FDA Certificate

What is the FDA?

The FDA (U.S. Food and Drug Administration) is an agency of the United States Government responsible for dietary supplements, food, drugs, blood products, biological medical products, radiation-emitting devices, medical devices, cosmetics, and veterinary instruments. Founded in 1862 under the U.S. Department of Health, the FDA today operates with nearly 10,000 employees, analyzing and approving products to ensure safety.

The FDA plays a central role in protecting public health by overseeing pharmaceuticals, biomedical equipment, radiation-emitting devices, cosmetic products, and food safety.

What is an FDA Certificate?

The FDA Certificate is an official registration required for all domestic and foreign facilities engaged in producing, processing, packaging, or holding food intended for human or animal consumption in the United States. The certificate is issued by the FDA under the authority of the U.S. Department of Health and Human Services.

According to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), the FDA was designated as the sole regulatory authority for food safety in the U.S. From October 16, 2003 onward, every food, beverage, and drug shipped to the U.S. must be registered with the FDA. For foreign food, medical device, and pharmaceutical companies, FDA registration is mandatory. Cosmetic company registration is not required, but it provides trust in the U.S. market and is considered a strong marketing advantage.

How is FDA Certification Obtained?

FDA certification does not recognize any second-party certification and does not issue a traditional "certificate" after registration. Instead, importers and shipping companies often request proof of FDA registration or a facility’s FDA confirmation record. Some companies provide a free confirmation document for their clients as proof of registration. Customers can verify the FDA registration status of a company through official FDA systems.

The U.S. Congress later amended the act, requiring companies to demonstrate the safety of new drugs and extending regulations to include cosmetics and therapeutic devices.