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FDA enforcement action will be swifter, with less notice

The FDA has put supplement companies on notice that violators can expect earlier detection and prosecution. The agency has shifted to a policy of less talk and more action. The industry response must be to get better or get out.

Adverse Event Reporting (AER) Label Compliance

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 [...]