sultant. It considers control and blinding; duration (i.e., Does the effect persist?); dose-response relationship (i.e., Is there one?); recognized biological mechanisms (i.e., Is there a biological mechanism that is recognized and understood?); peer review or publication in a reputable journal (not a requirement, but it is a “plus”); and statistical significance and clinical meaning. Second, FTC examines the context of the studies that the company is relying on for substantiation. That is, how do the studies fit into the surrounding literature? If there are any inconsistencies, how are those inconsistencies reconciled? Some claims may need to be qualified in such a way that consumers understand the claim is based on emerging science. Claims should not be made if the weight of the evidence contradicts the claim. Rusk noted that this last point may appear self-evident, but FTC does sometimes encounter situations where a marketer makes a claim based on a single preliminary study. Third, FTC examines the relevance of the science to the claim being made. This is where many companies “slip up,” Rusk noted. For example, many weight-loss product claims fail by claiming a much greater weekly weight loss than studies actually show. FTC considers both the amount and the form of an ingredient (e.g., effective dose, strain specificity), the population studied, the degree and nature of the effect, and the strength of the science.
Examples of Recent Actions
Rusk highlighted two recent actions taken by FTC, both consent agreements (i.e., the companies did not admit to any law violations). The first was against advertisements for two Dannon yogurt products, DanActive and Activia. FTC challenged claims that DanActive, with its L. casei immunitatas probiotic, helps to prevent colds and flu. It also challenged the claims made during the Jamie Lee Curtis campaign that Activia yogurt, with its Bifidus regularis probiotic, relieves irregularity. One of the issues with the Activia campaign was that 8 of 10 studies showed no significant effect at the advertised dose. Rusk noted that FTC was one of many entities investigating the Activia ads and that Dannon settled with both FTC and 39 state attorneys general for a total of $21 million. Increasingly, FTC orders are not purely “cease and desist” orders but also seek monetary relief for the disgorgement of profits from deceptive claims. Where possible, the money is refunded to customers. Otherwise it goes to the U.S. Treasury.
The second action was in response to the Nestlé product Kid Essentials Boost, where the probiotic was embedded in the lining of the straw that comes with the drink. The commission challenged claims that the product prevents upper respiratory infections, helps protect against cold and flu, reduces absences from school, and reduces duration of acute diarrhea in children up to age 13. Nestlé submitted some good evidence to support