FTC and Two Well-controlled Clinical Studies

In their settlement with Dannon over claims on DanActive and Activia, the FTC again evoked its standard of “two well-control clinical trials” to support structure function claims.  This standard was previously applied to Nestlé’s Boost® Kids Essentials drink and POM Wonderful Pomegranate Juice (POM is challenging FTC’s 2 clinical trial standard but the courts have yet to weigh in).

FDA has written an extensive guidance document on claim substantiation without providing a definitive number of studies and instead relying on the interpretation of ‘adequate’ studies to support the claims.  FDA and FTC cooperate on cases involving claims on foods and supplements with FTC taking the lead in most cases.  Does this mean that FTC’s ‘two well-controlled clinical studies” will be the standard? Would ‘two well-controlled clinical studies’ prove to be a safe harbor for companies making structure function claims that do not directly or indirectly discuss disease states?  There’s just no telling but stay tuned.

The use of structure-function claims on food products has been increasing and FDA is watching closely and cracking down on companies making claims with help from the FTC.  As a review, food products may include claims about the levels of nutrients that have an established RDI or DV as long as the levels of fat and sodium do not exceed set limits. They may also make certain health claims that link nutrients to disease prevention and ‘qualified’ health claims that have weaker support (see FDA’s qualified health claims).

Food companies are getting into trouble when trying to make structure-function claims. These claims discuss how the product or ingredients in it affect the normal, healthy structure or normal, healthy function of the body or its systems and do not discuss any drug-like properties or imply that the product in any way may prevent, treat, or cure any disease.  It is possible to craft claims that discuss the effects of the product on ‘normal’ conditions that are occasional, mild, temporary and self-limiting such as occasional sleeplessness, occasional irregularity, and occasional indigestion.  All claims must be truthful, not misleading and backed by scientific evidence.

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