Generally, products related to consumer health or safety require a relatively high level of substantiation. This interactive working group will explore the necessary requirements and nuances of claims substantiation for FDA-regulated consumer products, including OTC drugs, dietary supplements, food, and cosmetics. The Working Group leaders will walk you through the complexities of interagency policies and procedures governing what claims you can safely make and those you cannot and will provide you with the key information necessary to make properly substantiated claims.

• Exploring the relationship between the FTC and FDA in this arena
  • Analyzing FTC advertising guidelines
  • Determining the scientific evidence necessary to meet FTC standards
  • Assessing if a clinical trial or study is necessary
• Taking a closer look at how the FDA views claims on these products via social media and influencers
  • Understanding when personal experiences require independent substantiation
• Distinguishing structure-function, health, wellness, cosmetic, performance, safety, and disease claims, including when language may position a product as a drug
• Reviewing “clinically proven,” “doctor recommended,” “science-backed,” “safe,” and similar claims that may imply a higher level of proof
• Examining ingredient-related claims where consumer expectations may exceed regulatory requirements 
  • Natural 
  • No Artificial Flavors
  • Simple Ingredients
  • “Clean”
  • Nothing Artificial
  • Made with Real Ingredients
• Understanding how FDA initiatives around GRAS reform and ultra-processed food are influencing advertising claim development and litigation risk
• Implementing practical substantiation, claim review, and risk-mitigation strategies for food, beverage, supplement, wellness, and personal care marketing
• Examining the recent challenges involving FDA-regulated products
  • NAD challenges
  • Class actions