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Dietary Supplement and Food Safety Modernization Act (FSMA)

Due to the complexity of FSMA, some dietary supplement companies have misperception that they are exempt from the FSMA rules since they are already subject to Dietary Supplement cGMP (21CFR111).  Actually, under FSMA, dietary supplement companies who manufacture, pack, label, or hold dietary supplement products are only exempted from some subparts in  Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (21CFR 117) and Foreign Supplier Verification Programs (FSVP) (21CFR 1, Subpart L), but are fully subject to all other FSMA rules.

Dietary supplements are required to comply with the cGMP requirements in subpart B of 21CFR part 117 while exempt from subpart C - Hazard Analysis and Risked-Based Preventive Controls (HARPC) and subpart G - Supply Chain Program in 21CFR117.  However, dietary supplement ingredient suppliers are fully subjected to 21CFR117, which means that dietary supplement companies should verify their ingredient suppliers based on 21CFR117.

Under Foreign Supplier Verification Program (FSVP) (21CFR 1, Subpart L),   modified requirements apply to three categories of importers of dietary supplements:

  1. Importers who are required to establish and verify components specifications under 21CFR111 are not required to comply with most of the standard FSVP requirements. 

  2. Importers whose customers are required to establish and verify components specifications under 21CFR111 would have to obtain written assurance from its customers assuring that they are complying with those requirements.

  3. Importers of dietary supplements who do not belong to category 1 & 2 are required to comply with most of the standard FSVP requirements (except the hazard analysis requirement), but focus on verification requirements under 21CFR111

The following table summarizes how FSMA rules as well as dietary supplement cGMP apply to dietary supplement verses general food and food ingredients:

 

 

Furthermore, if a company has both food products and dietary supplement, the business is subject to both 21CFR117 and 21CFR111.  In addition, many retailers and third-party certification companies already have included Hazard Analysis and Risked-Based Preventive Controls (HARPC) and Supply Chain Program in 21CFR117 into their supplier qualification programs or certification requirements. 

 

Our regulatory experts can help dietary supplement companies and their ingredient suppliers to comply with FSMA rules as well as retailer supplier qualification programs.