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Overview of Federal Food, Drug, and Cosmetic Act

Congress passed the Federal Food, Dug, and Cosmetic Act (FDCA) in 1938. The FDCA set up the Food and Drug Administration (FDA) to enforce the Act. The goals of the FDCA were to assure that foods are pure and safe to eat, that drugs and medical devices are safe and effective, and that cosmetics are safe. The FDCA banned adulterated and misbranded food from interstate commerce. The FDCA also regulates the labeling and packaging of foods, drugs, medical devices, and cosmetics. Under the FDCA, the FDA was given authority to adopt regulations dealing with food, drug, medical device, and cosmetic safety.

The Food Additives Amendment of 1957 amended the FDCA to regulate food additives. The Delaney Clause of 1958 prohibited the use of substances in food if such substances, particularly food coloring, had been found to cause cancer in laboratory animals.

The Drug Amendments of 1962 also changed the FDCA. These amendments required drug manufacturers to show that their drugs are safe as well as effective. A new drug cannot be marketed unless a new drug application is in effect.

In 1976, Congress passed the Medical Device Amendments to the FDCA. These amendments separate medical devices into three categories. Class I devices pose no unreasonable risk of illness or injury and require only general manufacturing controls. Class II devices pose a greater potential risk of illness or injury and are subject to more stringent controls. Class III devices pose a potential unreasonable risk of illness or injury and are subject to the FDA's strictest regulation.

In 1997, Congress passed the Food and Drug Administration Modernization Act (Modernization Act), which amended the provisions of the FDCA relating to food, drugs, medical devices, and biological products. The goal of the Modernization Act was greater patient access to new medical products. The result has been an expedited approval process for new drugs. One provision of the Modernization Act exempts compounded drugs from the FDA's standard drug approval requirements if the drug providers comply with several restrictions. One restriction was that the drug providers could not advertise or promote particular compounded drugs. In 2002, the United States Supreme Court struck down the ban on advertising as an unconstitutional restriction on commercial speech.

In 2003, Congress passed the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Prescription Drug Act), which again amended the FDCA. The Prescription Drug Act eliminates a new drug application holder's ability to obtain multiple stays to delay the marketing of a generic drug. The Prescription Drug Act also provides for a Medicare-approved discount card to help pay for prescription drugs.