The United States Federal Food, Drug and Cosmetic Act (FDCA)
came into effect in 1938. The act gave the FDA the power to oversee the safety
of food, drugs and cosmetics. And in a way, the FDA as we know it today was
born partially as a result of 1937 "Elixir Sulfanilamide Mass Poisoning
Scandal" disaster
Seventy-one adults and 34 children died in the fall of 1937
after taking a drug called Elixir Sulfanilamide to treat a variety of ailments,
from gonorrhea to sore throat. At that time, the FDA, which had been launched
in 1906 as the Bureau of Chemistry, served simply to police claims made about
food and drug ingredients.
In 1932, German pathologist and bacteriologist Gerhard Domagk
discovered that a chemical called prontosil protected against certain bacterial
infections in mice. Further research demonstrated that the compound’s active
ingredient, sulfanilimide, could fight streptococcal infections in humans,
prompting several pharmaceutical companies—including Merck, Squibb, and Eli
Lilly—to begin making sulfanilamide drugs. These medicines were mostly formulated
as capsules and tablets, but the S.E. Massengill Company of Bristol, Tennessee,
decided that a liquid form of sulfanilamide could also be a big seller.
Despite reports indicating that DEG was dangerous to humans, Massengill’s chief chemist concocted a solution of 10 percent sulfanilamide, 72 percent diethylene glycol, and 16 percent water. The company’s internal control lab approved the solution’s appearance, taste, and fragrance—it was flavored with raspberry extract, saccharin, and caramel, among other ingredients—and by September 1937, Massengill had distributed 240 gallons of the liquid, called Elixir Sulfanilamide, across the country.
At
the time of distribution, there were no rules demanding safety testing of new
medicines before they went on sale. And while drug companies routinely carried
out animal testing, in this case Massengill hadn’t undertaken any.
Soon
after the raspberry-flavored elixir hit the market in September 1937, there
were reports of the 100 deaths, and subsequent investigations isolated the
cause. The scandal led to the passing of the FDCA, but the Massengill
Company was only subject to a minimum fine due to the stipulations of the
previous 1906 Pure Food and Drugs Act. Still, with his trial pending, the
company’s chief pharmacist took his own life.
Contributing Sources:
https:///...r-tragedy-1937-39231
https://en.wikipedia.org/wiki/Elixir_sulfanilamide
http:///...scandals-in-history/
