Laws Enforced by FDA

The Pure Food and Drug Act of 1906 was the first of more than 200 laws that constitute one of the world's most comprehensive and effective networks of public health and consumer protections. Here are a few of the congressional milestones:

• The Federal Food, Drug, and Cosmetic Act of 1938 was passed after a legally marketed toxic elixir killed 107 people, including many children. The FD&C Act completely overhauled the public health system. Among other provisions, the law authorized the FDA to demand evidence of safety for new drugs, issue standards for food, and conduct factory inspections.
• The Kefauver-Harris Amendments of 1962, which were inspired by the thalidomide tragedy in Europe (and the FDA's vigilance that prevented the drug's marketing in the United States), strengthened the rules for drug safety and required manufacturers to prove their drugs' effectiveness.
• The Medical Device Amendments of 1976 followed a U.S. Senate finding that faulty medical devices had caused 10,000 injuries, including 731 deaths. The law applied safety and effectiveness safeguards to new devices.
• The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) was enacted in 2009, giving FDA authority to regulate the manufacture, distribution, and marketing of tobacco products.

Today, the FDA regulates $1 trillion worth of products a year. It regulates all foods and food ingredients introduced into or offered for sale in interstate commerce except for meat, poultry and some egg and catfish (which are regulated by USDA); ensures the safety and effectiveness of all drugs, biological products (including blood, vaccines and cellular and gene therapy products), medical devices, and animal drugs and feed; and makes sure that cosmetics and medical and consumer products that emit radiation do no harm.

Related Resources

• Food and Drug Administration Amendments Act (FDAAA) of 2007
• Animal Drug User Fee Act of 2003
• Office of the Chief Counsel

Resources for You

Recent Legislation