Pepper mills, antibiotics, and the FDA

2016/11/17

In the US, we mostly take the purity of our food and drugs for granted. I think the exception proves the rule: many people are surprised that dietary supplements, including herbal supplements, are regulated differently than drugs, under an “assumption of safety”. Essentially, you can put whatever you want in there, and the FDA will only investigate your supplement if they have a particular reason to. This means that many dietary supplements contain real drugs. In 2015, an NBA player was discovered unconscious in a brothel, and the subsequent investigation revealed that one of the “herbal”, “Viagra-like” supplements he was taking were just actual Viagra masquerading as an herb.

Before the Pure Food and Drug Act of 1906, food and drugs were not required to list their ingredients, they were not prohibited from making false claims, and there were no controlled substances. This situation feels unbelievable to me. Can you imagine a world where you are legally allowed to lie to consumers? A world where drugs for children contained alcohol or morphine? Crazy. In high school, I was taught that the proximal cause for the Act was the public’s reaction to Upton Sinclair’s novel The Jungle, which includes (fictional) stories of human workers falling into meat-grinders and being rendered along with the beef lard.

The Pure Food and Drug Act was the first step in a series of laws that led to the establishment of the FDA. One (amusingly-named) step along the way was the suit United States v. Forty Barrels & Twenty Kegs of Coca-Cola, which began in 1911 and ended in the Supreme Court. The suit included a debate over whether caffeine was additive and toxic and thus whether adding caffeine to Coca-Cola constituted adulteration.

Another important step in the development of our modern FDA was a mass poisoning caused by an antibiotic.

Penicillin, an enormously important drug, was not the first antibiotic. That honor lies with Protonsil, the trade name for an antibiotic made by a German drug firm that was the predecessor of Bayer. Protonsil is a prodrug: the thing that a patient eats is not the drug; the human body breaks down the prodrug into different molecules, one of which is the actual drug. The actual drug in this case was sulfalinamide. Sulfalinamide is a sulfonamide drug, meaning that it is entirely different from penicillin or penicillin derivatives: its chemical structure is totally distinct, and it kills bacteria in an entirely different way. (Sulfonamindes, though not in the limelight, remain important: one of the most-prescribed antibiotics in the US, known by the trade name Bactrim, contains a sulfonamide.)

In 1938, when the alluded-to mass poisoning happened, the Pure Food and Drug Act was in effect, but there was no mechanism to ensure the safety of new drugs. Imagine that all drugs were marketed and regulated like today’s herbal supplements. A drug maker created a product labeled as an “elixir sulfalinamide”. (Elixir, which definitely makes me think of something magical, at that time meant that the active ingredient was dissolved in alcohol.) The drug maker added raspberry flavoring. Sounds nice.

The trouble was that the raspberry flavoring was dissolved in diethylene glycol (not to be confused with the more familiar ethylene glycol, which is used as antifreeze). Diethylene glycol is toxic, but the drug maker did not know this, and they did not find out because animal testing was not required under the existing laws. About a month after the drug went on the market, it became clear to the nascent FDA that something was wrong. Around a hundred people died in the poisoning.

The chemist who added the raspberry flavoring killed himself before going to trial, but the manufacturer did not express such remorse: “We have been supplying a legitimate professional demand and not once could have foreseen the unlooked-for results. I do not feel that there was any responsibility on our part.”

It’s a chilling story, and I think it says something about how easy it can be for people to compartmentalize their responsibilities: I’m a drug manufacturer, and drug testing is not required under the law, so if people died because of something I did it’s not my fault.

What’s the connection with pepper mills? At a talk about her new book, I heard Sarah Lohman tell this story. Before the Pure Food and Drug Act, there was no assurance that ground pepper was actually pepper. It could be burnt toast crumbs. People ground pepper because it was the only way to be sure it was actually pepper. Sometime after the Act, the novelty of pre-ground pepper caught on. Pre-ground pepper doesn’t lose its heat, but it does lose its aromaticness, and when the Food Network started showing Americans images of fancy chefs grinding pepper, the old ways caught on again. Maybe home-grinding your herbal supplements with a mortar and pestle will catch on next.