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A look at the FDA review process
Olestra, aspartame, Benecol (McNeil Consumer Healthcare, Ft Washington, Pa): You've heard the names, debated the benefits, even tried the products. But before they can hit the shelves at your local grocery, these products have to make it through the review process at the US Food and Drug Administration (FDA)-- one of the toughest regulatory bodies in the world.
The FDA's strict policies are no mistake, says Donna Porter, PhD, RD, a specialist in life sciences for the nonpartisan Congressional Research Service who works closely with Congress on FDA food issues. "The agency tends to be very conservative," she says. "But it sits in judgment over products that will be used by millions of people. Its concern is not primarily economics, but public safety. It makes sure that hazards to the public are minimal, and that products don't promise something they can't deliver."
The FDA is the primary regulatory body that oversees the safety and truthfulness in labeling of everything from human drugs like Xenical (Roche Laboratories Inc, Nutley, NJ) to animal drugs, cosmetics, medical devices, food additives, color additives, and dietary supplements. The agency's many divisions each concentrate on one particular area-the Office of Drug Evaluation and Research, for example, has jurisdiction over obesity drugs such as orlistat.
The Center for Food Safety and Applied Nutrition, which has jurisdiction over the substances added to conventional foods, dietary supplements, and cosmetics, is one of the busiest sections of the FDA in light of the public's increasing interest in maintaining their own health. "The line between food, supplements, and drugs is so blurry these days that it's hard to know what any product is anymore," says Porter. "You could call anything a dietary supplement, even things grown in your backyard."
HOW ARE FOODS AND SUPPLEMENTS REGULATED?
The FDA. contrary to popular misconception, does not approve foods or dietary supplements for use in the United States. Rather, the FDA's mandate is to protect the public from harmful or misleading ingredients in the products we use every day. Its jurisdiction is over food additives and preservatives, labeling, and the structure/ function claims of a product's ingredients.
Two amendments to the Federal Food, Drug, and Cosmetic Act of 1938 create specific labeling...