MELBOURNE, Fla. — The U.S. Food and Drug Administration (FDA) has stayed a marketing denial order (MDO) issued to Bidi Vapor for its flavored Bidi Sticks, allowing them to remain on the market for the time being, the company said.
The FDA’s administrative stay is pending the agency’s review of Bidi Vapor’s request that the MDO be rescinded based on product-specific scientific evidence in its premarket tobacco product applications (PMTAs).
"We appreciate FDA's decision to stay, or put on hold, the MDO as it reconsiders its denial,” said Niraj Patel, the company's CEO. “As we explained to the agency, Bidi Vapor submitted scientifically rigorous PMTAs that contained product-specific evidence demonstrating that the added benefit of our flavored BIDI Sticks to adult smokers outweighs any potential risks to youth, especially considering our stringent youth-access prevention measures and commitment to mature, adult-focused marketing. That said, we are still seeking a formal, judicial stay from the appellate court pending the outcome of the lawsuit.”
Bidi Vapor submitted PMTAs for 11 flavors of its Bidi Stick, a disposable electronic nicotine delivery systems (ENDS) product, by the court-ordered Sept. 9, 2020, deadline. The detailed applications ran more than 285,000 pages and contained significant information supporting the products as appropriate for the protection of the public health, according to Bidi Vapor.
Bidi Vapor received an MDO for its flavored Bidi Sticks in early September, and later that month, filed a lawsuit against the FDA and the Department of Health and Human Services (DHHS) challenging its decision.
Bidi Vapor, Melbourne, Fla., requested the appellate court vacate the MDO and provide such additional relief as may be appropriate, including such relief as necessary to ensure that Bidi may continue to market the products subject to the MDO to its adult customers. The company filed a Motion for Stay Pending Review with the 11th Circuit Court of Appeals because of the “continued irreparable harm the MDO has caused,” it said.
The FDA did not respond to CSP’s request for comment on the matter.
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