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US health officials are sounding the alarm about the use of electronic cigarettes among teens, calling the outbreak problem and ordering manufacturers to reverse the trend or risk that their flavored vaping products are withdrawn from the market.
The warning from the Food and Drug Administration, released on Wednesday, cited recent data indicating a sharp increase in the use of devices by minors, including Juul, Vuse and others.
This marks a change in the agency's tone on e-cigarettes. Since 2017, FDA Commissioner Scott Gottlieb has discussed e-cigarettes as a potential tool to deter adult smokers from smoking, although this benefit has not been proven.
But Gottlieb said in a speech at FDA headquarters that he had failed to predict the current epidemic of youth addiction, mainly due to flavored products.
"The worrying and accelerated trajectory of use we see in youth and the path to addiction must stop," Gottlieb told agency staff and reporters.
The FDA has stated that it remains committed to exploring e-cigarettes as a less harmful alternative for adult smokers, but Gottlieb added that "this work can not be done to the detriment of children."
Electronic cigarettes are vapor-emitting devices that have become a multi-billion dollar industry in the United States, despite little research on their long-term effects, including their ability to help smokers quit. They are generally considered a less dangerous alternative to conventional cigarettes. But health officials have warned that nicotine in e-cigarettes is harmful for brain development.
They usually contain nicotine and sometimes aromas such as fruit, mint or chocolate.
Health advocates worry about the popularity of vaping products in children and the potential impact on smoking rates in the future. A report commissioned by the government in January found "substantial evidence" that young people who use e-cigarettes are more likely to try cigarettes.
Gottlieb has quoted unpublished federal figures that he says will be made public in the coming months.
"We have not foreseen the magnitude of what has become one of our greatest challenges," he said in prepared remarks. "The setback and the data we have now fully reveal these trends."
In June, a government study found that teenage vape use seemed to hold up last year. Some experts have been cautious about the results. According to analysts' estimates, they noted that the investigation did not specifically focus on Juul, an elegant and heavily marketed electronic cigarette brand that exploded in the market and accounts for 70% of sales in the United States.
"I think it has become clear to the FDA that if they do not care about this issue, the use of these products by children across the country would undo decades of progress," said Matthew Myers of the Campaign for children without tobacco. His group and several others are suing the FDA for having decided to postpone the federal review of most e-cigarettes.
According to regulations developed by the Obama administration, manufacturers had to submit most of the products for review by August 2018. But last year, Gottlieb had postponed the deadline until 2022, claiming that the agency and the industry needed more time to prepare.
The decision has been criticized by advocates for the cause of smokers who say that electronic cigarette manufacturers are targeting kids with candy and marketing flavors that portray their products as flashy portable gadgets.
In Wednesday's announcement, the top five manufacturers of electronic cigarettes will have 60 days to develop plans to end the minor use of their products. The companies sell Vuse, Blu, Juul, MarkTen XL and Logic electronic cigarette brands, which account for 97% of US electronic cigarette sales, according to the FDA.
If plans fail, the FDA could block product sales by requiring companies to provide detailed design and health data for their products before marketing them. The delay by the FDA in this regard has allowed the industry to thrive with little oversight. But the speed with which the decision could be reversed is unclear.
Wells Fargo analyst Bonnie Herzog said Juul was the most at risk brand of FDA crackdown and a potential ban on the company's products would boost Altria and other cigarette manufacturers selling also electronic cigarettes.
Shares of major tobacco companies rose sharply on Wednesday. Altria Group Inc. and British American Tobacco Plc recorded the largest gain in a day in about a decade.
Juul, based in San Francisco, said he was working to prevent the use of his products by minors, but added that the flavors could help adult smokers quit smoking.
"By working together, we think we can help adult smokers while preventing access to minors," the company said in a statement.
The FDA has also announced 1,300 warning letters and fines to online and traditional stores that illegally sold Juul and other electronic cigarettes to minors. Regulators said it was the biggest coordinated crackdown in the agency's history.
The FDA is launching a major anti-smoking initiative to help smokers quit smoking by reducing nicotine levels in regular cigarettes. As part of this plan, Gottlieb suggested that some smokers could be referred to alternative products that deliver nicotine without the carcinogens of cigarettes. These products could include electronic cigarettes, even though the FDA has not given any company permission to advertise its device as a smoking cessation aid.
On Wednesday, Gottlieb criticized the way electronic cigarette companies were dealing with the problem of using minors, saying they had addressed it as "a public relations challenge rather than seriously considering their legal obligations."
"I am here to tell them today that this prior approach is over," he said.
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