E-cig maker committed to demonstrating its ENDS product is appropriate for the protection of the public health, providing alternative to combustibles for adult cigarette smokers.
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.
Thomas Mulloy – CStoreDecisions – 2021-09-27.
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