Post-Conference Workshop B: Master Class on Substantiating Claims on FDA Regulated Consumer Products – Proper Steps for Ensuring Claims on Food Products, Dietary Supplements, and Cosmetics

Feb 1, 2019 1:30pm - 4:30pm



Katie Bond
Amin Talati Upadhye LLP (Washington, D.C.)

Kristen Klesh
Venable LLP (Washington, D.C.)

Mark Levine
Associate General Counsel
RB Health (Parsippany, NJ)

What is it about?

(Registration Begins at 1:00 PM)

This interactive master class will explore the particular requirements and nuances of claim substantiation for non-pharmaceutical FDA-regulated consumer goods such as food, dietary supplements and cosmetics.

The Master Class instructors will lead you through the complexities of inter-agency policies and procedures governing what claims you can safely make as well as those you cannot. Points of discussion will include:

  • Reviewing the advertising guidelines published by the FDA and FTC
    • What is the difference between a health claim and a qualifying health claim?
    • Dietary guidance
    • Structure and function claims
  • Discussing the relationship between the FDA and FTC relative to claims made of these products
  • Clarifying the FDA and FTC’s jurisdiction over influencers
  • Determining the proper steps when substantiating the claims of a product relying on ingredients such as plants and minerals
  • Exploring terms such as “all-natural”, “100% real ingredients”, and “wholesome”
    • Are these terms puffery?
    • What testing is necessary to substantiate these claim for a food or cosmetic product?
    • Expected guidance on the term “all-natural”
  • Identifying the types of claims that exist for weight loss products, probiotics, joint supplements, and other nutritional supplements and the substantiation required for them
  • Analyzing the substantiation utilized for recent advertising claims on anti-aging and skin care products
  • Assessing available enforcement actions for unsubstantiated claims of FDA regulated products
    • Warning letters
    • How can companies remedy these issues?
    • Discussing recent enforcement action
  • Examining the recent challenges made by companies and consumers on claims made for these types of products
    • FTC
    • NAD challenges
    • Class actions