Section II of this non-binding recent FTC settlement requires two controlled human clinical studies by separate, independent researchers on a dietary supplement to support any claim of weight loss or rapid weight loss. This is a radical departure from long-standing FTC precedent applying a much more general and flexible standard of “competent and reliable evidence” for substantiation of ad claims, and flatly inconsistent with the FTC’s own policy statements and guidelines for the substantiation of claims in general and dietary supplement claims in particular, including weight loss. In applying the “competent and reliable” standard to dietary supplement efficacy claims, including, but not limited to, weight loss, FTC (and FDA, which follows the FTC here) guidance documents essentially say that controlled clinicals are required wherever feasible, but do not mandate either more than one, or that they be on the actual product versus the active ingredients, or that multiple studies be done by separate, independent researchers.
The advertiser in Iovate made “clinically proven” claims of rapid and substantial weight loss (i.e., “Lose 32 pounds fast!”). The FTC does specifically require clinical proof of such “establishment” claims, but the settlement does not differentiate between types of weight loss claims in applying the two-clinical requirement. Instead, it applies it to any express or implied weight loss claim, no matter how specific or vague, great or small.
Until the FTC brings more cases or makes some pronouncement, it is unclear whether this settlement represents an official change in policy on the standard for substantiating weight loss claims, or is an outlier, reflecting only the peculiar facts of a single case. Whatever it ends up being, though, such a standard effectively imposes a de facto prohibition on the making of ANY weight loss claims for dietary supplements, since the time and cost of doing at least two clinicals would be, in almost all cases, prohibitive. This would be an extreme and perverse outcome, which undoubtedly would face legal challenges on a number of grounds, not least of which would be constitutional.