Last week, FDA Commissioner Scott Gottlieb stated that youth vaping has become an epidemic. He specifically called out manufacturers Juul, Vuse, MarkTen, XL, Blu, and Logic.
Gottlieb said that the relatively new-on-the-scene companies had 60 days to submit plans aimed at preventing youth vaping, or the agency would halt all U.S. sales.
According to the FDA, these companies represent over 97 percent of the US electronic cigarette industry.
The new announcement comes after review of data on youth vaping, which has forced the FDA to reconsider its overall approach, according to Gottlieb.
The 2017 National Youth Tobacco Survey, which was released in June, outlines how widespread the issue has become. Close to 12 percent of high school students and even 3 percent of middle school students have used a nicotine vaping device in the past 30 days, and over 2 million middle school, high school, and college students use the devices regularly.
“No one can look at the data and say there’s no problem,” the commissioner says.
The simple rulemaking process announced by the FDA earlier this year had many of these companies “grandfathered in” and not forced to undergo vigorous regulation by the agency due to being on the markets prior to 2016. Now, a company will need to show that it has an overall net benefit for public health.
A large part of the debate thus far has been whether the vaping industry as a cessation aid for adult smokers outweighs the risk of young people being drawn to nicotine addiction by vaping.
With the new report, Gottlieb has said that he’s willing to put the cessation benefits on the backburner if it will benefit teens and keep them away from nicotine. Moreover, Gottlieb outlined the difference between the cartridge-based products he’s targeting and the older model “open tank” vaping systems that have been on the market longer. More teens use cartridge-based products because they are smaller, easier to buy, and easier to conceal.
Juul CEO Kevin Burns says that the company will support “reasonable regulation” regarding restrictions on advertising, while also stating that restrictions on flavored products will “negatively impact current adult smokers.” The company has taken out numerous full-page ads in newspaper as a means of informing parents of the dangers of teen vaping.
