The United States District Court for the District of New Jersey recently granted summary judgment in favor or Bayer HealthCare LLC in a consumer class action over efficacy claims relating to its probiotic dietary supplement. Read more, here.
The plaintiffs filed a notice of appeal on May 17, 2017.
The District Court judge held that “[in] sum, plaintiffs failed to present competent evidence to create a genuine issue of material fact that Bayer’s claims that PCH promotes overall digestive health and helps defend against occasional constipation, diarrhea, gas, and bloating are actually false or misleading.”
The product at issue here is the very same one that was the subject of recent litigation with the Federal Trade Commission. A win for dietary supplement marketers, the court in the FTC matter ruled that Bayer’s efficacy claims were substantiated with competent and reliable scientific evidence. The court further opined that competent and reliable scientific for dietary supplements does not require drug-level clinical trials, and “the government cannot try to reinvent this standard through expert testimony.”
Reports from recent industry events include vocal criticism of the FTC’s attempt to impose stricter requirements than those set forth by the 1994 Dietary Supplement Health and Education Act. The DSHE was intended, in part, to establish standards with respect to dietary supplements, and for other purposes.
In response, an FTC official within the Division of Advertising Practices, stated that the Commission never implemented any formal policy mandating two double-blind, randomized controlled trials with respect to dietary supplements.
Many marketers would clearly disagree with that representation, to wit, that the Commission has not sought to apply a similar standard to drugs and dietary supplements. Importantly and for quite some time, the Commission has required at least two RCTs to substantiate efficacy claims in its orders with business that have been found in violation of the FTC Act’s prohibition of deceptive trade practices.
One RCT, two or three, without limitation, marketers: (i) must possess “competent and reliable scientific evidence” to substantiate representations in ad copy; (ii) cannot misrepresent any material aspect of the efficacy or characteristics of a product; (iii) must possess appropriate evidence, before disseminating advertisements, that substantiate express and implied claims; (v) must disclose if there exists no data or inconsistent data; and (vi) maintain a file of scientific literature that supports each of the claims made.
Given today’s aggressive regulatory environment, all necessary precautions should be taken by dietary supplement marketers in an effort to minimize potential liability exposure. The foregoing includes, without limitation, thoroughly assessing available scientific literature and evaluating express and implied product efficacy claims.
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