FDA cracks down

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FDA cracks down

September 12, 2018

Citing a “substantial increase” in youth vaping this year versus 2017, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb this morning announced new steps to address youth e-cigarette use.

The FDA gave five tobacco companies 60 days to submit plans describing how they will address youth access and use of their products.

The companies include Juul, Philip Morris, Fontem Ventures, British American Tobacco and Logic.

If the companies fail to comply they will have to go through a formal FDA review/approval process to re-enter the market.

In addition, the FDA issues 12 warning letters to online retailers that are selling misleadingly labeled and/or advertised e-liquids that resemble kid-friendly food products such as candy or cookies.

“We’re committed to the comprehensive approach to address addiction to nicotine that we announced last year. But at the same time, we see clear signs that youth use of electronic cigarettes has reached an epidemic proportion, and we must adjust certain aspects of our comprehensive strategy to stem this clear and present danger, said Gottlieb.

“This starts with the actions we’re taking today to crack down on retail sales of e-cigarettes to minors. We will also revisit our compliance policy that extended the dates for manufacturers of certain flavored e-cigarettes to submit applications for premarket authorization. I believe certain flavors are one of the principal drivers of the youth appeal of these products.

“While we remain committed to advancing policies that promote the potential of e-cigarettes to help adult smokers move away from combustible cigarettes, that work can’t come at the expense of kids. We cannot allow a whole new generation to become addicted to nicotine. In the coming weeks, we’ll take additional action under our Youth Tobacco Prevention Plan to immediately address the youth access to, and the appeal of, these products

“Today, we asked five e-cigarette manufacturers to put forward plans to immediately and substantially reverse these trends, or face a potential decision by the FDA to reconsider extending the compliance dates for submission of premarket applications. Our comprehensive plan on nicotine and tobacco regulation remains intact and we remain committed to its goals to reduce tobacco-related disease and death, including our efforts to reduce the nicotine in combustible products to render cigarettes minimally or non-addictive.

“We’re also fully committed to the concept that products that deliver nicotine exist on a continuum of risk, with combustible products representing the highest risk, and electronic nicotine delivery systems perhaps presenting 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. But in enabling a path for e-cigarettes to offer a potentially lower risk alternative for adult smokers, we won’t allow the current trends in youth access and use to continue, even if it means putting limits in place that reduce adult uptake of these products.”

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