FDA Import Requirements for Food and Cosmetics

FDA's Authority Over Imports

The U.S. Food and Drug Administration (FDA) regulates the importation of food, dietary supplements, cosmetics, drugs, medical devices, tobacco products, and radiation-emitting electronics. For food and cosmetics specifically, FDA has broad authority to refuse admission to any product that appears to be adulterated, misbranded, or in violation of US regulations — and the agency does not need to examine every shipment to do so. FDA uses a risk-based approach, screening import entries electronically through the PREDICT system and targeting shipments for examination based on product type, country of origin, manufacturer history, and compliance track record.

Food Import Requirements

Prior Notice

The Bioterrorism Act requires that FDA receive prior notice before food arrives in the United States. Prior notice must be submitted electronically through the FDA Prior Notice System Interface (PNSI) or through ACE. The timing requirements depend on the mode of transport: no more than 15 days and no fewer than 2 hours before arrival by land, 4 hours before arrival by air or rail, and 8 hours before arrival by water. The prior notice must include the FDA product code, manufacturer, shipper, grower (if known), country of origin, and anticipated arrival details.

Facility Registration

Foreign facilities that manufacture, process, pack, or hold food for US consumption must register with FDA under the Food Safety Modernization Act (FSMA). Registration is free and must be renewed biennially during October-December of even-numbered years. Each foreign facility must also designate a US Agent — a person or firm residing or maintaining a place of business in the US who serves as FDA's point of contact. Food from unregistered facilities will be refused entry.

Food Labeling Requirements

• All food labels must be in English (bilingual labels are permitted but English is mandatory).
• The Nutrition Facts panel must follow FDA's format and include serving size, calories, fats, sodium, carbohydrates, protein, and micronutrients.
• The ingredient list must be in descending order of predominance by weight.
• Allergen declaration is required for the 9 major allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame.
• Country of origin must be declared on the label.
• Net quantity of contents must be in both metric and US customary units.
• The name and address of the manufacturer, packer, or distributor must appear on the label.

Cosmetics Import Requirements

Under the Modernization of Cosmetics Regulation Act (MoCRA) of 2022, cosmetics are subject to enhanced FDA oversight. Foreign facilities manufacturing cosmetics for the US market must register with FDA, and each cosmetic product must be listed. Cosmetics must comply with labeling requirements including ingredient declaration (in descending order of predominance), warning statements where applicable, and the name and address of the responsible person. Cosmetics may not contain prohibited or restricted ingredients as listed in FDA regulations.

How to Avoid FDA Detention

1. Ensure your foreign supplier's facility is registered with FDA and the registration is current.
2. File prior notice accurately and on time — incomplete or late filings are a common cause of refusal.
3. Review labels against FDA requirements before shipping — relabeling at the port is expensive and delays clearance.
4. Maintain an FSVP program if you are the US importer of food products.
5. Check FDA Import Alerts (accessible on FDA's website) to see if your product type or supplier country is on heightened scrutiny.
6. Use Camtom Docs to extract and verify product data from supplier documentation before goods ship, catching discrepancies early.