Keller and Heckman’s food and drug attorneys, in collaboration with our in-house scientists, counsel clients on all aspects of dietary supplements, nutraceuticals, and functional foods, including ingredient, claims, classification, safety testing, and litigation, if the need arises. We advise manufacturers and distributors regarding the types of claims that may appear in advertising and on labeling, in addition to promotional materials for these products, including the claims used to market dietary supplements using the internet. We review client labels, labeling, and advertising for product compliance issues and advise on the classification of a product as a dietary supplement, conventional food, or a drug based on the product claims.  

Keller and Heckman counsels clients on various regulations and laws, including the Dietary and Supplement Health and Education Act’s (DSHEA) adulteration, current good manufacturing practices, new dietary ingredient, and misbranding provisions. In addition, we advise clients on whether premarket review or authorization is needed under global regulatory systems and how to obtain it. Keller and Heckman attorneys, in conjunction with in-house scientists who have expertise in molecular biology, toxicology, and genetic engineering, provide guidance to clients on safety testing for dietary ingredients, including toxicology, carcinogenicity, and sensitivity testing on volunteers. We also provide counsel to clients on potential product liability issues and defend related court cases.

Representative Matters

• Defended against Federal Trade Commission (FTC) complaints, enforcement actions, prosecutions, and competitor challenges in court and other forums
• Assessed the regulatory status of ingredients for dietary supplements and evaluated claims for such products
• Defended a dietary ingredient supplier in a Federal Trade Commission (FTC) investigation of claims for the ingredient