Does FDA registration mean FDA approval?
No. Registration is not the same as approval or clearance.
FAQ
Short answers to common FDA market-entry questions.
Use these answers as orientation, then confirm the correct path for your exact product and claims.
Who needs an FDA US Agent?
Many foreign establishments exporting FDA-regulated products to the United States may need a US Agent.
What does MoCRA require?
MoCRA introduced facility registration, product listing, adverse-event recordkeeping, and related obligations for many cosmetic companies.
Can approval be guaranteed?
No. The desk provides consulting, preparation, review, and coordination support. Final determinations rest with FDA.
Can Chinese-language teams be supported?
Yes. Client coordination can be in Chinese while regulatory records are maintained in English where needed.
When is the 2026 FDA food facility registration renewal window?
The biennial renewal window is 1 October through 31 December of each even-numbered year. For 2026, food and dietary-supplement facilities that must register should renew during 1 October–31 December 2026. FDA does not charge a registration or renewal fee.
Does a foreign food facility need a D-U-N-S number and a US agent?
FDA uses the D-U-N-S number as the acceptable unique facility identifier for food-facility registration. A foreign food facility must also designate a US agent who resides in the United States or maintains a US place of business and is physically present in the United States.
Primary sources: FDA's biennial renewal user guide and FDA's D-U-N-S identifier guidance.