We are happy to announce that Bidi Vapor has been granted a stay order by the FDA.
Which means all 11 flavors of the BIDI®️ Stick are now legal to market and distribute as the FDA is currently reviewing the previously released MDO.
To Our Valued Wholesalers, Retailers, and Future Partners:
Synthetic nicotine is now officially an issue. Is it yours too?
As of March 15, 2022, a new federal law gave the U.S. Food and Drug Administration (FDA) authority over electronic nicotine delivery systems (ENDS) using synthetic nicotine. The new legislation includes language indicating that ENDS originally formulated with tobacco-derived nicotine that was refused or denied authorization by FDA, then modified to use synthetic nicotine instead (and that is the only modification), will effectively be banned on April 14, 2022.
Manufacturers of synthetic nicotine versions of previously denied products will not be given an opportunity to submit a new Premarket Tobacco Product Application or PMTA (due by May 14, 2022). This appears to be Congress’ way of doubling down on products that, in Congress’ view, switched to synthetic nicotine to get around the PMTA process, according to Keller and Heckman LLP, Washington, D.C.
We at Bidi Vapor have complied with the FDA from the beginning. And while the journey has been difficult, Bidi Vapor takes great pride in announcing that all BIDI® Stick flavor options remain available for sale.
To partner with Bidi Vapor, click here.
Getting here wasn’t easy. Although Bidi Vapor submitted a comprehensive PMTA, its non-tobacco flavored BIDI® Sticks were the subject of a marketing denial order (MDO) in September 2021. Bidi Vapor challenged FDA’s decision in court and on February 1, 2022, the U.S. Court of Appeals for the Eleventh Circuit granted a Judicial Stay of the MDO. The court-ordered stay means that the MDO is not legally in force. This means that Bidi Vapor is able to continue marketing and selling all eleven BIDI® Stick products, including its tobacco, menthol, and flavored products, subject to FDA enforcement discretion, while its merits case challenging the legality of the MDO continues.
With the Judicial Stay in place, we expect a significant increase in sales for the simple fact that BIDI® Sticks can be sold and distributed to our retail and wholesale partners, where other competing products will not be.
Why Work with Bidi Vapor?
Based on the Goldman Sachs’ Equity Research Report through February 12, 2022, on the Nielsen data for total nicotine volumes, the BIDI® Stick was the top-selling disposable ENDS product in the United States. We have millions of adults 21 and older using our product as a viable option for combustible cigarettes.
Going into the future, we will stand behind our product. If the BIDI® Stick MDO is reinstated or if the PMTA is ultimately denied, we will purchase inventory back from all current and potential retailers and wholesalers. This statement should remove any fear of becoming our partner in the near term.
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