If the companies do not respond to the agency's satisfaction, the FDA said, it will consider removing their products from stores. Former smokers who vape may return to traditional cigarettes if flavored e-cigarettes are no longer available.
A former Trump campaign strategist says the Food and Drug Administration (FDA) commissioner has "lost his mind" after he threatened to take all flavored e-cigarettes off the US market if retailers don't do more to control use among teens.
And some of the retailers that received warning letters are still advertising and selling these products, he said.
The Campaign for Tobacco-Free Kids said the steps announced by Gottlieb "have the potential to make a fundamental difference".
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.
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.
"The agency is asking each company to submit to FDA within 60 days plans describing how they will address the widespread youth access and use of their products", the FDA said in a release.
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.
The FDA is trying to set up a framework for regulating e-cigarettes.
The agency will furthermore be rising federal enforcement actions on e-cig gross sales to minors in convenience stores and other retail sites, Gottlieb said, and would explore closely at a alter to called "straw purchases", wherein adults search recommendation from internet-basically based mostly entirely stores and remove in bulk to resell to minors.
Dr. Gottlieb said his agency's aggressive posture may create obstacles for adults who use e-cigarettes as substitutes for traditional smokes, but he added that he is willing to pay that price to stop children from getting hooked on tobacco. Earlier this year, as criticism of the company mounted, it committed $30 million over the next three years for independent research, youth and parent education and community engagement.
Mr Gottlieb said the five largest e-cigarette manufacturers will have 60 days to produce plans to immediately reverse under-age use of their products. "In enabling a path for e-cigarettes to offer a potentially lower risk alternative for adult smokers", he says, "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".
Since 2017, FDA officials have discussed e-cigarettes as a potential tool to ween adult smokers off cigarettes. Juul takes up almost 71 percent of the entire e-cig market with its USB sized device that comes with single inserts containing the same amount of nicotine as an entire pack of cigarettes.
Gottlieb also signaled that his agency is prepared to take more sweeping steps. This is the largest single enforcement action in agency history. 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. We must factor in whether these products get kids addicted to nicotine.
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