FDA Threatens to Stop Sales of Flavored E-Cigarettes

FDA puts e-cig makers on notice

US government considers ban on flavored e-cigarettes over youth 'epidemic'

Food and Drug Administration issued a stern warning Wednesday to the makers of electronic cigarettes: Control the "epidemic" use by teens or the products will be banned for everyone.

"We must do more to stem what I see as an epidemic of use of e-cigs among teens, and deeply disturbing trends that show no sign of abating", he said.

'We won't allow the current trends in youth access and use to continue, even if it means putting limits in place that reduce adult uptake of these products, ' Gottlieb said.

Gottlieb announced the agency sent 1,100 warning letters to stores for the illegal sale of e-cigarettes to minors under the age of 18, and issued 131 fines to stores that continued to violate the restrictions on sales to minors.

Under Wednesday's announcement, the five largest e-cigarette manufacturers will have 60 days to produce plans to stop underage use of their products.

The agency is giving makers of some of the most prevalent vaping devices 60 days to submit plans showing they can keep their products away from teens. The agency may also ban sales of some flavored e-cigarette products, which Gottlieb says are particularly appealing to underage users, and consider shortening a grace period that now gives e-cigarette companies until 2022 to apply for FDA approval. The FDA said more than two million middle school and high school students used e-cigarettes past year.

The appeal of e-cigarettes is that users are said to inhale far fewer toxins than cigarette smokers.

A report by the National Academy of Sciences, Engineering, and Medicine that was released in January said that while e-cigarettes aren't free of health risks, they are likely to be less risky than regular cigarettes.

Despite the fact that not one person casted a vote for Gottlieb, his board at the FDA has the future of flavored e-cigarettes in their hands.

"Our mission is to improve the lives of adult smokers by providing them with a true alternative to combustible cigarettes", Juul said in a statement.

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It's bad for business when regulators target one of your fastest-growing products - unless they also go after a competitor working to put you out of business.

Almost all e-cigarettes contain nicotine, and research shows that young adults who smoke or who use e-cigarettes are much more likely to binge drink than nonsmokers, the health department said. "They must demonstrate they're truly committed to keeping their products out of the hands of kids".

The team found that the nicotine concentrations in Juul and similar products ranged from 21.8 mg/mL to 56.2 mg/mL - significantly higher than what is seen with other e-cigarette technologies.

On Wednesday, Gottlieb criticized e-cigarette companies' handling of the underage use problem, saying they approached it as "a public relations challenge rather than seriously considering their legal obligations".

The San Francisco-based company sold $1.29 billion in vape kits and nicotine pods over the 12 months ended August 11 - more than half of the $2.31 billion for the entire category, according to Nielsen data compiled by Wells Fargo analyst Bonnie Herzog. "Appropriate flavors play an important role in helping adult smokers switch", the company said.

Since the surge in teen use of the products began, the FDA and Juul have battled over the products consistently.

The penalties follow a summer-long "undercover blitz" of both traditional and online stores in what the Food and Drug Administration called "the largest coordinated enforcement effort" in its history.

In his remarks to FDA staffers, Gottlieb acknowledged that some adults might get hurt by a crackdown on flavored e-cigarettes.

"The way that e-cigarettes are marketed, they are really are marketed to naive users of tobacco products and they're also marketed to younger people", Kirshenbaum said.

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