Food and Drug Administration

The Food and Drug Administration (or FDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating food, dietary supplements, drugs, cosmetics, medical devices, biologics, and blood products in the U.S.

Food and Drug Administration Organization

The FDA is divided into five major Centers:

The Center for Biologics Evaluation and Research (CBER)
The Center for Devices and Radiological Health (CDRH)
The Center for Drug Evaluation and Research (CDER)
The Center for Food Safety and Applied Nutrition (CFSAN)
The Center for Veterinary Medicine (CVM)

Each center has its own origins and history, the oldest being CBER, which oversees blood products, vaccines, and newer therapeutics related to stem cells and gene therapy. CDER, which regulates human pharmaceuticals, receives considerable public scrutiny. Regulatory enforcement is carried out by Consumer Safety Officers within the Office of Regulatory Affairs and criminal matters are handled by special agents within the Office of Criminal Investigations (OCI).

Today, the FDA is headed by acting Commissioner, Dr. Andrew von Eschenbach, who succeeds Dr. Lester Crawford who resigned on September 23, 2005 only two months after his final Senate confirmation and a stormy tenure as deputy commissioner and acting commissioner, prior to his confirmation.

Food and Drug Administration Mandate

The over-arching mandate of the FDA is to regulate the multitude of medicinal products in a manner that ensures the safety of the American public and the effectiveness of marketed drugs. The FDA's budget for approving, labeling, and monitoring drugs is roughly $290 million per year. "Review teams" employ around 1,300 employees to approve new drugs. The "safety team" has 72 employees to determine whether new drugs are unsafe or present risks not disclosed in the product's labeling. The safety team monitors the effects of more than 3,000 prescription drugs on 200 million people with a budget of about $15 million a year. The FDA requires a four phased series of clinical trials, with phase three being the largest and usually requiring 1,000-3,000 patients.

One aspect of its jurisdiction over food is regulation of the content of health claims on food labels. However, because regulating the content of labels implicates the First Amendment, FDA must balance concerns about the public health with the right to free speech. Daniel Troy, Chief Counsel of the Food and Drug Division from August 2001 to November 2004, raised the agency's focus on First Amendment issues.

The FDA does not pre-approve dietary supplements on their safety and efficacy, unlike drugs. In contrast, the FDA can only go after dietary supplement manufacturers after they have put unsafe products on the market. However, certain foods (such as infant formula and medical foods) are deemed special nutritionals because they are consumed by highly vulnerable populations and are thus regulated more strictly than the majority of dietary supplements.