Retail infant food preparations must comply with FDA's nutrition labeling regulations for infant foods (21 CFR Part 107 for formula; broader food labeling rules for other infant foods), including age-appropriate serving size declarations and allergen disclosures. The label must be in English and meet US format requirements — foreign-language-only labels are grounds for refusal of entry.

Yes. Foreign facilities producing infant foods for US import must be registered with FDA under FSMA and are subject to Foreign Supplier Verification Program requirements. FDA also conducts foreign facility inspections for high-risk food categories, and infant foods are generally treated as a priority category. Importers should confirm that their supplier's facility registration is current and that a FSVP plan is in place before shipment.