On December 20, 2022, the Federal Trade Commission (FTC) issued its Health Products Compliance Guidance (“Health Products Guidance”). This is the first update in nearly 25 years to FTC’s guidance regarding advertising claims for dietary supplements, foods, over-the-counter drugs, and other health-related products. The update draws on the over 200 new cases since the last guidance was published to illustrate potentially false and misleading claims and proper claim substantiation. Key updates and changes include:

• 23 new examples to broaden the guidance to cover foods, over-the-counter drugs, devices, and other health-related products;

• Clarification of FTC’s coordination with FDA regarding health product claims;
• Detailed guidance on the FTC’s standards for proper “clear and conspicuous” disclosure of claim qualifications; and
• Expanded discussion on the required “competent and reliable scientific evidence” and testing methodology required to substantiate health-related claims.

I. FTC AND FDA – JURISDICTION AND COOPERATION

FTC and FDA both have jurisdiction over marketing of dietary supplements, foods, non-prescription drugs, devices, and other health-related products. The agencies signed a memorandum of understanding that clarifies FDA has primary responsibility for labeling claims (“including the package, product inserts, and other promotional materials available at point of sale”) and FTC has primary responsibility for advertising claims (“traditional TV, radio, print,...

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