Bidi Vapor LLC has released a new webcast that brought together experts from both the legal and marketing sides of the business to tackle the confusion surrounding flavored vaping devices, explaining what can and can’t be sold in stores.
Watch the webcast here.
In the webcast, Bidi Vapor founder Niraj Patel stated that one important development has been with synthetic nicotine. After July 2022, all vaping devices that use synthetic nicotine cannot be legally sold in the U.S. without going through the proper regulatory steps. At this point, no product using synthetic nicotine has received authorization from the U.S. Food and Drug Administration (FDA).
“Unfortunately, products containing synthetic nicotine still flood the market,” Patel said. “Enforcement is key. It should occur at the manufacturer, wholesale and retail levels. But we’re not seeing it.”
“We see products on shelves we know have no PMTA (pre-market tobacco product application), or have MDOs (marketing denial orders), or are synthetic. None of that seems to have gone away,” said Russell Quick, president of Kaival Marketing Services (KMS), which supports Bidi Vapor and its electronic nicotine delivery system (ENDS) branded BIDI Stick.
Quick referred to the FDA process by which vaping products are authorized for sale in the U.S. It involves turning in a PMTA. During the review process, many companies that sold flavored devices received MDOs, which meant they needed to take their products off store shelves.
Speaking specifically to synthetic nicotine, Azim Chowdhury, partner with the Washington, D.C.-based Keller & Heckman, stated in the webcast that at the beginning of 2022, Congress changed the definition of tobacco products. The previous description was limited to products containing tobacco-derived substances and nicotine. In March 2022, 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.
Not only did Congress expand the definition and capture all these products, but it also created a new PMTA deadline, Chowdhury explained. The PMTA deadline for traditional products was back in 2020, but the FDA allowed firms to submit PMTAs for synthetic products within 60 days, essentially until May 14. Companies that could submit applications on time by that the deadline was given until July 13, 2022, to market their products without the threat of enforcement.
The webcast panel elaborated on the status of Bidi Vapor’s PMTAs both for its “Classic” tobacco flavored device and its 10 other flavored varieties, saying that while it received MDOs for its flavors, a court ruling in August of 2022 set aside those MDOs. Currently, Bidi Vapor can legitimately sell its flavored products as the FDA continues its scientific review, subject to the agency’s enforcement discretion, Chowdhury said.
Based in Melbourne, Fla., Bidi Vapor maintains a commitment to responsible adult-focused marketing, strict youth access prevention measures and age-verification standards, as well as sustainability through its BIDI Cares recycling program. Bidi Vapor’s 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.