Legal Review: FTC Seeks Backdoor Ban of Weight-Loss Claims1 Dec, 2010 By: William I. Rothbard Response
With little fanfare, the Federal Trade Commission (FTC) has signaled a major policy shift on substantiation of weight-loss and disease claims for dietary supplements and foods. Longstanding FTC policy requires “competent and reliable evidence,” determined by a matrix of factors, including type of product and claim. Health claims, including “establishment” (i.e., “clinically proven”) claims, generally have required the most substantiation — controlled human clinical trials or other scientific evidence. Still, FTC guidelines have applied the requirement flexibly, allowing for the degree of proof to be determined case-by-case.
In a settlement reached in Federal Trade Commission v. Iovate Health Sciences USA Inc., the FTC decreed that weight-loss claims must be supported by at least two controlled human clinical studies conducted by different researchers, and that disease claims can be made only if they have been approved in over-the counter (OTC) drug monographs and drug applications by the FDA.
Case Merits Notice
It is tempting to dismiss Iovate as just a settlement, binding only the parties and lacking precedential value — tempting, but perilous. The FTC does not alter standard substantive order provisions without forethought and approval at the highest agency levels. There can be no doubt Iovate represents an institutional decision to jettison “competent and reliable” in favor of the rigid standards imposed there.
Embarking on this new policy course was so important to the FTC that it reportedly accepted less money from the Iovate defendants than it normally would have demanded in order to obtain their assent to the new requirements.
The best evidence the FTC is determined to apply Iovate widely is the lawsuit filed against the commission by juice maker POM Wonderful for telling it that these requirements now represent official policy, and demanding that it surrender to them. Unlike the Iovate parties, POM Wonderful has chosen to take the fight to the FTC rather than make peace with a new substantiation regime it apparently feels it cannot live with. The FTC has responded in kind, suing POM Wonderful, too.
It is rare for an advertiser to sue the FTC. What could propel a company to take such an unorthodox step, at such risk and expense? The answers are: principle and survival. The “one-standard-fits-all” Iovate approach presumes that weight-loss and disease claims can be supported only one way: by multiple human clinical trials on the actual product for weight-loss claims, and prior FDA approval for disease claims. On what scientific basis does the FTC, a non-scientific agency, reach this sweeping conclusion? We have no clue, since the FTC has chosen to make radical policy changes through the backdoor of settlements rather than through open proceedings.
But it is easy to imagine many such claims that can be substantiated by “competent and reliable” proof other than the Iovate methods. Glucomannan, for example, has been shown in several controlled human clinical trials to produce weight loss without diet or exercise. A company should be able to make a weight-loss claim for a glucomannan product supported by these studies, perhaps together with a study of its own. Under the new FTC policy, however, it would be forbidden because it hadn’t done at least two more studies in addition to those already reported.
The First Amendment protects truthful commercial speech. The new FTC policy, by having the capacity to prohibit claims even if true, violates this guarantee.
Enforcement of the Iovate standards would not lead to more accurate claims. Perversely, it would result in no weight-loss and disease claims at all — even truthful claims backed by solid evidence far less onerous and costly than the type now being demanded by the FTC.
The “competent and reliable” standard, illuminated by FTC guidance documents and case law, has served the public well. There is no evidence it is broken. The FTC therefore shouldn’t fix it. ■