Federal Food, Drug, and Cosmetic Act of 1938
The Federal Food, Drug, and Cosmetic Act of 1938 is a significant piece of legislation in the United States that was enacted to enhance consumer safety in the food, drug, and cosmetics industries. This law was largely a response to a public health crisis that resulted from the distribution of a toxic medication, which led to numerous fatalities. As a result, the act mandates that companies must conduct animal testing on their products and submit safety reports to the Food and Drug Administration (FDA) prior to marketing. Notably, it expanded the FDA’s regulatory authority to include cosmetics, in addition to food and drugs, and allowed for inspections of production facilities.
The act also established standards for labeling, requiring clear ingredient lists and quality markings on packaging to inform consumers. It removed previous legal protections for manufacturers against prosecution for mislabeled products, shifting the burden of proof to them. Additionally, while the Federal Trade Commission oversees advertising regulations, the FDA retains authority over prescription drug advertising. The Federal Food, Drug, and Cosmetic Act has been amended several times in response to advancements in science and technology, continuing its role in safeguarding public health. This legislation represents an ongoing commitment to ensuring that the products available to consumers meet safety standards.
Federal Food, Drug, and Cosmetic Act of 1938
The Law Invested authority in the Food and Drug Administration to oversee the food, drug, and cosmetics industries
Also known as FFDCA
Date 1938
Allowed for the regulation of food, drug, and cosmetics industries for purposes of safety and truth in advertising.
In 1937, the S. E. Massengill Co. distributed sulfanilamide that had been prepared with the solvent diethylene glycol, a toxic substance. Massengill had not performed any animal testing with the medication, instead releasing it directly to the public. Reports began to surface of deaths associated with this medicine, and more than one hundred people were believed to have died from this poisoning.
In response, Congress enacted the Federal Food, Drug, and Cosmetic Act in 1938 in order to protect the safety of the American people. Part of the law required companies to test their products on animals and submit reports to the Food and Drug Administration (FDA) before marketing their products.
Though the FDA already had some power in regulating the food and drug industry, the act extended this power to the cosmetics industry as well. Also, the FDA was given the power to inspect facilities that handled or produced food, drug, or cosmetic products. The FDA could also determine safe levels for unavoidable substances that could cause potential harm. Furthermore, the FDA had the responsibility to set standards for the packaging of food, drugs, and cosmetics; this task included marking clearly ingredient lists, weights, and quality on packages.
Furthermore, the act removed a previous provision known as the Sherley amendment, giving the FDA power to prosecute mislabeled items whether or not the manufacturer intended to mislead the consumer. The responsibility for regulating advertising of these products fell to the Federal Trade Commission, under the Wheeler-Lea Act. The FDA maintained authority in the regulation of the advertising of prescription drugs.
Impact
Congress gave the FDA more power to regulate the food, drug, and cosmetics industries to ensure the safety of the products of these industries. This act has been amended several times as advancements have been made in each field.
Bibliography
Hilt, Philip J. Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation. Chapel Hill: University of North Carolina Press, 2004.
Kay, Gwen. Dying to Be Beautiful: The Fight for Safe Cosmetics. Columbus: Ohio State University Press, 2005.