At least until the end， the retail sale of cartridge-based flavorings for electronic cigarettes — with tobacco and menthol flavors the only exception.
The filing began a 30-day countdown — to Feb. 6 — for manufacturers of cartridge-based e-cigarettes, such as Juul Labs Inc., R.J. Reynolds Vapor Co., NJoy and Fontem Ventures, to stop making, distributing and selling “unauthorized flavorings,” or risk enforcement actions.
The countdown also began for retailers to stop selling the products by Feb. 6. Some retailers, such as Sheetz, have already notified customers that they will no longer be selling those products. Sheetz has posted flyers at its stores saying sales will end Feb. 1.
The menthol and tobacco flavors still allowed for cartridge electronic-cigarette flavorings are the same as those that are legal in traditional cigarettes.
“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,” U.S. Secretary of Health and Human Services Alex Azar said on Jan. 2.
The FDA said these products have been available at retail since August 2016 “as an exercise of its enforcement discretion.”
FDA Commissioner Stephen Hahn, a physician, said federal regulators will review the use of tobacco and menthol flavorings by underage individuals and will be prepared “to take additional restrictive actions.”
The FDA raised the legal smoking age from 18 to 21 on Dec. 20.
The FDA also said on Jan. 2 that makers of nicotine liquids, also known as e-liquid, for open-pod e-cigarettes are now considered as manufacturers, thus subject to a May 12 deadline for submitting a premarket application to the FDA.
The premarket standard requires the FDA to consider products’ existing risks and benefits to the population as a whole, including users and nonusers, particularly compared with traditional cigarettes.
The nicotine liquids for use with open-pod e-cigarettes will remain available for now in tobacco and vape shops — in large part because FDA and other Trump administration officials believe that those products don’t appeal to people under 21 and that those shops are more responsible about verifying ages than other retail outlets.
Pro-vaping advocates have complained that for most vape shops the premarket application process is too costly — estimated to be between $500,000 and several millions of dollars per application — and too cumbersome. They predict the majority of shops will go out of business shortly after the May 12 deadline unless Congress or the FDA amend the new regulatory requirements.
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.
For manufacturers that submit premarket applications, their 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.
“Importantly, the FDA’s enforcement priorities are not a ‘ban’ on flavored or cartridge-based ENDS,” the FDA said, using the acronym for electronic nicotine delivery system. If a product meets the premarket standards, “then the FDA could authorize that product for sale.”
The original Vuse version by Reynolds Vapor 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 on Nov. 30 it would review whether Vuse can claim it is a lower-risk tobacco product.
Reynolds spokeswoman Kaelan Hollon said on Jan. 2 that the company “is well-positioned to submit applications for the remaining Vuse portfolio ahead of the deadline of May 12.”
“The FDA guidance provided … is clear that flavors can return to the entire marketplace once they have been cleared through the (premarket) process,” Hollon said.
Federal health officials have said they view the nicotine liquids in open-pod vaping systems as a lower regulatory priority.
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 target underage users or promote the use of these products by those underages.
Azar 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.”
More about Flavored E-Cigarettes Ban:
- FDA Bans Mint and Fruit-Flavored Vaping Products but Exempts Menthol and Tobacco
- President Trump to Ban All E-Cigarette Pod Flavors Except Tobacco and Menthol
- India Bans All E-Cigarettes Citing Health Risks
- New York First State to Enact Ban of Flavored E-Cigarettes Amid Deaths Linked to Vaping
Source: WINSTON SALEN JOURNAL