FDA Temporarily Lifts Ban on Juul E-Cigarettes

Juul Labs Inc. Virginia tobacco and menthol flavored vaping e-cigarette products are displayed in a convenience store in El Segundo, Calif., on June 23, 2022. Patrick T. Fallon/AFP via Getty Images

The U.S. Food and Drug Administration (FDA) on July 5 paused its marketing denial order on Juul electronic cigarettes while it carries out a review into “scientific issues” unique to the company’s application.

“On July 5, 2022, FDA administratively stayed the marketing denial order. This administrative stay temporarily suspends the marketing denial order during the additional review but does not rescind it,” the department announced on Twitter.

“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. The stay and the agency’s review does not constitute authorization to market, sell, or ship JUUL products.”

The move comes after a three-judge panel of the U.S. Court of Appeals for the D.C. Circuit on June 24 temporarily paused the ban on Juul products by the FDA so that the court has “sufficient opportunity” to hear further arguments on the matter.

The order to temporarily pause the ban should not be “construed in any way as a ruling on the merits of that motion,” the court order read.

Forced to Remove Juul Products

The FDA’s ban focused on Juul’s device and four types of JUULpods, forcing retailers to remove the products from their inventories, in what was a blow to the popular e-cigarette company.

FDA Commissioner Robert M. Califf said the ban was to ensure “all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards.”

According to the FDA, the e-cigarette company’s application submitted more than two years ago “lacked sufficient evidence” regarding the toxicology levels of their products. Some of the evidence was found to be “insufficient and conflicting,” including those regarding the genotoxicity and potentially harmful chemicals in the company’s e-liquid pods.

Juul challenged that assertion, previously telling The Epoch Times the company provided the FDA with “sufficient information and data based on high-quality research to address all issues raised by the agency.”

The e-cigarette company believes its application “appropriately characterized the toxicological profile of Juul products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being ‘appropriate for the protection of the public health.’”