FDA Gets Tough on Juul, Other E-Cigarette Makers

Modesto Morganelli
Settembre 13, 2018

In a speech at FDA headquarters, Commissioner Scott Gottlieb said the agency would also revisit a policy that extended the dates for some manufacturers of flavored e-cigarettes to get FDA approval before selling their products.

"I now have good reason to believe that it's reached nothing short of an epidemic proportion of growth", Gottlieb said.

Gottlieb said the FDA recognized the impact this might have on adults trying to stop smoking, but said that emerging research on how flavored products encourage excessive use by young people shows action must be taken.

Shares of British American Tobacco, which owns the Vuse brand, closed up almost 6 percent, while shares of cigarette-maker Imperial Brands PLC, which owns Blu, rose more than 3 percent. "These products are new and there are other chemicals in the electronic products you are inhaling and putting in your lungs and with these products there are concerns that it could damage your DNA, may lead to respiratory cancers after using these products for years and years", Delaney said. British American, which produces Camel cigarettes, climbed as much as 6.4 percent in London, the biggest intraday increase in 10 years.

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

"This could result in a bullet through the head of Juul, the driver of youth initiation", said Nico von Stackelberg, an analyst with Liberum in London, told the news agency. He declined to disclose the evidence.

The five brands account for 97 per cent of e-cigarette sales in the United States.

"There is no question that a lot of the youth use is being driven by Juul", Gottlieb said.

The Juul in particular resembles a USB drive, making it easy for teenagers to hide and even bring to school. Those products could include e-cigarettes, though the FDA has not given any company permission to advertise its device as a quit-smoking aid. Otherwise, the FDA could require the tobacco makers to stop selling the flavored products that appealed to children.

Those broader recommendations would constrain the ability of e-cigarette companies to reach adult smokers and make ENDS less appealing to them. "Appropriate flavors play an important role in helping adult smokers switch".

Fontem Ventures, makers of blu, issued a similar statement. Regulators said it was the largest coordinated crackdown in the agency's history.

Since 2017, FDA officials have discussed e-cigarettes as a potential tool to ween adult smokers off cigarettes.

He said the vaping industry had not taken prior warnings seriously. 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". In addition, the agency pushed back until 2022 a deadline for electronic-cigarette companies to submit applications to the FDA.

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.

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