The FDA said Wednesday that it has issued more than 1,300 warning letters and fines to retailers that illegally sold e-cigarette products to minors during a national sting operation at brick-and-mortar and online stores this summer.
Five of the biggest e-cigarette manufacturers - JUUL, Vuse, MarkTen, blu e-cigs, and Logic - must also report to the agency within 60 days with plans to address the concerns, or face penalties, it said. Gottlieb is talking about reneging on the FDA's four-year extension of the deadline for seeking regulatory approval to continue selling e-cigarettes, which would wreak havoc with a market that he concedes has great potential for reducing smoking-related disease and death.
"I have grown increasingly concerned around what we see as rising youth use in these products, and I'm disappointed in the actions the companies have taken to try to address this", Gottlieb said in an interview.
Today's announcement is part of a series of product standards the agency will roll out as part of their Youth Tobacco Prevention Plan, which they launched earlier this year.
Studies show that teens who vape are also more likely to go on to smoke traditional burned cigarettes.
The appeal of e-cigarettes to teens is widespread and has raised alarms in other countries, including the UK.
Under regulations developed by the Obama administration, manufacturers were supposed to submit most products for review by August 2018.
The FDA also warned e-cigarette companies that they have 60 days to show they can keep their products away from kids or risk being taken off store shelves. The FDA's delay on that requirement has allowed the industry to flourish with little oversight.
Shares of British American Tobacco were up almost 6 percent and shares of cigarette-maker Imperial Brands PLC were up more than 3 percent.
The owners of Vuse, MarkTen XL, Blu and Logic did not immediately respond to requests for comment.
E-cigarettes are battery-powered devices that heat a nicotine liquid into a vapor that can be inhaled. Regulators said it was the largest coordinated crackdown in the agency's history. We think right now we can step into this market with a combination of enforcement actions against the places that we know kids are getting access to these products, which includes retail establishments that are selling them without putting proper restrictions in place or without carding minors, as well as the online sites, where we think that there are a straw purchases being made, where - where someone's going online, buying a lot of these products, and then reselling them to kids. If the FDA sees continued underage use as an argument for banning e-cigarettes, the industry is doomed, even though it offers what the agency recognizes as "an alternative for adult smokers who still seek access to satisfying levels of nicotine, but without all of the harmful effects that come from combustion". But it added that "appropriate flavors play an important role in helping adult smokers switch", spokeswoman Victoria Davis said.
In April the agency launched a Youth Tobacco Prevention Plan, created to address some of the known public health risks, such as flavors, that contribute to adolescent use of e-cigarettes.