The agency remains committed to the tobacco framework, Gottlieb told staffers Wednesday, but he acknowledged that it "didn't predict what I now believe is an epidemic of e-cigarette use among teenagers". It's simply not tolerable.
They also ordered five e-cigarette brands, including vaping giant JUUL, to submit plans to address teen use of their products.
Despite the fact that they can not legally be sold to anyone under 18, e-cigarettes - hand-held vaporizers that create aerosols from liquids typically packed with nicotine and other chemicals, often including flavorings - are now the most popular tobacco product among high school students, recent federal data shows.More news: Many fleeing to Jacksonville ahead of Hurricane Florence
Of the 3.6 million middle- and high-school students who said in 2017 they are current tobacco-product users, 2.1 million used e-cigarettes, according to the Centers for Disease Control and Prevention.
One manufacturer in the FDA's crosshairs, Juul Labs, said in a statement, "JUUL Labs will work proactively with FDA in response to its request".
The burgeoning popularity of e-cigarettes among young smokers has caused traditional cigarette industry players a great deal of trouble by eating into their market share. This is the largest single enforcement action in agency history. As part of today's action, the agency sent an additional 12 warning letters to another 12 companies that continue to sell the products.
"By working together, we believe we can help adult smokers while preventing access to minors", the company said in a statement. "The FDA won't tolerate a whole generation of young people becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same products".More news: China welcomes United States invitation for new round of trade talks
However, Gottlieb claims e-cigarette brands haven't done enough to stop kids from using the products.
"Far too many teens are being introduced at an early age to e-cigarettes", said Minnesota Education Commissioner Brenda Cassellius in the release.
"We're committed to the comprehensive approach to address addiction to nicotine that we announced previous year", Gottlieb said.
In addition, the FDA on Wednesday issued 12 warning letters to online retailers for selling misleadingly labeled and/or advertised e-liquids resembling kid-friendly food products such as candy and cookies. "It's now clear to me, that in closing the on-ramp to kids, we're going to have to narrow the off-ramp for adults who want to migrate off combustible tobacco and onto e-cigs". The agency will then determine whether the plans go far enough. Since past year, FDA commissioner Scott Gottlieb and other federal officials have discussed e-cigarettes as a potential tool to ween adult smokers off cigarettes, although that benefit hasn't been proven. Appropriate flavors play an important role in helping adult smokers switch. According to the NYTS, the incidence of past-month smoking among high school students fell from 15.8 percent in 2011 to 7.6 percent in 2017. Upon review, the FDA could require the firms to change their sales and marketing practices, stop distributing to retailers that sell to youth or halt the sale of some or all of their flavored e-cigarette products altogether until the companies clear the applications process.More news: Gov. Deal issues state of emergency ahead of storm - Updated Version
The FDA point out that, despite lacking tobacco and plenty of the nasties present in normal cigarettes, nicotine itself is hardly a benign substance.