ADVERTISING LABELING & CLAIMS SUBSTANTIATION

Balancing Advertising and Brand Promotion of Your OTC Drug Product with the Latest FTC Guidance on Health Claims and Green Claims

January 23, 2024 1:00pm

Kellie Combs
Partner
Ropes & Gray

Jennifer Santos
Attorney
National Advertising Division (NAD)

Nikki Reeves
Partner
King & Spalding LLP

  • Grappling with the implications of the FTC’s new Health Products Claim Substantiation Guidance on OTC drug products
    • How much evidence, and what type of evidence, will be needed going forward to substantiate health-related claims for OTC drugs?
    • Developing effective advertising, labeling and substantiation strategies while steering clear of compliance pitfalls
  • Examining the proposed changes to the Green Guides and the impact that FTC’s contemplated rulemaking could have on environmental marketing claims for OTC drug products (eco-friendly, biodegradable, etc.)
    • Exploring differences in FTC’s guidance and state law requirements for the term “recyclable”
  • Understanding the nuances between superiority and comparative efficacy claims
    • Analyzing the clinical data requirements needed to support these claims
    • How are FTC and NAD viewing/treating these claims?
  • Developing a roadmap for testing and claims substantiation that will protect your OTC drug product from FTC and NAD scrutiny, as well as attacks from the plaintiff’s bar
  • Special considerations for making and substantiating ESG claims