1937: Sulfanilamide Elixir Disaster (1937)

In the autumn of 1937, S.E. Massengill Company of Bristol, Tennessee, marketed a liquid preparation
of the newly popular sulfonamide antibiotic sulfanilamide dissolved in diethylene glycol—an
industrial solvent selected because it dissolved the drug well and tasted sweet. The product was
labelled "Elixir Sulfanilamide" and distributed nationally without any safety testing, as US law
at the time required only that drugs be labelled correctly—not that they be proved safe before sale.

Diethylene glycol is a nephrotoxic compound now known to cause acute kidney injury through
metabolism to toxic glycolic and oxalic acids. Within weeks of distribution, reports began
reaching the American Medical Association (AMA) of patients dying with oliguria, severe abdominal
pain, nausea, and progressive renal failure. The final death toll reached 107 individuals, including
many children who had taken the preparation for sore throats or other infections. The company's
chief chemist, Harold Cole Watkins, committed suicide after learning of the deaths.

The disaster was the direct catalyst for the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C
Act), which for the first time required drug manufacturers to demonstrate the safety of new drugs
before marketing. The law also required FDA approval of safety data, prohibited false therapeutic
claims, and gave the FDA authority to inspect factories. Although the FD&C Act did not yet require
proof of efficacy, the 1938 legislation fundamentally transformed the regulatory landscape and
created the precedent for the modern drug approval process.