MELBOURNE, Fla. — An appeals court has granted a judicial stay of the marketing denial order (MDO) the U.S. Food and Drug Administration (FDA) had issued to Kaival Brands Innovations Group Inc. for its Bidi Stick.
The U.S. Court of Appeals for the Eleventh Circuit granted a judicial stay of the MDO on Feb. 1. This allows Bidi Vapor and Kaival Brands to market and sell its Bidi Stick disposable electronic nicotine delivery system (ENDS)—including its tobacco- and menthol-flavored products—while Bidi’s lawsuit against the FDA is ongoing.
Bidi is asking the FDA to put its premarket tobacco product application (PMTA) for the flavored ENDS back under scientific review.
“We expect this judicial stay will result in a rebounding of Bidi Stick sales,” said Niraj Patel, president and CEO of both Kaival Brands and Bidi Vapor. “Many wholesale and retail partners had discontinued or slowed purchases of the Bidi Stick, until we heard back from the courts on the likelihood of our merits case succeeding. This is what our wholesale and retail partners have been waiting for.”
Bidi Vapor believes it has developed substantial scientific evidence that supports its product is appropriate for the protection of the public health, Patel said. The FDA had already issued an administration stay of Bidi’s MDO, along with issuing stays or rescinding several other product’s MDOs.
“The company believes that this decision signals a new milestone in the path toward providing adult smokers 21 and older with a viable alternative to combustible cigarettes. Distributors, wholesalers, retailers and adult consumers are all anxious to see positive outcomes not just for Bidi Vapor, but for the vaping industry as a whole. We believe in science-based regulation of ENDS and hope the courts will require FDA to adhere to the law as it reviews Bidi Vapor’s PMTAs, Patel said.
Bidi Vapor, Melbourne, Fla., submitted PMTAs for all 11 flavor varieties of its Bidi Stick prior to the court-ordered Sept. 9, 2020, PMTA deadline. In September, it filed a lawsuit against the FDA and the Department of Health and Human Services (DHHS) challenging the FDA’s issuance of an MDO for its flavored Bidi Sticks.
Members help make our journalism possible. Become a CSP member today and unlock exclusive benefits, including unlimited access to all of our content. Sign up here.