Working Group on Substantiating Advertising Claims for FDA Regulated Consumer Products: OTC Drugs, Food, Dietary Supplements and Cosmetics

Jan 30, 2020 2:00pm – 5:30pm

Cynthia L. Meyer
Kleinfeld Kaplan & Becker LLP

Megan Olsen
Assistant General Counsel
Council for Responsible Nutrition (Washington, D.C.)

This interactive working group will explore the necessary requirements for claims substantiation of FDA-regulated consumer products, including OTC drugs, dietary supplements, food, and costmetics. The session will provide you with the information necessary to make properly substantiated claims. Points of discussion will include:  
  • Exploring the relationship between the FTC and FDA in this arena
    • Analyzing FTC advertising guidelines
    • Defining a reasonable basis for objective representations
    • 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
  • Reviewing terms such as “all-natural” and “100% real ingredients”
    • Determining the substantiation necessary to make these claims
    • Exploring FTC enforcement action when a synthetic product is found in the ingredients
  • Examining regulations for homeopathic products
  • Studying the current status of CBD relative to FDA regulated consumer goods
    • Where do the FDA and FTC stand on the use of this ingredient?
    • Do hemp products hold different regulations from products containing CBD?
  • Exploring enforcement activity for unsubstantiated claims
  • Examining the recent challenges made by companies and consumers on claims made for these types of products
    • NAD challenges
    • Class actions