The Food and Drug Administration is preparing to order Juul Labs Inc. to take its e-cigarettes off the U.S. market, according to people familiar with the matter.
The FDA could announce its decision as early as Wednesday, the people said. The marketing denial order would follow a nearly two-year review of data presented by the vaping company, which sought authorization for its tobacco- and menthol-flavored products to stay on the U.S. market.
Uncertainty...
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The Food and Drug Administration is preparing to order Juul Labs Inc. to take its e-cigarettes off the U.S. market, according to people familiar with the matter.
The FDA could announce its decision as early as Wednesday, the people said. The marketing denial order would follow a nearly two-year review of data presented by the vaping company, which sought authorization for its tobacco- and menthol-flavored products to stay on the U.S. market.
Uncertainty has clouded Juul since it landed in the FDA’s sights four years ago, when its fruity flavors and hip marketing were blamed for fueling a surge of underage vaping. The company since then has been trying to regain the trust of regulators and the public. It limited its marketing and in 2019 stopped selling sweet and fruity flavors. Juul’s sales have tumbled in recent years.
The FDA has barred the sale of all sweet and fruity e-cigarette cartridges. The agency has cleared the way for Juul’s biggest rivals, Reynolds American Inc. and NJOY Holdings Inc., to keep tobacco-flavored e-cigarettes on the market. Industry observers had expected Juul to receive similar clearance.
Juul had no immediate comment. The company could pursue an appeal through the FDA, challenge the decision in court or file a revised application for its products.
Write to Jennifer Maloney at jennifer.maloney@wsj.com
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