Appeals Court Rules Bidi Vapor Can Continue Selling Its Flavored ENDS

GRANT, Fla. — The U.S. Court of Appeals for the Eleventh Circuit granted a judicial stay of the marketing denial order (MDO) previously issued by the Food and Drug Administration (FDA) to Bidi Vapor LLC.

The Feb. 1 ruling allows Bidi Vapor and Kaival Brands Innovations Group Inc., global distributor of Bidi Vapor products, to market and sell all its BIDI Stick ENDS while the company continues with its merits lawsuit compelling the FDA to place Bidi Vapor's premarket tobacco product application (PMTA) for the flavored ENDS back under scientific review.

The agency issued its MDO to Bidi in September.

"We expect this judicial stay will result in a rebounding of BIDI Stick sales," said Niraj Patel, president and CEO of 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."

In preparing for its PMTA, Bidi Vapor developed substantial scientific evidence through, among other things, surveys, behavioral studies and clinical trials establishing support that the product is appropriate for the protection of the public health, according to Patel.

"Following on FDA's initial administrative stay of the MDO, we believe that this recent judicial stay is a good indication that the court finds some merit in Bidi Vapor's arguments and puts Bidi Vapor's PMTA one step closer to being properly and fully evaluated by FDA," he said. "We are extremely pleased with the court's decision on this judicial stay order and continue to expect to be successful on the merits case as well."

Bidi Vapor submitted PMTAs for all 11 flavor varieties (nine flavored ENDS as well as menthol and tobacco) of its BIDI Stick prior to the Sept. 9, 2020 PMTA deadline. After the FDA issued it MDO for the flavored BIDI Sticks, Bidi Vapor filed a Petition for Review with the U.S. Court of Appeals for the Eleventh Circuit, seeking judicial review of the MDO under the Tobacco Control Act, the Administrative Procedure Act, as well as the U.S. Constitution.