Bidi Vapor, one of the largest disposable e-cigarette manufacturers in the United States, announced that the U.S. Food and Drug Administration (FDA) has ordered it to remove all products except tobacco flavors from the market.

The marketing denial order (MDO) includes its mint-flavored "Arctic" products. Bidi believes that this particular decision of the FDA is wrong and is currently exploring the next steps to resolve this situation.

"It seems that the FDA has made mistakes in many, many situations," said Azim Chowdhury, a partner at the law firm Keller and Heckman, where he advises Bidi and other clients on nicotine regulations. "I have received MDO from many companies, but these MDOs are also recognizing their menthol products. It seems that the FDA is eager to get all of these out. They are not doing very thorough work."

Like all other e-cigarette companies, Bidi has to go through an expensive and onerous pre-market tobacco product application process (PMTA), in which the FDA reviews whether the submitted materials are suitable for health protection-this definition has recently been understood to mean a given The product has the potential to help adult smokers transition to safer alternatives without causing potential nicotine dependence among young people.

The steam company must submit an application before September 9, 2020; the FDA has issued hundreds of MDOs, and then must review a large number of PMTAs on the same day in 2021, reaching millions.

The FDA recently stated that it will not complete its review before that date. Most of the largest players are now in a state of uncertainty, waiting for a decision, because the agency continues to send MDOs to smaller manufacturers who do not have the means or resources to complete the application, let alone within the tight time frame NS.

Bidi's seasoning products have obtained MDO, and the company has recently taken the initiative to use single-word, non-characteristic terms to identify its products in an attempt to follow the FDA's enforcement priorities (so as not to attract young people remotely). Fruity mango becomes gold; Dragon poison becomes rich; Berry Blast becomes Solar. In the process, it changed Mint Frozen-mint flavor-to Arctic.

"I want to be careful how we describe challenge or resistance. Because the FDA may be confused."

Therefore, it is possible that the FDA issued an MDO to Bidi for its flavoring products, including Arctic, because the agency considers it to be a flavor other than menthol, because it is not actually called menthol.

When asked whether this is the case, an FDA spokesperson told the media that the agency is aware of the company's public statement and is investigating it.

"I want to be careful how we describe challenge or resistance," Chowdhury said. "Because the FDA may be confused and try to get them out before the deadline. If they look at the ingredients or the actual substance, they may find that this is actually a menthol product."

"However, it's not just Bidi," he added. "I want to make it clear that there are many people."

Niraj Patel, CEO of Bidi, admitted that some of the company’s product research has not yet been completed but is still in progress, just like the research of many other e-cigarette manufacturers, and the FDA has not given enough time to complete what may take up to 6 years. Research. Even nine months. The FDA has issued a draft document on tobacco product perception and intention (TPPI) research, which will be included in the PMTA application at least one month after the September 2020 deadline.

"We are doing all these studies, and we are constantly updating the FDA with the companies we have hired. This is the timeline on which we will give you results," Patel said.

Of course, continued denials will be disastrous, as they have already affected most industries.

In a press release, Bidi saw its most recent quarterly revenue drop sharply from $324,000 to $3.4 million in the same quarter compared to the same quarter last year in 2021, which mainly blamed the FDA for a significant decline in its regulatory procedures. Bidi also mentioned the delay in the manufacture of its tobacco-derived nicotine bags, citing COVID-related reasons.

Kaival Brands Innovations Group, a publicly traded company that distributes Bidi Vapor, has its share price fallen.

"We are willing to work within a regulatory framework. We must be so."

Bidi also stated in the press release that the removal of synthetic nicotine from the market—that is, laboratory-made nicotine, rather than nicotine from tobacco—will 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 regulatory agency.

PUFFBar, according to Nielsen’s data, shows that the number one disposable e-cigarette is probably Bidi’s biggest competitor. The company that has been condemned for its mysterious ownership and attractiveness to young people has turned to synthetic nicotine.

"We are willing to work within the regulatory framework." Patel said. "We must be so. Products sold in the United States must be safe, which is important to public health."

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