By Katie Bond –
Recent actions by FDA and the FTC serve as reminders that both agencies will consider the use of scientific literature in determining whether marketing for a food or dietary supplement conveys disease treatment or prevention.
FDA recently issued a warning letter to a company that sells eye health dietary supplements. FDA alleged that the company’s website included “therapeutic claims” that established that its products were unapproved new drugs. The warning letter cited several examples of claims that expressly referenced treating or slowing the symptoms of macular degeneration. The letter further alleged that “online summaries of two studies” contributed to a message of disease treatment or prevention. FDA addressed the use of the studies as follows:
[U]nder 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a dietary supplement is considered to be a claim about disease treatment or prevention if the citation refers to a disease use, and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease. The home page of your website provides links to online summaries of two studies that pertain to prevention and treatment of macular degeneration: ‘Age-Related Eye Disease Study (AREDS), National Eye Institute, National Institutes of Health’ [and] ‘Age-Related Eye Disease Study 2, The Lutein/Zeaxanthin and Omega-3 Supplementation Trial.’ Your website promotes your products . . . for prevention and treatment of macular degeneration by claiming that [your products] contain the same ingredients used in these studies.
Since 2006, FDA has sent 31 warning letters that have included similar allegations and similar explanations regarding the use of scientific studies. Last year, it sent four such letters. The recent warning letter is the first of its kind this year.
Unlike FDA, the FTC does not per se prohibit food or dietary supplement advertisers from making disease claims. The FTC, however, holds disease claims to a high standard of substantiation – requiring well-designed clinical trials. The FTC has made clear its position that an array of textual elements or imagery – including references to scientific studies – might further the message that a food or dietary supplement has been scientifically shown to be effective in treating or preventing a disease. The FTC’s case against POM Wonderful provides a recent example of the FTC’s approach to scientific literature.
FTC Staff challenged claims that POM Wonderful juice and dietary supplements treat, prevent, or reduce the risk of heart disease, prostate cancer, and erectile dysfunction and that clinical studies prove that POM products do so. The POM Wonderful websites included descriptions of and links to multiple scientific studies with titles such as, “Effects of Pomegranate Juice Consumption on Myocardial Perfusion in Patients with Coronary Heart Disease.” One site also included a discussion of various scientific studies by a medical researcher. The FTC’s full Commission issued a decision in the case in January, following appeals from both sides of an initial decision by the FTC’s administrative law judge. The Commission found that the references to and descriptions of “scientific studies” and “medical journals” on the POM Wonderful websites and in print ads “helped convey” the claims that FTC Staff alleged POM had made. See POM Claims Appendix A. The Commission noted, in particular, that “the characterization of the research specifically as ‘medical’ (as opposed to simply ‘research’ or even ‘nutritional research’) contribute[d] to the net impression that the ads conveyed the challenged claims.” As we reported last month, the POM defendants have appealed the Commission’s decision in federal court. For now, however, the Commission decision – including its findings on scientific literature – stands.
The recent FDA warning letter and the FTC’s decision in POM Wonderful demonstrate that, especially where a scientific study includes the name of a disease, marketers need to proceed with caution. The FDA and FTC actions certainly do not foreclose the use of disease-related scientific literature in marketing, but it may be that careful explanations or disclosures are necessary in order to avoid conveying disease claims.