What is the FDA?

The Food and Drug Administration, or FDA, is a United States Department of Health and Human Services agency that is charged with regulating food (both human and animal), dietary supplements, drugs (human and animal), cosmetics, medical devices (human and animal) and radiation emitting devices (including non-medical), biologics, and blood products in America.

The agency’s main objective is to protect citizens from products that are inherently unsafe or that make claims of effectiveness that cannot be substantiated. The FDA has the power to regulate a multitude of products to ensure the safety of the American public and the effectiveness of marketed food, medical and cosmetic products. Regulations include, but are not limited to, outright ban, controlled distribution, and controlled marketing.

The FDA also sets the standards under which individuals may be licensed to prescribe drugs or other medical devices. Unlike drugs, the FDA does not pre-approve dietary supplements on their safety and efficacy. Rather, the FDA can only pursue dietary supplement manufacturers after they have put unsafe products on the market. However, certain foods (such as medical foods or baby formula) are deemed special nutritionals due to their consumption by highly vulnerable populations, and are therefore regulated more strictly than the majority of dietary supplements.

The FDA is currently divided into five major Centers. These include The Center for Food Safety and Applied Nutrition (CFSAN), The Center for Biologics Evaluation and Research (CBER), The Center for Veterinary Medicine (CVM), The Center for Drug Evaluation and Research (CDER), and The Center for Devices and Radiological Health (CDRH).

Author: Jase Donaldson