Workshop B — Working Group on Substantiating Advertising Claims for FDA Regulated Consumer Products: OTC Drugs, Food, Dietary Supplements and Cosmetics – Special COVID-19 edition

Feb 2021

Megan Olsen
Vice President & Associate General Counsel
Council for Responsible Nutrition (Washington, DC)

Thomas Cohn
General Counsel and Corporate Secretary
The Avon Company

Danielle Lemack
Assistant General Counsel,
HP Hood LLC (Lynnfield, MA)

Ivan Wasserman
Managing Partner
Amin Talati Wasserman LLP (Washington, DC)

Claims made for FDA regulated consumer products have come to the forefront as a result of the COVID-19 pandemic. Claims for everything from food to vitamins to soap have touted some prophylactic effect against novel coronavirus.

This interactive working group will explore the necessary requirements for claims substantiation of FDA-regulated consumer products, including OTC drugs, dietary supplements, food, and cosmetics. The session will provide you with the information necessary to make properly substantiated claims in view of COVID as well as ordinary matters.

Points of discussion will include:

  • Understanding how COVID-19 has raised the bar for claims substantiation of FDA regulated consumer goods
  • Exploring the relationship between the FTC and FDA in this arena
  • Analyzing FTC advertising guidelines (deception, substantiation, environmental, endorsements/testimonials, Made in USA)
  • Determining the scientific evidence necessary to meet FTC claim substantiation standards
  • Assessing if a clinical trial or study is necessary in view of recent pronouncements
  • Taking a closer look at how the FTC and FDA views claims on these products via social media and influencers
  • Assessing how OTC Monograph reform may influence claims substantiation
    • Examining how the FDA’s Final Sunscreen monograph has impacted claims substantiation in the advertising of those products
  • Reviewing the latest pronouncements on “organic,” “all-natural” “green,” “clean” and “100% real ingredients” claims
  • 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, including recent warning letter analysis
  • Examining the recent challenges against claims made for these types of products
    • NAD challenges
    • Class actions