Exporting Food and Consumer Products to the United States in 2025: What Foreign Manufacturers Must Know

The United States imports more goods than any other country in the world. For food and consumer product manufacturers outside the US, this creates a clear commercial opportunity — but also a complex regulatory entry process. Unlike tariff-focused trade restrictions, FDA's requirements are administrative and documentation-based: they apply before the first shipment arrives at the US border, and failure to have the right registrations and paperwork in place results in detention, refusal, or destruction of goods. This is what foreign manufacturers need to know about the US import process for food and regulated consumer products in 2025.

The agencies that regulate US imports

Two agencies are most relevant to foreign food and consumer product manufacturers. US Customs and Border Protection (CBP) controls the physical entry of goods, collects duties and tariffs, and enforces import admissibility requirements. The Food and Drug Administration (FDA) regulates food safety, cosmetics, drug products, medical devices, and radiation-emitting products that enter the US. CBP and FDA coordinate at ports of entry — CBP passes import records to FDA electronically, and FDA issues admissibility decisions that CBP enforces. For food importers specifically, FDA also receives Prior Notice electronically before each shipment arrives, which triggers an FDA admissibility review before goods land.

FDA registration: the first requirement

Any foreign food facility that manufactures, processes, packs, or holds food for US consumption must register with FDA before the food is exported to the US. This registration — submitted through FDA's FURLS system — assigns a Food Establishment Identifier (FEI) number to the facility. The FEI is the primary identifier used to look up a facility's status at the US border. An unregistered facility's food is subject to refusal at the US port of entry regardless of tariff or trade status. Cosmetic manufacturers must register under MoCRA. Drug manufacturers must register drug establishments. Each product category has its own FDA registration pathway and timeline.

Prior Notice: the shipment-level requirement

For food shipments specifically, FSMA requires that FDA receive advance notice before every shipment arrives in the United States. This Prior Notice — submitted through FDA's Prior Notice System Interface (PNSI) or through CBP's ACE system — must include the facility registration number, the product description, the shipper and importer information, and the estimated arrival date and port of entry. FDA uses Prior Notice data to screen incoming shipments against risk profiles and to direct inspection resources. A food shipment that arrives without Prior Notice will be refused entry. Prior Notice must be submitted no more than 15 days and no less than a few hours before arrival, depending on mode of transport.

Labeling requirements that apply at the border

FDA reviews product labels at import as part of its admissibility screening. Food labels sold at retail in the US must include: product name, net quantity of contents, ingredient list in descending order by weight, allergen declarations for the nine major allergens, nutrition facts panel (in FDA-required format), name and address of the US responsible party, and country of origin. Labels that fail to include allergen declarations for egg, milk, wheat, soy, peanuts, tree nuts, fish, shellfish, or sesame are subject to refusal. In 2023, sesame was added as the ninth major allergen under FASTER Act — all current labels on products containing sesame must include a sesame declaration. Labels in foreign languages must have an English overlay or be fully relabeled before import.

Tariffs, trade agreements, and FDA compliance are separate

A product that qualifies for zero or reduced tariffs under a US free trade agreement (such as CAFTA-DR, KORUS, or USMCA) is still subject to FDA registration and labeling requirements. Trade agreement benefits affect duty rates, not FDA admissibility. Similarly, a product that is exempt from tariffs under a Generalized System of Preferences (GSP) designation must still meet FDA requirements. Foreign manufacturers sometimes assume that a trade facilitation benefit reduces their FDA compliance obligations — it does not. The two regulatory systems operate independently.

How FDABridge supports foreign manufacturers entering the US market

FDABridge handles FDA food facility registration, US Agent designation, DUNS number acquisition, and food label review for foreign manufacturers preparing their first US export. We serve manufacturers across food, cosmetics, and drug categories from more than 30 countries. Visit fdabridge.com for a full service overview or fdabridge.com/contact to discuss your product and timeline.