With vaping products increasingly popular among youth and more than three dozen vaping-related deaths to date, the Trump administration may—or may not—be getting closer to moving forward with a ban on flavored vaping products first announced in September.
Last week, Trump told reporters, “We’re talking about the age, we’re talking about flavors, [and] we’re talking about keeping people working.”
According to CDC data, the rate at which middle and high school students are using e-cigarettes is rapidly rising, from 3.6 million in 2018 to 5.3 million in 2019. And the popularity of e-cigarettes far outweighs that of traditional cigarettes.
In 2018, 8.1% of high school tobacco users reported smoking cigarettes, compared with the 20.8% who reported using e-cigarettes. This popularity among teens is attributed to the wide variety of vaping flavors available.
“The FDA has known for decades that menthol and other flavors make it easier for kids to begin using and continuing to use tobacco products,” Lauren Lempert, a law and policy specialist at the Center for Tobacco Control Research & Education at UC San Francisco, told Fortune. “Prohibiting flavors would be effective to make e-cigarettes less appealing to kids.”
Traditional cigarettes are responsible for 500,000 deaths in the U.S. each year, according to the FDA, but flavored tobacco products, like menthol cigarettes, are not on the chopping block. And the reason is simple: They are exempt—at least for now.
Menthol Cigarettes Can Only Be Regulated
The FDA didn’t begin regulating the tobacco industry until 2009, when the Obama administration signed the Family Smoking Prevention and Tobacco Control Act (TCA) into law. The law gave the FDA the authority to regulate the manufacture, distribution, and marketing of tobacco products and led to the creation of the Center for Tobacco Products at the FDA. It also prohibited the FDA from banning tobacco and nicotine outright.
While the law left the door open for future flavored tobacco products to be banned, existing tobacco and cigarette products would not be subject to the new regulations, meaning that the agency could only review products that were introduced to market post-2007. Menthol was first added to cigarettes in the 1920s.
But with teen tobacco use on the decline, experts now worry that electronic nicotine delivery systems, or ENDS, are raising the prospect of a new generation of kids addicted to nicotine, who might later transition to traditional tobacco products, like menthol cigarettes.
“The interest in regulating ENDS is coming from the shocking wakeup call of more than 1,000 serious lung injuries and several dozen deaths, including in young people,” explained Dr. Joshua Sharfstein, vice dean for public health practice and community engagement at Johns Hopkins University and a former FDA deputy commissioner. “But it also reflects deep concern that millions of youth are now addicted to nicotine because of these products.”
By 2011, the FDA announced that it would include e-cigarettes under the umbrella of tobacco products regulated by the TCA, but it took until 2014 for the FDA to propose any regulations for the products. That meant that while the FDA legally had the authority to regulate e-cigarettes (as they appeared on the market late enough in 2007), no vaping products were actually reviewed before they hit the shelves. After two years of public comment, the FDA issued its final rule on the matter in 2016.
Lempert notes that while the FDA has had the authority to regulate flavors in tobacco products since 2009, and in e-cigarettes since 2016, the agency hasn’t taken any measurable steps in doing so. “FDA’s failure to act on flavors has contributed greatly to youth tobacco use, especially e-cigarette use,” she said.
“FDA has failed to use its regulatory authority, leaving e-cigarettes on the market with, to first approximation, no regulations,” Lempert explained. “So while companies are required to undergo rigorous FDA reviews before being permitted to market new sunscreen products, companies have been free to sell and aggressively market e-cigs and other new tobacco products to kids and adults without any regard to their health impacts.”
The Moving Goalpost of E-Cig Regulations
Effective Aug. 8, 2016, it immediately became illegal to sell e-cigarettes or other ENDS to anyone under the age of 18. The sale of all other tobacco products, including menthol cigarettes, were already limited to those 18 and older.
The 2016 rule also defined the process for pre-market review of any products that were not on the market as of Feb. 15, 2007. This process gives the FDA “the ability to evaluate important factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users.”
The rule initially stipulated that manufacturers would have up to two years to continue selling their product while they submit the application, and an additional year while the FDA reviewed it. In practice, however, that hasn’t been the case.
Companies have largely failed to comply with the requirements, and FDA enforcement of the rule has been inconsistent to date. Trump’s then-FDA Commissioner Scott Gottlieb granted a four-year reprieve to e-cigarette companies in 2017, giving them until 2021 to submit products for review. In July of this year, a federal judge in Maryland moved the deadline up to May 2020, but then a vaping industry group filed a suit in August to move back the deadline.
“Some companies are making unauthorized claims that their e-cigarettes are effective to help adults quit smoking (which have not been demonstrated and are illegal unless and until the company first obtains authorization from FDA to make such claims, which no product has obtained except for Swedish Match Snus),” Lempert said. “However, there has been no evidence demonstrating that mango- and unicorn poop- flavored products are necessary to help adult smokers quit. So prohibiting kid-popular flavors is a no-brainer approach to begin tackling the youth e-cig problem.”
Despite or perhaps due to the moving goalpost of e-cigarette regulations, a number of cities and states have attempted unilateral moves to restrict vaping products—and menthol cigarettes.
States Take On Flavored E-Cigs—And Tobacco
Last November, the FDA proposed banning menthol-flavored cigarettes due to their appeal to teen smokers. No action has yet been taken on the national level, but cities and states are stepping in.
On Wednesday, the Massachusetts House voted to ban the sale of flavored vaping and tobacco products, including menthol cigarettes. Colorado will ban menthol cigarettes effective January 1. In September, Michigan became the first state to ban flavored e-cigarettes, followed by New York, Oregon, Rhode Island, and Washington.
San Francisco banned menthol cigarettes and other flavored tobacco products in 2018 and became the first city to ban the sale and distribution of e-cigarettes in June, with a number of other cities following suit. The city of Sacramento, Calif., will ban all flavored tobacco, including menthol cigarettes, effective January 1. Yet some of these efforts have already faced their own legal hurdles, with New York’s ban, for example, already blocked.
Meanwhile, Lempert notes that while the ordinance in San Francisco, for example, has been deemed a “ban,” in actuality it seeks only to prohibit sales of vaping products that have not been authorized by the FDA. “If and when a company obtains FDA authorization to sell their product, they will be permitted to sell it in San Francisco.”
Any kind of national regulation—ban or otherwise—appears subject to the whims of the White House for the time being.
Signaling he might consider walking back plans to outright ban vaping flavors, Trump said this week that he planned to meet with pro-vaping advocates and medical professionals “to come up with an acceptable solution to the Vaping and E-cigarette dilemma.”
Trump is expected to make an official announcement on flavored vaping regulations this week.
Appearing before the Senate Committee on Health, Education, Labor and Pensions on Wednesday, director of the FDA’s Center for Tobacco Products Mitch Zeller referred questions to the White House.
“We are in a deliberative process,” Zeller said. “The White House made an announcement in September, and we are working to advance a policy consistent with taking steps to do everything that we can to protect kids from these products.”
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