FDA nears day of reckoning on e-cigarettes

Now FDA is days away from a deadline that could signal how it will approach tobacco regulation for years to come. The agency has already said it is considering major changes. FDA announced in April that it planned to release a proposal within a year to ban menthol cigarettes and flavored cigars — products disproportionately used by African Americans and teens. The agency is also reportedly considering whether to seek limits on nicotine levels in cigarettes to reduce their addictive potential. Similar concerns about addictive potential and risks to young people lie at the heart of FDA’s imminent verdict on vapes.

“FDA really is at a critical juncture,” said Matthew Myers, the president of the Campaign for Tobacco-Free Kids. “In some critical ways how FDA will be perceived will probably be defined with what it does now with regard to pending applications.”

In the meantime, the vaping industry is bracing for the possibility of major changes that could tilt the balance in favor of big tobacco companies who have expanded into the e-cig market.

Many vaping products are produced by smaller companies that don’t have the resources to thoroughly answer FDA’s scientific questions about safety, said Ken Warner, a professor emeritus of public health and tobacco control at the University of Michigan. Large companies such as Juul only sell a handful of types of e-cigarettes, but have the financial resources to stack their applications to make them more likely to be cleared by the agency.

FDA, which has said it will likely miss the Sept. 9 deadline for some applications, is prioritizing its review queue based on applicants’ market share. Juul alone controls over 40 percent of the e-cigarette market; its majority shareholder is Altria — the parent company of Philip Morris USA.

FDA has not yet made decisions on applications submitted by the market’s larger players, which account for only a handful of the submissions waiting for review. But the agency has already told some smaller companies to stop selling their products.

In some cases, FDA outright denied applications from these firms due to the nature of the e-cigarettes in question. These products, all of which were flavored, “lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products,” the agency stated.

In other cases, however, the agency has issued either “Refuse to Accept” or “Refuse to File” notices to smaller firms whose applications were incomplete or otherwise not meeting technical requirements. Those companies can refile their applications but cannot continue to sell affected products in the meantime.

Dave Morris, who owns a company called Vape Gravy Brands in Phoenix, Arizona, said that his initial application cost about $7,000 per flavor for 14 of the flavors he sells. “We’ve spent pretty much every penny we saved up on the last six years for this,” he said. And with the uncertainty around FDA’s decision, “I don’t know if I’ll have a company in two weeks,” he said, referring to the Sept. 9 deadline.

Morris and other small e-cigarette companies argue that their products — including flavored ones — are designed for adults who are looking to quit smoking cigarettes, not to entice new, young tobacco users.

“I started smoking and then quit with vaping,” said Victoria Drower, the owner of two small vape shops in southern California. “I should be working myself out of a job — that is my goal.”

Morris said that all of his products are designed to fill the large, tank-style e-cigarettes that teenagers often eschew in favor of vape pens. Even if they are flavored, he argued, that appeals to adult smokers, not only to teens.

The vaping industry and some public health experts also argue that vaping can help wean smokers from cigarettes and other traditional forms of tobacco.

“People who are trying to quit use more e-cigarettes than any other product,” Warner said. In a recent paper published in the American Journal of Public Health, Warner and others argued that policies to reduce teen vaping may also help adults’ use e-cigarettes to quit smoking tobacco.

According to a CDC study, roughly 15 percent of adult smokers successfully quit smoking using e-cigarettes, compared to 3.3 percent who rely on non-cigarette tobacco products such as cigars or cigarillos. A study in the New England Journal of Medicine found that among smokers who quit, 18 percent remained cigarette-free after a year, compared to 9.9 percent who used nicotine-replacement therapies.

But e-cigarettes have still undoubtedly harmed public health. The focal point for most lawmakers and several public health advocacy groups has been vapes’ appeal to teens and even children. A 2020 CDC study found that nearly 20 percent of high school students and 5 percent of middle school students had vaped regularly, and mostly used flavored products.

Several lawmakers and state attorneys general have urged the FDA to ban all flavors of e-cigarettes, including menthol, because of their appeal to teens. Already, the agency has banned the sale of reusable flavored e-cigarettes, such as those once sold by Juul. But it still allows the sale of disposable flavored products.

But anti-vaping advocates argue that flavors are totally unnecessary to sell products to adults. Smokers “are accustomed to tobacco-flavored products,” said Dennis Henigan, the vice president for legal and regulatory affairs at the Campaign for Tobacco-Free Kids. “Why in the world do they need strawberry-flavored e-liquids as opposed to tobacco-flavored products?”

Others argue that even the smaller players in the e-cigarette industry aren’t as altruistic as they seem. “It’s hard to have sympathy for businesses that haven’t even attempted to play by the rules,” said Desmond Jenson, a lawyer at the Public Health Law Center at the Mitchell Hamline School of Law who focuses on commercial tobacco policy.

“No one has attempted to file applications or legally market these products [before now], no one has filed applications to make modified risk claims legally,” he added. “The whole idea that e-cigs are a cessation device — why has no company filed a drug application to say it’s a cessation device?”

Still, most public health experts agree that there should be some kinds of e-cigarettes on the market to help wean adults from cigarettes, pipes and other smoked forms of tobacco.

“If you have e-cigarettes on the market, that gives smokers a legal option to go to,” said Eric Lindblom, a former official at FDA’s Center for Tobacco Products who is now a senior scholar at the Georgetown University Law Center.

“I personally would like to see more alternatives approved on the market for many different companies,” said Mike Cummings, a professor of psychiatry at the Medical University of South Carolina. Alternatives that are acceptable for current smokers to use to stop smoking could be a public health tool. But, he said, “you can’t have willy-nilly [FDA] clearances.”

No matter what FDA’s ultimate decision is on e-cigarettes, some parties are going to be angry. “I can’t in my mind see the FDA threading a needle here that doesn’t result in litigation from someone,” Jenson said. “It’s kind of impossible.”