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How the FDA Works

        Culture | Agencies

A Look at Regulation
FDA workers inspect everything from the obvious food and drugs to the unexpected -- items like radiation-emitting products and medical devices.
FDA workers inspect everything from the obvious food and drugs to the unexpected -- items like radiation-emitting products and medical devices.
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The FDA oversees a staggering amount of goods sold in the United States. According to one estimate, they're responsible for ensuring the safety of items accounting for 20 cents out of every dollar consumers spend [source: FDA, "Origin"]. Of course, the FDA can't examine every factory and test every product, so they do the best they can with a mix of regulations, guidelines, inspections and approval processes.

All FDA regulations are governed by more than 100 separate laws passed by Congress. One of the most important is the Food, Drug and Cosmetic Act of 1938, which expanded the 1906 law we discussed earlier. This landmark legislation, among other things, created food standards, allowed for factory inspections and forced drug companies to prove their products are safe. Other milestones include the Kefauver-Harris Amendments of 1962, which greatly bolstered drug safety rules, in addition to the Medical Device Amendments of 1976, which improved the safety of medical devices [source: FDA, "Legislation"].

What, then, is the FDA supposed to regulate? The general categories include foods, drugs, biologics, medical devices, radiation-emitting products, cosmetics, veterinary products and tobacco products. When a regulation is proposed, the FDA accepts public comment before it issues the final rule, which then becomes law. If you've got a lot of free time on your hands, you can check them out in Title 21 of the Code of Federal Regulations. Short of a regulation, the FDA can also issue guidance. This is sort of like the assembly instructions for a piece of furniture: It's the agency's best advice for how a regulation could be carried out, but it doesn't necessarily have to be done that way [source: FDA, "Difference"].

To ensure the regulations are being followed, the FDA may inspect some products and facilities. Agency inspectors visit more than 16,000 facilities per year, including food-processing and drug-manufacturing facilities, dairy farms and even blood banks [source: Swann]. Because the FDA can't examine every facility and product they oversee, they will also conduct impromptu inspections if they receive a specific complaint. Additionally, the agency will approve certain products they've reviewed for safety and effectiveness. Depending on the product regulation, this may be done before or after the item goes on the market. Such "FDA-approved" items include drugs and food additives for people and animals, biologics and high-risk medical devices [sources: FDA, "Inspect" and FDA, "Approved"].


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