The US is the world's largest single food and beverage market. FDA oversees food safety and labelling under a framework updated significantly by the Food Safety Modernization Act (FSMA) of 2011. Foreign manufacturers wanting to export food to the US must comply with FSMA requirements — including the Foreign Supplier Verification Program — and meet FDA labelling standards that differ materially from EU and UK norms.
Every food manufacturer, processor, packer, or holding facility that manufactures food for US consumption must register with the FDA under the Bioterrorism Act. Registration is free and done online at FDA's registration portal. Registrations must be renewed every two years (in even-numbered years). FDA can suspend a facility's registration if it determines food from that facility has a reasonable probability of causing serious adverse health consequences.
Under FSMA, US importers are responsible for verifying that their foreign suppliers produce food in a manner that meets US safety standards — this is the FSVP. For foreign exporters, this means US buyers will ask for: hazard analysis documentation, supplier verification activities (audits, testing), and your food safety plan. Having this documentation ready makes you a preferable supplier to US importers who must meet their FSVP obligations.
US food labels must carry a Nutrition Facts panel (not Nutrition Information as in the EU). The panel shows: serving size, calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, dietary fibre, total sugars, added sugars, protein, vitamin D, calcium, iron, and potassium — all per serving and per container where relevant. Units are US customary (oz, fl oz) not metric for net weight declarations on primary display panel. Labels must be in English.
Ingredients used in US food must either have pre-market approval as a food additive (via FDA petition) or qualify as GRAS (Generally Recognized as Safe). GRAS status can be self-affirmed by a panel of experts or confirmed via FDA's voluntary GRAS notification program. Many ingredients common in European or Asian food products do not have US GRAS status — check before formulating for the US market. Non-GRAS, non-approved ingredients cannot be used in food sold in the US.
Food shipments entering the US must be reported to FDA via Prior Notice — submitted electronically through the FDA PNSI (Prior Notice System Interface) or through the CBP ACE system at least 2 hours before arrival for land borders (8 hours for air shipments, 4 hours for sea). FDA reviews the prior notice and may hold, examine, or refuse entry. Shipments from registered facilities with a good compliance history typically clear faster. Products with detention history or from countries with poor compliance records face more scrutiny.
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