Expo West 2024 was full of energy and excitement, with an estimated 65,000 attendees and 3,000 exhibiting companies. Venable was pleased to once again serve as the official legal and regulatory sponsor.
On day one, co-chairs of Venable's FDA Group, Claudia Lewis and Todd Harrison, spoke to a full room about the legal issues of the day, including the Modernization of Cosmetics Regulation Act (MoCRA), the Food Traceability Rule, the Food and Drug Administration's latest guidance on new dietary ingredient notifications, flavor claims, Proposition 65, enforcement activity, class action lawsuits, and more. Additionally, Venable attorneys provided companies the opportunity throughout the week to ask questions about the business and legal issues they are currently facing.
From Venable's presentation and one-on-one meetings, here were some of the questions you asked:
FDA Questions
- What are some new developments from the FDA that could affect my business?
- How do I respond to an FDA Warning Letter?
- Is my ingredient a New Dietary Ingredient (NDI)? What is FDA's guidance for evaluating ingredients?
- What is the difference between an NDI submission and a Generally Recognized As Safe (GRAS) notification?
- Does my ingredient qualify for GRAS notification?
- If I want to sell a product with CBD, what do I need to keep in mind?
- How do I declare flavor and color additives? What if my entire flavor profile is "natural"? When do I need to disclose "artificially flavored" on my label?
Product Questions
- How can I evaluate whether my labels comply with applicable laws and regulations?
- Does my product require a Proposition 65 warning? Can I put the warning on the website instead?
- How should we assess whether a recall is necessary?
Substantiation Questions
- How do I substantiate structure/function claims?
- I want to discuss the environmental benefits of my product. How can I permissibly make "green" claims?
- I want to describe my products as vegan, vegetarian, or cruelty-free—what do I need to do?
- How do I substantiate Made in USA claims? Do I need to qualify the claim if I use sources outside of the United States?
General Business and Brand Protection Questions
- What are the responsibilities of a product manager versus a distributor for GMP purposes?
- How do I protect myself against class action plaintiffs' attorneys?
- What kind of insurance, contracts, and indemnification should I be thinking about?
- Should I be concerned about the National Advertising Division (NAD)? What are the pros and cons of challenging my competitor claims?
- We want to offer our products on a subscription basis. What should we be thinking about?
These questions are not only on companies' minds—they overlap with the issues piquing the FTC's and FDA's interest. If you did not see your question above or get your questions answered at Expo West, please contact us here to schedule a meeting.
Tune in to our 10th Advertising Law Symposium to learn more about some of the issues above! For our most recent blogpost on NDI Guidance, click here. To access our Advertising Law Tool Kit, click here.