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NEW YORK – The director of the US Food and Drug Administration on Wednesday told Juul and other electronic cigarette manufacturers that they should show in the next two months how they will keep the devices out of reach of young people .
Noting an "epidemic" push for the use of electronic cigarettes among teens, FDA Commissioner Dr. Scott Gottlieb warned that the FDA could force companies to change their sales and marketing practices; stop distributing products to retailers selling to children; and remove flavored electronic cigarette products from the marketplace.
"I use the word epidemic with great care," Gottlieb said. "E-cigarettes have become an almost ubiquitous – and dangerous – trend among teenagers. The worrying and accelerated use trajectory we see in young people and the path to addiction must stop. It's just not tolerable.
Juul, MarkTen, Vuse, Blu and Logic control 97% of the e-cigarette market, the FDA said. Over the next 60 days, the FDA plans to investigate the marketing and sales practices of the five electronic cigarette companies, with possible "field inspections," Gottlieb said.
The agency will also increase federal enforcement measures regarding sales of electronic cigarettes to minors in convenience stores and other retail sites, Gottlieb said. On Wednesday, she announced a "historic action" against more than 1,300 retailers who illegally sold Juul and other electronic cigarettes to minors during the crackdown on retailers this summer. Gottlieb called the action a greater coordinated coercive effort in the agency's history.
The FDA will also closely examine "straw purchases," in which adults visit online stores and buy wholesale to sell to minors. Federal law prohibits the sale of electronic cigarettes to persons under 18 years of age.
"If young adults go online and buy 100 units of a product for sale to teens, this activity should be easy to identify for a product manufacturer," Gottlieb said. If the manufacturers are not willing to do the research, the FDA will do it for them, with the appropriate consequences.
"Let me be clear: everything is on the table," Gottlieb said. "This includes the resources of our tools of civil and criminal repression."
A generation addicted?
Electronic cigarette manufacturers argue that the devices help adult smokers quit smoking – potentially saving them from related diseases – by giving them a dose of nicotine that is smoke and odor free from combustible cigarettes. The scientific consensus, however, is still about the long-term effects of steam.
The FDA has recognized the impact that its actions could have on adults who are trying to quit smoking, said Gottlieb, but new research on how flavored products encourage excessive use by young people show that we must act.
According to the FDA, more than 2 million high school and high school students were current users of e-cigarettes in 2017, and e-cigarettes were the most popular tobacco products used by young people. According to the US Centers for Disease Control and Prevention, young people are more likely than adults to take revenge.
"I will be clear. The FDA will not allow a generation of young people to become nicotine addicted to allow adults to have unlimited access to these same products, "Gottlieb said Wednesday.
"We are particularly focused on flavored electronic cigarettes. And we are seriously considering a policy change that would lead to the immediate removal of these flavored products from the market. "
Juul Labs, which controls about 70% of the market, said in its statement that "the appropriate flavors" play a role in changing smoking habits among adults, but add that they "commit to preventing minor use of our product and we want to be part of the solution to keep electronic cigarettes out of reach of young people.
Several other manufacturers targeted by the FDA – MarkTen, Vuse, Blu and Logic – have also issued statements recognizing the need to limit access to minors and announcing their willingness to work with the FDA to find a solution.
The Vapor Technology Association, which represents more than 600 manufacturers and distributors of vaping, also supports limiting teen access, but adds that new FDA actions have "ventured into dangerous territory."
In a statement, VTA Executive Director Tony Abboud asked, "Does the FDA really want millions of Americans to start smoking cigarettes again?
A change of plan
Last year, the FDA announced that it would delay regulations that could have put an end to sales of many electronic cigarettes. Instead, the agency granted extensions until August 2022 to new and existing vaping products. The agency said it was allowing additional time to strike a proper balance between regulation and encouraging the development of innovative tobacco products that could help older smokers quit smoking.
At this time of overtime, Gottlieb said Wednesday that the agency did not anticipate the teenage drinking epidemic that has become one of the plan's biggest challenges.
"Today, we can see that this addictive epidemic has emerged when we announced our plan last summer," Gottlieb said. "The setback and the data we have now reveal these trends."
As Wednesday's action did not change the current regulatory review timeline for 2022, some said the agency's action was insufficient.
"We need to go further," said Michael Bloomberg, the billionaire philanthropist who has worked for years to reduce smoking.
"The FDA should immediately take steps to regulate flavored electronic cigarettes, instead of waiting until 2022, as it expects to do now," Bloomberg said in a statement.
The Campaign for Tobacco-Free Children also called for more action.
In a statement, Campaign Chairman Matthew Myers said the FDA action would only be a turning point if it "reverses its policy and demands that all of these products be reviewed now, not in four years ".
Dr. Barbara McAneny, of the American Medical Association, also said the FDA could do much more, promising that the association "would continue to advocate for tougher policies."
US Senate Democrat Senator Dick Durbin and Republican Senator Lisa Murkowski have also called on the FDA to put an end to delays. In a statement, they called for support for their bipartite legislation, passed in July, which would ban flavored cigars and impose stringent controls on electronic fruit juice flavors.
FDA shares up to now
In April, the agency launched a youth smoking prevention plan designed to address some of the known public health risks, such as flavors, that contribute to teens' consumption of electronic cigarettes. .
Shortly after the launch, the FDA cracked down on e-liquids marketed to look like child-friendly foods like juice boxes, candies and cookies. As part of today's action, the agency sent 12 additional warning letters to 12 other companies that continue to sell the products.
The FDA also targeted Juul retailers this spring, issuing 56 warning letters and six civil monetary penalties. Today's effort marks this action, becoming, said Gottlieb, "the largest coordinated initiative ever against violent sales in the history of the FDA."
The agency plans to unveil a new e-cigarette public education campaign next week and will soon announce greater access to new nicotine replacement therapies to help more adult smokers quit smoking.
The-CNN-Wire
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