Is It Really 'FDA Approved?'
January 17, 2017 —
"FDA approved!"
Maybe you saw those words on a company's website, or in a commercial promoting a new product or treatment. Some marketers may say their products are "FDA approved," but how can you know for sure what the U.S. Food and Drug Administration approves?
FDA is responsible for protecting public health by regulating human drugs and biologics, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation.
But not all those products undergo premarket approval -- that is, a review of safety and effectiveness by FDA experts and agency approval before a product can be marketed. In some cases, FDA's enforcement efforts focus on products after they are already for sale. That is determined by Congress in establishing FDA's authorities. Even when FDA approval is not required before a product is sold, the agency has regulatory authority to act when safety issues arise.
Here is a guide to how FDA regulates products -- and what the agency does (and doesn't) approve.
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