The Federal Trade Commission’s Bureau of Consumer Protection has issued a compliance guidance document for businesses selling health products. The Health Products Compliance Guidance is the agency’s first revision of its business guidance in this area in nearly 25 years.

The revised guide represents “a substantial update” to the 1998 guide titled “Dietary Supplements: An Advertising Guide For Industry.”

Since that guide was issued, the FTC has brought more than 200 cases challenging false or misleading advertising claims for dietary supplements, foods, over-the-counter drugs, and other health-related products. The revised guide draws on those cases with 23 new examples.

The FTC’s broad mandate is to prevent “unfair or deceptive acts or practices.”

Why It’s Important

The major revision is to extend the guidance covering dietary supplements to all health-related products. The revised guide also reflects updates to other FTC guidance documents, including the guidance on endorsements and testimonials and the enforcement policy statement on homeopathic drugs.

Among other things, the new guide includes a much more detailed discussion of the amount and type of evidence needed to substantiate health-related claims, with more emphasis on the fact that the FTC, as a general rule, expects high-quality, randomized, controlled human clinical trials.