The Federal Trade Commission’s (FTC) Bureau of Consumer Protection has announced the issuance of Health Products Compliance Guidance, the agency’s first revision of its business guidance in this area in nearly 25 years.

The revised business guide represents a substantial update to the staff’s 1998 guide, 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 (OTC) drugs, and other health-related products. The revised guide draws on those cases with 23 new examples.

One 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.

For more information, visit www.ftc.gov.