Major Disposable Vape Maker Disputes FDA’s Marketing Denial Order

In a recent announcement, Bidi Vapor, one of the leading disposable vape producers in the United States, revealed that the Food and Drug Administration (FDA) had issued a marketing denial order (MDO) instructing the removal of all its products, excluding tobacco flavors, from the market. Notably, this MDO also included the popular menthol flavor known as “Arctic.” Bidi Vapor believes that the FDA’s decision is a mistake and is currently exploring the next steps to address this situation. Let’s delve into the details and examine the key points surrounding this dispute.

FDA’s Rushed Decision-Making

Azim Chowdhury, a partner at the law firm Keller and Heckman, which advises Bidi Vapor and other clients on nicotine regulations, expressed concerns about the FDA’s decision-making process. According to Chowdhury, the FDA seems to be making errors in multiple cases, including the identification of menthol products in the MDOs. He suggests that the FDA, in its haste to address the issue, may not be thoroughly reviewing each case.

The PMTA Process and FDA’s Review Delay

All vape companies, including Bidi Vapor, were required to undergo the premarket tobacco product application (PMTA) process, a costly and burdensome procedure. The FDA reviews these submissions to determine if they are “appropriate for the protection health.” This definition emphasizes the product’s potential to help adult smokers transition to safer alternatives while avoiding the introduction of nicotine dependence among teenagers. Vape companies had until September 9, 2020, to submit their applications. However, the FDA stated that it would not be able to complete its review by that date. As a result, many companies, including Bidi Vapor, are left waiting for decisions, while smaller manufacturers with limited resources receive MDOs without adequate time to complete the applications.

Bidi’s Flavor Renaming Initiative

To comply with the FDA’s enforcement priorities and avoid attracting young consumers, Bidi Vapor took the initiative to adopt one-word, non-characterizing terms to identify its products. For instance, “Fruity Mango” became “Gold,” “Dragon Venom” became “Regal,” and “Berry Blast” became “Solar.” In this process, Bidi Vapor changed the name of its menthol flavor from “Mint Freeze” to “Arctic.” It is possible that the FDA included “Arctic” in the MDO for flavored products, assuming it to be a flavor other than menthol due to its name.

FDA’s Response and Possible Confusion

When asked about this scenario, an FDA spokesperson stated that the agency is aware of Bidi Vapor’s public statements and is looking into the matter. Azim Chowdhury highlighted the need to exercise caution when characterizing the situation. He believes that the FDA might have been confused and rushed to issue the MDOs before the deadline. If the FDA had thoroughly examined the ingredients or substance, they would have realized that “Arctic” is, indeed, a menthol product. Chowdhury emphasizes that this issue extends beyond Bidi Vapor and affects numerous other companies.

Bidi’s Argument and FDA’s Center for Tobacco Products

Bidi Vapor is arguing that the wording in the FDA’s press releases from the Center for Tobacco Products (CTP) allows the company to continue selling menthol flavors for its electronic nicotine delivery system (ENDS) devices, despite the MDO. According to one such document, companies that have submitted premarket applications for other products, including ENDS devices, tobacco-flavored ENDS, or menthol-flavored ENDS, which are still pending, remain under FDA’s review. Bidi Vapor asserts that this provision allows them to continue selling menthol flavors.

Incomplete Studies and Denial Consequences

Niraj Patel, the CEO of Bidi Vapor, acknowledged that some of the company’s product studies, similar to many other vape manufacturers, were incomplete and ongoing. The FDA’s failure to grant sufficient time for studies that could take several months led to the denial of Bidi Vapor’s applications, as well as many others. Continued denials would be catastrophic for the industry, which has already faced significant challenges.

Impact on Bidi Vapor and the Industry

Bidi Vapor experienced a substantial drop in revenue, with its most recent quarterly revenue falling from $32.4 million to $3.4 million in 2021, compared to the same quarter last year. The company primarily attributes this significant decline to the FDA’s regulatory procedure. Bidi Vapor also mentioned manufacturing delays of its tobacco-derived nicotine pouch, citing COVID-related reasons. As a result, Kaival Brands Innovations Group, the publicly traded company that distributes Bidi Vapor, has witnessed a decline in its stock price.

Transitioning to Synthetic Nicotine

In its press release, Bidi Vapor stated that the removal of synthetic nicotine from the marketplace would be a positive event. Many small- and medium-sized manufacturers are now transitioning to synthetic nicotine, considering it a legal gray area outside the FDA’s regulatory authority. Puff Bar, the leading disposable vape company based on Nielsen data, has already made the switch to synthetic nicotine. Bidi Vapor is willing to work within the regulatory framework, emphasizing the importance of ensuring the safety of products distributed in America for public health reasons.

Conclusion

Bidi Vapor’s dispute with the FDA’s marketing denial order has highlighted the challenges faced by the disposable vape industry. The FDA’s rushed decision-making, delayed review process, and confusion regarding flavor identification have led to significant consequences for companies like Bidi Vapor. The impact on revenue and the need to adapt to regulatory changes have further complicated the situation. As the industry navigates these challenges, the transition to synthetic nicotine and adherence to regulatory guidelines remain crucial.

FAQs

Q: How has the FDA’s marketing denial order affected Bidi Vapor?
- A: The marketing denial order has resulted in the removal of all Bidi Vapor products, except tobacco flavors, from the market, impacting the company’s revenue significantly.
Q: What is Bidi Vapor’s argument regarding the FDA’s marketing denial order?
- A: Bidi Vapor argues that the wording in the FDA’s press releases allows them to continue selling menthol flavors for their ENDS devices, despite the marketing denial order.
Q: How has the PMTA process affected the vape industry?
- A: The PMTA process has imposed a costly and burdensome procedure on vape companies. Delays in the FDA’s review have left many companies in limbo, awaiting decisions while struggling to meet the application requirements.
Q: What alternative has Bidi Vapor suggested for nicotine production?
- A: Bidi Vapor supports the removal of synthetic nicotine from the marketplace, as many manufacturers are transitioning to it due to its legal gray area outside the FDA’s regulatory authority.
Q: How has Bidi Vapor’s revenue been affected by external factors?
- A: Bidi Vapor attributes the significant drop in revenue to the FDA’s regulatory procedure and manufacturing delays of its tobacco-derived nicotine pouch, citing COVID-related reasons.