INTERNATIONAL TRADE LAW
U.S. Food Laws: A Plain-English Guide for Importers
U.S. food law is built on one foundational statute — the Federal Food, Drug, and Cosmetic Act — and split between two agencies, the FDA and the USDA, that divide the food supply between them. For anyone importing or exporting food, the practical questions are always the same: which agency regulates my product, what makes food “adulterated” or “misbranded,” and what does the law require before a shipment can enter the United States. This guide answers those questions in plain English.
The Foundation: the FDCA and FSMA
The Federal Food, Drug, and Cosmetic Act (FDCA), codified at 21 U.S.C. § 301 and following, is the backbone of U.S. food regulation. It gives the FDA authority to prevent the sale of food that is unsafe (adulterated) or dishonestly labeled (misbranded) in interstate commerce.
The biggest modern change came with the FDA Food Safety Modernization Act (FSMA) of 2011. FSMA shifted the system from reacting to contamination toward preventing it. It gave the FDA new tools, including the authority to order a mandatory recall when there is a reasonable probability that a food is adulterated or misbranded and will cause serious health consequences, and it created the import-side requirements discussed below.
Who Regulates What: FDA vs. USDA
Two federal agencies share responsibility for the food supply, and knowing which one governs your product is the first compliance question to answer.
| Agency | Regulates | Key statutes |
|---|---|---|
| FDA | Most foods — including produce, seafood, packaged and processed foods, dietary supplements, bottled water, shell eggs, and wine under 7% alcohol | FDCA; FSMA |
| USDA (FSIS) | Meat, poultry, and processed egg products | Federal Meat Inspection Act; Poultry Products Inspection Act; Egg Products Inspection Act |
The FDA covers the large majority of the food supply. The USDA’s Food Safety and Inspection Service (FSIS) handles the narrower but heavily regulated categories of meat, poultry, and processed egg products, which are subject to continuous inspection. A few products sit on the line — for example, FSIS regulates closed-faced meat sandwiches while the FDA regulates open-faced ones — so when in doubt, confirm jurisdiction before you build a compliance plan.
Two Concepts That Run Through Everything: Adulteration and Misbranding
Almost every food enforcement action turns on one of two ideas.
Adulteration is about safety and purity. A food is adulterated if it contains a harmful substance, was prepared or held under unsanitary conditions, or otherwise fails the law’s purity standards. Adulteration is the basis for most seizures and recalls.
Misbranding is about labeling. A food is misbranded if its labeling is false or misleading, omits required information, or makes unauthorized claims. Mislabeled allergens, missing nutrition information, and unapproved health claims are common misbranding problems.
A single shipment can be both — for example, a product that is contaminated and carries a label that hides an allergen.
Labeling: Allergens and the “Big 9”
Food labeling is one of the most common compliance traps, and allergen labeling is the sharpest edge. Under the Food Allergen Labeling and Consumer Protection Act (FALCPA), labels must clearly declare major food allergens. The original list named eight: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans.
The FASTER Act, passed in 2021, added sesame as the ninth major allergen, effective January 1, 2023. The list is now commonly called the “Big 9.” Any imported food containing one of these allergens must declare it in the manner FALCPA requires — a frequent reason imported products are detained or refused at the border.
What U.S. Food Law Requires of Importers
For importers, the general food-safety rules come with three import-specific obligations created largely by FSMA and earlier bioterrorism legislation:
- Food facility registration. Foreign and domestic facilities that manufacture, process, pack, or hold food for U.S. consumption must register with the FDA and renew that registration every two years.
- Prior notice. The FDA must receive advance notice of most food shipments before they arrive, so it can screen incoming food (21 CFR Part 1, Subpart I). A missing or defective prior notice can lead to a shipment being held at the port.
- Foreign Supplier Verification Program (FSVP). Importers must verify that their foreign suppliers produce food meeting U.S. safety standards and that the food is not adulterated or misbranded as to allergens. FSVP failures are now a leading cause of FDA import warning letters.
Food that does not meet these requirements can be detained, refused entry, or placed on an import alert. For how that enforcement plays out at the border, see our guide to FDA import regulations for food and the mechanics of how to import food products.
Frequently Asked Questions
What is the main U.S. food safety law? The Federal Food, Drug, and Cosmetic Act (FDCA) is the foundation, and the FDA Food Safety Modernization Act (FSMA) of 2011 modernized it with prevention-focused and import-specific requirements.
Does the FDA or USDA regulate my food product? The USDA’s FSIS regulates meat, poultry, and processed egg products. The FDA regulates almost everything else, including produce, seafood, packaged foods, supplements, and shell eggs.
What is the difference between adulteration and misbranding? Adulteration concerns whether a food is safe and pure; misbranding concerns whether its labeling is truthful and complete. A food can be either, or both.
How many major food allergens must be labeled? Nine. The original eight under FALCPA plus sesame, which became the ninth major allergen under the FASTER Act effective January 1, 2023.
Importing or exporting food and unsure which rules apply? Reidel Law Firm prepares flat-fee import/export compliance memos that map your product to the right agency, requirements, and risks. Get an import/export compliance memo →
