Bidi Vapor Forges Ahead With Product-Specific Studies to Meet FDA's Rigorous Public Health Standard for Marketing ENDS

Thursday, 23. September 2021 14:30

MELBOURNE, Fla., Sept. 23, 2021 (GLOBE NEWSWIRE) -- Despite the recent setback for its flavored BIDI® Sticks, which were caught up in the wave of Premarket Tobacco Product Application (PMTA) marketing denials issued by U.S. Food and Drug Administration (FDA) against all non-tobacco and non-menthol flavored electronic nicotine delivery systems (ENDS), Bidi Vapor, LLC, remains committed to compliance with FDA standards, stringent youth-access prevention measures and developing product-specific scientific evidence to support that its ENDS are appropriate for the protection of the public health (APPH), and should remain on the market as an alternative for adult (21+) combusted cigarette smokers.

Prior to the court-ordered Sept. 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 the Company re-branded to align with FDA's 2020 Enforcement Priorities Guidance1: the Arctic (menthol), Classic (tobacco), Dawn, Classic, Gold, Marigold, Regal, Summer, Tropic, Winter, Zest and Solar BIDI® Sticks. The detailed applications ran over 285,000 pages and contained significant information supporting the APPH status of the products.

According to Raj Patel, CEO, "Bidi Vapor stands behind its scientifically rigorous PMTAs, which we believe meet the Tobacco Control Act's public health standards. Among other things, our applications included in vitro toxicity testing, e-liquid and aerosol analysis of harmful and potentially harmful chemicals, comprehensive literature reviews, hardware and battery safety information, such as our UL-8139 certification, manufacturing best practices and quality control details, independent and validated consumer insight surveys, environmental assessments and stability data, as well as details about our unique BIDI® Cares recycling program, youth-access prevention measures, adult-focused marketing practices and post-market surveillance strategies."

Following submission of its PMTAs, and as encouraged by FDA, Bidi Vapor continued to work with leading experts to develop robust and reliable product-specific studies to further support its applications. In particular, following publication of FDA's draft guidance on Tobacco Product Perception and Intention (TPPI) studies in October 20202, the Company immediately began working with highly regarded research organizations and scientific experts to design and conduct behavioral studies that would measure the perception and appeal of the BIDI® Sticks, including the non-tobacco flavored BIDI® Sticks, on current and never users. These behavioral studies would further assess the role of non-tobacco flavored BIDI® Sticks in combusted cigarette switching for adult smokers. As suggested in the FDA guidance, the experts designed studies to evaluate BIDI® Stick consumer perceptions and intentions (e.g., likelihood of use and patterns of use). Additionally, experts executed a clinical pharmacokinetic ("PK") study to measure the abuse liability and dependence potential of the BIDI® Sticks, as well as the exposure to nicotine during product use (compared to combusted cigarettes and other ENDS products).

Each of these studies are designed to provide key evidence to inform the FDA's APPH evaluation — and specifically that the public health impact of the non-tobacco BIDI® Sticks for adult combusted cigarette smokers outweighs any risks to youth posed by flavored ENDS, in light of the Company's extensive marketing restrictions and youth-access prevention measures.3 Indeed, preliminary PK data indicates an important scientific observation and discovery. Critically, for adult smokers, the BIDI® Stick delivers nicotine very similar to a combusted cigarette, and more effectively than other tested ENDS and heat-not-burn tobacco products. In addition, preliminary PK data indicates both the tobacco and non-tobacco flavored BIDI® Sticks are likely to be used by existing smokers as a comparable satisfying alternative to smoking combusted cigarettes. We hope to share all data via a peer reviewed science process. Bidi Vapor also continues to update its comprehensive literature review with the latest published research on, among other things, the impact of non-tobacco flavored ENDS on the public health, focusing on abuse liability, initiation, transition and cessation.

Although its flavors have been denied marketing authorization at this time, Bidi is not wavering in its commitment to meeting FDA's high demands and demonstrating that each of its BIDI® Stick products are appropriate for the protection of the public health, the standard established by the Tobacco Control Act as an alternative for adult cigarette smokers. In this regard, Bidi is continuing to engage with FDA as it considers its options, including a formal appeal of the marketing denials and potential legal relief. In the meantime, Bidi plans to complete its ongoing studies, focus on its Classic (tobacco) and Arctic (menthol) BIDI® Stick in the United States, and expedite global distribution of all flavors, which have been approved for sale in 11 European markets, including the United Kingdom.

ABOUT BIDI VAPOR

Based in Melbourne, Florida, Bidi Vapor maintains a commitment to responsible marketing, supporting age-verification standards and sustainability through its BIDI® Cares recycling program. The Company's premier device, the BIDI® Stick, is a premium product made with medical-grade components, a UL-certified battery and technology designed to deliver a consistent vaping experience for adults 21 and over. Bidi Vapor is also adamant about strict compliance with all federal, state and local guidelines and regulations. At Bidi Vapor, innovation is key to our mission, with the BIDI® Stick promoting environmental sustainability, while providing a unique vaping experience to adult smokers.

For more information, visit www.bidivapor.com.

For additional questions about this press release, email Angel Abcede, press manager, QRx Digital for Bidi Vapor, LLC at angel@qrxdigital.com.



 

1                 See U.S. Food & Drug Admin., Guidance for Industry: Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (Revised) (April 2020) (available at https://www.fda.gov/media/133880/download).

2             See U.S. Food & Drug Admin., Draft Guidance for Industry: Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies (October 2020) (available at https://www.fda.gov/media/143322/download).

3          See Kaival Brands Innovations Group Press Release, Kaival Brands Issues Statement Prioritizing Compliance with the Tobacco Control Act and the PACT Act, available at https://www.prnewswire.com/news-releases/kaival-brands-otcqb-kavl-issues-statement-prioritizing-compliance-with-the-tobacco-control-act-and-the-pact-act-301321636.html.


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Image 1: BIDI Stick


Bidi Vapor produces a premium e-cigarette branded BIDI Stick.



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