FDA may ban flavored e-cigarettes, cites teen use 'epidemic'

FDA puts e-cig makers on notice

The Food and Drug Administration (FDA) declared teen e-cigarette use an epidemic today, threatening to slap manufacturers including Juul with crushing fines if they don't present plans to curb sales to minors.

Of the 3.6 million middle- and high-school students who said they are tobacco-product users, 2.1 million used e-cigarettes, according to the Centers for Disease Control and Prevention.

But Gottlieb acknowledged Wednesday that the agency failed to predict an "epidemic of addiction" among youth, mainly driven by flavored products.

"The disturbing and accelerating trajectory of use we're seeing in youth and the resulting path to addiction must end", Gottlieb told agency staffers and reporters.

However, Gottlieb claims e-cigarette brands haven't done enough to stop kids from using the products. 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 past year in the Monitoring the Future Study, which began in 1975. "It's that simple", Gottlieb said in a statement. "And every time, we ask", Lee said. He said in June tobacco companies "better step up and step up soon" but he didn't divulge what consequences the industry could face - until now. The agency will then determine whether the plans go far enough.

However, there is little consensus about how to regulate the industry. They're generally considered a less unsafe alternative to regular cigarettes.

As part of its plan of action to address the epidemic, the FDA also sent more than 1,300 warning letters to stores for the illegal sale of e-cigarettes to minors and issued another 131 civil money penalties to stores that continued to violate the restrictions on sales to minors. A government-commissioned report in January found "substantial evidence" that young people who use e-cigarettes are more likely to try cigarettes. The findings of this investigation have yet to be made public. "Hindsight, and the data now available to us, reveal these trends". Some experts were cautious about the results, however.

"I'll be clear. The FDA won't tolerate a whole generation of young people becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same products". His group and several others are suing the FDA over a decision to delay federal review of most e-cigarettes.

It has warned that most such products contain nicotine, which is addictive and can affect brain development. But previous year Gottlieb delayed the deadline until 2022, saying both the agency and industry needed more time to prepare. "They must demonstrate that they're truly committed to keeping these new products out of the hands of kids, and they must find a way to reverse this trend", Gottlieb said.

State health department officials continue to be anxious about JUUL, a device that looks like a flash drive, which they say dominates more than 70 percent of the e-cigarette market.

If the plans fall short, the FDA could block sales of the products by enforcing a requirement that companies provide detailed design and health data about their products before marketing them. But it's not clear how quickly the decision could be reversed.

The FDA is also targeting retailers who have sold e-cigarettes to minors.

Shares of Big Tobacco companies surged in trading Wednesday.

San Francisco-based Juul said it is working to prevent underage use of its products but added that flavors can help adult smokers quit.

Fontem Ventures, makers of blu, issued a similar statement.

Now, Gottlieb is coordinating the largest scale initiative to enforce regulations against selling e-cigarettes to-date.

In July 2017, the FDA said it was considering lowering nicotine levels in traditional cigarettes.

The FDA is trying to set up a framework for regulating e-cigarettes. "And they [teens] have adopted it", Gould said.

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