The Food and Drug Administration on Monday issued a marketing denial order (MDO) to Bidi Vapor LLC for its Bidi Stick e-cigarette. The company cannot sell or distribute this product in the United States without risking FDA enforcement action, the agency said.
The Bidi Stick is a closed-system, disposable, tobacco-flavored e-cigarette device. After reviewing Bidi Vapor’s PMTA for the product, the FDA determined the application lacked sufficient evidence to demonstrate that permitting marketing of the product would be appropriate for the protection of public health. 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 FDA said.
“Bidi Vapor is disappointed by the FDA's decision and is currently reviewing the opinion based on its merits,” Niraj Patel, CEO of Bidi Vapor, Melbourne, Florida, told CSP Daily News. “In the meantime, the decision only affects our Classic or tobacco-flavored product. Our remaining 10 flavors are still under scientific review and not an enforcement priority for the FDA.”
The FDA had already issued a separate MDO, which it later stayed in October 2021, for Bidi Vapor’s flavored Bidi Sticks. Then in August 2022, a federal court ruled in favor of Bidi and set aside the MDOs on its 10 non-tobacco flavored PMTAs, putting them all back into scientific review.
Retailers should contact Bidi Vapor with any questions about product inventory, the FDA said.
“FDA has a key role to protect the public from the dangers of tobacco use,” said Matthew Farrelly, director of the Office of Science within FDA’s Center for Tobacco Products (CTP). “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 has received premarket tobacco product applications (PMTAs) for more than 26 million tobacco products, most of which are e-cigarettes. It has made determinations on 99% of these applications and has authorized 23 tobacco-flavored e-cigarette products and devices to date.
“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 CTP Director Brian King. “The center remains committed to processing submitted applications as expeditiously as possible while ensuring the utmost scientific integrity of the reviews.”
This is the most recent denial in a recent string from the FDA. On Friday, the agency denied PMTAs for certain Suorin and Blu Plus e-cigarette products and before that it denied 22 Smok e-cigarettes from Shenzhen IVPS Technology Co. Ltd.
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