FDA on Thursday issued new guidance ordering companies to stop manufacturing, distributing, and selling certain cartridge-based, flavored e-cigarettes by early February, in response to a recent surge in youth use of the products.
Recent data from CDC's annual National Youth Tobacco Survey showed e-cigarettes were the most popular tobacco product used among middle and high school students for the sixth year in a row. According to the survey, 27.5% of high school students and 10.5% of middle school students in 2019 reported using e-cigarettes in the 30 days leading up to the survey. Further, data from a separate federal survey showed teens are most attracted to fruit- and mint-flavored e-cigarettes.
In response to rising e-cigarette use among youth, FDA last September said it intended to finalize a compliance policy to clear the market of unauthorized, non-tobacco-flavored e-cigarettes, including mint and menthol flavors.
Details of the new guidance
However, the final guidance FDA issued on Thursday does not go as far as the policy the agency had proposed in September. The new policy prohibits companies from selling unauthorized cartridge-based e-cigarettes with fruit, candy, mint, and dessert flavors. The policy does not apply to menthol and tobacco-flavored e-cigarette cartridges. In addition, the new policy doesn't apply to open-tank vaping systems, which typically are sold in age-restricted vape shops and commonly used by adults.
FDA in the guidance said the agency would take enforcement actions, including fines and seizures, against companies that do not comply with its order to cease manufacturing and distributing the affected products. The agency under the new guidance also will take enforcement actions against companies found to be promoting any vaping products to minors or failing to take steps to keep vaping products away from minors.
FDA officials said the policy will take effect 30 days after the guidance is published in the Federal Register, which they expect to occur early next week.
But FDA in a release stressed that the new policy will not implement a complete ban on flavored and cartridge-based e-cigarettes. The agency noted that it already has "accepted and begun review of several premarket applications for flavored [e-cigarette] products through the pathway that Congress established in the Tobacco Control Act." FDA added, "If a company can demonstrate to the FDA that a specific product meets the applicable standard set forth by Congress, including considering how the marketing of the product may affect youth initiation and use, then the FDA could authorize that product for sale."
Trump admin says new policy strikes 'right balance'
HHS Secretary Alex Azar on Thursday said the policy "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." Azar said the Trump administration decided to scale back FDA's initial proposal after data showed menthol-flavored e-cigarettes are less popular among teens than mint- and fruit-flavored products.
President Trump said, "We have to protect our families. At the same time, [the e-cigarette industry is] a big industry. We want to protect the industry."
Mitch Zeller, director of FDA's Center for Tobacco Products, said the agency under the new guidance will closely monitor e-cigarette manufacturers and retailers to determine whether the policy is sufficient to combat the rise in youth vaping.
Industry praises policy—but public health groups, Democratic lawmakers push back
Some vape-shop owners praised the scaled-back guidance. For example, Spike Babaian, owner of VapeNY in New York City, said, "We're thankful the guidance doesn't shut down flavors in every aspect."
But several Democratic lawmakers and public health groups criticized the guidance, saying the policy will not adequately address the youth vaping epidemic because teens who vape could switch to menthol-flavored products.
Sen. Jeff Merkley (D-Ore.) said, "I'm deeply disturbed that industry lobbyists were able to get … Trump to gut the ban on flavors that the FDA was belatedly planning."
Rep. Frank Pallone (D-N.J.) in a statement said the new guidance "falls far short" of what the administration had promised last September. "A so-called flavor ban that exempts menthol and vape shops is no ban at all. Unfortunately, the Trump administration caved to industry lobbying pressure and decided to prioritize politics over people's health," Pallone said.
Nancy Brown, CEO of the American Heart Association, said, "Big Tobacco's shameful record includes targeting youth and adults in minority and underserved populations with menthol products. Keeping menthol e-cigarettes on the market would enable the tobacco industry to extend a dangerous legacy that began with menthol cigarettes."
Sally Goza, president of the American Academy of Pediatrics, said she believes "leaving any [e-cigarette] flavor on the market is dangerous for children's health."
Matthew Myers, president of Tobacco-Free Kids, "We face a true public health crisis. This is a totally preventable crisis because we have solutions and first and foremost the solution is to sweep the market entirely of all flavored e-cigarettes" (McGinley, Washington Post, 1/2; Lupkin, "Shots," NPR, 1/2; Maloney/Burton, Wall Street Journal, 1/2; AP/New York Times, 1/2; Owermohle, Politico, 1/2; McGinley/Dawsey, Washington Post, 1/2; FDA release, 1/2).