FDA warns e-cig makers to keep devices out of kids' hands

Teenage use of electronic cigarettes is a nationwide epidemic, the U.S. Food and Drug Administration declared Wednesday as it gave five e-cig makers 60 days to demonstrate how they’ll keep the devices out of the hands of minors.

 As part of a one-two punch against producers and sellers, the agency also sent a flurry of letters to scores of retailers warning them about selling e-cig products to kids and issued 131 fines against stores that had already violated the rules.

The stiff warnings — and tight deadline — came as a growing body of evidence has shown that teens are exposed to potent levels of nicotine through “vaping,” using a wide range of devices, especially the popular Juul system. Vaping is so pervasive among teens that it has replaced the habit of smoking traditional combustible cigarettes, experts said Wednesday.

 “I use the word epidemic with great care,” FDA Commissioner Dr. Scott Gottlieb said in a statement. “E-cigs have become an almost ubiquitous — and dangerous — trend among teens.”  

Five e-cig makers were named by the FDA: Juul Labs; MarkTen, a registered trade name of Altria Group; RJR Vapor Co.’s Vuse; Imperial Grand, maker of “blu;” and e-cig products produced by Logic. All produce flavored products .

Doctors have long criticized the e-cig industry’s pervasive sale of flavored e-liquids, which are manufactured to appeal to teens. The fruity tastes hook kids on products that contain more nicotine than cigarettes do.

Gottlieb underscored: If the companies do not demonstrate how the products will be kept away from minors, the agency would consider taking legal action against them, which may include removing them from the market.

Juul Labs issued a statement Wednesday vigorously defending its vaping system and its flavorings, stating that flavored products are important for adults who are weaning themselves off combustible cigarettes. The company acknowledged that it was “committed to preventing underage use of our product, and we want to be part of the solution.”

More than 1,000 major retailers were targeted and warned about the sale of e-cig products to minors. That list included major outlets, such as 7-Eleven stores and Walgreens.

“Let me be clear that nicotine isn’t a benign substance. This is especially true when it comes to children and the effects that nicotine has on a developing brain,” Gottlieb said.

The FDA’s announcement Wednesday was met with mixed reactions.

Dr. Rachel Boykan, a pediatrician at Stony Brook Children’s Hospital, applauded the FDA’s stance. She’s among a cadre of medical investigators who are pioneering research into the use of e-cigs by minors.

 Her recently reported study in the journal Tobacco Control found that youngsters who used vaping systems, such as Juul, had higher levels of a nicotine byproduct — cotinine — in their urine than teens who smoked cigarettes.

Juul has been widely criticized because it delivers a larger nicotine dose than other e-cig systems  — and more than combustible cigarettes. “People really have to understand how serious this is,” Boykan said of her cotinine findings. “It’s kind of scary to see.”

The American Lung Association, however, found neither the 60-day deadline nor threat of banning products to be a penalty with teeth.

“We have been calling on the FDA to take meaningful action to protect youths for years,” said Erika Sward, national assistant vice president for advocacy at the lung association. “The FDA gave these companies 60 days. It didn’t say they would immediately order them off the market.

 “The FDA said it will consider taking action. So there are a lot of steps before taking products off the market.”