Many Sri Lankan food manufacturers aiming to export to the U.S. are unsure about FDA registration and FSMA compliance. This blog answers the 10 most common questions, helping you navigate the process smoothly and avoid costly mistakes.
1. What is FDA registration and who needs it in Sri Lanka?
FDA registration is a mandatory process for all foreign food facilities that manufacture, process, pack, or hold food for consumption in the United States. Any Sri Lankan food processing facility exporting food, beverages, or dietary supplements to the U.S. must register with the FDA.
2. Is FDA registration the same as FDA approval?
No. FDA registration is not the same as FDA approval. The FDA does not “approve” food products, except for specific items like food additives and colorants. Registering a facility means notifying the FDA that your facility exists and complies with applicable U.S. laws.
3. What is the Food Safety Modernization Act (FSMA)?
The FSMA is a U.S. law that focuses on preventing food safety problems before they occur. It requires foreign suppliers (including those in Sri Lanka) to implement preventive controls and food safety plans, and it enables FDA to inspect foreign food facilities exporting to the U.S.
4. Is FSMA compliance mandatory for Sri Lankan exporters?
Yes. Any Sri Lankan food business exporting to the U.S. must comply with FSMA regulations. This includes preparing a Food Safety Plan and participating in the Foreign Supplier Verification Program (FSVP).
5. What is the Foreign Supplier Verification Program (FSVP)?
The FSVP requires U.S. importers to verify that their foreign suppliers, like those in Sri Lanka, produce food in compliance with U.S. safety standards. As an exporter, you must ensure your U.S. importer can demonstrate your food safety compliance.
6. Do Sri Lankan food exporters need a U.S. Agent?
Yes. All foreign facilities must designate a U.S. Agent when registering with the FDA. The agent acts as a communication link between the FDA and your company and must be located in the United States.
7. How often should FDA registration be renewed?
FDA registration must be renewed every even-numbered year (e.g., 2024, 2026). If not renewed by December 31st of the renewal year, the registration will be considered expired.
8. What are the penalties for non-compliance with FDA or FSMA?
Non-compliance can result in FDA detention of your products at the U.S. border, product recalls, fines, or even bans from entering the U.S. market. It’s crucial to remain compliant and up-to-date.
9. What documentation is required for FDA registration and FSMA compliance?
Typical requirements include:
- Food facility details
- U.S. agent information
- Product categories
- Food safety plan (for FSMA)
- Preventive controls documentation
- Supply chain program details
10. Can a consultant help with FDA and FSMA compliance?
Absolutely. Experienced consultants like SAFO Consultancy can guide you through the FDA registration, FSMA compliance, U.S. agent selection, and audit preparation process. We ensure your documentation and systems meet U.S. standards without delay.
Conclusion
Navigating FDA and FSMA regulations can be overwhelming for Sri Lankan food businesses. However, with the right knowledge and expert guidance, compliance becomes a strategic advantage—not a barrier. If you’re planning to export to the U.S. or already do, make sure your registration is active, your FSMA plan is in place, and you’re working with a qualified consultant or U.S. agent.
Need Help with FDA or FSMA?
Contact SAFO Consultancy Pvt Ltd today. We specialize in food safety compliance for exporters and offer end-to-end support for FDA registration, FSMA audits, and U.S. agent representation.