The Trump administration announced plans Wednesday to in response to an "epidemic" rise in e-cigarette use among youth and increasing reports of vaping-related illness and death.
Within the next few weeks, FDA officials will finalize a compliance policy that would result in the withdrawal of non-tobacco flavored e-cigarette products, including mint and menthol products, from the market pending approval through the premarket authorization process, according to Health and Human Services (HHS) Secretary Alex Azar.
"The Trump Administration is making it clear that we intend to clear the market of flavored c-cigarettes to reverse the deeply concerning epidemic of youth e-cigarette use that is impacting children, families, schools and communities. We will not stand idly by as these products become an on-ramp to combustible cigarettes or nicotine addiction for a generation of youth," Azar said in a statement.
An earlier plan to ban most flavored e-cigarette liquids was put in place last March by then-FDA Commissioner Scott Gottlieb, MD, with . But that prohibition wouldn't go into effect until August 2021, and it excepted mint and menthol flavorings pending more study by the agency.
Administration officials didn't say when the more comprehensive ban would take effect. "The FDA plans to share more on the specific details of the plan and its implementation soon," the HHS statement said.
The policy change comes as new preliminary data from a national survey of youth tobacco use shows that e-cigarette use among middle-school and high-school students continued to skyrocket for the second straight year. Data from the 2018 National Youth Tobacco Survey (NYTS) showed a roughly 80% increase in e-cigarette use among high-school students nationwide and a 48% rise among middle schoolers. New NYTS survey data are expected to become public in the coming weeks.
President Trump and first lady Melania Trump met with Azar and FDA Acting Commissioner Ned Sharpless, MD, on Wednesday to discuss efforts to curb youth e-cigarette use.
Trump told reporters gathered in the Oval Office that the government can't allow the nation's youth to be affected.
"A lot of people think vaping is wonderful, it's great. It's really not wonderful," Trump said. "I think we can say definitely it's not a wonderful thing. It has big problems and we have to find out the extent of the problem."
Last week, Michigan became the first state in the country to . New York governor Andrew Cuomo earlier in the week amid growing health concerns, and bans are also under consideration in other states, including Massachusetts and California.
Health groups applauded the Trump administration's announcement of a possible ban on flavored cigarettes Wednesday afternoon, and they also called out the nation's leading e-cigarette seller, JUUL Labs.
"JUUL and other e-cigarette companies have preyed upon youth and adolescents with million-dollar marketing campaigns and thousands of appealing flavors that are proven to attract kids," American Heart Association CEO Nancy Brown said in a statement. "These companies did this knowing that nicotine is an addictive drug that rewires the developing brain and poses significant health risks to e-cigarette users."
Campaign for Tobacco Free Kids president Matthew Myers called the Trump administration's announcement "a necessary and long-overdue step to address the epidemic of youth e-cigarette use" in the U.S.
"It has taken far too long to stop JUUL and other e-cigarette companies from targeting our nation's kids with sweet-flavored, nicotine-loaded products that are addicting a new generation and threaten decades of progress in reducing youth tobacco use," Myers said in a statement.
JUUL Labs did not respond to 鶹ý's request for comment on the Trump administration announcement.
As of this week, six deaths and around 500 cases of respiratory illness believed to be related to vaping have been reported in the U.S. Most cases reported vaping products containing tetrahydrocannabinol (THC), either acquired legally or illegally, but some cases reported vaping only nicotine products.
No cases of illness have been specifically linked to JUUL or any other commercially available e-cigarettes containing nicotine only.
But these products also remain largely unregulated, and many new products have entered the market illegally.
As of early August 2016, all electronic nicotine delivery systems (ENDS) products were required to file premarket tobacco product applications within two years to the FDA.
"ENDS products currently on the market are not being legally marketed and are subject to government action," the HHS said in a press statement released Wednesday afternoon. "The compliance policy the FDA anticipates announcing in the coming weeks will outline enforcement policy addressing non-tobacco-flavored e-cigarette products that lack premarket authorization moving forward."