The Food and Drug Administration’s decision to regulate e-cigarettes will bring needed oversight to a booming industry that, until now, has mostly operated by its own rules, and whose products haven’t been studied long enough to determine their health risks. E-cigarettes have been promoted as a safer alternative to tobacco products because users inhale nicotine-laced vapors instead of smoke. But many doctors wonder how those vapors might affect brain development in teenagers, and worry about the presence of formaldehyde and other toxic substances. And while smokers aren’t exposed to the cancer-causing tar that’s in tobacco, they’re still getting hooked on nicotine, a drug that’s tough to quit in any form.
Most states — including Massachusetts — already restrict the sale of e-cigarettes and tobacco products to anyone under 18 years old. On Wednesday, California became the second state to raise the threshold to 21. The new FDA rules, detailed in a 499-page document released Thursday and scheduled to be phased in over the next few years, will promote consistent enforcement of states’ regulations, says Cyndi Roy Gonzalez, a spokeswoman for Massachusetts Attorney General Maura Healey. “This will make it so much easier to keep these products out of the hands of kids nationwide,” Gonzalez says. “Vaping” is soaring in popularity, especially among teens — about 16 percent of high school students used e-cigarettes last year, according to a survey by the FDA and the Centers for Disease Control and Prevention, up from 1.5 percent in 2011.
But the agency’s new directive isn’t just about making it tougher for kids to buy e-cigarettes (or cigars and hookah tobacco, which also have somehow escaped FDA oversight until now). Companies that produce e-cigarettes will for the first time have to disclose the ingredients they use, how they make their products, and whatever scientific data they’ve collected. In addition, free samples will no longer be permitted, packaging must indicate that the products contain nicotine, and manufacturers won’t be able to pitch an e-cigarette brand as “light,” “low,” or “mild” without the FDA signing off on such claims. In most cases, they’ll also have to seek retroactive approval from the agency for products that went on the market after Feb. 15, 2007.
“These are common-sense protections for our nation’s health,” says Erika Sward, a spokeswoman for the American Lung Association in Washington, D.C. “The numbers overwhelmingly show that if you don’t use tobacco by the time you’re 21, you’re not going to.”
Unfortunately, federal regulators did not act on complaints that e-cigarette liquids are sold in flavors that appeal to young people — like bubble gum, and peanut butter and jelly — although the FDA is expected to add flavored cigars to an existing ban on flavored cigarettes. Sward calls the agency failure to impose an outright ban on flavored e-cigarettes a “stunning decision.”
Despite their apparently victory, supporters of strict oversight for e-cigarettes would be wise to remain on guard. Major tobacco companies, including Altria Group Inc. and Reynolds American Inc. have invested a lot of money in vaping products as way to offset steep declines in cigarette sales. They will put intense pressure on Congress to have the regulations weakened or delayed. “We are going to see the tobacco industry harness its access and power in ways that we have not seen in a long time,” says Sward. Smaller e-cigarette makers and retailers are fighting the restrictions too — mainly on the grounds that the expense of the product-approval process will drive them to financial ruin.
But the arguments by those who are profiting from the surge in e-cigarette sales conveniently ignore the fact that they’re selling a highly addictive drug. Whether e-cigarettes are less harmful than tobacco is mostly irrelevant. The FDA has an obligation to do everything it can to keep America’s teens from developing long-term habits with unknown health consequences.