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HS codes

Origin and trade agreements

FDA rules for US imports

What FDA needs at US entry for food, drugs, devices and cosmetics: the product code, Prior Notice, registration, affirmations of compliance and holds.

Updated · 13 official sources

Every FDA-regulated product entering the US needs FDA data on its entry line: an FDA product code, the intended use and the affirmations of compliance its program asks for. Food also needs Prior Notice confirmed by FDA before it arrives, 2 to 8 hours ahead depending on the mode, or before it is sent when it travels by mail.

Rules as of 30 October 2026.

Which imports does FDA regulate?#

FDA regulates imports of food (including beverages and dietary supplements), drugs, medical devices, biologics, cosmetics, radiation-emitting products, tobacco and veterinary drugs. Each is a program in CBP's ACE system (FOO, DRU, DEV, BIO, COS, RAD, TOB and VME), and HTS lines that may hold FDA goods carry one of four FD flags telling the filer what to send.

Flag Meaning What to file
FD1 FDA data may be required FDA data, or a disclaim if the product isn't FDA's
FD2 FDA data is required FDA data
FD3 Prior Notice data may be required Prior Notice and FDA data, or a disclaim if it isn't food
FD4 Prior Notice data is required Prior Notice and FDA data

The HS code classifier finds the 10-digit code whose flag to check. Meat, poultry and egg products under USDA's exclusive jurisdiction go to USDA's Food Safety and Inspection Service instead. The agencies overview lists the other agencies that check imports.

What FDA data goes on the entry?#

FDA data on an entry line answers what FDA's March 2026 Industry Quick Reference Guide calls the what, why, how, who, when and where of the import: the product, its intended use, how compliance can be checked, the firms involved, the arrival and the origin. Its core is the product code, the intended use code and the affirmations of compliance.

The FDA product code is exactly seven characters in five parts: a two-digit industry code, a class code, a subclass code, a process indicator code and a two-character product code, with a hyphen standing in for a subclass or process indicator that doesn't apply. Only one goes on each FDA line, and the industry code must fit the program: cosmetics, for example, take industry code 50 or 53. FDA's Product Code Builder puts it together.

The intended use code says why the goods are coming in: 081.001, for example, is the standard import of a foreign-made finished medical device, and 100.000 is an import for personal use, not for sale. Affirmations of compliance (AofCs) are codes that point FDA to registrations, listings and approvals, often with a number as qualifier:

AofC What it gives
PFR The manufacturer's food facility registration number
COS A cosmetic registration number
DLS A drug listing number
LST A medical device listing number
PM# A device's premarket number

Some AofCs are mandatory for a program and intended use, and others are voluntary but speed up review. border.bot's Comply API returns the product code, program, intended use and AofCs for each item.

When is Prior Notice required for food?#

Prior Notice is required for all food for people or animals imported or offered for import into the US, including gifts, samples, food for future export and food passing through to another country. FDA must confirm it before the food arrives, by a deadline that depends on the mode, and before the parcel is sent for mail.

Arriving by Prior Notice confirmed at least
Road 2 hours before arrival
Rail 4 hours before arrival
Air 4 hours before arrival
Water 8 hours before arrival
International mail Before the food is sent; the confirmation number goes on the CN22 or CN23 customs declaration

Notice can be filed through ACE up to 30 days ahead, or through FDA's Prior Notice System Interface up to 15 days ahead. It isn't needed for food a traveler carries for personal use, homemade food sent as a personal gift, food under USDA's exclusive jurisdiction, or food exported again without leaving the port. Food an online seller ships to a customer is none of these; US postal parcels covers how mailed food is entered.

Do foreign food facilities need to register with FDA?#

Yes. A foreign facility that manufactures, processes, packs or holds food for consumption in the US must register with FDA before it starts, unless an exemption applies, and name a US agent in the registration. Registrations are renewed every other year, between 1 October and 31 December of each even-numbered year, so the current window closes on 31 December 2026.

A renewal with no changes can use FDA's abbreviated process, and the registration number goes on entries as an affirmation of compliance, such as PFR for the manufacturer.

What should be ready before an FDA-regulated product ships?#

FDA-regulated products ship most smoothly when the FDA line can be filed in full before the goods leave. For food that means a current facility registration and a Prior Notice confirmation; for every program it means the product code, the intended use and the registration or listing numbers the program's affirmations of compliance call for.

What happens when FDA holds a shipment?#

FDA reviews the data on each FDA line, can ask for a sample, and can detain goods that appear to break its rules. Sampled goods must be held, not distributed, until FDA or CBP reports the result. A product facing refusal gets a notice giving the owner or consignee time to present testimony.

That testimony can be oral or written, and can include a proposal to relabel the goods or take other steps to bring them into compliance.

If the problem isn't overcome, FDA refuses admission. Refused goods must be exported within 90 days of the notice of refusal, or within the extra time the regulations allow, or they are destroyed; FDA may destroy a refused drug valued at $2,500 or less without the option to export it. Products with a history of violations can be placed on an import alert, which lets FDA detain later shipments without physical examination until the importer shows they don't have the problem.

Common questions#

Does food sold online and sent by post need Prior Notice?#

Yes. Prior Notice must be confirmed by FDA before the parcel is mailed, and the confirmation number goes on the customs declaration. The exclusions cover food a traveler carries, homemade personal gifts, USDA-only products and food that never leaves the port, not food sold to customers.

What is an FDA product code?#

A seven-character identifier that tells FDA what the product is: a two-digit industry code, a class, a subclass, a process indicator and a two-character product code, built with FDA's Product Code Builder.

Sources#