heavier burden in proving its position in each such case.  That is especially so where basic structure/function claims, similar to Bayer’s, are at issue.

Takeaway 2: Bayer did not turn on strain-specific support although there was a question as to whether, as the FTC expert posited, Bayer must have tested its entire product formulation (i.e., all three of its probiotic strains together).  In accepting Bayer’s evidence, the court rejected the proposition that full product testing was required.  The FTC’s guidance – and FTC orders on supplements – also allow testing on either the product or certain ingredients.