FDA nears day of reckoning on e-cigarettes

Now the FDA is just days away from a deadline that could signal how it will approach tobacco regulation in the years to come. The agency has already announced that it will consider major changes. The FDA announced in April that it would publish a proposal within a year to ban menthol cigarettes and flavored cigars – products that are disproportionately used by African Americans and adolescents. The agency is also reportedly considering limiting the nicotine content of cigarettes to reduce their potential for addiction. Similar concerns about the potential for addiction and the risks to young people are at the center of the upcoming FDA ruling on vapes.

“The FDA is really at a critical juncture,” said Matthew Myers, president of the Campaign for Tobacco Free Children. “In some ways, the FDA’s perception will likely be defined by what it does now with respect to pending applications.”

In the meantime, the vapor industry is preparing for the possibility of big changes that could shift the balance in favor of large tobacco companies that have expanded into the e-cigarette market.

Many vaping products are made by smaller companies that don’t have the resources to thoroughly answer the FDA’s scientific questions about safety, said Ken Warner, a professor emeritus in Public Health and Tobacco Control from the University of Michigan. Big companies like Juul only sell a handful of types of e-cigarettes but have the financial resources to stack their applications so they’re more likely to get approved by the agency.

The FDA, which has announced that it will likely miss the September 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.

The FDA has not yet made any decisions about applications from the major market players, which make up only a handful of the applications pending consideration. But the agency has already advised some smaller companies to stop selling their products.

In some cases, the FDA denied applications from these companies due to the nature of the e-cigarettes in question. These products, all of which were flavored, “lacked sufficient evidence that they would be of sufficient benefit to adult smokers to overcome the public health threat posed by the well-documented, alarming consumption of such products by adolescents,” the agency said.

In other cases, however, the agency has issued either “denial of approval” or “denial of filing” to smaller firms whose applications were incomplete or did not meet the technical requirements. These companies can submit their applications again, but in the meantime will not be able to resell the affected products.

Dave Morris, who owns a company called Vape Gravy Brands in Phoenix, Ariz., Said his initial use was about $ 7,000 per flavor for 14 of the flavors he sold. “We’ve spent pretty much every penny we’ve saved in the past six years,” he said. And given the uncertainty about the FDA’s decision, “I don’t know if I’ll have a business in two weeks,” he said, referring to the September 9 deadline.

Morris and other small e-cigarette companies argue that their products – including flavored ones – are designed for adults who want to quit smoking, rather than to attract new, young tobacco users.

“I started smoking and then stopped vaping,” says Victoria Drower, the owner of two small vape shops in Southern California. “I should work my way out of a job – that’s my goal.”

Morris said all of its products are designed to fill the large, tank-style e-cigarettes that teenagers often eschew in favor of vape pens. Even when flavored, he argues that this will appeal to adult smokers, not just teenagers.

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

“People who try to quit use more e-cigarettes than any other product,” said Warner. In a recent article published in the American Journal of Public Health, Warner and others argued that guidelines for reducing vaping in teenagers can also help adults use e-cigarettes to quit smoking.

According to a CDC study, about 15 percent of adult smokers using e-cigarettes have successfully given up smoking, compared with 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 18 percent of smokers who quit stayed cigarette-free after a year, compared to 9.9 percent who used nicotine replacement therapies.

But e-cigarettes have undoubtedly still harmed public health. The focus of most lawmakers and several public health stakeholders has been the appeal of vapes 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 vaped regularly and mostly used flavored products.

Several lawmakers and attorneys general have urged the FDA to ban all flavors of e-cigarettes, including menthol, because of their appeal to teenagers. The agency has already banned the sale of reusable flavored e-cigarettes like those once sold by Juul. But it still allows single-use products to be sold with flavor.

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

Others argue that even the smaller players in the e-cigarette industry are not as altruistic as they seem. “It’s hard to feel sorry for companies that haven’t even tried to obey the rules,” said Desmond Jenson, an attorney at the Public Health Law Center at the Mitchell Hamline School of Law who focuses on commercial tobacco policy .

“Nobody has tried to file applications or legally market these products [before now], no one has filed a motion to legally enforce modified risk claims, ”he added. “The whole idea that e-cigarettes are a weaning device – why hasn’t a company filed a drug application to say it was a weaning device?”

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

“If you have e-cigarettes in the market, smokers have a legal option,” said Eric Lindblom, a former officer with the FDA’s Center for Tobacco Products and now a senior scientist at Georgetown University Law Center.

“Personally, I would like to see more alternatives approved in the market for many different companies,” said Mike Cummings, professor of psychiatry at the Medical University of South Carolina. Alternatives acceptable to current smokers to quit smoking could be a public health tool. But, he said, “You can not have arbitrary” [FDA] Approvals. ”

Regardless of the FDA’s final decision on e-cigarettes, some parties will be furious. “I can’t see the FDA threading a needle here that won’t lead to a lawsuit,” said Jenson. “It’s kind of impossible.”

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