561.404.4350 [email protected]

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...

FDA Seeks Comments on Puzzling amendments to FDCA

CFSAN issued this press release recently that announces the publication in the Federal Register of a notice (73 FR 43937; July 29, 2008) requesting comment on Section 912 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). Here is FDA’s summary...