Vaping is receiving another nail in the cfin, this time as a directive from the FDA which has issued a policy today prioritizing enforcement against certain unauthorized flavored e-cigarette products that appeal to kids, including fruit and mint flavors.
Currently, there are no authorized flavored e-cigarette products. Enforcement the premarket authorization requirements set forth in August 2016 was deferred as “an exercise the FDA’s] enforcement discretion.” Now that underage vaping is apparently reaching epidemic levels, as the United States Department Health and Human Services calls it, FDA is resuming enforcement.
Under this policy, companies that do not cease manufacture, distribution and sale unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days (ending February 2, 2020) risk FDA enforcement actions.
“The United States has never seen an epidemic substance use arise as quickly as our current epidemic youth use 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,” said HHS Secretary Alex Azar. “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 f-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.”
According to the 2019 National Youth Tobacco Survey (NYTS) results on e-cigarette use, more than 5 million U.S. middle and high school students are current e-cigarette users (having used within the last 30 days) – with a majority reporting cartridge-based products as their usual brand.
Importantly, the FDA clarifies that this is not a ban on flavored or cartridge-based e-cigarettes. “The FDA has already accepted and begun review several premarket applications for flavored ENDS products through the pathway that Congress established in the Tobacco Control Act,” the press release states.
Juul, the most popular cartridge-based e-cigarette, already preemptively removed all fruit and mint varieties from their online store as well as physical retailers back in October and November 2019, respectively.