Great news!
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.
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.
MELBOURNE, Florida – Despite a federal ban on electronic nicotine delivery systems (ENDS) that use nicotine derived from synthetic sources, confusion remains over what’s legal and what’s not. Azim Chowdhury, a regulatory specialist from the law firm Keller and Heckman based in Washington, D.C., recently participated in a Bidi Vapor webcast, informing the audience on pertinent legal matters concerning the industry.
At the beginning of 2022, because of the flood of synthetic nicotine products coming to the market, Congress changed the definition of tobacco products, Chowdhury told listeners to the February webcast. The previous description in the Food, Drug and Cosmetic Act (FDCA) was limited to products containing tobacco-derived substances and nicotine. In March 2022, he said Congress amended the definition, expanding it to include not just tobacco-derived substances but also any product that contains nicotine from any source.
“With that stroke of a pen, synthetic nicotine products became regulated tobacco products subject to all those exact requirements under the Tobacco Control Act, including premarket review,” Chowdhury said, referring to the FDA’s Premarket Tobacco Product Application (PMTA) process. “Of importance, though, not only did Congress expand the definition and capture all these products, but it also created a new PMTA deadline.”
The PMTA deadline for products using nicotine derived from tobacco was back in 2020, but after Congress made its decision on synthetic nicotine in March of 2022, the FDA allowed firms making devices with synthetic nicotine to submit new PMTAs by May 14, 2022. Companies that were able to submit new PMTAs by that deadline were given until July 13, 2022, to market their devices without threat of enforcement.
“After July 13th, the statute says that products without authorization from the FDA and actual PMTA Marketing Granted Orders are illegal and must come off the market,” Chowdhury said. “That’s the case for all products not subject to authorization. It’s up to the FDA to enforce.”
That’s where companies like Bidi Vapor and others striving for compliance hope to see additional enforcement from the FDA and other authorities, according to Niraj Patel, founder and president of Bidi Vapor, LLC, Melbourne, Florida.
In the webcast, Patel noted that Bidi Vapor products are derived from tobacco leaves and are not subject to the new authorization process around synthetic nicotine. He added that their flavored products—which use nicotine derived from tobacco—are currently under the FDA’s scientific review and are legal to sell in U.S. markets, subject to the agency’s enforcement discretion.
To listen to the Bidi Vapor webcast, click here.
BIDI Vapor has updated its Terms & Conditions effective December 11, 2020 | Terms & Conditions Update >
Thank you for signing the Wholesalers and Direct Retailers Agreement & Terms (“Agreement”). By signing this Addendum, you agree to the following clarification of the intent of the Agreement with regard to the Age-Verification process and online sales as it relates to your role as a reseller to another reseller (those that resell to other resellers, herein “Wholesalers”). The following clarification does not apply or modify the terms of the Agreement related to any sales to, or marketing you may make directed to, end user customers of BIDI® Sticks (the “products”).
With regard preventing underage access to the product and marketing to underage persons, to the extent you do not control the sales practices of your resellers, you agree to act responsibly and comply with your own obligations under the law and in support of the policies in the Agreement in your role as a reseller of the products you purchase and sell under the Agreement. For instance, although you may not control that a cashier checks IDs, you will not sell to those resellers who have a history of selling to minors, as indicated in the FDA’s retailer inspection database. You will not sell and will cease selling to resellers upon knowledge of underage sales of the products or other non-compliance with the law related to sales of such products.
As a reminder, Kaival Brands Innovations Group, Inc. (“Kaival”) specifically prohibits any sellers at any level from selling the products via online sales to end user customers without prior written approval from Kaival. You as a Wholesaler agree you will not sell to those resellers that you know intend to sell the products online, and you will not permit such activity in terms with resellers or otherwise.
You will make our requirements for resellers known to those you sell product to, which can include providing them a copy of Bidi Vapor’s Retailer Pledge, and a link to our website where our terms reside and/or passing down policies (including by posting them on an internal ordering portal) so that such resellers are aware of them. All other terms of the Agreement as it relates to Wholesaler shall continue to apply.
Please indicate your agreement by clicking below.
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