Does an appeals court's ruling in the POM v. FTC case change anything?

Ivan Wasserman, Partner

February 3, 2015

2 Min Read
The POM Wonderful circuit court decision, in one tweet

To impress my kids and hipper friends, here is a summary of the U.S. Court Of Appeals for the District of Columbia's January 30, long-awaited decision in the case of POM Wonderful v. FTC, in less than 144 characters:

#Pom'sclaimsweredeceptive;#diseaseclaimsneedRCTsupportbut#FTCcan'trequiretwoRCTs inconsent ordersinceonemaybeenough.

Now, a brief translation and background. As you may know, this case involves advertising claims for POM Wonderful's pomegranate juice and supplement products.  The Federal Trade Commission previously held that, despite attempts by the company to qualify its claims that the products could treat and prevent certain diseases, they were not backed by adequate scientific support and were therefore deceptive. The FTC also sought to require, as it has done in other recent cases, POM to have at least two randomized, placebo controlled clinical trials (RCTs) to make disease-related claims in the future. POM disagreed, and the case went to court.

The court agreed with the FTC that POM's claims were not backed by adequate science and were therefore deceptive. It found that it is appropriate that such claims be supported by at least one RCT, at a minimum, to ensure that the claimed benefit is not due to a placebo effect (although it left the door open to the possibility of adequately qualified claims).

On the other hand, the court found that the FTC's requirement in this case that going forward, POM must have at least two RCTs, violated the First Amendment because, in part, one may be enough to support certain claims.

What does this all mean? Has anything changed? While going forward the FTC may be less likely to require two RCTs in consent orders, FTC's standards for supporting claims have not changed and, in fact, have been upheld by the court. So, for dietary supplements and functional foods you must continue to be very careful how you craft claims to ensure that they are supported by the totality of the existing science. Also, either side may try to appeal the decision, so we still may not have the last word.

About the Author(s)

Ivan Wasserman

Partner, Amin Talati Upadhye

Ivan Wasserman is one of the nation’s premier attorneys for health, wellness, beauty and other consumer products. Companies of all sizes making, marketing and selling food, dietary supplements, cosmetics, over-the-counter drugs and medical devices praise the depth of his knowledge and experience, his humor and his ability to maintain the human perspective while leading them through this heavily regulated landscape. Frequently cited by the media as a legal authority, Ivan helps his clients launch products and create and execute advertising campaigns that match the clinical evidence they have for their products, paying close attention to the changing rules governing internet marketing, consumer testimonials and social media.

Ivan advocates for clients subject to the often overlapping jurisdictions of the U.S. Food and Drug Administration, the Federal Trade Commission,  and the U.S. Consumer Product Safety Commission.   When advertising disputes arise, he regularly represents companies before the National Advertising Division (NAD) and the Electronic Retailing Self-Regulation Program (ERSP). He has been included in Best Lawyers in America from 2007 – 2017.

Subscribe and receive the latest updates on trends, data, events and more.
Join 57,000+ members of the natural products community.

You May Also Like