FTC Opinion in Dietary Supplement Case: FDC Act Not Binding on the Commission; Advertising Substantiation Also Addressed

By Cassandra A. Soltis –

The Federal Trade Commission ("FTC") made clear in a recent opinion that the Federal Food, Drug, and Cosmetic Act ("FDC Act") is not binding on the Commission in its enforcement of Sections 5 and 12 of the Federal Trade Commission Act (FTC Act).  The Commission also addressed some First Amendment issues and described the type of substantiation necessary when making certain health-related efficacy claims.

The FTC upheld charges against Daniel Chapter One and James Feijo (the "Respondents") for unsubstantiated claims that the Respondents’ dietary supplements would prevent, treat, or cure cancer or tumors and other serious illnesses.  In the Matter of Daniel Chapter One and James Feijo, No. 9329 (Dec. 18, 2009), at 1.  The Commission disagreed with the Respondents’ argument that the claims made for the products were protected by the First Amendment because they were ideas or opinions about the products’ efficacy, stating that “Respondents made assertions not just about what they believed those products might do, but represented that the [dietary supplements] would in fact treat or cure cancer, prevent or shrink tumors, and ameliorate the side effects of radiation and chemotherapy.”  Id. at 12.  Furthermore, the FTC noted that the representations “constituted commercial speech, not simply practicing religion or engaging in ‘charitable solicitations,’” as the Respondents suggested.  Id. at 13.  The Commission indicated that because the speech in question was commercial in nature and false or misleading, it is not afforded First Amendment protection.  Id. at 14. 

The Commission also disagreed with the Respondents’ claim that the representations made for the dietary supplements were immune from FTC challenge because they were structure/function claims, as defined in the Dietary Supplement Health and Education Act ("DSHEA"), which amended the FDC Act.  Id. 16.  The FTC stated that the representations were not structure/function claims, and even if they were, DSHEA requires that they be truthful and not misleading and supported by adequate substantiation.  Id.  The Commission concluded that “even if the [FDC Act] departed from the FTC Act and its relevant case law, Respondents offer no authority that it would be binding on the Commission.”  Id.

According to Dr. Dennis Miller, who was the FTC’s expert and a board-certified pediatric hematologist/oncologist, in order to support a claim that a product “treats, cures, or prevents cancer, the products’ efficacy and safety must be demonstrated through controlled clinical studies (tests on humans).”  Id. at 18.  Dr. Miller also indicated that studies performed on animals or in test tubes are insufficient and that “the need to substantiate a claim by clinical studies (i.e., on humans) was the same whether the purported agent was a herbal medicine or a more conventional pharmaceutical agent.”  Id.

Dr. Miller concluded that the reference materials relied on by the Respondents “did not constitute competent and reliable scientific evidence that any of the [dietary supplements] prevent, treat or cure cancer; that most of those materials were not peer-reviewed papers but instead consisted of author opinions and literature reviews; that many of the studies involved in vitro or animal studies, not studies on humans; that [other reference materials] relied on the efficacy or safety of ingredients of the [dietary supplements] rather than the products themselves” and that, without evidence that the dietary supplements “contained exactly those ingredients in the proportion tested, those studies were not probative; and that there is no competent and reliable scientific evidence that the [dietary supplements] are effective, either alone or in combination with” the other products sold by the company.  Id. at 18-19.  For those reasons and others, the Commission denied the Respondents’ appeal and issued a final Order requiring the Respondents to cease certain practices.