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FDA gets tough on e-cigarette makers

E-cigs might be bad for your teen

By Elaine Owen, Editor

The Food and Drug Administration announced a crackdown on makers of electronic cigarettes and said they must come up with a plan to prevent their products from getting in the hands of minors.
Responding to an “epidemic of nicotine addiction” among American youths, the U.S. Food and Drug Administration on Wednesday (Sept. 12) 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.”
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.
“Thousands of small-business vape shops across America do not engage in irresponsible marketing practices and don’t even sell the products being targeted by the FDA with threatening letters,” said Gregory Conley, president of the American Vaping Assn., a nonprofit organization that advocates for what it calls “sensible regulation.”
“Despite this, Commissioner Gottlieb is threatening to shut down all these businesses unless larger manufacturers unilaterally choose to change their marketing practices,” Conley added. “It is absolutely absurd and a perversion of how regulatory agencies are supposed to approach their work.”
Conley called Gottlieb’s initiative “nothing more than a gift to the tobacco industry,” whose stock prices jumped on news of the FDA’s vaping crackdown.
Gottlieb said the new enforcement actions mark the start of a “sustained campaign to monitor, penalize and prevent e-cigarette sales in convenience stores and other retail sites” to minors. He promised, too, that the FDA would be keeping close tabs on manufacturers’ own internet storefronts and distribution practices to detect sales to minors.
“The FDA has at its disposal both civil and criminal remedies to address demonstrated violations of the law,” he said.
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.
The U.S. market for vaping products has exploded as well. Analysts at Wells Fargo estimated that Americans bought more than $1.4 billion worth of e-cigarettes between February 2017 and February 2018, and they expect annual sales to reach $2 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 $5.5 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.
“This may create some obstacles for adults who want to enjoy e-cigarettes,” Gottlieb said. “But in closing the on-ramp for kids, we’re going to have to narrow the on-ramp for adults.”
Gottlieb also signaled that his agency is prepared to take more sweeping steps. He gave five e-cigarette manufacturers — the makers of Vuse, Blu, JUUL, MarkTen XL, and Logic vaping products — two months to submit plans to “immediately and substantially reverse these trends.”
Failure to comply might prompt the agency to reconsider an earlier decision that gave manufacturers of tobacco products not on the market by August 2016 more time to submit new products to the FDA for pre-market review. He also said the agency is “considering the immediate removal … from the market” of e-cigarette flavorings that cater to underage users.
“Let me be clear: everything’s on the table,” said.
Collectively, the five companies command over 97% of the U.S. market for e-cigarettes, and Gottlieb took them to task for their response to concerns expressed earlier by the FDA about underage marketing and sales.
“They treated them as a public relations challenge,” Gottlieb said. “They’re now on notice.”
As part of its effort to turn the tide, the agency launched a new campaign to education children and teens about the dangers of e-cigarettes.
Gottlieb said the FDA will continue to monitor underage trends and promised to release new data on e-cigarette use by minors in the coming months. Further evidence of rising rates of use would bring stiffer actions, he vowed.
“Industry must step up to this problem,” he said. “They must demonstrate they’re truly committed to keeping their products out of the hands of kids.”