### The Regulatory Landscape for US Dietary Supplements Under the Dietary Supplement Health and Education Act (DSHEA) and 21 CFR 111, the brand whose name appears on the retail label bears primary legal responsibility for product identity, purity, strength, and composition. ### 4 Mandatory Steps for Seamless US Clearance 1. **Foreign Supplier Verification Program (FSVP)**: The US importer must review and maintain foreign facility food safety hazard evaluations and batch laboratory certificates. Shilergy supplies qualified clients with turnkey FSVP documentation packages. 2. **Prior Notice of Imported Foods**: Submitted electronically to the FDA via the ACE/ITACS portal prior to shipment arrival. 3. **Compliant Supplement Facts & Label Copy**: Labels must strictly feature structure/function claims supported by scientific substantiation, accompanied by the mandatory FDA disclaimer ("These statements have not been evaluated..."). 4. **Heavy Metals Documentation for Proposition 65**: Maintain lot-specific ICP-MS certificates to demonstrate compliance with California daily intake limits.