USA: Dietary supplement ingredient advisory list

The U.S. Food and Drug Administration removed 5-alpha-hydroxy-laxogenin and octopamine from the Dietary Supplement Ingredient Advisory List because, based on available information, the ingredients fall into one of the three categories described:

  1. The ingredient appears to be excluded from use in a dietary supplement;
  2. The ingredient does not appear to be a dietary ingredient and does not appear to be either an approved food additive or generally recognized as safe for use; or
  3. The ingredient appears to be subject to the requirement for pre-market notification, but the requirement has not been satisfied.

Although this list reflects ingredients for which the FDA has made a preliminary assessment, it is not an exhaustive list of ingredients that may or may not be lawfully included in dietary supplements. Ingredients may be added to or removed from this list as the FDA continues its evaluation.

The Americas – USA: Draft Guidance for Industry: Policy Regarding N-acetyl-L-cysteine

The purpose of this guidance is to advise dietary supplement manufacturers, distributors, and other stakeholders of our intent to exercise enforcement discretion with respect to the sale and distribution of certain products that contain N-acetyl-L-cysteine (NAC) and are labeled as dietary supplements. As described below, the enforcement discretion policy would apply to products that would be lawfully marketed dietary supplements if NAC were not excluded from the definition of “dietary supplement” and that are not otherwise in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).