Responding to an "epidemic of nicotine addiction" among young Americans, the U.S. Food and Drug Administration on Wednesday announced a comprehensive crackdown on e-cigarette manufacturers, directing the industry's giants to draw up detailed plans for halting sales to minors and threatening to pull a wide range of products, including flavorings that appeal to underage buyers, from an exploding market.
FDA Commissioner Scott Gottlieb called the agency's steps the largest coordinated enforcement effort in his agency's history and said it was prompted by alarming new evidence that e-cigarette use by minors has risen to levels he called "simply not tolerable."
Selling to minors
In response to a nationwide undercover investigation of brick-and-mortar and online stores over the summer, the FDA levied civil fines on e-cigarette retailers found to have sold their products to minors and issued more than 1,300 warning letters.
What's more, Gottlieb said the vaping industry appears to have turned a blind eye to the online practice of "straw purchasing" by retailers and individuals intent on buying vaping products and reselling them to minors.
The agency also ordered 12 online retailers to halt their continued marketing of e-liquids resembling kid-friendly food products such as candy and cookies. Although the FDA had acted in May to limit the sale of such products, they were still being offered, with the offending labeling and advertising, by the 12 online retailers, several of whom were also cited for sales to minors.
The FDA move was greeted with defiance and derision from the vaping industry.
E-cigarettes have become the tobacco product most commonly used by American adolescents. Their popularity is rising "very sharply," Gottlieb said: In 2017, more than 2 million middle and high school students acknowledged they were current users of vaping products, according to the Monitoring the Future survey.
Data from the Centers for Disease Control and Prevention indicate that e-cigarettes have become the tobacco product of choice among middle and high school students.
In 2017, 11.7 percent of high-schoolers who participated in the CDC's National Youth Tobacco Survey said they had vaped a tobacco product within the past month, up from 1.5 percent in 2011. In addition, 3.3 percent of middle school students called themselves current users of e-cigarettes, up from 0.6 percent in 2011.
Market for vaping products
U.S market for vaping products has exploded as well. Analysts at Wells Fargo estimated that Americans bought more than $2.3 billion worth of e-cigarettes between August 2017 and last month, and they expect annual sales to reach nearly $4 billion this year.
Add in other vaping products _ including vapor cartridges and related items sold at specialty shops _ and analysts say the entire market could be worth $6.6 billion this year.
In a speech at the agency's headquarters in Silver Spring, Md., Gottlieb acknowledged that e-cigarettes present a public health conundrum.
In its bid to wean adult smokers from traditional cigarettes, the agency has sought to make a wider range of "reduced risk" tobacco products available to American consumers. Those products include e-cigarettes.
At the same time, the FDA has sought to avoid creating a new generation of Americans addicted to those products, or to the nicotine that has served as a powerful hook.
On Wednesday, Gottlieb put manufacturers on notice that the agency's balancing act will lean more heavily on preventing youth addiction.
As part of its effort to turn the tide, the agency launched a new campaign to educate children and teens about the dangers of e-cigarettes. A primary concern for health experts is that kids will become addicted to nicotine and graduate to traditional cigarettes, putting them at risk for lung cancer. A report in the Journal of the American Medical Association found that 20 percent of high-schoolers who vaped frequently at the start of the study were smoking cigarettes frequently six months later, and another 12 percent were smoking occasionally. Meanwhile, among students who never vaped, only 2 percent started smoking during the same period of time.