In response to the recent CDC data on youth tobacco and e-cigarette usage, which reported a 78% increase in vaping among high schoolers and a 48% increase among middle schoolers, the FDA has proposed its strongest regulations of tobacco and electronic nicotine delivery systems (ENDS) to date.

In a press statement, FDA commissioner Scott Gottlieb, MD, called for the outright banning of menthol flavors in cigarettes and cigars, and proposed stricter rules on e-cigarettes to require direct point-of-sale for all flavored vaping products.

He noted the CDC data, specifically the fact that vaping increased by 1.5 million students from 2017 to 2018, and more than two-thirds (67.8%) are using flavored e-cigarettes.

“These data shock my conscience,” Gottlieb said in the statement. “These increases must stop. And the bottom line is this: I will not allow a generation of children to become addicted to nicotine through e-cigarettes.”

“…It’s clear that we must do more – specifically, several policy changes to target what appear to be the central problems – youth appeal and youth access to flavored tobacco products,” he added.

According to the statement, the FDA will require all flavored ENDS products (other than tobacco, mint and menthol flavors or non-flavored products) to be sold in age-restricted, in-person locations and, if sold online, under heightened practices for age verification.

Gottlieb said the changes will not include mint- and menthol-flavored ENDS, which he claimed are more popular with adults than with kids and may be important as a smoking cessation strategy for adult smokers.

At the same time, however, the FDA will seek to ban menthol in combustible tobacco products, and will ban all flavors in cigars.

[Read the full FDA statement here.]

Reaction to the FDA proposed rules has been mixed. While many health experts applaud the restrictions, they also question why it’s taken so long as well as the FDA’s decision to allow for industry feedback before implementing any regulations.

Specifically, the American Thoracic Society issued a statement that strongly supported the initial announcement, but said “more concrete action is needed.”

“While we regret it took the FDA so long to ban menthol and characterizing flavors in [cigarettes and cigars], the ATS congratulates the agency for finally taking bold action on flavorings.”

Their criticism was more pointed at the FDA’s decision not to ban the same flavors in e-cigarettes. “We are concerned that the FDA has not taken as bold an approach on e-cigarette products. … Limiting where these products can be sold is an incremental step. … To truly address youth e-cigarette use, we strongly urge the FDA to ban characterizing flavors in all e-cigarette products.”

“If the FDA has been aware of this information for months, why aren’t they taking concrete actions today?” said Harold Farber, MD, MSPH, chair of the Tobacco Action Committee of the ATS.  “The promised future regulatory action, while welcomed, seems to lack the urgency this public crisis requires.”

Of course, a proposed rule is hardly a rule, as an article by NBC News pointed out. According to that article, some expect “Big Tobacco” and “Big Vape” to hit back and scuttle the increased regulations.

“Anti-tobacco advocates know the agency faces an uphill battle … The agency threw the gauntlet down to three large industries: traditional Big Tobacco, a growing e-cigarette industry, and retailers. All can be expected to push back,” the NBC article reports.

The same article pointed out that two Big Tobacco members — Altria Group and Reynolds American — have already issued statements expressing concern about the proposed FDA rules.

The ATS, meanwhile, remained hopeful: “Commissioner Gottlieb, MD, has called the rise in youth e-cigarette use an epidemic. We agree. We hope today’s announcement is only the first of several actions the agency will take to reduce both the access and appeal of e-cigarettes to our nation’s youth.”