FDA puts e-cigarette companies on notice over teen access

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

The FDA Is Considering Pulling Some Flavored E-Cigarettes From the Market to Fight 'Epidemic' of Youth Vaping

Federal officials called it a blitz - "the largest coordinated enforcement effort in the FDA's history" in response to concerns that e-cigarette use has become an "epidemic" among youths.

"We welcome FDA's action today and look forward to sharing our thoughts about how to prevent and reduce youth use, an issue we have focussed on for decades", Altria spokesman George Parman said in a statement. It's simply not tolerable.

"Today, we asked five e-cigarette manufacturers to put forward plans to immediately and substantially reverse these trends, or face a potential decision by the FDA to reconsider extending the compliance dates for submission of premarket applications", Gottlieb said.

The undercover investigation took place from June through the end of August, with the majority of violations involving the sale of products by the five manufacturers, which make up more than 97 percent of the USA e-cigarette market. The value of all sales reached $2.35 billion in 2016.

Erik Nesson, an associate economics professor at Ball State University, said the will have to tread carefully in its crackdown because restricting the use of e-cigarettes could cause adolescents to flock to traditional tobacco cigarettes. "But in closing the on-ramp for kids, we're going to have to narrow the on-ramp for adults". Former smokers who vape may return to traditional cigarettes if flavored e-cigarettes are no longer available.

"We're committed to the comprehensive approach to address addiction to nicotine that we announced previous year", he said.

The FDA issued more than 1,300 warnings and fines to retailers over the past three months, accused of illegally selling e-cigarette products to minors- among them were 16 Arizona locations. Appropriate flavors play an important role in helping adult smokers switch.

The FDA moves come as it seeks to balance its approach on e-cigarettes, which can be used to wean lifelong smokers onto less harmful nicotine products, but also risk drawing a new generation to nicotine addiction. Many researchers say the devices are less unsafe than traditional, combustible cigarettes because they don't contain tobacco's cancer-causing ingredients. And, you know, you've got to remember e-cigarettes - you know, they're thought to be safer than regular cigarettes, but they're not totally safe. "These five brands now comprise over 97 percent of the USA market for e-cigarettes", the FDA said.

"I believe certain flavors are one of the principal drivers of the youth appeal of these products", Gottlieb said.




"The action FDA threatened to "consider" using against the manufacturers of five e-cigarette brands - removing certain products that are clearly aimed at youth from the market - is the very authority the American Lung Association has urged the FDA to actively use, broadly".

Chris Hansen, president of the American Cancer Society Cancer Action Network, lamented the delay, as well as the years it took for the FDA to implement regulations following the 2009 law that provided it with new powers.

Makers argue that e-cigarettes can help adult smokers transition away from burnt tobacco products.

The agency's latest action follows a sting operation in the spring that targeted businesses selling JUUL brand e-cigarette products to minors, which resulted in more than 60 warning letters and fines.

The FDA is trying to set up a framework for regulating e-cigarettes.

Data from the Centers for Disease Control and Prevention indicate that e-cigarettes have become the tobacco product of choice among middle and high school students.

He also notes that while many adults who use e-cigarettes report that these products helped them stop smoking combustible tobacco, "the benefits of vaping devices for cessation has not yet been borne out at the population level in clinical or observational studies".

Bottles of flavor packets for e-cigarettes stand displayed in a tobacco shop in New York on June 23, 2015.

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