In 2023 the FTC finally issued its new Health Products Compliance Guidance heightened substantiation requirements for health-related claims. While FTC’s original guidance—released some 25 years prior—applied only to dietary supplements, this latest guidance also applies to health claims made about foods, OTC drugs, devices, and any other health related consumer products.

Against this backdrop, the FDA issued a new definition of “healthy” for food labels. This panel will take a deep dive into what these new guidelines will mean for companies making health-related claims going forward.

• Examining the new and expanded substantiation requirements set forth by the FTC’s new guidance
• Analyzing the new guidance’s emphasis on randomized controlled clinical trials (RCTs)
• How much evidence, and what type of evidence, will be needed going forward to substantiate health-related claims?
• Are there exceptions to using RCTs, what type of evidence can be used in lieu of RCTs, and how do advertisers document the relevance of this evidence?
• What expectations has FTC created in the guidance regarding clinical trial quality, practices and analysis, including statistical analysis of clinical trial results?
• Addressing how the new guidelines will impact the use of ingredient clinical studies
• Understanding how court precedent impacts the guidance and what to do where precedent contradicts FTC’s guidance updates
• Taking a look at health claims from a supplier’s standpoint: what level of substantiation is needed?
• Examining FDA’s proposed new definition of “healthy” and how it will impact claims made by food, supplement and other companies