Russ WareThere’s bad news for fans of the Bidi Stick Classic as the FDA handed a marketing denial order (MDO) to the makers, Bidi Vapor LLC, on Jan. 22, 2024.
The Bidi Stick Classic, a closed-system, disposable, tobacco-flavored e-cigarette, is just the latest of the brand’s devices to be denied marketing authorization. Previous PMTAs for various flavored disposables were rejected in 2021, but those MDOs have been appealed by Bidi Vapor and are thought to be still under FDA review.
The reason given for the latest MDO was that:
“the application lacked sufficient evidence to demonstrate that permitting marketing of the product would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.”
More specifically, the FDA announcement stated that:
“evidence submitted by the applicant did not demonstrate an overall net benefit to people who use tobacco products and lacked sufficient evidence to address health risks.“
January has already been a busy month for the FDA and a bad month for vape brands and vapers alike, with MDOs being handed to SMOK, Blu Plus+ and Suorin, preventing the marketing, distribution, or sale of more than 35 different vape devices and products.
Brian King, Ph.D., M.P.H., director of FDA’s Center for Tobacco Products is quoted as saying “The Center has made considerable progress in reviewing the massive volume of tobacco product applications submitted to the agency, thanks to the tireless efforts of our dedicated legion of civil servant scientists. The Center remains committed to processing submitted applications as expeditiously as possible while ensuring the utmost scientific integrity of the reviews.”
Pre-filled disposable vape devices have been hit particularly hard by the changes made to the Tobacco Control Act in 2016. Only a handful of devices granted marketing authorization following the submission of PMTAs are pre-filled, and all of them are tobacco-flavored.
Interestingly, no vaping product (of any type) has been approved since current FDA Center for Tobacco Products Director Brian King was appointed in July 2022.
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