In 1938, the United States government became involved in drug regulation to make sure that drugs were both safe and effective. Even after the establishment of the Pure Food and Drug Act of 1906, thousands of patient drug-related deaths occurred each year.
The act was instituted after one particularly grisly incident where 100 patients in the United States died from a chemical additive used to dissolve the drug sulfanilamide.
The main objectives of the Federal Food, Drug, and Cosmetic Act of 1938 was to establish testing and safety standards and to ensure that drugs were neither adulterated nor misbranded.
- Adulterated Drug - Any drugs that contains decomposed substances.
- Misbranded Drug - Any drug whose label is false, misleading, or proper warnings and directions are excluded.
The act has twenty chapters and includes prohibited actions & penalties for food, drugs and devices, cosmetics, bottled water, tobacco products, homeopathic preparations,dietary suppliments, imports/exports,and it establishes the general authority of the FDA.
In addition, the act allows the Federal Trade Commission (FTC) to oversee the marketing/advertising of all FDA regulated products.
The Federal Food, Drug, and Cosmetic Act of 1938 replaced the weaker Pure Food and Drug Act of 1906 and it strengthened and cemented the role of the FDA.