Quick Answer
According to the US Food and Drug Administration (FDA), FDA does not, by law, pre-approve, certify or license individual imported food products, labels or shipments; food can be imported as long as the facilities that make, store or handle it are registered with FDA and Prior Notice is submitted before each shipment arrives, though shipments may still be examined and detained if non-compliant. In addition, US importers must run a Foreign Supplier Verification Program (FSVP) under the Food Safety Modernization Act (FSMA) to verify their foreign suppliers’ food safety. Since 7 May 2025, Taiwan-made goods exported to the US also need a declaration of origin for goods exported to the United States.
5 Key Requirements for Exporting to the US
| Requirement | Who is responsible | Details |
|---|---|---|
| Food Facility Registration | Foreign facilities that manufacture, process, pack or hold food | Register with FDA and renew every other year under FSMA |
| U.S. Agent | Foreign facilities | Must be designated when a foreign facility registers |
| Prior Notice | The importer or its agent | Notify FDA before each food shipment arrives in the US |
| Foreign Supplier Verification Program (FSVP) | US importer | Verify the foreign supplier’s food safety |
| Labeling | Exporter and importer | Must meet US food labeling rules (ingredients, nutrition, allergens, etc.) |
Food Facility Registration
FDA explains that under Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by FSMA, registered food facilities must renew their registration every other year, and FDA can suspend a facility’s registration in certain circumstances. Taiwanese exporters should confirm that the actual manufacturing facility is registered and that the registration number is valid.
FSVP: The US Importer’s Responsibility
FDA’s FSVP rule requires importers to perform risk-based verification of foreign suppliers, confirming the food is produced in a way that provides the same level of public health protection as US requirements. In practice, US importers ask Taiwanese suppliers for food safety plans or HACCP documents, test reports, certifications and audit records. Factories certified to HACCP, ISO 22000 or FSSC 22000 make verification smoother; see HACCP vs ISO 22000 vs FSSC 22000.
US Export Checklist
- Confirm the facility’s FDA registration and U.S. Agent
- Confirm ingredients and labels meet US rules
- Prepare food safety documents to support the importer’s FSVP
- Agree who submits Prior Notice for each shipment
- Prepare the commercial invoice, packing list, bill of lading and other shipping documents
- Attach the declaration of origin for Taiwan-made goods exported to the US
- Make sure origin marking is correct to avoid illegal transshipment; see What Happens If You Use Transshipment to Evade Tariffs?
Tang Sugar’s Export Practice
Tang Sugar follows FDA registration, filing and food regulatory procedures as target markets require; our partner factories hold ISO 22000 (SGS verified), FSSC 22000 and HACCP certification. US buyers sourcing bubble tea ingredients from Tang Sugar can see How to Import Bubble Tea Ingredients from Taiwan or contact us directly.
FAQ
Does FDA approve imported food?
No. FDA states it does not, by law, pre-approve, certify or license individual imported foods; but facilities must be registered and shipments need Prior Notice, and imports may still be examined and detained.
Do food exporters to the US need FDA registration?
Facilities that manufacture, process, pack or hold food for the US must register with FDA and renew every other year under FSMA.
Who is responsible for FSVP?
The US importer. Importers must verify foreign suppliers’ food safety, so they ask exporters for supporting documents.
Do Taiwanese exports to the US need a declaration of origin?
Yes. Since 7 May 2025, Taiwan-made goods exported to the US must be accompanied by a declaration of origin for goods exported to the United States.
Further Reading
- Taiwan Food Export Process
- HACCP vs ISO 22000 vs FSSC 22000
- How to Import Bubble Tea Ingredients from Taiwan
- Food Business Registration in Taiwan
- Tea Shop Opening Services
Sources
- U.S. FDA: Importing Food Products into the United States (updated 2024-12-11)
- U.S. FDA: Registration of Food Facilities and Other Submissions
- U.S. FDA: FSMA Final Rule on Foreign Supplier Verification Programs (FSVP)
- Central News Agency (2025-04-25): Taiwan-made exports to the US require a declaration from 7 May (in Chinese)
