What is the role of the Food and Drug Administration (FDA)?

The Food and Drug Administration (FDA) regulates all food and food ingredients introduced into or offered for sale in the U.S. except for meat, poultry, catfish, and processed egg products (liquid, frozen, or dried) (which are regulated by the U.S. Department of Agriculture, or USDA). This includes shell eggs; dietary supplements; bottled water; food additives; infant formula; and prepared foods like breads, cereals, canned and frozen foods, snacks, desserts, and drinks.

Raw fruits and vegetables are regulated by the FDA under the Food Safety Modernization Act (FSMA), including the Produce Safety Rule. (The USDA only regulates specific produce programs (such as certain grading or marketing orders), not general produce safety.))

The FDA regulates pet food in the U.S. under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Pet food must be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled.

The FDA also ensures the safety and effectiveness of all drugs; biological products (including blood, vaccines, and cellular and gene therapy products); medical devices; and animal feed and drugs; and ensures that cosmetics and radiation-emitting medical and consumer products are safe. The agency also regulates tobacco products.

Companies involved in the production, distribution, and sale of food, drugs, medical devices, and other regulated products must comply with FDA regulations. This includes food manufacturers and processors, pharmaceutical companies, medical device manufacturers, cosmetic manufacturers, tobacco product manufacturers, retailers and distributors, and companies that import FDA-regulated products into the U.S.