Dietary supplements are “food” as defined in the Federal Food, Drug, and Cosmetic Act (FD&C Act). In general, a foreign or domestic facility that manufactures, processes, packs, or holds human food for consumption in the United States has to register with FDA under section 415 of the FD&C Act and is subject to the requirements related to preventive controls of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule, unless subject to an exemption. An exemption for dietary supplements is provided in 21 CFR section 117.5(e) which states that subparts C (hazard analysis and preventive controls requirements) and G (supply-chain program requirements) of 21 CFR part 117 do not apply to any facility with regard to the manufacturing, processing, packaging, or holding of a dietary supplement that is in compliance with the requirements of 21 CFR part 111 (Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements) and section 761 of the FD&C Act (21 USC section 379aa-1) (Serious Adverse Event Reporting for Dietary Supplements).
