How to Sell Dietary Supplements Legally in the U.S.: A Compliance Guide with FSVPServices.com
Selling dietary supplements in the United States requires more than great branding and formulation—it requires strict compliance with FDA regulations. Whether you’re a foreign supplier, U.S. importer, or brand owner using contract manufacturers, aligning with U.S. laws is essential for market access, traceability, and regulatory safety.
FSVPServices.com, powered by Consultare Inc. Group, supports dietary supplement businesses in navigating these requirements—starting with FDA facility registration, FSVP compliance, and U.S. Agent services.
Step 1: Register Your Facility with the FDA
Under 21 CFR 1.225–1.241, all facilities that manufacture, process, pack, or hold dietary supplements intended for U.S. consumption must register with the U.S. Food and Drug Administration (FDA).
Required for:
- • Foreign manufacturers and exporters
- • U.S.-based contract manufacturers
- • Brand owners (if also managing distribution)
- • Facility identification (with a valid D-U-N-S® Number)
- • Designation of a U.S. Agent for foreign facilities
- • Renewal every even-numbered year (Oct–Dec)
- • Confirmation of FDA acknowledgment
Step 2: Understand the Role of FSVP (Foreign Supplier Verification Program)
For dietary supplements imported into the U.S., compliance with the Foreign Supplier Verification Program (FSVP) is critical. This is part of the Food Safety Modernization Act (FSMA) and requires U.S. importers to verify that foreign suppliers are producing supplements in accordance with U.S. safety standards.
✅ FSVP Requirements Include:
- • Verifying supplier compliance with 21 CFR 111 (Supplement cGMPs)
- • Reviewing product safety, labeling, and recall history
- • Performing risk-based evaluations
- • Maintaining detailed FSVP records
- • Having a Qualified Individual (QI) to manage the program
Step 3: Comply with the Bioterrorism Act
The Bioterrorism Act of 2002 mandates that businesses involved in importing and distributing dietary supplements maintain proper traceability records. These records must:
- • Identify both the immediate previous source and immediate subsequent recipient of each product
- • Be retrievable within 24 hours in case of an FDA inquiry or food safety incident
Step 4: Be Audit-Ready Year-Round
Whether you're preparing for a routine inspection or a customs review, audit preparedness is key. This includes:
- • Keeping your facility registration up to date
- • Having complete and current FSVP documentation
- • Retaining supplier qualification records
- • Demonstrating that your dietary supplements meet U.S. labeling and manufacturing standards
How FSVPServices.com Helps You Succeed
With deep expertise in dietary supplement compliance, FSVPServices.com offers:
- ✅ FDA Facility Registration Services
- ✅ U.S. Agent Representation for Foreign Facilities
- ✅ FSVP Qualified Individual Support
- ✅ Supplier Verification & Documentation Review
- ✅ Traceability & Recall Readiness Tools
- ✅ Audit & Inspection Preparation Services
Conclusion
The U.S. dietary supplement market is full of opportunity—but it demands precision in regulatory compliance. From FDA registration and U.S. Agent designation to FSVP management and audit readiness, FSVPServices.com is your dedicated compliance partner.
Ready to launch or scale your supplement business in the U.S.?
Visit FSVPServices.com to book a consultation and get started with expert support.