New Food and Drug Administration rules published today will bar the sale of electronic cigarettes to minors and require manufacturers to add labels warning that nicotine is addictive.
But the tobacco industry scored a massive win as well. The regulation, years in the making, doesn’t yet clamp down on advertising for electronic cigarettes, permitting e-cig ads to remain on television, billboards, and other forums where traditional cigarette ads have been largely banned for years.
Officials called the new rules “a foundational step” and said the agency would consider more restrictions in the future. “We obviously share the public health concern about the skyrocketing use of e-cigarettes, hookah, and cigars by kids,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in a call with reporters. Last year, 16 percent of high school students reported using e-cigarettes in the past 30 days, up from 1.5 percent four years earlier, according to data from the Centers for Disease Control.
The government’s own scientists have warned that how e-cigs affect the nation’s health depends on how they’re pushed to consumers. “The manner in which products are marketed and advertised will directly affect the impact of those products on public health," officials from the CDC wrote to counterparts in the FDA in July 2015 comments on the proposed regulations, according to documents obtained by Bloomberg through a public record request.
Though the new rule will prevent companies from making health claims about e-cigs without the permission of the FDA, the agency is taking a wait-and-see approach on the broader question of whether and how they should be advertised. "For now, there are no direct restrictions in the final rule on TV advertising,” Zeller said. "Over time we will look at the other tools that we have."
E-cigarettes and vaporizer sales reached $5.2 billion in 2015. The spread of the devices has raised important questions about how they’ll affect patterns of smoking conventional tobacco, which the CDC calls the leading cause of preventable death in the U.S.
Will vaping help people quit traditional cigarettes? Or will the devices keep smokers hooked by letting them discretely dose themselves with nicotine when lighting up is forbidden? Will they get more kids addicted to nicotine? And will people who start smoking e-cigarettes move on to burning tobacco?
"Nobody has the answers to those questions right now," Zeller said, but the FDA is funding research to find them.
In the absence of clear evidence, the CDC urged regulators to proceed with caution as they draft guidelines for companies intending to sell new e-cigarette products. One study cited by CDC officials of 3,600 American teens found that those who watched e-cig ads on TV reported that they were more likely to try the products. Tobacco cigarettes have not been advertised on TV since President Richard Nixon signed a ban in 1970.
The return of images of people puffing in broadcast ads for e-cigarettes could also hurt current smokers’ efforts to quit, according to research the CDC cited in its private comments to FDA. Such ads “may serve as smoking cues to smokers and former smokers, increasing the urge to smoke and undermining efforts to quit or abstain from smoking,” CDC officials wrote.
The new rules give the FDA authority to vet whether tobacco products are "appropriate for the protection of the public health." Products (including e-cigarettes) introduced since 2007 will have to apply to the agency for permission to stay on the market within the next two years. The agency will consider marketing and advertising plans in its evaluations, Zeller said.
In proposed guidelines for companies submitting those applications, the FDA indicated that manufacturers should assess the impact of their products on human health, including on current smokers, nonsmokers, and youth. That may included “data you collect on consumer perceptions of the harms of the new tobacco product and of its proposed labeling or advertising.” The agency also “recommends” that companies share their marketing plans and, for products already on the market, sales data “by population demographics and tobacco use status."
Avoiding a crackdown on e-cigarette ads is a big win for the industry. Several leading e-cigarette brands are owned by major tobacco companies: MarkTen and Green Smoke are owned by Altria, and Vuse is owned by Reynolds American. The companies didn't respond to requests from Bloomberg for comment on the new rule.
Public health advocates broadly praised the rule but want FDA to go further. "The FDA should immediately take action to address flavorings attractive to youth in all products and the egregious industry marketing practices,” Chris Hansen, president of the group, said in a statement. “The tobacco industry has taken full advantage to exploit the lack of regulations on these issues.”