FDA acknowledges youth e-cigarette use has hit epidemic proportions
16 September, 2018, 13:18 | Author: Mary Valdez
The companies sell Vuse, Blu, Juul, MarkTen XL, and Logic e-cigarette brands, which account for 97 percent of USA e-cigarette sales, according to FDA.
FDA Commissioner Scott Gottlieb called the agency's steps the largest coordinated enforcement effort in his agency's history and said it was prompted by alarming new evidence that electronic cigarette use by minors has risen to levels he called "simply not tolerable".
A few of the producers centered by the FDA - Juul, MarkTen, Vuse, Blu and Common sense - issued statements agreeing with the wish to restrict access to minors and announcing their willingness to work with the FDA to reach a resolution.
The FDA requested that Juul and four other e-cigarette brands submit plans to "address widespread youth access and use of their products".
According to data published Wednesday, the FDA sent warning letters to 28 Arkansas retailers.
To gain clearance to return to the market, the companies would have to prove that the benefits to adults who use e-cigarettes to stop smoking outweigh the risks associated with youth vaping.
Budding research on e-cigarettes also suggests that these flavors contain terpenes that may be more damaging to the lungs than other flavors are.
Actions being considered - but not yet undertaken - include the immediate removal of certain flavored e-cigarettes from the market and shortening the time to market review for most cigarettes now being sold.
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Chris Hansen, president of the American Cancer Society Cancer Action Network, lamented the delay, as well as the years it took for the FDA to implement regulations following the 2009 law that provided it with new powers. The agency may require the companies to revise their sales and marketing practices, to stop distributing products to retailers that sell to kids and to stop selling some or all of their flavored e-cigarette products until the companies clear the application process. "I think education is the answer to fixing the problem, just like how we have educated young people about alcohol and other tobacco products over the years", Delaney said.
The FDA also plans to revisit its policy that extended the dates for manufacturers of certain flavored e-cigarettes to apply for premarket authorization.
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.
Despite the fact that they can not legally be sold to anyone under 18, e-cigarettes - hand-held vaporizers that create aerosols from liquids typically packed with nicotine and other chemicals, often including flavorings - are now the most popular tobacco product among high school students, recent federal data shows. The academy said Gottlieb has the authority to intervene in the market to protect minors, and any further delay runs the risk that "a generation of young people will become addicted to these unsafe products".
The companies say they are working with the FDA to prevent young people from using their devices. If the companies do not respond to the agency's satisfaction, the FDA said, it will consider removing their products from stores.
Juul e-cigs are available with 3 percent nicotine and 5 percent nicotine - about a much as pack of cigarettes, according to its website.
"Not a lot of people want to go to a tobacco flavor coming off tobacco", Villmer said with a smile.
The agency said it allowed the extra time to strike an appropriate balance between regulation and encouraging the development of innovative tobacco products that may help older smokers quit. Juul, a company that has become popular with teenagers has said they will "work proactively with the request". "Our mission is to improve the lives of adult smokers by providing them with a true alternative to combustible cigarettes".
Hurricane-force winds were blowing 80 miles from its centre, and tropical storm force winds reached up to 195 miles from the eye. Workers are being brought in from the Midwest and Florida to help in the storm's aftermath, it said.
Hurricane Florence , the Category 2 storm heading straight for my parents' SC house, has the country on high alert. Three feet of storm surge moving onto the coastline will result in higher tides and higher water moving onshore.
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Emergency officials warned residents that the peril had probably not passed, as the storm continued to dump torrential rain. Its top sustained winds have dropped to 70km/h and it's at a near standstill, moving west at just 6 km/h.
More than 80,000 people were already without power as the storm began buffeting the coast, and more than 12,000 were in shelters. He confirmed that due to rising waters, some people are waiting for rescue in their attics and on their roofs.
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The ocean waters that Florence is travelling over are about 2.7 degrees (1.5 degrees Celsius) warmer than normal, McNoldy said. Most manure pits could handle up to 25 inches of rain, Curliss said. "We've been very dry with hardly any rain in August".
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Nationwide, more than 1,245 flights have been cancelled through Friday , according to flight tracking site FlightAware.com. Overall, Florence is approximately400 miles in diameter, according to The Associated Press in a report on September 13.
The coastal area of SC features hundreds of inlets while North Carolina has barrier islands miles away from the mainland. More than 12,000 people were in shelters in North Carolina and 400 in Virginia, where the forecast was less dire.
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