Prior to the court-ordered September 9, 2020, PMTA deadline and despite considerable business and logistical challenges due to the COVID-19 pandemic, Bidi Vapor submitted PMTAs for all 11 flavor varieties of its BIDI® Stick, which is intended exclusively for adult cigarette smokers and tobacco users, 21 and over. The detailed applications ran over 285,000 pages and contained significant information supporting the products as appropriate for the protection of the public health (APPH). Despite submitting scientifically rigorous PMTAs and keeping FDA informed about its ongoing clinical and behavioral studies, Bidi Vapor received an MDO for its flavored BIDI® Sticks, along with nearly all other manufacturers of flavored ENDS, in early September 2021.
On September 29, 2021, 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 (TCA), the Administrative Procedure Act (APA), as well as the U.S. Constitution. Accordingly, Bidi Vapor has requested the appellate court to 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.
"We appreciate FDA's decision to stay, or put on hold, the MDO as it reconsiders its denial. 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," said Niraj Patel, the Company's CEO.
https://finance.yahoo.com/news/fda-enters-administrative-stay-bidi-121300554.html