In 1937, S. E. Massengill Company, a pharmaceutical manufacturer, created a preparation of sulfanilamide using diethylene glycol (DEG) as a solvent, and called the preparation "Elixir Sulfanilamide". DEG is poisonous to humans and other mammals. At the time, there were no regulations requiring premarket safety testing of new drugs. Massengill started selling and distributing the medication in September 1937. By October 11, the American Medical Association received a report of several deaths caused by the medication. The FDA was notified and an extensive search was conducted to recover the distributed medicine. At least 100 deaths were blamed on the medication.

Bottles of Elixir Sulfanilamide

The Federal Food, Drug, and Cosmetic Act of 1938 completely overhauled the public health system. Among other provisions, the law authorized the FDA to demand evidence of safety for new drugs, issue standards for food, and conduct factory inspections.

Learning Objectives:

- 1.1 - Describe the role of the FDA and other regulatory bodies in the manufacturing of medical devices.