The Trump administration made official Thursday its plans to implement heightened — and controversial — restrictions on most flavored electronic cigarettes by early February.
The Food and Drug Administration confirmed the regulatory change that was cited anonymously Tuesday by administration officials and hinted at by President Donald Trump.
The agency would eliminate all cartridge electronic-cigarette flavorings except for tobacco and menthol — those that are legal in traditional cigarettes.
The FDA is providing manufacturers of cartridge-based e-cigarettes, such as Juul Labs Inc., R.J. Reynolds Vapor Co., NJoy and Fontem Ventures, with just 30 days to stop making, distributing and selling “unauthorized flavorings” or risk enforcement actions.
“The United States has never seen an epidemic of substance use arise as quickly as our current epidemic of youth use of e-cigarettes,” HHS Secretary Alex Azar said in a statement.
“HHS is taking a comprehensive, aggressive approach to enforcing the law passed by Congress, under which no e-cigarettes are currently on the market legally.”
The FDA said these products have been available at retail since August 2016 “as an exercise of its enforcement discretion.”
FDA Commissioner Dr. Stephen Hahn said federal regulators will review the use of tobacco and menthol flavorings by underage individuals — those under age 21 since Dec. 20 — and will be prepared “to take additional restrictive actions.”
The 30-day countdown goes into effect once the FDA’s notice is published in the Federal Register, likely early next week.
The countdown appears to affect tobacco and vape shops that make their own nicotine liquids for open-pod e-cigarettes. Some vaping advocates have said the premarket application process is too costly and too cumbersome for most vape shops.
“A vape shop that is in the business of manufacturing, by mixing nicotine and flavors, has a decision that it has to make about what business it wants to be in going forward,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.
“If they are involved in the manufacturing process, they are subject to the law.”
Lyle Beckwith, senior vice president of government relations for the National Association of Convenience Stores, said that “our initial feeling is that while the open-pod flavors will not be a priority enforcement, any vape shop that mixes flavors will have to apply by May 12” or go out of business.
The FDA said for manufacturers and vape shops that submit premarket applications for their e-cigarette and vaping products by a court-ordered May 12 deadline, those products would be allowed to stay on the market for what is projected to be a 12-month review process from the time of submission.
The premarket standard requires the FDA to consider products’ existing risks and benefits to the population as a whole, including users and non-users, particularly as it compares with traditional cigarettes.
“Importantly, the FDA’s enforcement priorities are not a ‘ban’ on flavored or cartridge-based ENDS,” the FDA said. If a product meets the premarket stands, “then the FDA could authorize that product for sale.”
The original Vuse version by R.J. Reynolds Vapor Co. is the No. 2 selling e-cigarette. Its current flavors are tobacco, menthol, mint, rich tobacco, chai, crema, fusion, tropical, mixed berry, melon and nectar.
Unlike Juul, which limited itself to menthol and tobacco flavors in November, Reynolds has not voluntarily removed any of its flavors.
Reynolds Vapor entered the FDA’s regulatory gauntlet Oct. 11 with its submission for premarket approval of multiple Vuse e-cigarette products. The FDA said Nov. 30 it would review whether Vuse can claim it is a lower-risk tobacco product.
It is not clear whether a flavored e-cigarette other than menthol and tobacco can remain in the marketplace past early February if it is already part of a premarket application, or it would have to removed and then return once it is included in a premarket application submission.
Reynolds spokeswoman Kaelan Hollon said Thursday the company “is well positioned to submit applications for the remaining Vuse portfolio ahead of the deadline of May 12.”
“We have submitted a (premarket application) for multiple Vuse products, which includes several flavors. The FDA guidance provided today is clear that flavors can return to the entire marketplace once they have been cleared through the (premarket) process.”
Jack Bowles. chief executive of British American Tobacco Plc, said in a statement that "we have long said it is not the marketing of these products per se that is the concern; it is the irresponsible marketing of them that should be robustly addressed.
"For us, smart regulatory frameworks partnered with responsible marketing and appropriate enforcement will ensure the sustainability of adult consumer choice across all categories.”
"We are confident that, as required by the (premarket) process, all Vuse products will be shown to be appropriate for the protection of public health," Bowles said.
Federal health officials have said they view the nicotine liquids in open-pod vaping systems as a lower regulatory priority in part because those products have been of limited appeal to date to underage individuals, and in part because those outlets have been viewed as being better at enforcing age restrictions than other retail outlets, including convenience stores.
“This move will allow thousands of small businesses to remain open, but short-term exemptions will mean little without long-term reforms at the FDA,” said Gregory Conley, president of American Vaping Association. “We are now 130 days away from the exact class of vaping products President Trump exempted from his ban — open tank systems — being banned because of the sky-high costs associated with Obama-era rules the FDA is retroactively enforcing on vaping companies.”
The 30-day deadline also affects all electronic nicotine delivery products where manufacturers have failed to adequately put into place measures to prevent underage use, or products determined to target underage users or promote use of these products by those underage.
Azer said the regulatory changes serve to strike a balance “by prioritizing enforcement against the products that are most widely used by children and by maintaining e-cigarettes as a potential off-ramp for adults using combustible tobacco while ensuring these products don’t provide an on-ramp to nicotine addiction for our youth.”
Fontem Ventures, maker of blu eCigs brand, continues to sell sweeter flavors, including honeymoon, neon dream, blue ice and melon time.
Juul, maker of the controversial top-selling e-cigarette, said Nov. 7 that it had reduced its flavorings to Virginia tobacco, classic tobacco and menthol flavorings — the same flavors allowed for traditional cigarettes. It ceased online sales of its mint pod products and halted orders from retailers and wholesalers.
In November 2018, Juul stopped selling its creme, cucumber, fruit and mango flavorings at retail outlets, but kept them available via age-verification requirements on its website.
“The evidence indicates that if menthol e-cigarettes are left on the market, kids will shift to them,” Myers said. “Decades of experience with menthol cigarettes demonstrate that menthol appeals to kids — in fact, over half of current youth smokers smoke menthol cigarettes.”
Myers claimed Juul would “exploit this menthol loophole by reclassifying its popular mint products as menthol.”
FDA officials said they would monitor any attempts to sell current mint flavors as menthol.