The Federal Trade Commission (FTC) just published its Health Products Compliance Guidance (“Guidance”), which it issued to replace an advertising guide from 1998 focused on dietary supplements. For this new Guidance document, the FTC explains:

“Like the 1998 guide, this document provides guidance from FTC staff on how to ensure that claims about the benefits and safety of health-related products are truthful, not misleading, and supported by science.  Since 1998, the FTC has settled or adjudicated more than 200 cases involving false or misleading advertising claims about the benefits or safety of dietary supplements or other health-related products, including foods, over-the-counter (OTC) drugs, homeopathic products, health equipment, diagnostic tests, and health-related apps.  This update draws on the issues raised in those cases to illustrate how the FTC identifies the express and implied claims conveyed in advertising and how the agency evaluates the scientific support for those claims.  While most of the examples involve dietary supplement advertising, the same legal principles apply to the marketing of any health-related product.”

The Guidance begins with the foundational principles that (1) advertising must be truthful and not misleading; and (2) advertisers must have adequate substantiation for all objective product claims that are conveyed to consumers. The Guidance then provides an overview of the regulatory framework (e.g. the FTC’s authority over the marketing of dietary supplements, foods, drugs, devices, and other health-related products and the relationship of FTC law with FDA law for such products), an application of FTC law to the advertising of health-related products (e.g. an explanation of health claims and disclosures and the requirement of substantiation), and a discussion of other advertising issues (e.g. the use of testimonials and endorsements). In its Conclusion, the FTC writes:

Marketers of health-related products, including dietary supplements, should be familiar with the requirements under both FDA law and FTC law that labeling and advertising claims be truthful, not misleading, and substantiated.  The FTC approach generally requires that health-related claims be backed by competent and reliable scientific evidence substantiating that the representations are true.  To ensure compliance with FTC law, marketers of any health-related product should follow two important steps: 1) Consider what express and implied messages consumers are likely to take from your ads.  Where appropriate, carefully qualify your claims – in other words, clearly explain the limited circumstances in which the advertised benefits or results apply; 2) Carefully review the support for each claim to make sure it is scientifically sound, adequate in the context of the surrounding body of evidence, and relevant to the specific product and advertising claim.

The full Guidance document is available here.