June 25, 2022
JUUL SEEKS STAY AFTER FDA ISSUES MDOs
In response the Food and Drug Administration’s (FDA) marketing denial orders (MDOs) to Juul Labs Inc., the company said it is seeking a stay and “exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator,” said Joe Murillo, chief regulatory officer, Juul Labs, in a statement.
Today, the FDA issued MDOs for all JUUL products currently sold in the U.S. The notice calls for removal of Juul’s products from the U.S. market. The products include the JUUL device and four types of JUULpods: Virginia tobacco flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol flavored pods at nicotine concentrations of 5.0% and 3.0%.The Office of Management and Budget yesterday cleared both proposed rules for release.
“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,” said Murillo.
The FDA said that after it reviewed Juul’s premarket tobacco product applications (PMTAs) it determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.
“In our applications, which we submitted over two years ago, we believe that we 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,- said Murillo.
If Juul receives a stay, it would allow the continued sale of the company’s products while it pursues the appeals process.
STATEMENT BY JUUL LABS REGARDING RECENT FDA 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. In our applications, which we submitted over two years ago, we believe that we 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.”
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. 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.
— Joe Murillo, Chief Regulatory Officer at Juul Labs