Agency filings
FDA
U.S. Food and Drug Administration
Food and beverages, dietary supplements, cosmetics, drugs, medical devices, radiation-emitting electronics, tobacco, and animal food and drugs.
What CBP flags
- FD1 — may be required: FDA data may be required, FD&C Act 801(a)
- FD2 — required: FDA data is required, FD&C Act 801(a)
- FD3 — may be required: FDA Prior Notice data may be required, 801(m)
- FD4 — required: FDA Prior Notice data is required, 801(m)
What we file and what it costs
| Service | Our fee |
| FDA Prior Notice (food, before arrival) | $80 |
| FDA entry data for your shipment (product code, intended use, facility) | $80 |
| Cosmetics facility registration and product listing | $150 |
| Medical device or drug establishment registration and listing | $150 + FDA user fee at cost, where FDA charges one |
| Food facility registration with Appalachian Customs as U.S. Agent | $250 — see FDA Services |
Government fees, where an agency charges one, are passed on at cost and charged separately.
What we need from you
- Commercial invoice and packing list
- Manufacturer name and address (and its FDA registration number, if any)
- Product ingredients or specifications, and labels
Request a FDA filing
Tell us what you are importing and which filings you need. We reply with confirmation and a secure payment link before we start. Government fees are charged at cost, separately.