FDA suspends order banning Juul e-cigarette sales

An order the Food and Drug Administration issued last month barring the sale of Juul e-cigarettes has been administratively stayed, the agency stated on Tuesday.

In a Twitter thread, the agency’s tobacco section stated that the stay only temporarily suspends the marketing denial order while allowing for further study, according to Fox Business.

“All electronic nicotine delivery systems, or ENDS products, including those made by JUUL, are required by law to have FDA authorization to be legally marketed,” FDA Tobacco wrote. “The stay and the agency’s review does not constitute authorization to market, sell, or ship JUUL products.”

The U.S. Food and Drug Administration has ordered that Juul Labs Inc. stop selling its vape devices and cartridges on Thursday, citing “insufficient evidence to assess the potential toxicological risks” of using the products, according to a report by Fox News.

“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 Robert Califf said in a statement announcing the move.

“The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market,” he continued. “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.”

The FDA acknowledged that it “has not received clinical information to suggest an immediate hazard associated” with the use of Juul’s devices or pods and said the agency’s marketing denial orders (MDOs) against the company because “there is insufficient evidence to assess the potential toxicological risks” of using the products.

Juul disputed the FDA’s claims in a statement, saying they would appeal the agency’s decision:

“We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency,” Joe Murillo, Juul’s chief regulatory officer, said in a statement.

“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,” Murillo said. “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.”

Leave a Reply

Your email address will not be published.