Kaival Brands Shares Rise 90% Premarket After FDA Stay of Bidi Vapor Products Denial Order
October 27 2021 - 09:54AM
Dow Jones News
By Chris Wack
Kaival Brands Innovations Group Inc. shares were up 90% to $2.89
in premarket trading Wednesday after the company said Bidi Vapor
LLC, the manufacturer of the premium BIDI Stick electronic nicotine
delivery system, said the U.S. Food and Drug Administration issued
an administrative stay of its marketing denial order for
non-tobacco flavored BIDI Sticks.
Kaival Brands is a global distributor of Bidi Vapor
products.
The hold will remain pending the FDA's review of the company's
request that the marketing denial order be rescinded based on
product-specific scientific evidence in its Premarket Tobacco
Product Applications.
The FDA confirmed that while it reviews Bidi Vapor's request,
its flavored BIDI Sticks can remain on the market without the
threat of enforcement.
Prior to the court-ordered Sept. 9, 2020, premarket tobacco
product application deadline, Bidi Vapor submitted premarket
tobacco product applications for all 11 flavor varieties of its
BIDI Stick, which is intended exclusively for adult cigarette
smokers and tobacco users, 21 and over. Despite submitting the
premarket tobacco product applications and keeping the FDA informed
about its ongoing clinical and behavioral studies, Bidi Vapor
received an MDO for its flavored BIDI Sticks, along with nearly all
other manufacturers of flavored ENDS, in early September 2021.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
October 27, 2021 09:39 ET (13:39 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.