The US Supreme Court has denied POM Wonderful's final bid to overturn a Federal Trade Commission (FTC) decision that the company deceptively advertised its pomegranate-based products. This refusal highlights an important distinction to be made between disease claims and structure/function claims.
In 2013 the FTC affirmed – and in part expanded – an administrative law judge's decision that some POM fruit juice advertisements violated the FTC Act for claiming the product could treat certain diseases. Breaking new ground, the FTC held that certain types of advertisement violate the FTC Act unless they are supported by randomised, controlled, human clinical trials (RCTs).
In 2015 the US Court of Appeals for the District of Columbia Circuit affirmed the FTC's decision. However, the court noted that a disease claim may not need a RCT as long as the marketer "disclos[es] the limitations of the supporting research".
The DC Circuit also affirmed the FTC's prospective injunction requiring POM to possess at least one RCT for disease claims; it notably rejected the FTC's order that required POM to possess two RCTs for certain claims. The Supreme Court's denial of POM's cert petition ends POM's attempt to overturn the DC Circuit and FTC decisions.
More recently the FTC has attempted to expand this position by requiring RCTs for ordinary structure/function claims in addition to disease claims. A number of companies have entered consent decrees agreeing to the RCT requirement.(1)
However, when companies do not agree to an RCT standard for structure/function claims, they have had success in court: most notably, in United States v Bayer the court rejected the government's demand for RCTs and held that structure/function claims "do not require drug-level clinical trials" or RCTs of any kind.(2)
The line between structure/function claims and disease claims is critical. The POM case serves as an important reminder for dietary supplement and food companies not to make unapproved claims that their products can diagnose, mitigate, treat, cure or prevent any disease.(3) As demonstrated by POM, these claims must be supported by RCTs in most circumstances.
Companies that restrict their marketing to legitimate structure/function claims – as the company did in United States v Bayer – need not meet this high standard. Structure/function claims must be truthful and supported by competent and reliable scientific evidence, but RCTs are not required.
For further information on this topic please contact Scott Bass, Diane C McEnroe, Jonathan F Cohn or Benjamin M Mundel at Sidley Austin LLP by telephone (+1 202 736 8000) or email (email@example.com, firstname.lastname@example.org, email@example.com or firstname.lastname@example.org). The Sidley Austin LLP website can be accessed at www.sidley.com.
(1) See FTC v Iovate Health Sci USA, Consent Decree at 7, No 10-CV-587 (WDNY 29 Jul 2010); United States v Jason Pharm, Inc, Consent Decree at 3, 6, No 12-CV-01476 (DDC 17 Sept 2012).
(2) See United States v Bayer, Case 07-0001 (D. N.J.); see also FTC v Garden of Life Inc, 845 F Supp 2d 1328, 1334-35 (SD Fla 2012) aff'd in part and vacated in part, 516 F App'x 852 (11th Cir 2013); Basic Research, LLC v FTC, 2:09-cv-0779 at 26-27 (D Utah 25 Nov 2014).
(3) See 21 USC § 343(r)(6).
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