The result was the 1906 Pure Food and Drugs Act, which mandated that medicines list the presence of drugs and alcohol on their label and ensure the accuracy of their claims. This was enough to put many snake oil companies out of business, because it turned out most people did not actually want to drug their children to sleep.
But, according to Hurley’s book, the Food and Drug Administration as we know it didn’t really get going until 1938, after an antibiotic was laced with antifreeze, causing the long and painful deaths of 107 people, most of them children. No one had bothered to test the medication for safety. After that, Congress passed a law requiring drugs to prove their safety to the FDA before going on the market. This was right on time, as pharmaceuticals were multiplying, including antibiotics and vaccines that could cure or prevent many of the diseases that had stalked humans for all of history.
Around the same time, the 13 dietary chemicals that we now call vitamins were discovered, and they inspired excitement and hope: Milk and flour started to be fortified with vitamins and minerals. Because these substances were originally isolated from foods, they were thought of as food or food additives, and were regulated that way, separately from drugs.
But by the 1980s, as Hurley reports, the vitamin and supplement industry had developed into one that would be recognizable today: pills and powders with big claims. Again, it took catastrophe for there to be any appetite for regulation: L-tryptophan is the amino acid found in turkey and milk that makes you sleepy. In the 1980s, it became the next big thing. Mainstream magazines called the amino acid a “natural” or even “magic” sleeping pill, one that could also help with pain, stress and PMS.
The problem was that, in some people, it also caused L-tryptophan eosinophilia-myalgia syndrome or EMS—excruciating muscle and nerve pain, fatigue, rashes, heart problems, paralysis and even death. By 1991, 1500 cases of EMS were reported to the FDA and 36 people had died. An investigation revealed that all the illnesses seemed to be linked back to one Japanese manufacturer, but it remains unclear what it was in those pills that may have caused the disease. (Despite this, L-tryptophan is now back on the market.)
At the time, David A. Kessler was the new head of the FDA, and this was a hinge moment, an opportunity: The L-tryptophan scandal was a perfect example of how out-of-control the supplement industry had become, and Kessler vowed to put regulations in place to prevent anything like it happening again.
But the supplement industry was determined to stop him, as detailed in a Frontline documentary called Supplements and Safety. Kessler wanted to restrict the claims on supplement packaging to those that the company could prove represented “significant scientific agreement.” For instance, there is significant scientific agreement that folic acid can prevent birth defects during pregnancy, but that level of evidence is extremely rare in the supplement world. And the claims are everything. Why else would anyone spend good money on a supplement, if not to “support immunity,” or to get “healthy skin,” or “super cleanse” your liver?