Do Dietary Supplements need to comply with FSMA 21 CFR 121?
Do dietary supplements companies also need to be in compliance with FSMA’s finale rule for Mitigation Strategies to Protect Food Against Intentional Adulteration (21 CFR 121)?
The FDA's FAQ page says:
Q1. Is a manufacturer of dietary supplements exempt from the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule?
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).
Q.2 Is a manufacturer of bulk dietary supplements exempt from the preventive controls for human food?
The exemption applies to finished dietary supplements in bulk form. For example, bulk finished dietary supplements that will be packaged or repackaged are exempt if in compliance with 21 CFR part 111 and 21 USC section 379aa-1.
Q.3 Are dietary ingredients exempt from the preventive controls for human food rule?
The exemption does not apply to the manufacturing, processing, packing, or holding of dietary ingredients. Dietary ingredients are subject to the requirements of the rule, including the current good manufacturing practice (CGMP) requirements of 21 CFR part 117, subpart B; the hazard analysis and risk based preventive controls requirements of 21 CFR part 117, subpart C; the supply chain program requirements of 21 CFR part 117, subpart G; and the recordkeeping requirements of 21 CFR part 117, subpart F.
Q.4 Which Current Good Manufacturing Practice (CGMP) regulations apply to a manufacturer of dietary supplements, those in 21 CFR part 111 or those in 21 CFR part 117?
A dietary supplement manufacturer would be required to comply with the CGMP regulations in 21 CFR part 117, subpart B in addition to the regulations in 21 CFR part 111, unless the regulations conflict. To the extent regulations conflict, the manufacturer would comply with the regulation in part 111 (see the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule, Response 197; 80 Fed. Reg. 55908 at 55978).