On Wednesday, the commissioner of Food and Drug Administration, Scott Gottlieb declared that youth vaping is an “epidemic,” and also said to the the agency that he will halt sales of flavored electronic cigarettes if the major manufacturers can’t prove they are doing enough to keep them out of the hands of children and teens.
The FDA also said that it is giving a time of 60 days to the manufacturers of Juul, Vuse, MarkTen XL, Blu, and Logic to submit their plans to prevent youth vaping. FDA also added saying that if the agencies don’t think their plans go far enough, it could order their flavored products off the market as these five brands make up more than 97 percent of the U.S. market for e-cigarettes.
Gottlieb informed to the sources, “The FDA is “reconsidering our overall approach” after a review of preliminary data on youth vaping.”Teenagers are becoming regular users, and the proportion of regular users is increasing. We’re going to have to take actions.”
He also added to up saying, “No one can look at the data and say there’s no problem.”
As per the 2017 National Youth Tobacco Survey, more than 2 million middle school, high school, and college students use the battery-powered devices to heat liquid-based nicotine into an inhalable vapor. E-cigarettes are by far the most popular tobacco product among teens. It constitutes nearly 12 percent of high school students and 3 percent of middle school students used the device in the past 30 days.
The new approach of FDA is much faster than the rulemaking process the agency announced in March. The brands will no longer be largely immune from regulations simply because they were already on the market in August 2016 when the FDA announced e-cigarettes would be regulated like other tobacco products.
Companies whose products were ordered off the shelves would have to show they have a net positive public health benefit before resuming with their sales.
The FDA also announced the results of its largest enforcement effort yet against e-cigarettes. The agency targeted more than 1,300 online and brick-and-mortar retailers with warning letters or civil penalties for selling to minors. Officials said 131 of the retailers will have to pay penalties.
Last month, Gottlieb told our sources that the FDA was weighing the benefits of flavored e-cigarettes in helping adults quit smoking against the risk to young people who become addicted to tobacco through vaping.
Many adults prefer flavored e-liquid when they are trying to quit. However, Gottlieb said that he is ready to make vaping less attractive to adults if it reduces the harm to teens.
Gottlieb said the agency could also target “cartridge-based products” such as the USB-sized Juul, which is favored by teens and sold in convenience stores. Adults tend to use bulkier “open tank” vaping products, he noted.
Juul CEO Kevin Burns has said restricting flavors “will negatively impact current adult smokers” who want to switch from smoking to vaping.
He said the company would support “reasonable regulation” to restrict advertising and the naming of flavors such as cotton candy and gummy bear that target children.
The FDA said Wednesday for the first time that some be e-cigarettes might be on the market illegally. Officials said they’re investigating some manufacturers for violating rules that require regulators’ approval to introduce new products after August 2016. They would not say which companies they are investigating.
The Campaign for Tobacco-Free Kids, the anti-tobacco group Truth Initiative and other groups said last month that several large companies, including the parent company of Phillip Morris, were violating the so-called deeming rules.