On December 20, 2022, the U.S. Federal Trade Commission (FTC) released its Health Products Compliance Guidance, available at Health Products Compliance Guidance (ftc.gov).  This guidance is intended to replace the Dietary Supplements, An Advertising Guide for Industry, which was issued 25 years ago! 

What’s new?  The guidance is intended to be applied to all health-related products, not just dietary supplements.  This includes (but is not limited to) foods, over-the-counter drugs, dietary supplements (including botanical supplements and homeopathic medicines), health equipment, diagnostic tests, and health-related apps.  Also new is the very clear guidance on the “competent and reliable scientific evidence” substantiation standard, how it essentially requires, with little exception, data from robust randomized controlled trials (RCTs).  Information on factors that contribute to the robustness of RCTs (e.g., clinical trial registration, defining of primary and secondary outcomes and their statistical analysis, a priori, and adjustments for multiple statistical comparisons) is provided.  Other issues pertinent to claim wording, such as qualifying information and disclosures, as well as their proper placement and prominence in an ad, also are addressed.  The guidance is a compilation of lessons learned from over 200 FTC cases involving false or misleading advertising claims about the benefits or safety of health-related products.  In this complimentary webinar download, Intertek will highlight key aspects of the guidance, helping the industry understand substantiation requirements and how to minimize risk when developing advertising claims for health products.  

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