In 1933, the U.S. Food and Drug Administration (FDA) recommended a complete revision of the obsolete 1906 Food and Drugs Act. The first bill was introduced into the Senate, launching a five-year legislative battle. The Federal Food, Drug, and Cosmetic Act (FDCA) was finally enacted on June 25, 1938.

The FDCA established more stringent requirements for the approval of new drugs, mandating that they be adequately tested for safety before entering the market. It also introduced strict regulations on food and cosmetics, including prohibitions against unsafe practices and the necessity for proper labeling to inform consumers about ingredients and potential hazards.

One of the act’s key innovations was the empowerment of the FDA to oversee advertising and labeling standards, a role contested by other regulatory bodies like the Federal Trade Commission (FTC). This legislation marked a shift towards prioritizing public health and safety, laying the groundwork for future reforms aimed at ensuring that products are both safe and effective. The FDCA’s influence continues to be felt today, as it established principles that govern food and drug safety in the United States.