A History of the Food, Drug, and Cosmetic Act
Mrs. Brown, well-aware of the problems associated with mascara, consented to using Lash Lure to boost her eyelashes. The procedure, messy and uncomfortable, took longer than expected. As Mrs. Brown drove way from the salon, her eyes began to water up, filled with a burning sensation. She was so uncomfortable that she began to apply ointments of boric acid and mercury oxide, hoping to find a solution. Although she attended the PTA dinner, she was forced to leave early due to the pain. Mrs. Brown’s eyes began to ulcerate, eventually sloughing off her own corneas. She was left completely blind.
The aniline compound in Lash Lure was a paraphenylenediamine, which darkens as it oxidizes in the air. Although they were commonly used as hair dye in the 1920s and 1930s, Lash Lure contained up to 30 times the aniline used in hair dye, and used it for the sensitive eye area.
After the case of Mrs. Brown became publicized, a wave of new information about Lash Lure’s casualties was made evident. One 52-year-old woman, whose beautician daughter had dyed her lashes and brows, not only experienced severe burning and swelling, she was unable to open her eye a mere hour later. The next day, her fever was measured at 104 degrees. Her face was covered in ulcers, her lymph nodes were notably enlarged, and her heartbeat was irregular. Eight days later, she was dead.
In response, states began to create bans on aniline dyes. Unfortunately, the Food and Drug Administration (FDA)’s hands were tied. They had no authority to prevent the sale of Lash Lure or to correct the misleading ads released by the company.
What’s more, there were a myriad of products causing similar harm. Susan E. Wilson-Sanders outlines the case of “Anti-Mole, a remedy, [that] contained 50% nitric acid and 25% glacial acetic acid. It took off the moles along with the side of the victim’s face! Berry’s Freckle Ointment contained 12% mercury and produced mercury toxicity. Some unsuspecting people purchased Bleachodent to whiten their teeth and burned their gums and tongues because of the high content of hydrochloric and sulphuric acid. Carbon tetrachloride, which we know today is carcinogenic and produces hepatic toxicity, was a common ingredient of ‘dry’ shampoos. Is your scalp itching? Use Dr. Dennis’s Compound which ‘prevents and stops the itch in one minute’ because of its concentration of chloral hydrate, or Dewsberry Hair Tonic which stops an itching scalp with copper chloride and pyrogallic acid.”
|Teddy Roosevelt is concerned about your safety.|
The public was protected from some unscrupulous claims by the Pure Food and Drug Act of 1906. This law, signed by President Teddy Roosevelt the same day he signed the Federal Meat Inspection Act, required manufacturers of food and drugs to list potentially dangerous ingredients such as morphine, opium, and cannabis. The law also led to the creation of the Bureau of Chemistry and, subsequently, the FDA (the known as the Food, Drug, and Insecticide organization) in 1927.
Although this was an important step forward, products like Lash Lure demonstrated how limited the FDA’s powers truly were. In addition to Lash Lure, journalists highlighted radioactive beverages like Radithor (this radium-laced water claimed to boost virility; unsurprisingly to us, using it led to painful deaths), which were permitted under the Pure Food and Drug Act, and other potentially dangerous quackery. Additionally, new drugs were not required to be tested. In 1937, a sulfanilamide medicine called “Elixir sulfanilamide” resulted in the deaths of over 100 people. Due to lax legislation, the long legal trouble that the company faced was a small fine for calling a product without alcohol an “elixir”.
In response to these egregious oversights, Congress put together the Food, Drug, and Cosmetic Act of 1938. It was signed into law by the other Roosevelt: FDR. It significantly boosted the FDA’s power and created substantially more legislation for drug companies to adhere to. For example, animal testing became mandatory for new drugs, to help ensure that tragedies such as the Elixir sulfanilamide disaster were never repeated (any reasonable animal test would have easily demonstrated its toxicity). These laws have been updated many times since the 1938 law as additional tragedies (such as thalidomide birth defects in 1959) have demonstrated the need for more stringent animal testing.
When it comes to cosmetics, the Food, Drug, and Cosmetic Act prohibits the sale of makeup that contains substances or color additives known to be harmful, anything that’s decomposing, or anything that has been exposed to unsanitary conditions (these are referred to collectively as “adulterated cosmetics”). Additionally, it requires honest labeling that contains certain required information. The FDA is also authorized to inspect cosmetics manufacturing, and to take and test samples during inspections or after receiving complaints. They monitor imports to assure that imported cosmetics are also up to snuff. And, of course, they can pursue legal action against companies who break the law by selling adulterated or otherwise unsafe cosmetics.