- One year after the deadline for submitting Premarket Tobacco Product Applications, the FDA is targeting September 9, 2021 for an announcement on which products will be allowed for sale
- Kaival is the exclusive global distributor for products made by BIDI Vapor, which has seen its PMTAs pass two out of three phases in the FDA process
- Kaival competition was recently thinned considerably when the FDA rejected approximately 4.5 million of the 6.5 million PMTAs received
Despite efforts by the U.S. Food and Drug Administration in recent years to implement and enforce new regulation governing e-cigarette market, illegal goods and practices still abound. The days of illicit nicotine products may be dwindling down, representing a paradigm shift supported by companies like Kaival Brands Innovations Group (NASDAQ: KAVL) that are deeply committed to seeing only safe, 21-years and older use of vape products. Kaival, the exclusive global distributor of a portfolio of premium vape products manufactured by BIDI Vapor, LLC.
Last year, the FDA set September 9, 2020 as the deadline for companies to submit Premarket Tobacco Product Applications (“PMTA”) seeking authorization to market specific tobacco products. The long-and-short of new regulations is that there are only three ways to legally sell a tobacco product: one: a product can be grandfathered in by having been on the market before February 15, 2007; two: a brand can receive FDA approval to a Substance Equivalence application deeming a product similar to a grandfathered in product; and three, through submission of a PMTA, which identifies the product as introduced to the market after February 15, 2007 and unlike any grandfathered in. A company was required to submit a PMTA for every product it wishes to sell, including a separate PMTA for every different e-liquid flavor and device. This is the pathway for BIDI Vapor and its BIDI Stick electronic nicotine delivery systems (“ENDS”) product lineup that come in 11 different flavors.
BIDI’s PMTAs have passed the first two phases: receiving an acceptance letter from the FDA for the PMTA and subsequently receiving a filing letter indicating the application has met the FDA’s baseline criteria, allowing it to move into the final phase. The “substantive” phase involves the FDA’s scientific review of the PMTA (https://ibn.fm/WI59h) and associated data. BIDI and Kaival are waiting for a final decision in the coming weeks, with an approval officially designating the products as “appropriate for the protection of public health.”
The FDA received over 6.5 million PMTAs from over 500 countries by the deadline which are now under review, with a target completion date of September 9, 2021. The list was trimmed by over 70% on August 9, 2021 when the FDA issued a Refuse to File (“RTF”) letter to JD Nova Group LLC, the owner of Vapolocity (https://ibn.fm/Zy8o9). The RTF stated that the applications for approximately 4.5 million JD Nova products “lacked an adequate Environmental Assessment,” meaning that they will have to be removed from the market or risk enforcement action by FDA. The RTF effectively dismissed 75% of the new products looking to make it to market.
Kaival and BIDI, with their industry-leading regulatory and youth access prevention practices, continue to be relentless advocates for increased regulatory oversite to ensure e-cigarette products do not reach the hands of consumers under 21 years old, and are recycled, when possible, through their BIDI cares program. As the major FDA PMTA announcement approaches, some unethical companies are dumping their product into the markets before the crackdown and stiffer law enforcement begins. Ultimately, the announcement will determine which companies can remain on the market in a bit of a cleansing to weed out the industry’s bad actors for the good of public safety.
“We place enormous importance on our integrity and our brand name,” said Nirajkumar “Raj” Patel, Founder and Chief Executive Officer of Kaival Brands. Patel, which also owns and controls BIDI Vapor, added, “not only are we ready for increased regulation and enforcement, we both encourage and welcome it.”
For more information, visit the company’s website at www.KaivalBrands.com.
NOTE TO INVESTORS: The latest news and updates relating to KAVL are available in the company’s newsroom at http://ibn.fm/KAVL
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