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, Fla. – With Congress granting the U.S. Food and Drug Administration (FDA) authority over synthetic nicotine earlier this spring, most products, including electronic nicotine delivery systems (ENDS) using nicotine derived from synthetic sources, are no longer in compliance with FDA rules, experts say.
More specifically, after July 13, 2022, only synthetic nicotine products subject to timely submitted Premarket Tobacco Product Applications (PMTAs) that have received a Marketing Granted Order (MGO) from the FDA is permitted to remain on the U.S. market. As of mid-July, the FDA did not issue notice of any such product authorizations.
The development will largely hit retailers who sell e-cigarettes and ENDS that contain nicotine derived from non-tobacco sources and produced through the synthesization of chemicals—essentially “synthetic” nicotine. Prior to synthetic nicotine becoming prevalent, most ENDS products contained nicotine derived from tobacco leaves. While not many of these products are still on the market after the FDA’s marketing denial orders (MDOs), the BIDI® Stick remains, and continues to be the No. 1 selling disposable ENDS in the United States.
With PMTAs being difficult to develop, many industry observers expect most products with synthetic nicotine—including the bulk of flavored ENDS currently on the market—will fall out of FDA compliance.
“C-store retailers should pay close attention to what products are permitted for sale and are compliant with the requirements of the FDA, the Prevent All Cigarette Trafficking or PACT Act, and numerous state and local licensing and tax laws,” said Niraj Patel, president and CEO of Bidi Vapor, LLC, Melbourne, Fla. “We anticipate that as the FDA begins enforcement against illegally marketed and synthetic-nicotine vaping products, there may be an increased demand for the few remaining ENDS products made with tobacco-derived nicotine that are not currently subject to marketing denial orders, such as the BIDI® Stick.”
Bidi Vapor Can Help
Companies selling flavored vaping products have struggled to remain compliant with the FDA, Patel said. But Bidi Vapor remains one of the few independent vaping companies left on the market. Here are key points about the BIDI® Stick:
“We hope retailers take a serious look at who their partners are,” Patel said. “You want to partner with companies that comply with regulations and produce high-quality products. That’s the only way the industry will survive and thrive in the future and continue to benefit adult smokers.”
Please provide us the following information, and we’ll get back to you:
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.