Although Section 403(y) of the Federal Food, Drug, and Cosmetic Act (FFD&C Act) (21 U.S.C. 343(y), does not require a dietary supplement label to include anything other than a domestic address or phone number for the responsible person, the FDA recommends that the label also bear a clear, prominent statement informing consumers that the domestic [...]

The FDA has released new guidance for dietary supplement labeling pursuant to the Dietary Supplement and Nonprescription Drug Consumer Protection Act passed at the end of 2006. The Act requires supplement companies to report serious adverse events (adverse event reports or AER) concerning their products to the FDA. The AER reporting requirement went into effect [...]