Food, Drug, and Cosmetic Act of 1938. The Bureau of Chemistry was reorganized with the regulatory function going to the Food, Drug, and Insecticide Administration and was renamed the Food and Drug Administration in 1930.9 Between 1906 and 1938, numerous spurious products were available for sale with little to no repercussions to the sellers or manufacturers from FDA. At the time, there was no requirement to submit information to FDA prior to marketing, and the government bore the burden of proof to show that a drug’s labeling was false or misleading. Also, medical devices were not subject to the Pure Food and Drug Act. From the 1700s, fraudulent medical devices were being sold with claims of curing all types of diseases. In 1917, nose straighteners, height-stretching machines, and heated rubber applicators advertised as a cure for prostate gland disorders flooded the US market.10 Radiation added to the problem. The health hazards of radiation became known soon after the discovery of radium. Exaggerated health claims, brought to the attention of Congress in a 1926 report, continued for products containing radium. Most FDA enforcement activity at the time concerned getting fraudulent devices like these off the market. While the agency continued to monitor products, it could only assist the Federal Trade Commission and the US Post Office, which were charged with overseeing devices and enforcing criminal penalties for mail fraud, respectively, FDA could take no action on its own.10 In 1933, a bill was introduced to overhaul the Pure Food and Drug Act, but these efforts were largely unsuccessful until disaster struck. In 1937, more than 100 people, including many children, died after taking a sulfonamide antibacterial preparation called Elixir Sulfanilamide. The product utilized diethylene glycol, a poison, as a solvent.11 Public outcry to the disaster, including a personal plea to President Franklin Roosevelt from a grieving mother,12 helped to drive passage of the Food, Drug, and Cosmetic Act (FDCA), which he signed into law on 25 June 1938. This law included the following changes: medical devices were no longer defined as drugs; cosmetics and medical devices were regulated for the first time; manufacturers were required to provide scientific proof that new drugs were safe for their intended use before being placed on the market; and FDA was given authority to bring federal court injunctions, in addition to product seizures and criminal prosecutions, for violations of the FDCA.