UPDATED 7/08, 12:30 p.m. ET: The Food and Drug Administration has suspended its ban of Juul e-cigarettes as the company appeals the decision.
On Friday, Juul accused the FDA of failing to properly evaluate its application to allow the sale of its e-cigarette products, and making the decision based on political pressure. “We remain confident in the quality and substance of our applications and believe that ultimately we will be able to demonstrate that our products do in fact meet the statutory standard of being appropriate for the protection of the public health," Juul's chief regulatory officer Joe Murillo said in a statement provided to The Wall Street Journal.
"On July 5, 2022, FDA administratively stayed the marketing denial order. The agency has determined that there are scientific issues unique to the JUUL application that warrant additional review," said an FDA spokesperson, confirming that the plans for further review into the ban does not rescind the initial decision. "This administrative stay temporarily suspends the marketing denial order during the additional review but does not rescind it."
UPDATED 6/23, 10:55 a.m. ET: The FDA officially “issued marketing denial orders” to Juul Labs Inc. on Thursday. U.S. retailers are no longer permitted to sell Juul’s device or pods, and must remove currently stocked items.
FDA Commissioner Dr. Robert M. Califf stated, “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. The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. 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.”
Michele Mital, acting director of the FDA’s Center for Tobacco Products, added, “The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company. As with all manufacturers, JUUL had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions.”
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The U.S. Food and Drug Administration is expected to order Juul to remove its e-cigarette products from store shelves in the country.
Per the Wall Street Journal citing sources close to the matter, the FDA is set to announce the order as early as Wednesday, effectively banning Juul’s e-cigs being sold in the U.S. for the foreseeable future. The verdict comes around two years after the company applied to keep its products up for sale in the U.S., arguing they’re an overall plus to general public health by offering an alternative to smoking traditional tobacco products. The FDA previously banned the sale of fruity or sweet flavors for e-cigarette products.
As pointed out by Reuters, shares in tobacco company Altria Group Inc., which owns a 35 percent stake in Juul Labs Inc., were down 8 percent this morning. Juul products first hit the market in the mid to late 2010s, and became the most popular brand of e-cigarettes in the United States in 2017.
In the past, the FDA has blamed Juul for an uptick in vaping among teenagers, who aren’t legally allowed to purchase Juul’s products. Last year, Juul agreed to pay the state of North Carolina $40 million to settle a lawsuit that alleged the company specifically targeted young people in its marketing campaigns.
“For years Juul targeted young people, including teens, with highly addictive e-cigarettes,” said North Carolina Attorney General Josh Stein. “It lit the spark and fanned the flames of a vaping epidemic among our children—one that you can see in any high school in North Carolina.”
