The potential return of Juul to U.S. store shelves would represent a win for consumers and tobacco harm reduction, according to the Consumer Choice Center (CCC).
On June 6, the U.S. Food and Drug Administration rescinded its 2022 marketing denial order. While the move it neither an authorization nor a denial, it places the company’s premarket tobacco product application back into scientific review, meaning it could potentially be authorized at some point.
“This is a step in the right direction for consumers who want more nicotine alternatives to combustible tobacco,” said CCC U.S. Policy Analyst Elizabeth Hicks.
The FDA said in its June 6 statement that it had “conducted additional substantive review of the applications in a number of disciplines, including toxicology, engineering, social science, and clinical pharmacology” and that their change of course is based on a “review of information provided by the applicant” plus new case law based on court decisions involving MDOs for e-cigarette products.
“With over 26 million applications submitted to the FDA, less than 10 e-cigarette devices have been approved by the agency. Vaping is 95 percent less harmful than smoking combustible tobacco, and the FDA has an opportunity to help drastically improve public health by allowing consumers a choice when it comes to alternatives to combustible cigarettes,” said Hicks.
The FDA decision opens the door for Juul to return to the market in the future, and allow U.S. consumers the same choice as those in the U.K. and Canada.
“We hope the FDA provides a clear and transparent pathway for Juul Labs and the thousands of other companies who submitted product applications to finally gain authorization to offer their products to consumers in a regulated market,” concluded Hicks.