Caveat Vendor

For Some Disease and Health-Related Claims, Two Trials Is Too Much, Says FTC Commissioner

January 14, 2014

Behnam Dayanim and Devon Winkles

Perhaps one of the most controversial changes in approach at the Federal Trade Commission in recent years has been the agency’s requirements for disease and health-related claims. Now there appears to be some dissent within the agency itself.

For quite some time, FTC consent orders have commonly required marketers to substantiate health-related claims with two randomized controlled trials.   In recent years, the FTC has signaled that it may expect that level of substantiation for all health-related claims, even outside the context of a specific consent order (where a violation has been alleged and the parties have negotiated a disposition).  That position has triggered much controversy, including the contention by many observers that such a blanket standard is inconsistent with the application of the factors set out by the Commission four decades ago, in In the Matter of Pfizer Inc., 81 F.T.C. 23.
Well, last week, FTC Commissioner Maureen Ohlhausen joined the critics, signaling her view that the “two trials” rule imposes “an unduly high standard” for products that are already deemed safe, such as foods and vitamins.  Her remarks came in a statement dissenting in part from the consent agreements in a matter involving several marketers of genetically-customized nutritional supplements.  In the statement accompanying her decision, she stated that uniformly requiring two randomized controlled trials is inconsistent with the factors set out in Pfizer, which are meant to balance competing concerns, including the risk of a product and the risk of suppressing potentially useful information about that product.
Commissioner Ohlhausen was careful to note that she was not advocating that the agency permit unsubstantiated disease or health claims, even in products that are deemed safe, and she supports a higher burden of substantiation for drugs and biologics than for foods and vitamins, consistent with the Pfizer analysis.  Indeed, notwithstanding her dissent, she voted to approve consent agreements containing the two-study requirement for weight-loss products because those short-term weight loss claims could be assessed in less time and at a lower cost than other health- and disease-related claims.
Interestingly, Ohlhausen’s statement prompted FTC Chair Edith Ramirez and Commissioner Julie Brill to disavow any “de facto” two-trial standard in their statement  approving the consent agreement.  Chairwoman Ramirez and Commissioner Brill instead characterized the agency’s position as requiring a “case-specific factual determination as to what constitutes competent and reliable scientific evidence for the advertising at issue.”
The agency’s recent track record would seem to point to a two-trial requirement, but advertisers and their counsel should watch carefully to see how the agency grapples with this issue moving forward.

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