MELBOURNE, Fla. — Bidi Vapor LLC, the manufacturer of the Bidi Stick electronic nicotine delivery system (ENDS), has filed a lawsuit against the U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (DHHS) challenging the FDA’s issuance of a marketing denial order (MDO) for its flavored Bidi Sticks.
The Bidi Stick is an ENDS product made with medical-grade components, a UL-certified battery and technology designed to deliver a consistent vaping experience.
Prior to the court-ordered Sept. 9, 2020, premarket tobacco product application (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 more than 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, just ahead of FDA’s court-ordered PMTA review deadline.
Bidi Vapor is also adamant about strict compliance with all federal, state, and local guidelines and regulations, the company said.
“Bidi Vapor stands behind its PMTAs, which we believe meet the Tobacco Control Act’s public health standards, as well as our stringent youth-access prevention measures and commitment to mature, adult-focused marketing,” said Niraj Patel, CEO of the Melbourne, Fla.-based company. “We anticipated that FDA would follow its own guidance and procedures and were looking forward to working with the agency to respond to any questions regarding our applications, as FDA said it would do.”
He added, “Unfortunately, FDA is now taking a totally different approach and denying filed PMTAs for flavored ENDS without completing its scientific review and giving companies a chance to respond to any issues raised by FDA. Forcing our products off the market will be a real blow to the millions of adults who enjoy flavored BIDI Sticks in lieu of combusted cigarettes.”
While Bidi Vapor remains committed to regulatory compliance and the premarket review process and is forging ahead with its planned studies to support its PMTAs, the company is also challenging the legality of the MDO. In its Petition for Review filed on Sept. 29 in the U.S. Court of Appeals for the Eleventh Circuit, attorneys for Bidi Vapor are seeking judicial review of the MDO under the Tobacco Control Act (TCA), the Administrative Procedure Act (APA), as well as the U.S. Constitution. The company is seeking a determination that the MDO “is arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law, as well as contrary to constitutional right and in excess of statutory jurisdiction, authority, or limitations, or short of statutory right.”
Bidi Vapor has requested that 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.
“We believe in science-based regulation of ENDS and hope the courts will require FDA to adhere to the law as it reviews our PMTAs,” said Patel.
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.