FDA Enforcement Activities Protect Public

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FDA Enforcement Activities Protect Public

Many people know the Food and Drug Administration as the federal agency whose scientists approve the safety and effectiveness of drugs and medical devices, safeguard the wholesomeness of the nation's food supply, and ensure the safety of cosmetics. But FDA is also a law enforcement agency whose nearly 1,000 investigators, compliance officers, laboratory personnel, and attorneys work long and hard to make sure that the companies that produce products under the agency's jurisdiction comply with the federal Food, Drug, and Cosmetic (FD&C) Act and other statutes enforced by FDA.

It's a big job, covering merchandise accounting for nearly a quarter of all consumer spending. FDA-regulated goods are produced and distributed by 89,400 establishments, including 48,000 companies that handle food, 15,400 medical device firms, 13,600 companies that handle drugs for human use, and 5,800 firms that make and sell animal drugs and medicated feeds.

During an average year, FDA investigators inspect about 20,000 of these companies in the United States and 400 abroad, review about 1.5 million imported goods, and conduct 100,000 examinations at the wharves. In addition, agency scientists eacy year analyze 75,000 product samples.

FDA investigators look for violations of more than 20 specific "prohibited acts" in the FD&C Act, ranging from introduction into interstate commerce of unapproved new drugs and drug counterfeiting to adulteration or misbranding of any food, drug, medical device, or cosmetic. Many of these violations are noted during routine inspections or are reported by consumers.

Typically, FDA enforcement annually results in 25,000 import detentions, 8,000 "inspectional observations" of violations, and about 9,000 other measures, ranging from warning letters to voluntary corrections, product recalls, seizures, injunctions, and criminal prosecutions.

Statistics alone, however, do not illustrate the commitment and skill of FDA investigators. FDA …