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 subject to requirements in subpart B - current Good Manufacturing Practice 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.
Importers who are required to establish and verify components specifications under 21CFR111 are not required to comply with most of the standard FSVP requirements.
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.
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 and dietary supplement cGMP apply to dietary supplement versus general food and food ingredients:
When a company has both food products and dietary supplement, the business is subject to both 21CFR117 and 21CFR111. Most major retailers and third-party certification companies have already included Hazard Analysis and Risked-Based Preventive Controls (HARPC) and Supply Chain Program in 21CFR117 into their supplier qualification programs or certification requirements, Dietary Supplement companies are requested to comply with 21CFR117 if they want to sell their products to those retailers or get certified by those third-party certification organizations.
Our regulatory experts can help dietary supplement companies and their ingredient suppliers to comply with applied FSMA rules and meet the requirements of retailers and third-party certification bodies.
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