The Food and Drug Administration on Thursday ordered the popular Juul e-cigarette pulled from shelves — saying its maker, tobacco company Altria, submitted insufficient safety data.
The device, which uses disposable pods, accounts for roughly 50% of the e-cigarette market. According to a Gallup survey last year, about 6% of US adults — or more than 15 million people — use e-cigarettes.
“[T]he company must stop selling and distributing these products. In addition, those currently on the U.S. market must be removed, or risk enforcement action,” the FDA said.
The decision is likely to enrage people who credit Juul with helping them stop or reduce smoking. But it may please the parents of teens who use Juuls because they lack the stench of combustible cigarettes, making detection harder.
Gregory Conley, president of the American Vaping Association advocacy group, slammed the FDA move, calling it “the latest in a series of missteps from the FDA that signal something is seriously wrong within the agency.”
“From turning a blind eye to the opioid crisis to having no plans to combat a baby formula shortage, the FDA keeps coming up short on issues of vital importance to Americans,” Conley told The Post.
The FDA said it based the decision on product-safety grounds, rather than on the better-known debate about illegal underage use.
“[T]he FDA determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health,” the health agency said.
“In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data – including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods – that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications.”
In response, Juul said it believed it had “appropriately characterized the toxicological profile of Juul products” adding that it believes its e-cigarettes meet federal health and safety standards.
“We intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator,” Juul’s chief regulatory officer Joe Murillo said in a statement. “We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide.”
In response to a briefing question Wednesday from The Post, White House press secretary Karine Jean-Pierre declined to comment on President Biden’s involvement in the then-looming decision and referred questions to the FDA.
Biden’s approval rating among young adults aged 18-34 already was just 22%, according to a poll this month from Quinnipiac University.
Juul users are politically diverse. First daughter Ashley Biden was photographed over the weekend carrying a Juul while walking on the beach with her mother, first lady Jill Biden. On the other end of the political spectrum, Fox News host Sean Hannity once was caught sneaking a puff from the device during a commercial break.
The Juul device came to dominate the e-cigarette market because it used an efficient nicotine salt-based e-liquid packaged in small pods — largely displacing the larger and leakier vaping tank systems that required users to refill cartridges themselves with bottles of liquid.
In response to criticism, Juul in 2018 and 2019 voluntarily pulled most flavor options, such as mango, fruit and mint, which critics said fueled a teen vaping boom.
The FDA has taken an inconsistent approach toward products similar to Juul. Last month, the agency gave marketing approval to a less-popular device marketed under the brand name Vuse by tobacco company R.J. Reynolds. And many vape shops in cities sell unapproved brands that aren’t as well-known.
E-cigarettes emerged more than a decade ago promising people addicted to nicotine a safer alternative to smoking combustible cigarettes, which contain an array of chemicals that cause cancer, heart disease and other ailments. Health advocates, users and industry leaders have clashed repeatedly on whether flavors should be allowed and whether the health benefit to adults offset the potential allure to teens.
Former President Donald Trump at points resisted the guidance of health bureaucrats seeking to rein in vaping. In late 2019, Trump even moderated a free-wheeling debate in the White House Cabinet Room between pro-restriction advocates including Sen. Mitt Romney (R-Utah) and pro-vaping advocates including Conley.
“If you don’t give it to them, it is going to come here illegally,” Trump said at the meeting. “They could be selling something on a street corner that could be horrible.”