WASHINGTON, D.C. — The US Food and Drug Administration announced on Thursday a plan to clear the market of most flavors for cartridge-based e-cigarettes in the United States.
Under the new policy, vape companies will have 30 days from when the policy publishes in the federal register to stop manufacturing, distributing and selling flavored cartridge-based e-cigarettes, other than tobacco or menthol, the US Department of Health and Human Services announced on Thursday.
The policy will not apply to flavored products for open tank systems that are sold in vape shops. Cartridge-based e-cigarettes have been popular among youth.
“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 is taking a comprehensive, aggressive approach to enforcing the law passed by Congress, under which no e-cigarettes are currently on the market legally,” HHS Secretary Alex Azar said in Thursday’s announcement.
“By prioritizing enforcement against the products that are most widely used by children, our action today seeks to strike the right public health balance 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. We will not stand idly by as this crisis among America’s youth grows and evolves, and we will continue monitoring the situation and take further actions as necessary,” he said.
Moving forward, manufacturers that wish to market any vape products, including flavored e-cigarettes or e-liquids, must submit an application to the FDA for premarket authorization of their products. After May 12, the FDA intends to issue enforcement against any vape products that continue to be sold and for which the manufacturers have not submitted a premarket application, according to the HHS announcement.
To date, no e-cigarette products have been authorized by the FDA.
The announcement noted that by prioritizing enforcement against cartridge-based products and not other flavored vape products, the FDA has attempted to “balance” the public health concerns related to the youth use of vape products with considerations regarding adult users who may vape to try to quit smoking.
CNN has contacted the Vapor Technology Association, a trade group that represents e-liquid manufacturers, vape shops and other vaping professionals, for comment.
Since raising the tobacco buying age to 21 last month, this is the Trump administration’s latest move to address youth vaping — and the move has been months in the making.
Trump administration officials announced in September that the FDA would try to curb a youth vaping epidemic by stripping all flavors except tobacco from the market.
Vaping advocates have argued that a flavor sales ban would curtail some adult smokers’ efforts to quit, put small vaping companies out of business and eliminate jobs. A Trump campaign adviser previously told CNN that Trump’s political aides have warned him that such a ban may not be helpful with his base and that he should reconsider.
Some lawmakers, health advocates and parents groups now are expressing concern about how the new policy is a scaled-back version of the administration’s original plan.
“Today the Trump administration failed to take the strong action necessary to address the youth e-cigarette epidemic. The guidance could have been a meaningful victory for children’s health and instead is a major missed opportunity that will still leave young people at risk for addiction,” Dr. Sally Goza, president of the American Academy of Pediatrics, said in a statement Thursday. “Science shows us that flavors lure children in and this guidance will allow thousands of flavors — like mango, grape, and green apple — to stay on the market in vape shops across the country for use in refillable vaping devices. As a pediatrician, I know that children like flavored products. We give children flavored medicines because they taste better. But adding a flavor to a dangerous product like tobacco is a recipe for disaster.”
Rep. Nita Lowey, chair of the House Appropriations Committee, said in a statement on Thursday, “Watering down the flavor ban, limiting restrictions to pods, and allowing menthol to continue to be sold will fuel a new generation’s addiction to nicotine and cause countless harmful side effects.
“Sadly, the Administration is again rewarding special interests rather than protecting the health and well-being of Americans.”
Gary Reedy, CEO of the American Cancer Society and American Cancer Society Cancer Action Network, called the FDA’s decision to clear the marketplace of most but not all flavored e-cigarettes “unconscionable.”
“Instead of moving forward with an effective proposal that could have a meaningful effect in curbing the youth e-cigarette epidemic, we once again have a hollowed-out policy that will allow the tobacco industry to continue to attract kids to a lifetime of nicotine addiction,” Reedy said in a written statement on Thursday.
“In the limited locations where most flavors will be prohibited, we will now have a situation that provides a path for more youth users to continue to use or migrate toward menthol flavored e-cigarettes. Menthol is a derivative of mint, and there is little difference between these flavors,” he said in part. “The American Cancer Society Cancer Action Network urges the Department of Health and Human Services, in coordination with the FDA, to reconsider its finalized guidance.”