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The FDA is considering drugs to help children abandon weapons



There are no FDA-approved nicotine disruption products for e-cigarette users under the age of 18.

"A few years ago, it would have been incredible to me that we would be here today and discuss the potential for drug therapy to help dependent young people quit," said FDA commissioner Dr. Scott Gottlieb, who commented on the importance of continuing important FDA operations, such as Friday's hearing, despite the partial lapse in funding due to the federal government's closure.
In November, the agency announced that gunpowder increased by almost 80% among high school students and 50% among high school students since the previous year. Experts worry that the devices can endanger children's development brains, get them connected nicotine early in life and be a gateway to smoking and other drugs. But the long-term effects are not clear.

Almost no data & # 39; on Treatment of Children Connected

Medical experts say there is an urgent need for research into the use of treatments for treatment of nicotine-dependent children. Many healthcare providers are already using some off-label, such as nicotine rubber but without solid data on how well they work and how to best use it with advice and other resources.
According to experts, most of what we know about nicotine addiction in teenagers, we know from cigarettes. But weapons technology and chemistry can pose a completely different threat.
"These products deliver very high levels of nicotine, which means that even short experimentation is likely to put young people at risk of prolonged dependence," Dr. Susanne Tanski, former president of the American Academy of Pediatrics Tobacco Consortium, told the FDA on Friday.
  When your child vibrates, what should a parent do?

"Clinicians urgently need new solutions to safely and effectively help them stop using these and all tobacco products for good," said Tanski, also a pediatric lecturer at the Geisel School of Medicine in Dartmouth. "Unfortunately, there is hardly any data on how to treat a youth with e-cigarette addiction."

But some present believe that the FDA should have focused the hearing on preventing children from recording vapes in the first place.

"I think the FDA asked the wrong questions for today's meeting," said Lauren Lempert, a law and policy specialist for the Center for Tobacco Control Research and Education at the University of California, San Francisco.

Instead of discussing the role of nicotine replacement and drug therapy, the agency should "focus on policies that prevent youth initiation with e-cigarettes and nicotine addiction," Lempert CNN said in an email prior to the hearing.

In her statement to the FDA Friday, Tanski decided.

"Prevention of juvenile use in the first place should be the FDA's primary goal," she said. "We all have to admit that if a youth has developed a nicotine addiction due to vaping, we have already failed."

Could the regulation proceed?

Lempert said the FDA has a number of effective regulatory tools in its arsenal: it may require market research on e-cigarettes and tobacco products. It can regulate marketing and prohibit unauthorized claims from e-cig companies on health, safety and quit smoking. And it can ban all tastes.

Instead of requiring e-cigarettes to be approved by the FDA before being sold, the agency decided in 2017 that it would allow such products to remain on shelves until 2022 without market investigation. 19659008] #JUUL: How social media hyped nicotine for a new generation "data-src-mini =" // cdn.cnn.com/cnnnext/dam/assets/181205161629-juul-story-top-graphic-illustration-small- 169.jpg "data-src-xsmall =" // cdn.cnn.com/cnnnext/dam/assets/181205161629-juul-story-top-graphic-illustration-medium-plus-169.jpg "data-src-small = "http://cdn.cnn.com/cnnnext/dam/assets/181205161629-juul-story-top-graphic-illustration-large-169.jpg" data-src-medium = "// cdn.cnn.com /cnnnext/dam/assets/181205161629-juul-story-top-graphic-illustration-exlarge-169.jpg "data-src-large =" // cdn.cnn.com/cnnnext/dam/assets/181205161629-juul- story-top-graphic-illustration-super-169.jpg "data-src-full16x9 =" // cdn.cnn.com/cnnnext/dam/assets/181205161629-juul-story-top-graphic-illustration-full-169 .jpg "data-src-mini1x1 =" // cdn.cnn.com/cnnnext/dam/assets/181205161629-juul-story-top-graphic-illustration-small-11.jpg "data-demand-load =" not -loaded "data-eq-pts =" mini: 0, xsmall: 221, small: 308, medium: 461, large: 781 "src =" that a: image / gif; base64, R0lGODlhEAAJAJEAAAAAAP /////// wAAACH5BAEAAAIALAAAAAAQAAkAAAIKlI + py + 0Po5yUFQA7 "/>
Flavorings are at the heart of the legislative debate: Some say they are an important tool to make adults switch from flammable cigarettes while others want to ban them completely because they appeal to children and minimize how harmful and addictive vapes are perceived as being
Mark Anton, CEO of the Industrial Smokeless Alternatives Trade Association, told CNN that his group shares the goal of preventing children from using vapes, but does not think taste should be the goal.

"Flavorings have been for a long time," he told CNN prior to his presentation at the hearing. "You can't just give [the recent spike in youth use] a taste."

On the other hand, the health advocates say Gottlieb's November proposal, excluding some tastes, did not go far enough.

"There is no evidence that adults need these flavors to stop smoking," Bonnie Halpern-Felsher, founder and CEO of the Stanford Tobacco Prevention Toolkit, said at the hearing on Friday.
Halpern-Felsher's own research suggests that the majority of children who have tried pod-based e-cigarettes started with one who was flavored.

"All tastes must be removed," she said.

Generation of damage control & # 39;

Experts also called for the development of non-medical therapies.

Although medications may be important in some advanced cases of nicotine addiction to teenagers, experts say they are not enough; Children also need counseling to cope with urgency and combat being surrounded by e-cigarettes when in school and social events.

In the FDA hearing, a representative of a tobacco organization, Truth Initiative, promotes its text message-based quitting program.

Amanda Graham, Truth Initiative's senior vice president of innovation, said in a statement on Friday morning that "e-cigarette users do not identify as smokers. They have different barriers to quitting, and, especially when it comes to teenagers and young adults, many will have an anonymous way of continuing to quit without involving their parents or friends, which subtitles provide. "

" There is great demand for help to quit, "she said at the hearing . "We simply can't wait for science to catch up."

Smokefree Teen, a program from the National Cancer Institute, also has a smartphone app and SMS program aimed at teenagers.

Some of those who demand action at the FDA meeting were teenagers themselves.

Caleb Mintz, 17, and Phillip Fuhrman, 15, told the FDA how transparent weapons had become in their social circles and how it had affected their lives. The boy's mothers co-founded a group of lawyers last year, Parents against Vaping e-cigarettes.

Mintz feels it might be too late to prevent weapons among children of his age – now a "generation of damage control" said. His friends, who vape, can hardly knock it down for more than three days at a time, he added.

Previously, Fuhrman – who first tried Juul, the eighth-grade dominant e-brand – tried his dependency on him to spend large amounts of money on eBay, ultimately causing a great excitement at home. And he is far from alone: ​​

"I see so many of my friends who had the same problem I did … and have no idea how to stop it," said the 15-year-old.


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