In a significant move on January 22, 2024, the U.S. Food and Drug Administration (FDA) issued a marketing denial order (MDO) to Bidi Vapor LLC for its Bidi Stick – Classic e-cigarette. This product, a closed-system, disposable, tobacco-flavored e-cigarette device, can no longer be marketed or distributed in the United States, failing which the company risks facing FDA enforcement action. Bidi Vapor may submit a new application addressing these deficiencies for review.
Dr. Matthew Farrelly, Director of the Office of Science within FDA’s Center for Tobacco Products, emphasized the FDA’s critical role in safeguarding the public from the dangers of tobacco use. The denial is rooted in the principle that any tobacco product’s application must scientifically demonstrate a net benefit to public health that outweighs the known risks. Unfortunately, the science backing Bidi Stick did not meet this criterion.
The FDA’s evaluation of premarket tobacco product applications (PMTAs) is grounded in a public health standard that balances the benefits and risks to the overall population. The denial follows the conclusion that Bidi Vapor’s application lacked sufficient evidence to prove that marketing the Bidi Stick would be appropriate for protecting public health. This standard is mandated by the 2009 Family Smoking Prevention and Tobacco Control Act. The application fell short in demonstrating a net benefit to tobacco users and did not adequately address health risks.
Brian King, Ph.D., M.P.H., director of FDA’s Center for Tobacco Products, highlighted the Center’s progress in reviewing the massive volume of tobacco product applications received since 2020, including over 26 million for e-cigarettes. To date, only 23 tobacco-flavored e-cigarette products and devices have received FDA authorization, adhering to stringent scientific review standards. The FDA also intends to ensure compliance by distributors and retailers, and retailers have been advised to contact Bidi Vapor LLC regarding any questions about their inventory.
Insights
The FDA’s decision to deny marketing approval for Bidi Stick – Classic reflects a cautious and science-based approach to public health, which I find commendable. In an era where vaping is increasingly popular, especially among younger demographics, the need for rigorous assessment of e-cigarettes is crucial. This decision underscores the importance of balancing the potential benefits of e-cigarettes for adult smokers against the risks, particularly the initiation among youth.
While I understand the frustration this might cause among adult vapers and companies in the industry, the FDA’s stance is necessary to ensure public health safety. It’s a delicate balance between supporting innovations in less harmful alternatives for smokers and preventing a potential public health crisis stemming from insufficiently tested products. The denial also serves as a reminder to e-cigarette manufacturers about the importance of presenting robust scientific evidence when seeking approval.
Ultimately, the decision aligns with the broader goal of reducing tobacco-related harm while preventing new health risks. It’s a complex issue, but erring on the side of caution, especially when it comes to public health, is a prudent path to take.
