The Food and Drug Administration (FDA) is responsible for ensuring the safety and efficacy of a variety of products, including drugs, medical devices and foods. The FDA provides important and timely clinical information about safety issues involving medical products, including prescription and over-the-counter drugs, biologics, medical devices, and special nutritional products, including medical foods and dietary supplements. The FDA issues and/or announces product safety alerts, recalls, withdrawals, and important labeling changes that may affect the health of all Americans. The FDA recently announced its major initiative to more aggressively protect Americans.

A RECALL is an action taken to remove a product from the market. Recalls are conducted by FDA request or on the initiative of the manufacturer. In many recall situations (Class I Recall) there may be a reasonable probability that the use of or exposure to a product will cause serious injury or death. A Class II Recall is a situation where use or exposure to a product may cause temporary or medically reversible injury. The recall of a defective or harmful drug or product is sometimes publicized in newspapers and in news broadcasts. The FDA publicizes a recall only when it believes the public needs to be alerted about a serious hazard.

The FDA expects companies to take full responsibility for product recalls, including follow-up checks to assure that recalls are successful. After a recall is completed, the FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective.

A SAFETY ALERT is a notice or warning issued in situations where a medical device or product may present an unreasonable risk of substantial harm. In some cases, these situations are also considered recalls.

Between 1997 and 1998, approximately 20 million patients took at least one of several drugs subsequently withdrawn from the market, and since 1993, pharmaceutical drugs have been implicated in at least 1,000 deaths. The largest and most serious drugs recalls in recent years have been the diet drugs known as fen-phen used by over 6 million people, the cholesterol drug Baycol, and the diabetes drug Rezulin, each used by over 700,000 people. Additionally, a number of drugs still on the market have also received safety warnings or notices from the FDA- including, the anti-depressant Serzone, the arthritis drug Arava, the painkiller Vioxx, and the hormone replacement treatment pill called Prempro. In addition to prescription drugs, a number of popular herbal and dietary supplements, such as the ephedra based supplements, have been linked to serious health risks.