Purpose of the Food, Drug and Cosmetic Act

The Food and Drug Administration (FDA) is the oldest consumer protection agency in the U.S. federal government. The FDA's modern regulatory functions began in 1906 with the passage of the Pure Food and Drug Act. The Foodm Drug &Cosmetics (FD&C) Act is regulated by the FDA and was passed in l938 in response to a drug poisoning crisis. The public reaction to this and other disasters led to the passing of this landmark legislation. The Act keeps potentially harmful, mislabeled foods, cosmetics, medical devices and dangerous drugs from being distributed to consumers.

• Consumer safety.

The Sulfanilamide Disaster

• Fd&C Act passed in 1938.

  One of the most famous mass poisonings on record was caused by an antibiotic drug mixture called Elixir of Sulfanilamide, manufactured by the S. E. Massingill Company in 1937. The product contained what is used today as antifreeze. Most of the 107 deaths occurred in children. This incident prompted Congress to pass the Food,Drug and Cosmetic Act of 1938.

Amendments

• Keeping drugs sfe for consumers.

  The FD&C Act of 1938 has been amended many times. The Kefauver-Harris amendments of l962 were inspired by a birth defect tragedy in Europe caused by the drug thalidomide. This amendment kept a potentially harmful drug from being marketed in the United States. The Medical Device Amendment of l976 provides for safety and effectiveness standards for new medical devices. Since l980 the FD&C has been amended an additional 16 times to cover diverse issues like drug price competition, infant formula, dietary supplements and pediatric research.

FD&C Definitions

• Cosmetics.

  The FD&C Act considers the legal use of a product to determine whether or not it is a cosmetic, food, or a drug. Cosmetics are deemed to be "articles intended to be rubbed, poured, sprinkled or sprayed, introduced into, or otherwise applied to the human body . . . for cleansing, beautifying, promoting attractiveness, or altering the appearance." The FD&C Act classifies toothpaste and deodorant as well as cosmetics. The FD&C also defines certain soaps as drugs if they have a therapeutic function. Over-the-counter nonprescription drugs are also regulated by the FD&C, and the agency publishes rules for these products.

Cosmeceuticals

• The FD&C Act does not recognize any category called "cosmeceuticals." A product is either a cosmetic or a drug. "Cosmeceuticals" is a marketing term and according to the FD&C Act has no meaning under the law. Consumers should read the labels of these products; they are usually carefully worded to avoid any statements claiming drug properties.

Labeling

• Labeling of all drugs and cosmetics is regulated by the FD&C Act. Misbranding of consumer products is illegal. Misbranding includes a label not providing proper ingredient information, a label not properly displayed or a label that does not comply with the Poison Prevention Packaging Act of 1970. The FD&C Act does not approve cosmetics prior to marketing. It is considered mislabeling to claim FDA approval for any cosmetic.

Consumer Involvment

• The FD&C Act regulations are a line of defense you can access for reporting problems or concerns. The agency provides a consumer complaint coordinator and MedWatch, a toll free number---1-800-322-1088, to quickly address public concerns.