FDA chief threatens to take e-cigarettes out of the market
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By Maggie Fox
Food and Drug Administration Commission Dr. Scott Gottlieb threatened his most direct threat to e-cigarette companies on Friday and said they were facing a " existential threat "If they do not stop marketing to youth.
Gottlieb said he was appalled by the recent rapid growth in youth wars. He called out the most popular product ̵[ads1]1; Juul-by name and said his efforts to make businesses voluntarily call back on candy-tasting and heavy-handed marketing techniques didn't have much effort.
The FDA has the ability to stop e-cigarette sales and force decision makers to go through the formal FDA approval process. The Agency has not yet done so, much to the disappointment of groups such as the Campaign for Tobacco Free Kids, the American Heart Association and the American Cancer Society Cancer Action Network.
Gottlieb said he is ready to do so.
"I tell you this. If youth use continues to rise and we see significant increases in use in 2019, on top of the dramatic increase in 2018, the whole category will face an existential threat," he said at a meeting. [19659007] "It gets the game over to these products until they can successfully cross the regulatory process. "
There is little debate that vaping has hit record highs among children and teenagers. In November, the figures from the Centers for Disease Control and Prevention found an increase of 78 percent in secondary school guns, with 3.6 million secondary and mid-sized students now using e-cigarettes.
Gottlieb said he has met several times with the gun industry. "I find myself discussing with the tobacco makers and retailers the benefits of selling fruity flavors in ways that remain readily available to children," he said. 19659007] In November last year, Gottlieb said he started the process of limiting the sale of flavored e-cigarettes, as well as banning menthol in flammable cigarettes.
"I have questions about whether they live up to the very modest promises they made, "It is important that e-cig makers cannot respect even modest, voluntary commitments they have made to the FDA."
Gottlieb spoke in a hearing intended amle suggestions on how to help young people already rely on nicotine in e-cigarettes. Most experts agree that there is not much evidence of what can work, although several said it is important to help teens with anxiety and social pressure that go together with vaping.
But Dr. Susanne Tanski, pediatrician and former chair of the American Academy of Pediatrics Tobacco Consortium, said that even the question was distracting from the more immediate problem of keeping vapes away from teenagers and children.
"We all have to realize that if a youth has developed a nicotine addiction as a result of Vaping, we have already failed," Tanski told the hearing, held at the FDA headquarters outside of Washington, DC
"Where we are, it is big and they are addictive. "
" The FDA's recently announced regulatory action on e-cigarettes does not go far enough and we encourage much stronger action. Strong tobacco control policies aimed at keeping tempting products away from youth can be more effective at achieving youth cessation t he medical intervention, "she added.
"Unfortunately, there is hardly any data on how to treat an adolescent with e-cigarette addiction. As it stands today, there is no single randomized controlled trial that has tested strategies to help teenagers quit e-cigarettes, and there is a significant need for research in this area. We simply do not know if our traditional approach to cigarette interruption will apply to youth weapon interruptions. "
It will take years before the studies are completed that answer the question of what works for Helping people rely on e-cigarettes, often living nicotine in large doses and in formulations that can make them even more addictive than traditional cigarettes.
"The FDA is asking the wrong question," Lauren Lempert, a researcher at the University of California San Francisco Center for Tobacco Research and Education. "E-cigarettes are recreational products, not drugs. Let's face it – kids think e-cigarettes are cool and they use them as recreational products."
Lempert said the FDA should focus on stopping youth from using e-cigarettes in at all.
"The FDA should fulfill its legal mandate and immediately withdraw from the market any non-pre-approved e-cigarettes," she said. "They should ban all Internet sales of e-cigarettes." Age verification schemes don't work, she said and teenagers find ways to buy vapes online.
Let's face it – kids think e-cigarettes are cool and they use them as recreational products. "
Dr. Bonnie Halpern-Felsher, studying youth e-cigarette use at Stanford Children's Health, agreed on all sales of flavored vape products, should be eliminated." There is no evidence that adults need these flavors to quit smoking, "said Halpern-Felsher to the meeting.
But she said the FDA also helps mud the waters by saying that e-cigarettes are safer than flammable tobacco products." We must stop saying that Cigarettes are safe or safer and prevent e-cigarette companies from making these unauthorized risks, "she said." Youth hears them. We must stop saying that e-cigarettes help adults stop smoking when it is not clear that is the case. "
In addition, these statements confuse teenagers and children." It gives them the idea that they are therefore safe and easy to use, "she said.
Juul and other e-cigarette manufacturers have said they are working to keep Juul has launched an advertising campaign to point out that e-cigarettes are only for adults.
Lempert said it only makes vaping more seductive to teenagers. "Adult-only messages attract kids," "The tobacco industry has long used the forbidden fruit message to connect to new smokers," she said. "I feel we are living in the past," Anne DiGiulio of the American Lung Association said. "The E-cigarette companies are playing cigarette company games. playbook, "DiGiulio told NBC News." You see it with his advertising. You see it with appealing to children, tastes, everything. It is incredibly frustrating to see. "
Warnings on the packaging and in ads also do not work," said Halpern-Felsher. "Package warnings are not understood by youth," she said. She has studied teenagers, ask them what such warnings mean, and she said "Do not understand them correctly." Youth does not understand addiction, "she said." They do not understand that this means they will not be able to stop using these products at will. "
Smoking cessation experts say it takes time and is Don Seibert, who owns Smokenders in Birmingham, Alabama, says his program only has a success rate of 60 percent.
"The younger one starts using a tobacco product, the harder it is for them to quit," DiGiulio said. "We have a program to help the kids quit. But with this new epidemic, we need more than just counseling. "
RuthAnne McCormack of Rockville Center Coalition for Youth at Rockville, Long Island, said that the problem is not in order." Where we are, it is big and they are addicted, "she said.
" They begin as young as fourth grade, "she added." Although e-cigarette companies promised they would remove the fruit and other flavors, they are still available in our stores and those who sell them do not ask for ID. "
She asked the FDA to do something it could to help. "The kids tell me," I'm not addicted, "and they have dared for maybe five or six years," McCormack said. "They are agitated, they become anxious, they gets nervous, they can't sleep. They need help. Maggie Fox