Kaival Brands Innovations Group, Inc. (KAVL) in Grant, Fla., distributes electronic nicotine delivery systems (ENDS Products) and related components in the United States. The company is the exclusive global distributor of all products manufactured by Bidi Vapor, which is owned and controlled by the same principal.
KAVL shares have declined 92.4% in price over the past year and 62.4% over the past six months. Investors were anxious about the impact of the FDA’s Premarket Tobacco Product Application (PMTA) process. In 2019, a Maryland federal court judge gave FDA a deadline of one year to review all submitted PMTAs. And in 2021, it issued marketing denial orders (MDO) for virtually all PMTAs for flavored vaping products. Later, the manufacturer of the premium BIDI® Stick ENDS requested that the FDA reconsider its MDO based on scientific evidence while also seeking a judicial stay of the MDO with the 11th Circuit Court of Appeals. And last month, the company announced that it had been granted a judicial stay of the marketing denial order as a legal fight for the review of Bidi Vapor’s PMTA continues.
