For the first time in nearly 25 years, the Federal Trade Commission (FTC) Bureau of Consumer Protection has revised its business guidance for health products. According to an announcement from FTC, the new Health Products Compliance Guidance represents a "substantial" update to the 1998 guide Dietary Supplements: An Advertising Guide For Industry.

In the report, which is intended as business guidance only, FTC explains: "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."

FTC's Health Products Compliance Guidance includes:

  • Guidance covering all health-related products (not just dietary supplements).
  • 23 new examples to help direct marketers and sellers of health products.
  • Updates to FTC guidance documents on endorsements and testimonials and the enforcement policy statement on homeopathic drugs.
  • More details on the amount and type of evidence needed to substantiate health-related claims. FTC said this includes its expectations related to high quality randomized, controlled human clinical trials.

Related: Regulatory and Enforcement Update on Notable Action in the Cognition, Adaptogen & Nootropic Space Are Your Supplements Really Regulated and How? Claims & Labeling: 5 Takeaways from the Dietary Supplements Regulatory Summit