Infant Food Preparations for Retail Sale

Infant formula is regulated by FDA under a framework separate from general food imports. Foreign manufacturers must notify FDA before introducing a new formula, and the product must meet specific nutrient composition requirements. Shipments are subject to FDA admissibility review at the port of entry, and importers should work with a licensed customs broker and confirm FDA registration status of the foreign facility well in advance of shipment.

The US tariff schedule draws a key distinction at 10% milk solids by weight, with separate lines for preparations containing oligosaccharides above that threshold (1901101100, 1901101600) and other high-milk-solid preparations (1901102900, 1901105400, 1901105600). Products below the threshold or based primarily on flour, starch, or other ingredients fall into different lines. Accurate compositional data from the manufacturer is essential for correct classification.