Food and dietary supplements offered for import into the United States must comply with the same FDA requirements that apply to domestic products. Foreign facilities that manufacture, process, pack, or hold food for U.S. consumption may be required to register with FDA, and prior notice must generally be submitted before the shipment arrives.
The importer should confirm product identity, intended use, ingredient acceptability, claims, label format, facility registration status, and the applicable Foreign Supplier Verification Program responsibilities. Dietary supplements must also be manufactured under applicable current good manufacturing practice requirements.
FDA does not pre-approve ordinary food products, dietary supplement labels, or individual shipments. Compliance is assessed through records, inspections, import screening, sampling, and enforcement. Products may be detained or refused if the label, ingredients, facility status, or entry information does not comply.
Import planning should begin before production. A regulatory review of the formula, claims, label, facility information, and entry documentation can identify issues before the goods reach a U.S. port.
APEX CS practical takeaway: Confirm the product-specific regulatory pathway before production, testing, labeling, or shipment. Requirements vary by device design, intended use, claims, market channel, and final configuration.