WASH/LA-The Food and Drug Administration said on September 12-they are considering a ban on flavored e-cigarettes in response to an "epidemic" of young people using e-cigarettes, the agency's leader said. 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.
"They come out with cherry flavored vodka and birthday cake flavored vodka".
"We see clear signs that youth use of electronic cigarettes has reached an epidemic proportion", Gottlieb said.
Now, I will say we do think the e-cigarettes offer a viable alternative for adult smokers.
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 government agency has ordered five leading brands, including Juul, which has 72% of the market as of mid-August, according to Wells Fargo, as well as BAT's Vuse, Altria's MarkTen, Imperial's Blue E-cigs and Japan Tobacco's Logic, to submit plans within 60 days detailing how they will combat excessive teen use of their products. The FDA took the largest enforcement action against more than 1,300 retailers and five manufacturers of selling e-cigarettes on Wednesday.
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The health department said 19 percent of high school students use e-cigarettes.
Much of the FDA's sharp change in course is a result of the phenomenal success of Juul, which looks like a USB flash drive.
Fontem Ventures, makers of blu, issued a similar statement. The FDA may also limit the sale of certain flavored products, Gottlieb said.
Those broader recommendations would constrain the ability of e-cigarette companies to reach adult smokers and make ENDS less appealing to them.
"We as a company focus on mature marketing and we are not in the business to sell to kids".
MarkTen's flavors, for example, include "menthol", "classic", and "summer blend", while Juul's flavors have included "fruit medley" and "creme brulee", recently shortened to "fruit" and "creme".
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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. The agency issued 12 warning letters to companies they declared have deceptive marketing labels on e-liquids.
"We can not allow a whole new generation to become addicted to nicotine", he said.
"JUUL Labs will work proactively with FDA in response to its request", said Kevin Burns, JUUL's CEO. Despite the constant warnings that increased experimentation with e-cigarettes would lead to more smoking, consumption of conventional cigarettes by teenagers stubbornly continues to decline, reaching a record low previous year in the Monitoring the Future Study, which began in 1975.
Failing to do so, or making unsatisfactory efforts, "could mean requiring these brands to remove some or all of their flavored products that may be contributing to the rise in youth use from the market until they receive premarket authorization and otherwise meet all of their obligations under the law", the FDA statement says. But "the youth risk is paramount", he said.
Logic Technology Development, owned by Japan Tobacco Inc, said it will demonstrate to the FDA "that Logic markets its products only to adults".
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