Food and Drug Administration

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services with broad regulatory, investigatory, and educative duties intended to protect the health and safety of American consumers. It administers the federal Food, Drug, and Cosmetic Act of 1938 and certain related laws. Its mission was updated by the FDA Modernization Act of 1997 and its jurisdiction is under continuous definition and expansion. In the wake of the September 11, 2001, and subsequent terrorist attacks, Congress has enhanced the FDA's resources by allocating funds to hire additional employees to ensure the safety of both domestically manufactured and imported products.

The FDA embodies eight centers, each with specific duties: the Centers of Biologic Evaluation and Research, Devices and Radiological Health, Drug Evaluation and Research, Food Safety and Applied Nutrition, Veterinary Medicine, Toxicological Research, and Offices of the Commissioner and of Regulatory Affairs. Under the direction of these centers, posts and field offices send out agents to monitor manufacturing facilities and warehouses, employ chemists and other specialists to analyze the samples, and maintain a legal staff. Its employees, both full-time and part-time, are hired and promoted by merit within the Civil Service system and must meet education and experience qualification requirements suitable to their duties. For example, the position of Paralegal Specialist GS-9 requires at least one year of specialized experience in the federal service, a master's degree, or two years of higher level graduate education leading to such a degree or an LLB or JD, if related to the duties.

The Office of Regulatory Affairs (ORA) directs the activities of approximately one third of FDA personnel. Stationed in more than 150 offices, resident posts, and laboratories throughout the United States, including Puerto Rico, this staff monitors more than 115,000 business establishments that produce, warehouse, import, and transport consumer goods. Consumer safety officers and inspectors examine plants before the FDA approves a product to ensure that firms are capable of high-quality production, monitor clinical trials that precede submissions for FDA approval, and check at intervals afterward to determine if the plants are following suitable processes. Scientists in 13 ORA laboratories analyze the products to determine whether they meet FDA standards. Included are imports that are overseen by inspectors at ports of entry. Public affair specialists explain FDA policies and actions to consumer groups, health care professionals and state health authorities, and the media and encourage compliance with FDA standards. They also respond with the rest of the field staff to public health emergencies, natural disasters, and product problems.

In addition to being the agency responsible for ensuring that foods are safe, wholesome, and properly labeled, the FDA regulates medicines, medical devices, blood products, vaccines, cosmetics, veterinary drugs, animal feed, and electronic products that emit radiation, such as microwave ovens and video monitors to ensure that they are safe and effective.

Other agencies handle issues related to restaurant food and sanitation, unsolicited products in the mail, accidental poisonings, pesticides or air and water pollution, hazardous household products, alcoholic beverages, drug abuse and controlled substances, hazardous chemicals in the workplace, warranties, dispensing and sales practices of pharmacies, and medical practice.

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