Elixir Sulfanilamide tragedy

In June 1906, President Theodore Roosevelt signed into law the Food and Drugs Act. The Act prohibited, under penalty of seizure of goods, the interstate transport of food which had been "adulterated", with that term referring to the addition of fillers of reduced "quality or strength", coloring to conceal "damage or inferiority," formulation with additives "injurious to health," or the use of "filthy, decomposed, or putrid" substances.

The Chemistry Bureau's (the forerunner of the FDA) authority was soon checked by judicial decisions. A 1911 Supreme Court decision ruled that the 1906 act did not apply to false claims of therapeutic efficacy; other court decisions set high standards for proof of fraudulent intent.

By the 1930s, muckraking journalists, consumer protection organizations, and federal regulators began mounting a campaign for stronger regulatory authority by publicizing a list of injurious products which had been ruled permissible under the 1906 law, including radioactive beverages, cosmetics which caused blindness, and worthless "cures" for diabetes and tuberculosis. The resulting proposed law was unable to get through the Congress of the United States for five years, but the Food, Drug, and Cosmetic Act (FD&C Act) was finally signed into law by another President Roosevelt (Franklin Delano) on June 25, 1938.

What caused Congress to finally agree and send to bill to the President? The public outcry over the 1937 Elixir Sulfanilamide tragedy, in which over 100 people died after using a drug formulated with a toxic, untested solvent. This week, we look at this horrible moment in US history.

TTFN, Fred.

Quote of the week: "Only the weak are cruel. Gentleness can only be expected from the strong." - Leo Buscaglia (US author & lecturer, 1925 - )

(scroll over or click on iPaper below to have a drop-down menu that includes a print option)

FDA Elixir Sulfanilamide