The Food and Drug Administration (FDA) is giving vaping companies 60 days to figure out how to reverse what it's calling an epidemic of youth usage, or risk having some of their products potentially pulled from the market.
In a speech at FDA headquarters, Commissioner Scott Gottlieb said the agency would also revisit its compliance policy that extended the dates for manufacturers of flavored e-cigarettes to submit applications for premarket authorization.
The FDA is also targeting retailers who have sold e-cigarettes to minors.
"I use the word epidemic with great care".
Manufacturers offer and market e-cigarette flavors that appeal to minors, including candy, bubble gum and fruit flavors.
Last year, the FDA announced that it would delay regulations that could have halted the sales of many e-cigarettes.
The agency is now demanding plans to reign in youth-targeted marketing campaigns and control illegal sales of their products to minors from Juul and four other e-cigarette makers within 60 days.
Gottlieb said that e-cigarette manufacturers have been given ample time to change their ways.
Investors in Juul's competitors appeared to welcome the FDA announcement.
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Following the news, shares of Altria, which owns the MarkTen brand, surged more than 7%, and British American Tobacco, which owns Vuse and Logic brands, jumped more than 6%. His group and several others are suing the FDA over a decision to delay federal review of most e-cigarettes. 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.
She said Altria could be well positioned because it has a long history of dealing with youth access to its products and has "limited/mature flavor profiles relative to Juul". 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.
At that time, Gottlieb said, the agency didn't foresee the "epidemic'"of adolescent use that has become one of the plan's biggest challenges".
The FDA's suggestions include rigorous age verification procedures for online direct sales (which Juul, the market leader, says it already has) and "discontinuing sales to retail establishments that have been subject to an FDA civil monetary penalty for sale of tobacco products to minors within the prior 12 months".
"The FDA will not tolerate a whole generation of young people becoming addicted to nicotine as a trade-off for enabling adults to have unfettered access to these same products", he said. "Appropriate flavors play an important role in helping adult smokers switch", Burns said in a statement.
The FDA said it remains committed to exploring e-cigarettes as a less-harmful alternative for adult smokers, but Gottlieb added "that work can't come at the expense of kids".
In a release, the FDA said it's taking "historic action" against companies that it believes promotes use and addiction of their products to young vapers. 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.
A nationwide sting operation from June through August resulted in more than 1,300 warning letters and fines to retailers who sold Juul products and other e-cigarettes to kids.