The FDA regulates a wide range of products, including foods (except for aspects of some meat, poultry and egg products, which are regulated by the U.S. Department of Agriculture); human and veterinary drugs; vaccines and other biological products; medical devices intended for human use; radiation-emitting electronic products; cosmetics; dietary supplements, and tobacco products. (See Regulated Products)
For a list of traditionally-recognized product categories that fall under FDA’s regulatory jurisdiction please visit the FDA Basics page.
To learn more about these products and their regulatory requirements please visit the following pages:
|Regulated Product||Find Information about:|
|Human Foods||Foods for human consumption, including dietary supplements, food and color additives, and food contact substances|
|Human Drugs||Active pharmaceutical ingredients and both prescription (Rx) and over-the-counter (OTC) medications|
|Vaccines, Blood and Biologics||Biologic products such as human blood, blood donor screening tests, human tissue, embryos, human plasma, and medical devices for use in blood banking operations|
|Medical Devices||Medical devices such as bandages, contact lenses, first aid kits, pacemakers, and surgical instruments|
|Radiation-Emitting Electronic Products||Radiation-emitting products such as x-ray machines, microwave ovens, CD-ROMs, LEDs, and laser pointers|
|Cosmetics||Cosmetic products such as shampoo, make-up, face creams, and eyelash extensions|
|Animal and Veterinary||Animal food and feed, including pet food, as well as veterinary medicines and devices|
|Tobacco Products||FDA-regulated tobacco products such as cigarettes, smokeless tobacco, e-cigarettes and other electronic nicotine delivery systems (ENDS), cigars, and all other tobacco products|
CBP Supplemental Guide
FDA Supplemental Guide for the Automated Commercial Environment/International Trade Data System (ACE/ITDS).
FDA Entry Process
FDA-regulated products imported into the U.S. must comply with the same FDA laws and regulations that apply to domestic products. Entries are submitted to U.S. Customs and Border Protection (CBP) which then refers entries of FDA regulated products to FDA for review.
Check FDA publications for detailed clarification on the requirements for specific products.