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Importing Food Products into the United States
Importers of food products intended for introduction into U.S. interstate commerce are responsible for ensuring that the products are safe, sanitary, and labeled according to U.S. requirements.
Importers can import foods into the United States without prior sanction by FDA, as long as the facilities that produce, store, or otherwise handle the products are registered with FDA, and prior notice of incoming shipments is provided to FDA.
What is prior notice?
Prior notice is notification to the FDA that an article of food, including food for animals, is being imported or offered for import into the United States in advance of the arrival of the article of food at the U.S. border.
Why is prior notice required to be submitted to FDA?
Prior notice is required by section 801(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 381(m)). Section 801(m) of the Contains Nonbinding Recommendations 6 FD&C Act requires advance notification to FDA prior to the arrival of food imported or offered for import into the U.S.
For the purposes of the prior notice regulation, what is food?
Food is defined in § 1.276 by reference to section 201(f) of the FD&C Act, which defines food as articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such articles (21 U.S.C. 321(f)). However, for purposes of prior notice, the definition of food does not include food contact substances or pesticides (21 CFR 1.276(b) (5)(i)). Examples of food subject to prior notice include: fish and seafood, live food animals, dairy products, shell eggs, fruits, vegetables, raw agricultural commodities for use as food or as components of food and animal feed (including pet food), food and feed ingredients, food and feed additives, infant formula, beverages (including alcoholic beverages and bottled water), bakery goods, snack foods, candy, canned foods, and dietary supplements and dietary ingredients.
When must prior notice be submitted?
Except for food being sent by international mail, prior notice must be submitted and the submission must be confirmed by FDA no less than:
2 hours before arrival, if the food is arriving by land by road;
4 hours before arrival, if the food is arriving by land by rail;
4 hours before arrival, if the food is arriving by air; and
8 hours before arrival, if the food is arriving by water (21 CFR 1.279(a)).
For a prior notice submitted via Automated Broker Interface/Automated Commercial System (ABI/ACS), you may not submit prior notice more than 30 calendar days before the anticipated date of arrival (21 CFR 1.279(b)(1)).
Can I submit any CBP entry or admission for food without prior notice?
No, not if the entry or admission contains food subject to the prior notice requirements. You cannot submit a CBP import entry or admission if you have not submitted prior notice to FDA for an article of food that requires prior notice, because the Harmonized Tariff Schedule (HTS) codes have been flagged to indicate foods that require or may require prior notice. You must submit prior notice either through the Automated Broker Interface of the CBP’s Automated Commercial System (ABI/ACS) or its successor system (along with the CBP entry information).
Does receipt of a Prior Notice (PN) Confirmation Number mean that the food will not be examined or sampled? Does meeting all the requirements of prior notice mean that the article of food will not be held or examined further?
No. Receipt of a PN Confirmation Number is evidence only that a prior notice has been received for FDA review. Based on review of the prior notice, FDA may determine that an article of food should not be allowed to proceed into the U.S. without further inspection and sampling at the border. The food may be refused under the prior notice regulation and section 801(m) of the FD&C Act and held if the prior notice is inaccurate or if it is untimely and FDA has not had sufficient time to receive, review, and respond to the prior notice information.
What happens to food that is imported or offered for import without adequate prior notice?
Except for food arriving by international mail or carried by, or otherwise accompanying, an individual, articles of food arriving with no prior notice, inaccurate prior notice, or untimely prior notice may be refused admission and, if refused, will be handled in one of the following ways:
Immediately exported, with CBP concurrence, from the port of arrival; or
Held within the port of entry, unless directed by CBP or FDA. See 21 CFR 1.283(a)(1)(i)-(iii) and (b).
Refused food is considered general order merchandise under section 490(a) of the Tariff Act (19 U.S.C. 1490(a)) and may move only under appropriate custodial bond (21 CFR 1.283(a)(2)). If the refused article is moved, the submitter must notify FDA of the hold location before the food is moved there. The refused food may not be delivered to the importer, owner, or ultimate consignee (21 CFR 1.283(a)(2)(ii)).
For food that is carried by or accompanies an individual arriving in the U.S. and the food is not for personal use, if adequate prior notice is not submitted or if the Prior Notice (PN) confirmation number cannot be provided to FDA or CBP, the food is subject to refusal. If before leaving the port, the individual does not arrange to have the food held at the port or exported, the article may be destroyed (21 CFR 1.283(b)).
For food arriving by international mail, if prior notice is inadequate or if the PN Confirmation Number is not affixed, the article will be held for FDA inspection and disposition. If refused and there is a return address, the parcel may be returned to sender. If there is no return address or the food in the shipment appears to present a hazard, FDA may dispose of or destroy the parcel at its expense. If FDA does not respond within 72 hours of the CBP hold, CBP may return the parcel back to the sender or, if there is no return address, destroy the parcel, at FDA expense (21 CFR 1.283(e)).