C.L. has specialized experience working with clients who are subject to the Food, Drug, and Cosmetic Act, such as dietary supplement makers and sellers, and the issues commonly faced by them. We can assist you in responding to FDA inspection reports, warning letters, product detentions, and civil forfeiture complaints. Our firm handles issues such as labeling and advertising compliance, subpoena responses, inquiries from state agencies, Proposition 65, and product liability and unfair competition litigation.
Supplement Industry Regulation
The FDA is increasingly regulating the dietary supplement industry outside of the formal rule-making process, such as through warning letters. CL can assist you with an understanding of the basis for any such warning, the preparation of an appropriate response, and an evaluation of any potential legal ramifications.
Supplement Ingredients
Whether or not a substance qualifies as a “dietary supplement” is not always clear. The law does not contain a list of ingredients that are permitted or a list of those that are not. CL has extensive experience in evaluating the legality of various ingredients and can advise not only as to ingredient selection, but also nutrient labeling and label claims.