FDA could crack down on vaping ‘epidemic’
Manufacturers required to submit ‘robust’ plans
Food and Drug Administration Commissioner Scott Gottlieb on Wednesday declared youth vaping an “epidemic,” and said the agency 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 says it’s giving manufacturers of Juul, Vuse, MarkTen XL, Blu and Logic 60 days to submit “robust” plans to prevent youth vaping. If the agency doesn’t think their plans go far enough, it could order their products off the market. Those five brands make up more than 97 percent of the U.S. market for ecigarettes, FDA says.
The FDA is “reconsidering our overall approach” after a review of preliminary data on youth vaping, Gottlieb told USA TODAY.
“Teenagers are becoming regular users, and the proportion of regular users is increasing,” says Gottlieb, a physician. “We’re going to have to take action.”
More than 2 million middle school, high school and college students use the battery-powered devices to heat liquidbased nicotine into an inhalable vapor. E-cigarettes are by far the most popular tobacco product among teens: Nearly 12 percent of high school students and 3 percent of middle school students used the device in the past 30 days, according to the 2017 National Youth Tobacco Survey.
Some parents want the FDA to go farther.
Kelli Cogan says her 15-year-old son was able to get free Juul cartridges online last year by using his father’s name and birth name and having them shipped to a different address. The Rocky River, Ohio, woman says the company offered to block her husband’s name from ordering, but she didn’t think that was sufficient.
Juul spokeswoman Victoria Davis says the company now requires an ageverified signature on delivery and has made other changes to protect against distributing e-cigarettes to children under the legal vaping age in their states.
The FDA’s new approach is much faster than the rule-making process the agency announced in March. That was quickly criticized as too little, too late by public health advocates.
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 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 brickand-mortar retailers with warning letters or civil penalties for selling to minors. Officials said 131 of the retailers will have to pay penalties.
Gottlieb told USA TODAY last month that the FDA was weighing the benefits of 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. But Gottlieb now says he’s prepared 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 said.
A spokeswoman for Vapers United, a group that promotes vaping as a way to quit smoking, said the FDA’s moves could send people back to cigarettes.
“The FDA needs to be very cautious about the adverse effects that flavoring bans or excess regulation could have on this trend – smokers using vapor as a way to stop consuming cigarettes and move towards a healthier lifestyle,” spokeswoman Liz Mair said.
The companies targeted by FDA struck a conciliatory tone.
JUUL Labs CEO Kevin Burns said the company “will work proactively with FDA in response to its request.”
“We are committed to preventing underage use of our product, and we want to be part of the solution in keeping ecigarettes out of the hands of young people,” he said in a statement.
A spokesman for Phillip Morris parent Altria, maker of the MarkTen XL, said the company welcomed the FDA action.
We “look forward to sharing our thoughts about how to prevent and reduce youth use, an issue we have focused on for decades,” spokesman David Sutton said.
“We strongly believe kids shouldn’t use any tobacco products and take a number of steps to prevent kids from getting access to all tobacco products,” he said.
Anthony Hemsley, Logic’s head of corporate affairs, said the company will work with the FDA “to demonstrate that Logic markets its product only to adults.”
R.J. Reynolds Vapor, maker of Vuse, said it supports “eliminating youth usage of all tobacco products.”
The maker of Blu did not respond to a request for comment.
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.
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“No one can look at the data and say there’s no problem.”
Scott Gottlieb Food and Drug Administration commissioner
Jack Cao, who co-owns a chain of vape shops, questions whether a ban on the sale of flavored e-liquid would have much impact. JACK GRUBER/USA TODAY