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
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
- NAD challenges
- Class actions