FDA
Food and Drug Administration
They need data on the filing
required: FD2required: FD4may be required: FD1may be required: FD3
- What it regulates
- Food, dietary supplements, drugs, medical devices, cosmetics, tobacco and e-cigarettes, radiation-emitting products and veterinary products.
- How you know you are flagged
- FD1 and FD3 mean data may be required — the line is flagged and the goods decide. FD2 and FD4 mean the data is required. All four cover eight FDA programmes, from foods to tobacco, so which of them applies depends on what the goods are.
- What must be filed, and when
- Prior notice before arrival for food. The message set transmits with the entry. A shipment that arrives without prior notice is held, not merely delayed.
- What goes wrong most often
- Supplements and vitamins are food to FDA, so the prior notice rule reaches them. Sellers routinely declare them as something else.
- When it arrives by mail
- Food sent without prior notice does not get the usual 30 days. It is held 72 hours, after which it can be destroyed or exported.
What the manufacturer or seller has to supply
This data starts with whoever made or sold the goods, in every mode. What changes is how it reaches the filing: on a mail parcel through the origin post's electronic data, otherwise through the shipper's documents. Seller means it can only come from them; seller + filer means we supply or confirm part of it. Ask for it at order time — it is far harder to get once the goods have shipped.
required: M mandatory on every filingmay be required: C conditional, only when it applies
| Field | M or C | Who supplies | Example |
|---|---|---|---|
| Commercial description | required: M | seller | GREEN TEA LEAVES, DRIED, RETAIL BOX 250 G |
| Product type | required: M | seller + filer | Processed food |
| Country where grown or made | required: M | seller | CN |
| Common or usual name | required: M | seller | DRIED GREEN TEA LEAVES |
| Manufacturer name and address | required: M | seller | ACME FOODS CO, 1 EXAMPLE RD |
| Shipper name and address | required: M | seller | Whoever tendered the goods to the carrier |
| U.S. consignee, state and ZIP | required: M | seller | LOS ANGELES, CA 90012 |
| Expected arrival date and time | required: M | seller + filer | 2026-10-30 10:15 |
| Prior notice confirmation number | may be required: C | seller | 12 digits. Only FDA can issue it. |
| Intended use (non-food) | may be required: C | seller + filer | Personal use |
| Registration or listing numbers | may be required: C | seller + filer | FDA registration number |
| Packaging levels | may be required: C | seller | 1 BOX of 10 PCS |
| Brand name | may be required: C | seller | Required for tobacco and some devices |
Worked examples
- Honey, 500 g jar0409.00.0010required: FD4
- Dried goji berries0813.40.2060AQ1 · FD4 · AM7
- Lip balm, retail3304.10.0000may be required: FD1
