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Ever heard the story of how the FDA was born? | Forum

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Admin Nov 7 '19

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.






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The Forum post is edited by Admin Nov 7 '19
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