The FDA moves come as it seeks to balance its approach on e-cigarettes, which can be used to wean lifelong smokers onto less harmful nicotine products, but also risk drawing a new generation to nicotine addiction. "And we're seriously considering a policy change that would lead to the immediate removal of these flavored products from the market".
It recognized the impact this might have on the use of these products by adults trying to stop smoking, but said that emerging research shows that action must be taken.
Youth vaping is an "epidemic", as far as the FDA is concerned, and if manufacturers don't submit "robust" plans to prevent kids from getting their hands on flavored e-cigarettes, the agency will take action-possibly going so far as to order the flavored products off the shelves. "We can not allow a whole new generation to become addicted to nicotine".
"This public campaign will bring these public health messages to online sites that we know teenagers access, and even to high school bathrooms", Gottlieb said.
In an effort to reverse that trend, the FDA on Wednesday sent letters to manufacturers of five e-cigarette brands often used by kids - Juul, Vuse, MarkTen XL, Blu and Logic - requesting that they draw up plans for limiting youth access to their products within 60 days. "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".
The Vapor Technology Association, which says it represents over 600 vaping manufacturers and distributors, also supports limiting teen access, but added that the new actions by the FDA ventured "into unsafe territory" by not being in the best interest of public health.
As of September 1, the FDA said it has conducted 978,290 retail inspections, issued 77,180 warning letters to retailers for violating the law, and initiated 18,560 civil money penalty cases in its checks of retail establishments selling tobacco products.
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Those broader recommendations would constrain the ability of e-cigarette companies to reach adult smokers and make ENDS less appealing to them. Regulators are considering restricting e-cigarette manufacturers from selling flavored nicotine liquid or forcing the products to undergo an agency review, as reported by CNBC.
"Let me be clear: Everything is on the table", said Gottlieb.
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San Francisco-based Juul said it is working to prevent underage use of its products but added that flavors can help adult smokers quit.
"Today we can see that this epidemic of addiction was emerging when we first announced our plan last summer", said Gottlieb. "Hindsight, and the data that's now available to us, fully reveal these trends". The agency issued 12 warning letters to companies that it says have deceptive marketing labels on e-liquids.
Gottlieb echoed those concerns, saying he's anxious about the effects of nicotine in e-cigarettes on the developing brain, and that a proportion of teenagers who use the devices will end up on regular cigarettes.
The FDA also targeted Juul retailers this spring, issuing 56 warning letters and six civil monetary penalties. But it added that "appropriate flavors play an important role in helping adult smokers switch", spokeswoman Victoria Davis said.