MONDAY, June 27, 2022 — A federal appeals court has ruled that for now, Juul Labs can continue to sell its electronic cigarettes on the U.S. market.
The Friday ruling came in response to the company seeking a temporary emergency hold while it appeals a ban of its products that was issued Thursday by the U.S. Food and Drug Administration.
The e-cigarette maker had asked the court to pause what it called an “extraordinary and unlawful action” by the FDA that would have required it to immediately halt its business, the Associated Press reported.
When issuing the ban last week, the FDA said Juul’s application left regulators with significant questions and didn’t include enough information to evaluate any potential health risks. Meanwhile, Juul said it submitted enough information and data to address all issues raised.
“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” FDA Commissioner Dr. Robert Califf said Thursday.
“The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market,” Califf said in an agency news release. “We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”
At one time, Juul controlled 75% of the e-cigarette market, the New York Times reported.
The products include the Juul vaping device and four types of Juul pods: pods labeled Virginia Tobacco flavor at nicotine concentrations of 5% and 3%, and menthol-flavored pods at nicotine concentrations of 5% and 3%, the FDA said.
The American Vapor Manufacturing Association (AVM), an industry trade group, hinted at the legal battle to come.
“Measured in lives lost and potential destroyed, FDA’s staggering indifference to ordinary Americans and their right to switch to the vastly safer alternative of vaping will surely rank as one of the greatest episodes of regulatory malpractice in American history,” AVM President Amanda Wheeler said in a statement.
The FDA has already banned the sale of fruit-flavored e-cigarettes after critics claimed the products targeted teens. Regulators have since been reviewing thousands of applications for vaping products after tightening their oversight of the electronic cigarette market.
Juul can challenge the expected ruling one of three ways: appeal the decision through the FDA; file a challenge in court, or file a revised application for its products.
Several years ago, Juul’s fruity flavors and “hip marketing” were blamed for jumps in underage vaping. Among the criticisms were that Juul used young adult models, celebrities and social media influencers in its marketing campaigns. In response, the company stopped using models, suspended all advertising in the United States and shut down its Facebook and Instagram accounts.
The company stopped selling its fruity and sweet flavors in 2019. In 2020, all manufacturers were required to submit their products to the FDA for review to stay on the market. They are considered a potentially less harmful alternative for adult smokers, but remain a concerning gateway to smoking for young people.
Juul’s submission to the FDA included only its menthol and Virginia Tobacco flavors. The company also pitched a new device that would only unlock for users who were 21 or older.
Juul’s popularity among young people is lower than it was in the past: It is now considered the No. 4 brand among high schoolers, according to a federal study released last September, the Wall Street Journal reported.
Underage vaping in general has dropped since federal restrictions raised the age to buy any tobacco products to 21, the newspaper added.
The FDA also plans to mandate the elimination of nearly all nicotine in cigarettes, saying it would upend the $95 billion U.S. cigarette industry. Tobacco companies could sue to fight it the ruling if it happens, the WSJ reported.
Sources
- Associated Press
- New York Times
- Wall Street Journal
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Posted June 2022
