Does the FDA Even Regulate E-Cigs? Actually Kinda Not
It’s been a rough summer for e-cigarettes. Once sold as the safer alternative to traditional, combustible cigarettes, e-cigs are now associated with a national outbreak of mystery respiratory illnesses, six deaths, and a fraudulent marketing campaign.
The Centers for Disease Control have advised people to stop vaping, and in September the Food and Drug Administration sent a stern warning to Juul, the largest American e-cigarette brand, to stop advertising its products as safe ways to quit smoking. The Trump administration even announced plans to ban flavored e-cigs. But as a new paper published this week in JAMA Internal Medicine shows, the FDA has done a poor and inconsistent job protecting the public from new tobacco products in the first place. “It’s really demonstrating a regulatory failure,” says Sven Jordt, an e-cigarette researcher at Duke who authored the paper.
This paper only looked at one ingredient in mint and menthol e-cigarette juice, but it points to a larger game of cat and mouse that the tobacco industry has been playing with regulators for more than a century—a game that has consistently limited the FDA’s authority, ignored scientific research, and marshalled courts and lawmakers against strong regulation. And the techniques that protected tobacco in the 1900s, 1960s, and 2000s ultimately led to the unchecked proliferation of under-studied and potentially dangerous new nicotine products now used by millions of American teenagers.
We’ll explore the wily machinations of big tobacco in a moment, but first let’s look at what this particular study found. Jordt and his colleague Sairam V. Jabba looked at five popular e-cigarette brands that contain a toxic chemical called pulegone, a carcinogen that can also cause liver and kidney failure. Then they calculated the risk of pulegone exposure for a vaper by dividing the safe level of exposure listed by the FDA by the amounts included in each e-cig. They found that mint- and menthol-flavored e-cigarettes contain extremely high levels of the chemical. Ingested in very large quantities, pulegone can be deadly; the chemical is banned in the European Union and in California. “If these amounts were in food, FDA would immediately ask the manufacturer to pull this off the markets or even impose fines,” Jordt says.
Jordt and Jabba found that the levels of pulegone in e-cigarettes were thousands of times higher than the amounts that would be acceptable in food products. E-cigs even had levels several thousand times higher than the concentrations in regular menthol cigarettes. The FDA doesn’t regulate tobacco and food the same way, and Jordt acknowledges that there are no studies that evaluate how inhaling pulegone affects the body. But, he says, the lungs are much more delicate and susceptible to toxins than our digestive systems, and regulatory agencies usually accept that inhaling a chemical will double the risks of exposure. The FDA has strictly regulated carcinogens in food since the 1920s but, Jordt says, “In e-cigarettes there’s basically currently no serious regulation.”
Indeed the FDA’s tenuous and questionable control over the tobacco industry traces back to the administration’s origins. The FDA actually emerged out of the outrage over Upton Sinclair’s 1906 book The Jungle, which shocked Americans with gory details of the unregulated meatpacking industry. The new regulatory body had a mandate to oversee everything from over-the-counter drugs and blood transfusions to food and, after 1938, cosmetics. But not tobacco.
Tobacco had long been considered a drug whose smoke could, like the sanitizing power of fire, stop infections. It was prescribed for toothaches, skin conditions, and the plague. But after Congress established the FDA, tobacco companies worked hard to make sure their product wouldn’t be considered a drug and therefore wouldn’t fall under the administration’s purview. In later years, the industry pressured senators and congressional representatives from tobacco-farming states to limit the FDA’s control over the product.