On Jan. 22, 2024, FDA issued a marketing denial order (MDO) to Bidi Vapor LLC for its Bidi Stick – Classic e-cigarette. This product is a closed-system, disposable, tobacco-flavored e-cigarette device. The company must not market or distribute this product in the United States or they risk FDA enforcement action. The company may submit a new application to the agency for review that addresses these deficiencies.
“FDA has a key role to protect the public from the dangers of tobacco use,” said Matthew Farrelly, Ph.D., Director of the Office of Science within FDA’s Center for Tobacco Products. “Integral to that role, our tobacco application review process relies on scientific evidence that demonstrates a product provides a net benefit to public health that outweighs the known risks. The science in this application did not show that.”
The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the benefits (e.g., benefit from adult users of more harmful tobacco products completely switching) and risks (e.g., initiation among youth) of the product to the population as a whole. After reviewing the company’s PMTA, the FDA determined 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. Specifically, 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.
“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,” said Brian King, Ph.D., M.P.H., director of FDA’s Center for Tobacco Products. “The Center remains committed to processing submitted applications as expeditiously as possible while ensuring the utmost scientific integrity of the reviews.”
Today’s action is just one of many FDA has taken to ensure any tobacco products that are marketed in the U.S. undergo science-based review and receive marketing authorizations by the agency. Since 2020, FDA has received PMTAs for more than 26 million tobacco products, the vast majority of which are e-cigarettes, and has made determinations on 99% of these applications. To date, FDA has authorized 23 tobacco-flavored e-cigarette products and devices. The distribution or sale of unlawfully marketed products is subject to compliance and enforcement action.
In addition to ensuring that manufacturers comply with this order, FDA intends to ensure compliance by distributors and retailers. Retailers should contact Bidi Vapor LLC with any questions about products in their inventory.