A Bidi Vapor representative has provided CStore Decisions with clarification of the recent FDA ruling regarding the issuing of a marketing denial order (MDO) for a Bidi Vapor product.
The company clarified that the FDA ruling only affects Bidi Vapor’s “Classic” or tobacco-flavored product, while premarket tobacco product applications (PMTAs) for its other 10 flavors are still undergoing the FDA’s scientific review process and did not receive MDOs.
“Bidi Vapor is disappointed by the FDA’s decision and is currently reviewing the opinion based on its merits,” said Niraj Patel, CEO, Bidi Vapor. “In the meantime, the decision only affects our ‘Classic’ or tobacco-flavored product. Our remaining 10 flavors are still under scientific review and available for sale. At this time, we are investigating legal remedies and expect to have updates in the coming days. For now, we ask that our wholesale and retail partners direct their questions to our sales representatives.”
During this time, MDOs for Bidi Vapor’s non-tobacco flavored ENDS products have been set aside by the FDA and remanded by the 11th Circuit Court of Appeals for being “arbitrary and capricious,” reported The National Law Review.
The company emphasized that the recent ruling from the FDA applied only to the PMTA for its Classic product, which did not receive an MDO in 2021.
More information from Bidi Vapor may be revealed as the process continues.