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 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 and older) 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 Guidance: the Arctic (menthol), Classic (tobacco), Dawn, 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.
“Bidi Vapor stands behind its scientifically rigorous PMTAs, which we believe meet the Tobacco Control Act’s public health standards,” said Bidi CEO Raj Patel. “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 In particular, following publication of FDA’s draft guidance on Tobacco Product Perception and Intention (TPPI) studies in October 2020, the company immediately began working with highly regarded research organizations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.
The 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 is 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. Indeed, preliminary PK data indicates an important scientific observation and discovery.
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.