FDA Threatens to Stop Sales of Flavored E-Cigarettes

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

Gottlieb said that around 97 percent of the products on the market were from the five brands it is now targeting: JUUL, Vuse, Blu, MarkTen and Logic.

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".

The more than 1,300 warning letters and fines to retailers that the FDA announced today were part of a large-scale, undercover nationwide blitz to crack down on the sale of e-cigarettes to minors at both brick-and-mortar and online retailers, which was conducted from June through the end of August.

In April, JUUL sent thousands of pages of records to be reviewed by the FDA - but apparently, it didn't bode well for the nicotine king. The agency is giving e-cigarette companies 60 days to come up with a plan for reducing use of their products among minors.

As of September 1, the FDA said it has conducted 978,290 retail inspections, issued 77,180 warning letters to retailers for violating the law, and initiated 18,560 civil money penalty cases in its checks of retail establishments selling tobacco products.

"While vaping devices have the potential to be disruptive to the combustible tobacco market, this can not be at the expense of increasing rates of nicotine addiction in young people", Ylioja said.

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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". Former smokers who vape may return to traditional cigarettes if flavored e-cigarettes are no longer available.

The FDA's moves come as the booming e-cig company Juul has been flagged by doctors, researchers and non-profits for health risks and deceptive marketing to attract minors. The FDA's four-year delay on that requirement has allowed the industry to flourish with little oversight.

"We're especially focused on the flavored e-cigarettes", said Gottlieb.

"This is potentially the most important step FDA has taken to curtail youth use of e-cigarettes", said the group's president, Matthew Myers.

Tobacco stocks surged after regulators threatened to pull e-cigarettes from shelves if manufacturers do not control "widespread" teen use.

Today more middle-and- high school students (over two million) are vaping than smoking tobacco cigarettes. The academy said Gottlieb has the authority to intervene in the market to protect minors, and any further delay runs the risk that "a generation of young people will become addicted to these unsafe products".

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The agency warned companies about labeling and flavors that attract or target kids, and about distributing products in easy-to-hide packages that could pass for candy.

The agency said it continues to check retail stores that sell tobacco, to ensure they are in compliance with federal laws. Altria Group Inc. and British American Tobacco Plc had the biggest one-day percentage gain in about a decade.

Kelli Cogan says her 15-year-old son was able to get free Juul cartridges online last year by using his father's name and birth name and having them shipped to a different address. If the blueprints don't promise to "substantially reverse" the youth-use trend, Gottlieb said the agency will consider steps that could lead to the temporary or permanent removal of flavored products from the market.

Responding to Gottlieb's announcement, JUUL Labs Chief Executive Officer Kevin Burns said the company "will work proactively with FDA in response to its request".

According to the company's website, the mission of JUUL products is to improve the lives of the world's 1 billion adult smokers.

The Centers for Disease Control and Prevention says that as e-cigarette advertising grows, use among youth grows, too.

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