While specifically exempted from Subparts C and G of 117, due to overlap with 111, dietary supplement manufacturers/companies have responsibility for compliance with subparts A (General Provisions), B (cGMPs), and F (Records that must be established and maintained).
FSMA spells out an exemption to subpart G, – Supply-Chain Program, but these exemptions apply only to finished dietary supplement products and dietary supplement companies still need to understand what Subparts C and G dictate to suppliers, both domestic and foreign.
Dietary supplement manufacturers should pay attention to Part 117 B GMPs for responsibilities relating to controlling allergens.
Everyone (ingredient manufacturers and handlers at all points, including supplement manufacturers and packagers) must be proactive and implement controls.
The only products outside the requirements for allergen controls are those secured in their finished goods packaging in warehouses dedicated to labeled and sealed finished goods.
Dietary Ingredient (DI) manufacturers are directly affected by FSMA.
They are allowed an exemption to HARPC if they are compliant with Part 111. Currently, ingredient manufacturers are not required to comply with 21 CFR Part 111 for dietary supplements, but under HARPC in Part 117.
Dietary ingredient manufacturers therefore need to undertake hazard analyses in preparation for developing, implementing and monitoring their risk-based preventive controls. They also need to review dates for their supply chain programs, as these interact with Foreign Supplier Verification Program (FSVP) requirements.
Dietary ingredient manufacturers have the following basic obligations:
Using approved suppliers
Determining how to verify suppliers
Ensure preventive controls are being implemented and are effective
Adequately documenting all the above
FSVP places responsibility for foreign supplier compliance upon the importers.
Importers would be required to analyze the hazards associated with each food they import.
Finished dietary supplements are required to have FSVP in place to be imported into the United States
Foreign ingredient manufacturers will need at least third-party oversight to ensure food safety plans are in place and have been verified to provide the same level of protection as those required under the preventive controls.
They must also verify the ingredients are not misbranded regarding allergen labeling.
