Bidi Vapor officials discuss what’s legal, what’s not regarding FDA rules
MELBOURNE, Florida – A new webcast, sponsored by Bidi Vapor, LLC, outlines what the U.S. Food and Drug Administration (FDA) considers noncompliant electronic nicotine delivery systems (ENDS) and high-priorities for agency enforcement.
Here are the top three telltale signs of noncompliance:
- Synthetic nicotine. Products containing nicotine derived from synthetic methods are not legal to sell as of July 2022, according to FDA rules. Compliant devices use nicotine derived from tobacco.
- No Premarket Tobacco Product Application (PMTA). Products without properly filed and accepted PMTAs are noncompliant and high-priority targets for FDA enforcement.
- Marketing denial order (MDO). Products with legally standing MDOs are noncompliant and high-priority targets for FDA enforcement.
Vaping devices that advertise high puff counts, tout kid-friendly flavor names or are called out in FDA warning letters fall outside of the FDA’s compliance parameters and are not legal to sell, webcast panelists said.
In the webcast, officials with the Melbourne, Fla.-based vape manufacturer also note how the FDA recently issued warning letters to retailers—over half of them convenience-store operators–flagged for selling noncompliant products. Additionally, the FDA recently enlisted the U.S. Customs and Border Protection to help it stop noncompliant product from entering the country.
The webcast panel elaborated on the status of Bidi Vapor’s PMTAs for both its “Classic” tobacco-flavored device and its 10 other flavored varieties, saying that while it received MDOs for their flavors, a court ruling in August of 2022 set them aside. “Currently, Bidi Vapor can legitimately sell its flavored products as the FDA continues its scientific review, subject to the agency’s enforcement discretion,” said Azim Chowdhury, partner with the Washington, D.C.-based Keller and Heckman LLP.
Meanwhile, Bidi Vapor officials are inviting c-store retailers at the 2023 NACS Show in Atlanta, Oct. 3-6, 2023, to visit them in Booth No. C8874.
ABOUT BIDI VAPOR
Based in Melbourne, Florida, Bidi Vapor maintains a commitment to responsible, adult-focused marketing, supporting age-verification standards and sustainability through its BIDI® Cares recycling program. Bidi Vapor’s premier device, the BIDI® Stick, is a premium product made with high-quality components, a UL-certified battery and technology designed to deliver a consistent vaping experience for adult smokers 21 and over. Bidi Vapor is also adamant about strict compliance with all federal, state and local guidelines and regulations. At Bidi Vapor, innovation is key to its mission, with the BIDI® Stick promoting environmental sustainability, while providing a unique vaping experience to adult smokers.
Nirajkumar Patel, the Company’s Chief Science and Regulatory Officer and director, owns and controls Bidi Vapor. As a result, Bidi Vapor is considered a related party of the Company.
For more information, visit www.bidivapor.com.
ABOUT KAIVAL BRANDS
Based in Grant, Florida, Kaival Brands is a company focused on incubating innovative and profitable products into mature and dominant brands, with a current focus on the distribution of electronic nicotine delivery systems (ENDS) also known as “e-cigarettes”. Our business plan is to seek to diversify into distributing other nicotine and non-nicotine delivery system products (including those related to hemp-derived cannabidiol (known as CBD) products. Kaival Brands and Philip Morris Products S.A. (via sublicense from Kaival Brands) are the exclusive global distributors of all products manufactured by Bidi Vapor.
Learn more about Kaival Brands at https://ir.kaivalbrands.com/overview/default.aspx.
ABOUT KAIVAL MARKETING SERVICES
Kaival Marketing Services has been the primary marketing and sales service provider for Kaival Brands since 2020. In addition to its sales force, KMS brings over 100 contracted employees dedicated to supporting Kaival Brands’ management team through its next stage of growth.
For more information, visit http://kaivalmarketingservices.com.