Sumary of Kaival Brands Reports Results for Fiscal Third Quarter 2021:
- Separately, we believe there were other retailers willing to purchase counterfeit or sub-optimal products from manufacturers who were selling these products at significantly reduced prices.
- These manufacturers were willing, we believe, to significantly reduce sales prices because they realized they would likely not receive the FDA’s PMTA authorization on September 9, 2021, and were attempting to recognize any revenues associated with what they believe will likely be unsellable product following the deadline.
- Story continuesIn addition, COVID-19 impacted Bidi Vapor’s ability to quality test because of supply chain disruptions and develop its new product the BIDI® Pouch in line with its targeted release date, which negatively impacted our ability to begin distribution of the BIDI® Pouch.
- However, we believe that in the longer term, the removal of all synthetic nicotine products in the U.S. market could prove to be a positive event for us.
- Based on the FDA’s PMTA decisions related to disposable ENDS products, we anticipate that Bidi Vapor’s naturally derived nicotine products will remain on the market following the completion of the FDA’s PMTA process.
- Over the past twelve months, together we have been preparing for a post-PMTA regulatory environment and have maintained our focus on providing an industry-leading premium vape experience along with establishing industry-best youth access prevention programs and protocols.
- As of September 10, 2021, the FDA announced that it has taken action on over 93% of applications and issued Marketing Denial Orders (“MDOs”) for more than 992,000 flavored ENDS products, while issuing zero marketing authorizations.
- ” However, because its Arctic BIDI® Stick is menthol, Bidi Vapor believes that this menthol BIDI® Stick is not subject to the MDO.