FDA changes its e-cigarette tune


The Campaign for Tobacco Free Kids is calling on the FDA to match its strong words with equally strong action by requiring these changes and agency review of products already on the market for years.

FDADeclaring that "youth use of e-cigarettes is reaching epidemic proportions", the Food and Drug Administration today threatened to remove vaping products from the market unless their manufacturers come up with satisfactory plans to prevent underage consumption.

Last year, the FDA announced that it would delay regulations that could have halted the sales of many e-cigarettes. Although these products were the subject of the agency's action in May, they are no longer being sold with the offending label no advertised by the companies that received the letters in May.

The agency also has issued more than 135 No-Tobacco-Sale Order Complaints, which can result in retailers being prohibited from selling tobacco products for specified periods of time.

Members of Congress, particularly Democrats, have been pressuring the FDA to address the trends in young people's use of e-cigarettes, and Wednesday's announcement was met with praise by lawmakers such as Illinois Democratic Sen.

But FDA commissioner Scott Gottlieb says the agency did not predict an "epidemic of addiction" among youth, mainly driven by flavored products.

E-cigarettes have become the tobacco product most commonly used by American adolescents. "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". "Appropriate flavors play an important role in helping adult smokers switch", Burns said. "And they [teens] have adopted it", Gould said.

The FDA is trying to set up a framework for regulating e-cigarettes. "We're going to have to take actions".

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Dr Gottlieb acknowledged that the toughened approach would force "hard trade-offs" when it comes to promoting e-cigarettes to adults.

According to the company's website, the mission of JUUL products is to improve the lives of the world's 1 billion adult smokers. Flavored e-cigarettes are said to be a tool that helps adults quit smoking traditional cigarettes, the main example of a plus the product can claim. Youth tobacco prevention is a priority for our companies.

The agency said it plans to unveil a new e-cigarette public education campaign targeted to youth next week, and will soon announce wider access to new nicotine replacement therapies to help more adult smokers quit cigarettes.

If the FDA isn't happy with the responses, it will reconsider whether it will continue to allow those e-cigarette products on the market before the companies file applications with the FDA.

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

The FDA also said that it is giving a time of 60 days to the manufacturers of Juul, Vuse, MarkTen XL, Blu, and Logic to submit their plans to prevent youth vaping. Other big players are owned by big tobacco conglomerates; Camel parent British American Tobacco makes Vuse e-cigarettes, and Marlboro parent Altria makes MarkTen e-cigarettes. And a 2016 report from the Office of the Surgeon General warned that nicotine could interfere with healthy brain development during adolescence, especially in regions related to attention, learning and impulse control.

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.

"I have grown increasingly concerned around what we see as rising youth use in these products, and I'm disappointed in the actions the companies have taken to try to address this", Gottlieb said at a press briefing.