US health officials say teenage use of e-cigarette has reached "epidemic" levels and are calling on the industry to address the problem or risk having their flavored products pulled off the market.
According to the FDA, e-cigarettes have become the most common tobacco product used by teens in the past two years.
Gottlieb says the five largest e-cigarette manufacturers will have 60 days to produce plans to immediately reverse underage use of their products.
Since 2017, FDA officials have discussed e-cigarettes as a potential tool to ween adult smokers off cigarettes.
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As regulators threatened to pull e-cigarettes from shelves if they do not address "widespread" teen use, shares of Altria Group Inc. Juul, a private company, represents 72 percent of sales, according to Nielsen data compiled by Wells Fargo analyst Bonnie.
Makers argue that e-cigarettes can help adult smokers transition away from burnt tobacco products. "We can not allow a whole new generation to become addicted to nicotine".
"They come out with cherry flavored vodka and birthday cake flavored vodka".
"If they fail to do so, or if the plans do not appropriately address this issue, the FDA will consider whether it would be appropriate to revisit the current policy that results in these products remaining on the market without a marketing order from the agency", the FDA said in a press release.
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The FDA said Wednesday that it has issued more than 1,300 warning letters and fines to retailers that illegally sold e-cigarette products to minors during a national sting operation at brick-and-mortar and online stores this summer. "We are committed to preventing underage use of our product, and we want to be part of the solution in keeping e-cigarettes out of the hands of young people", Juul spokesperson Victoria Davis said in a statement provided to TIME. Gottlieb would be on much firmer ethical ground if he took the opposite position: In trying to stop teenagers from vaping, we won't deny adult smokers access to products that could save their lives. More generally, the FDA wants Juul and the other companies to contemplate "the particular youth appeal of their products", which involves features, such as style and convenience, that adults also happen to like.
It will also "re-visit" the policy it announced a year ago, which gave e-cigarette companies more time to apply for regulatory approval. In 2016, the agency "deemed" that products such as e-cigarettes also were under its jurisdiction and told companies to file applications to market their products by August 2018. It is also illegal for retail merchants to sell e-cigarette products to youth under age 18. "Appropriate flavors play an important role in helping adult smokers switch", Burns said in a statement.
"Given the market's overarching concerns about Juul's impact on cigarettes, especially Marlboro, we think a potential "ban" on Juul would be positive for MO", Herzog wrote.
While applauding the FDA for today's actions, some said the agency should increase its efforts to protect the nation's youth from the dangers of vaping. Earlier this year, as criticism of the company mounted, it committed $30 million over the next three years for independent research, youth and parent education and community engagement. We must factor in whether these products get kids addicted to nicotine.
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The FDA's regulation of tobacco products has always been marked by twists and turns and years of debate.