On September 14, Bidi Vapor, one of the largest disposable vape producers in the United States, announced that the Food and Drug Administration (FDA) had ordered all of its products except tobacco flavors to be removed from the market. This marketing denial order (MDO) included its menthol flavor, “Arctic.”
Bidi believes that particular decision to be a mistake on the FDA’s part, and is currently exploring next steps to address the situation.
“It looks like FDA is making a mistake in many, many cases,” said Azim Chowdhury, a partner at the law firm Keller and Heckman, where he advises Bidi and other clients on nicotine regulations. “I have a number of companies that have received MDOs, but those MDOs are also identifying their menthol products. It seems like FDA, in their rush to get all these out, they’re not doing a very thorough job.”
Like all other vape companies, Bidi has had to undergo an expensive and onerous premarket tobacco product application process (PMTA) in which the FDA reviews whether submissions are “appropriate for the protection health”—a definition that has recently been understood to mean a given product’s likelihood of helping adult smokers transition to safer alternatives while not introducing teenagers to potential nicotine dependence. Vapor companies had until September 9, 2020 to submit their applications; the FDA, which has already sent out hundreds of MDOs, then had until that same date in 2021 to review an avalanche of PMTAs, numbering in the millions.
The FDA recently stated that it would not complete its review by that date. Most of the largest players now sit in limbo, awaiting decisions, as the agency continues to send out MDOs to smaller manufacturers without the means or resources to finish the applications, let alone in a tight time frame.
Bidi received an MDO for its flavored products, and the company had recently taken “the initiative of adopting one-word, non-characterizing terms to identify” its products in an attempt to follow FDA’s enforcement priorities (so as not to remotely appeal to youth). “Fruity Mango” became “Gold”; “Dragon Venom” became “Regal”; “Berry Blast” became “Solar.” In the process, it changed “Mint Freeze”—its menthol flavor—to “Arctic.”
“I want to be careful how we characterize the challenge or the defiance. Because FDA might have been confused.”
So there’s a likely scenario in which the FDA issued Bidi an MDO for its flavored products and included “Arctic” because the agency believed it to be a flavor other than menthol, since it was not literally called “menthol.”
When asked if that was the situation, an FDA spokesperson told Filter that the agency “is aware of the company’s public statements and is looking into it.”
“I want to be careful how we characterize the challenge or the defiance,” Chowdhury emphasized to Filter. “Because FDA might have been confused, trying to get these out before the deadline. If they had looked at the ingredients or the actual substance, they may have seen that this is in fact a menthol product.”
“It’s not just Bidi, though,” he added. “I want to be clear. It’s a ton of folks.”
Bidi is now arguing, essentially, that the wording in press releases from the FDA’s Center for Tobacco Products (CTP) allows the company to keep selling menthol flavors for its ENDS (electronic nicotine delivery system) devices despite the MDO: “Companies receiving these MDOs may have submitted premarket applications for other products (such as ENDS devices, tobacco-flavored ENDS, or menthol-flavored ENDS), and those products, if still pending, remain under review at FDA,” one such document reads. (Emphasis my own.)
Niraj Patel, the CEO of Bidi, acknowledged that some of the company’s product studies were incomplete yet ongoing, like those of so many other vape manufacturers, and that the FDA had not granted sufficient time to complete studies that could take up to six or even nine months. The FDA had issued a draft document on tobacco product perception and intention (TPPI) studies to be included in a PMTA application at least one month after the September 2020 deadline.
As a result, Bidi’s applications, like those from so many other companies, were incomplete and consequently denied.
“We are doing all of those studies, and we’ve constantly updated the FDA about the company we hired and this is the timeline in which we will get you a result,” Patel told Filter.
Continued denials, of course, would be catastrophic, as they have already been for much of the industry.
In a press release, Bidi, which saw its most recent quarterly revenue fall from $32.4 million to $3.4 million in 2021 when compared to the equivalent quarter last year, largely faulted the FDA’s regulatory procedure for the significant drop. Bidi also mentioned manufacturing delays of its tobacco-derived nicotine pouch, citing COVID-related reasons. (Kaival Brands Innovations Group, a publicly traded company that distributes Bidi Vapor, has seen its stock price sink.)
“We are willing to work within the regulatory framework. We have to be.”
Bidi also stated in the press release that a removal of synthetic nicotine—that is, nicotine made in a lab and not derived from tobacco—from the marketplace would be “a positive event.” Many small- and medium-sized manufacturers are now transitioning to synthetic nicotine, viewing it as a legal gray area outside the FDA’s regulatory authority.
Puff Bar, the number one disposable vape company according to Nielsen data reviewed by Filter, is likely Bidi’s biggest competitor. The company, which has been castigated for its mysterious ownership and attracting youth, has already made the switch to synthetic nicotine.
“We are willing to work within the regulatory framework,” Patel told Filter. “We have to be. It is important for public health that the products distributed in America have to be safe.”
Update, September 16: This article was updated to add the FDA’s comment.