There are opportunities for overseas specialty food manufacturers and brands to successfully launch products in the U.S. American consumers continue to embrace imported quality food products. Nutrition 50 has the experience and expertise to help small or medium-size companies overseas with successfully registering and gaining the import approvals at a lower cost.

Registering with the FDA.

Overseas Brands must register with the FDA.

U.S. food import requirements have changed dramatically with the enactment of a new law, the Food Safety Modernization Act.  Importers must now verify that suppliers are manufacturing food products in a manner that provides the same level of food safety standards as U.S. regulations through the use of onsite audits, sampling, and testing of a product and other means. Importers that fail to properly verify the food safety practices of the foreign suppliers are subject to criminal penalties imposed by the U.S. federal government.

FDA Prior Notice Filings

Notice of food imported for use, storage or distribution in the U.S. is required to be communicated to the U.S. Food and Drug Administration before arrival in a port of entry with limited exceptions. Prior notice must be submitted electronically to FDA in English through the U.S. Customs and Border Protection Automated Broker Interface (ABI) or the FDA Prior Notice System Interface.

Prior Notice must be submitted with FDA for foods:

Arriving by land by road, no less than 2 hours before arriving at the port of arrival

Arriving by land by rail, or by air, no less than 4 hours before arriving at the port of arrival

Arriving by water, no less than 8 hours before arriving at the port of arrival

Violations of the Prior Notice requirement can lead to refusal of admission, and federal civil and criminal penalties. U.S. Food Imports ensures that Prior Notice requirements are properly met

Labeling of Foods

Foods imported into the US must comply with the labeling rules for conventional foods according to FDA CFR 21 Part 101. In most cases this requires the addition of a Nutrition Facts panel that complies with all current rules issued by the FDA. There are currently changes taking place with respect to the Nutrition Facts panel. We are currently helping companies comply with the new rules going into effect January 1, 2020 for large companies (>10million USD revenue) and for companies with less revenue they are in effect on January 1, 2021.

Thomas Stratman is Principal of Nutrition 50.