FDA (Food and Drug Administration)

The Food and Drug Administration (FDA) is the U.S. federal agency responsible for regulating the safety, efficacy, and labeling of food, drugs, medical devices, cosmetics, dietary supplements, and tobacco products. For importers and Amazon FBA sellers, the FDA functions as a Partner Government Agency (PGA) that works alongside U.S. Customs and Border Protection to screen, inspect, and detain imported goods that fall under its jurisdiction. Any product regulated by the FDA must meet U.S. standards before it can enter commerce, and shipments that fail to comply can be refused entry, detained, or destroyed at the importer’s expense.

Products Under FDA Jurisdiction

The FDA regulates a broader range of products than most sellers realize. The categories include: all food and beverages (except meat, poultry, and egg products, which fall under USDA jurisdiction), dietary supplements, pharmaceuticals, over-the-counter drugs, medical devices (from bandages to surgical instruments), cosmetics (skincare, makeup, hair products), radiation-emitting electronic products (laser pointers, microwave ovens, UV lamps), and tobacco products.

For FBA sellers, the most commonly encountered FDA-regulated categories are food and beverages, dietary supplements, cosmetics, and certain electronic devices. A seller importing green tea from Japan, collagen supplements from South Korea, skincare serums from France, or LED beauty devices from China is dealing with FDA-regulated products in every case.

Prior Notice Requirement

The Bioterrorism Act of 2002 requires that the FDA receive prior notice before any food product arrives in the United States. This notice must be filed electronically through the FDA’s Prior Notice System Interface (PNSI) or through the ACE/ABI system. The filing window varies: prior notice must be submitted no more than 15 days and no fewer than 2 hours (for truck shipments) to 8 hours (for ocean shipments) before the food arrives at the U.S. port.

Failure to file prior notice results in the shipment being refused at the port. The food cannot be examined or released without a valid prior notice on file. This requirement applies to all food products, including ingredients, raw materials, and finished goods intended for commercial sale.

FDA Holds and Examinations

The FDA uses a risk-based screening system called PREDICT (Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting) to flag shipments for examination. Factors that increase the likelihood of examination include: the product type, the country of origin, the manufacturer’s compliance history, import alerts for specific products or producers, and whether the product has been previously detained or refused.

When the FDA places a hold on a shipment, the importer’s customs broker receives a “May Proceed” or “Refused” determination after examination. If the product is detained, the importer has the opportunity to provide evidence that it complies with U.S. regulations. This might involve submitting lab test results, certificates of analysis, or labeling corrections. If the importer cannot demonstrate compliance, the FDA issues a formal refusal, and the goods must be re-exported or destroyed.

Facility Registration

Foreign and domestic facilities that manufacture, process, pack, or hold food for U.S. consumption must register with the FDA under the Food Safety Modernization Act (FSMA). The registration must be renewed every two years during the October-to-December renewal period. FBA sellers who import food products should verify that their overseas suppliers maintain current FDA facility registration. Products from unregistered facilities are subject to detention at the port.

Labeling Requirements

FDA labeling requirements vary by product type. Food products must carry a Nutrition Facts panel, ingredient list, allergen declarations, and net quantity statement, all in English. Dietary supplements require a Supplement Facts panel and specific disclaimer language. Cosmetics must list ingredients in descending order of predominance using INCI (International Nomenclature of Cosmetic Ingredients) names. Products that arrive with non-compliant labels must be relabeled before entering U.S. commerce, a service that prep centers like MeisterPrep provide as part of their receiving and compliance workflows.