By Riëtte van Laack –
Earlier this week, the Federal Trade Commission (“FTC”) announced the settlement of a $3.7 million civil penalty case against Jason Pharmaceuticals (“Jason”), a subsidiary of Medifast Inc., for allegedly violating a 1992 FTC Order regarding weight loss claims. According to the complaint, filed in the United States District Court for the District of Columbia this week by the Department of Justice, the government claims that since at least November 2009, Jason violated the FTC’s 1992 Order by making unsubstantiated weight loss claims, primarily through consumer endorsements.
According to the FTC, the defendant’s testimonials conveyed the unsubstantiated message that the Medifast program resulted in a weight loss of 2 to 5 pounds per week with an overall loss of 30 lbs. According to the FTC, the disproportionate general disclaimer, “results will vary,” was insufficient to change the net impression to consumers that the testimonials were representative of what a consumer would achieve.
Interestingly, the settlement agreement, in the form of a court-issued Consent Decree, specifies that the company must have at least one (not two) adequate well-controlled clinical study of a “low calorie meal replacement program . . . designed to lower the user’s total caloric intake” that follows “acceptable designs and protocols” or a protocol “satisfying all of the criteria” specified in Appendix A to the Consent Decree. Appendix A describes in detail the protocol development and the execution of the study. For representations regarding weight loss, the clinical study must cover a period of at least 16 weeks, whereas studies to support any claims related to weight maintenance must cover a period of 52 weeks or more. For other health and safety claims, the standard is “competent and reliable scientific evidence.”
An obvious question is to what extent the Jason standard of one study will apply to claims for other weight loss products that are not based on reduced calorie intake. The answer to this question remains to be seen. Without more information, it is impossible to know if the Consent Decree reflects FTC’s new substantiation standard for weight loss claims.
Also of interest is the Decree’s definition of what constitutes “advertising,” particularly in light of the recent dispute between the FTC and POM Wonderful about whether statements by POM executives during unpaid appearances in TV talk shows qualifies as advertisements. It will also be interesting to see if the FTC decides the POM Wonderful case by requiring one, rather than two, study, and whether the FTC in that case will specify the details of the requirements of a clinical study, as the FTC did in the Jason case.