Kaival Brands Innovations Group Inc KAVL

KAVL Applauds FDA's Continued Enforcement

[AveragePenny]

https://www.prnewswire.com/news-releases/kaival-brands-applauds-fdas-continued-enforcement-against-unauthorized-ends-products-301357652.html

Kaival Brands not only takes extremely seriously its commitment to safeguard our youth, but also its capacity to provide the BIDI® Stick, a top-quality disposable ENDS, to adult tobacco consumers seeking a consistent vaping experience. While the Company continues to exceed stringent Food and Drug Administration ("FDA") compliance mandates and applauds the agency's enforcement efforts – including 140 warning letters so far this year to firms selling or distributing more than 16,800,000 unauthorized ENDS – it remains concerned about the numerous ENDS companies, particularly distributors of disposable ENDS, that appear to have taken advantage of FDA's ground-level enforcement struggles during the COVID-19 pandemic.

On or about September 9, 2021, FDA is expected to make a major announcement regarding its Premarket Tobacco Product Application, or PMTA, review process that could impact which companies can remain on the market. Kaival Brands believes that as we approach this deadline, other manufacturers in the industry are "dumping" non-compliant, potentially hazardous and poorly manufactured products into the marketplace. Further, it believes that given the potentially far-reaching consequences of the pending FDA decisions, which the Company believes will force many of these other manufacturers to cease production, some retailers may be lowering their usual standards in return for economic gain.