Label and Supplement Facts review before launch
Structure/function claims, notifications and FTC substantiation
Ingredient status and new dietary ingredient (NDI) notifications
Amazon takedowns, warning letters and class action defense
Legal Counsel for Dietary Supplement Companies
Supplement companies sell into a market with low barriers to entry and high exposure once a product is on the shelf. A single word on a label or product page can turn a supplement into an unapproved drug, and the same claim can draw an FDA warning letter, an FTC inquiry, a marketplace takedown and a class action.
Before Launch
Label review: statement of identity, Supplement Facts, ingredient and allergen declarations, and required disclaimers.
Claims strategy: structure/function claims and the 30-day FDA notification, nutrient content and health claims, and avoiding disease claims.
Ingredients: whether an ingredient is a lawful dietary ingredient, whether a new dietary ingredient notification is needed, and drug-exclusion issues.
Manufacturing relationships: private label and contract manufacturing agreements, cGMP responsibilities under 21 C.F.R. Part 111, and quality agreements.
Advertising and E-Commerce
We review websites, influencer and affiliate programs, reviews and testimonials against FTC substantiation and endorsement rules, and we help brands respond when Amazon or another marketplace removes a listing or asks for documentation.
When a Claim Is Challenged
FDA warning letters and import detentions (see FDA enforcement defense).
FTC and state attorney general inquiries.
Consumer class actions and demand letters over labels and ingredients, using the same approach as our food and beverage defense practice.
Competitor false advertising claims and trademark disputes.
Talk to Us
If you are launching a supplement, revising claims, or responding to a takedown, warning letter or lawsuit, contact us for a confidential consultation.
