Bidi Vapor, LLC, the manufacturer of the US disposable e-cigarette BIDI Stick, today disclosed its public debate on the extension of the pre-sale tobacco product application (PMTA) process regarding the denial of flavour MDO marketing in the electronic nicotine delivery system.

This article is from Bidi Vapor. Let’s take a look at how overseas e-cigarette companies defended themselves when they were rejected by the FDA to accept PMTA.

In 2019, a federal court judge in Maryland gave the U.S. Food and Drug Administration (FDA) an arbitrary period of one year to review all timely PMTA submissions and determine the fate of the e-cigarette industry. When the random and logically impossible deadline came on September 9, 2021, the agency made the quickest choice: dump the baby and bath water together.

It has issued a marketing rejection order MDO to almost all PMTAs that are used to flavor e-cigarette products.

While expressing disappointment, Niraj Patel, President and CEO of Bidi Vapor, based in Melbourne, Florida, said, “Ultimately, the FDA will not support an industry that is not responsible. Nor will the public.”

The decision will basically withdraw flavored e-cigarette products from the US market, and indeed may prevent some young people from trying or actively using e-cigarette products. But in doing so, the decision will cost millions of adult smokers who cannot obtain what may be the most viable alternative to combustible cigarettes ever invented. In the same move, the FDA also opened the floodgates of illegal, low-quality, and potentially dangerous products in industries that the agency is trying to regulate. As with any other ban, the established demand for flavored e-cigarette products will now undoubtedly grow unrestricted, requiring higher levels of enforcement without proper tax management.

In any company that tries to serve adult smokers (people who are obsessed with traditional combustible cigarettes for a lifetime), independent e-cigarette manufacturer Bidi Vapor may have made the most honest attempt to balance the needs of hardcore adult smokers with the enticement of attention Young people, non-users, and, worse still, minors, start to smoke e-cigarettes and embark on the road of habitual nicotine consumption.

San Francisco-based JUUL made all the critical mistakes as early as 2018. JUUL's compact bomb-replacement-based equipment quickly became popular, which in turn was catastrophically embraced by minors.

According to data from the Institute of Social Studies at the University of Michigan in Ann Arbor, Michigan, from 2017 to 2019, the proportion of teenagers who smoked nicotine approximately doubled in the past 12 months, and eighth graders increased from 7.5% to 16.5%. , The number of students in the tenth grade increased from 15.8% to 30.7%, and the number of students in the twelfth grade increased from 18.3% to 35%%. Although the number has stabilized, it is still very high.

Obviously, the damage has been done.

But for those who want to realize the true potential of e-cigarettes, the task that has already begun—meaning the careful allocation of non-combustible nicotine delivery options for adult smokers—has become very clear in terms of methods and scope.

Almost at the same time, the FDA itself laid the foundation for science to support the next step that seemed logical. It developed the PMTA process to assess the potential risks and benefits of e-cigarettes, putting the burden of research on the backs of e-cigarette manufacturers.

While drawing a seemingly well-meaning path, the FDA has paved a difficult and bumpy road. Applicants will have to compete with companies such as Big Tobacco, which may spend millions of dollars on research and development of a fully supported application process. For its part, Bidi Vapor is determined to stay in the game and help develop this emerging industry.

This is the path that most participants can start logically. I believe that the agency will keep its promises and evaluate the proven benefits of e-cigarettes to consumers. These benefits are reliable science-practical and irrefutable evidence- -It can be revealed.

On September 9, 2021, the FDA changed direction.

In the eyes of an entrepreneur, Bidi Vapor, this is the way that e-cigarettes were originally intended to be used.

Technology, transformation, and hope, like any enduring technology, e-cigarettes develop organically to meet demand. In this case, it is to create an alternative method of delivering nicotine to adult tobacco users while removing the tar and carcinogens that are caused by burning tobacco and inhaling smoke.

In 2013, Niraj Patel's grandfather founded a small tobacco business in India. He earned a degree in pharmacy in his country and then a degree in chemistry from the Florida Institute of Technology. Watching the development of this new and less harmful nicotine delivery method prompted him to manufacture and sell the BIDI Stick, which he eventually branded, which is a disposable e-cigarette product with 11 flavors, including tobacco and Menthol.

The device was not successful at first. When it went on the market in 2014, it was struggling with countless emerging products and e-cigarette methods, and the public hadn't even figured out what it wanted. If the smoker does want to switch, will he or she choose an open system, a closed system, something self-sufficient, something the size of a palm, or something similar to a cigarette?

At one point, Patel tried to change the use of his device, replacing his nicotine formula with hemp-based cannabidiol or CBD options. Nevertheless, success is still far away.

During this time, he is still full of hope, believing that his initial nicotine-based ideas and the equipment he created will have his own day.

Where the story begins, the real success of BIDI Stick begins in 2020, which is nearly five years after the product was first launched on the market. A series of events such as the maturity of the US e-cigarette market and the gathering of major business partners in the Bidi circle led to the significant growth of BIDI ® Stick.

Kaival Brands Innovations Group of Grant, Florida became the sole global distributor of Bidi Vapor products, and QuikfillRx, LLC also operated as QRx Digital, located in Jacksonville Beach, Florida, which took over marketing and sales. Kaival Brands provides a brand development platform that enables Bidi Vapor to leverage emerging market forces. At the same time, QRx Digital and its retail and tobacco-centric team provide online and retail channels for the device itself.

Through this cooperation, the new leadership team has formulated a return-to-market plan based on the original intention of the product to help die-hard adult smokers find alternatives to combustible cigarettes. At the same time, the leadership developed a larger vision. It not only includes a commitment to keep minors out of its products, but also a commitment to promote its disposable e-cigarette technology and high-quality components, as well as a recycling program that can reuse these high-quality components.

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