Citing Teen Vaping Epidemic, FDA Puts 5 e-Cigarette Makers on 60-Day Notice

Allison Inserro

The FDA, warning of an "epidemic," said that it is cracking down on the sale of e-cigarettes to kids in the largest enforcement crackdown to date. It also said it may pull the products or issue criminal penalties to keep the immensely popular vaping devices out of kids’ hands.

The products the FDA is focusing on are Juul Labs’s Juul device, RJR Vapor's Vuse, Altria's MarkTen, Imperial Grand’s blu, and devices made by Logic.

The agency is giving manufacturers 60 days to come up with a plan to restrict sales, and it issued more than 1300 warning letters and civil penalties to retailers who illegally sold Juul and other e-cigarette products to minors during a nationwide undercover sting of brick-and-mortar and online stores this summer.

E-cigarettes may help transition adult smokers off of traditional cigarettes, but the agency said it did not foresee the extent to which the trend would be embraced by adolescents, especially the flavored varieties.

The Juul device is so popular with teens that they have created a verb for it—“Juuling”— because teens hide the tiny device in their palms and use it during the school day when teachers are not looking.

“Unfortunately, I now have good reason to believe that it’s reached nothing short of an epidemic proportion of growth,” said FDA Commissioner Scott Gottlieb, MD, in a statement.

Last spring, the FDA issued warning letters to retailers for selling flavored e-liquids used in e-cigarettes, or vaping devices, with labeling or advertising that bears stark resemblances to kid-friendly food products, such as juice boxes, candy, or cookies. The FDA issued additional warning letters Wednesday.

In addition to cracking down on retail stores—the chains cited in Wednesday’s action included 7-Eleven stores, Walgreens, Circle K convenience shops, Kroger, Dollar General, and numerous gas stations—the agency will also monitor internet sales. For instance, if someone goes online and buys vast quantities of the devices—a “straw purchase”—that may be a sign they are reselling them to minors, he said.

The 5 manufacturers have 60 days to give the FDA what Gottlieb called “robust plans” for keeping the devices away from kids, or else the agency will “revisit the FDA’s exercise of enforcement discretion for products currently on the market.” Criminal penalties are possible, he said, and brands may have to totally revamp how they operate.

Gottlieb said that the agency may change the plan that was announced in July 2017 to extend the application compliance periods for e-cigarettes, as well as all tobacco products, that were on the market as of August 8, 2016. Under the current policy, the compliance date for filing applications for e-cigarettes was extended to August 8, 2022.

The FDA needs to determine if the policy is actually working. Gottlieb said that the agency is “actively considering whether we will enforce the premarket review provision earlier, when it is apparent that these products are now subject to widespread youth use.”

In addition, FDA enforcement actions will be in place for an indefinite period of time.

The agency also wants to know if manufacturers of certain e-cigarette products are selling new products that were not on the market as of August 2016, which means they are outside of the FDA’s compliance policy and have not gone through premarket review.

In a statement, Juul said that it will work "proactively" with the FDA and that flavoring "helps play an important role in helping adult smokers switch."

Next week, the FDA will launch a national campaign aimed at teenagers to warn them of the health dangers from nicotine and e-cigarettes.
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