Company: KAVL
Filing Date: 2025-02-10
Form Type: 10-K
Source: 0001731122-25-000185
Chunk: 39

Company: Kaival Brands Innovations Group, Inc.
Filing Date: 2025-02-10
Form: 10-K
Item: Item 1
Chunk 39
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 on the merits, with Bidi’s opening merits brief filed on April
15, 2024. FDA filed its response brief on June 7, 2024, and Bidi filed its reply brief on July 29, 2024. The 11th Circuit has
indicated that the oral argument will be held in April 2025. The Company cannot provide any assurances as to the timing or outcome. Unless
the MDO is ultimately remanded by the 11th Circuit, the Classic BIDI® Stick is considered an adulterated tobacco product
the continued marketing and distribution of which is prohibited.

If it is determined or perceived that the usage
of ENDS products poses long-term health risks, the use of ENDS products may decline significantly, which may materially and adversely
affect our business, financial condition, and results of operations. 

Negative publicity on the health consequences of ENDS
products or other similar devices may also adversely affect the usage of ENDS products. For example, the FDA and the United States Centers
for Disease Control and Prevention (“CDC”) issued a joint statement on August 30, 2019, linking a number of cases of respiratory
illnesses to ENDS product use. On November 8, 2019, the CDC announced that it had preliminarily linked cases of severe respiratory illness
to the presence of Vitamin E acetate, which was found in certain Tetrahydrocannabinol (THC)-containing ENDS cartridges for non-electronic
nicotine delivery systems (non-ENDS) products that may have been obtained illegally. However, evidence is not sufficient to rule out the
contribution of other chemicals of concern, including chemicals in either THC or non-THC products (THC is the
principal psychoactive constituent of cannabis). In January 2020, after further research, the FDA and CDC recommended against the
use of THC-containing ENDS products, especially those from unofficial sources, and that the underage, pregnant women and adults who do
not currently use tobacco products should not start using ENDS products. On February 25, 2020, the CDC issued a final update, stating
that the number of cases of severe respiratory illnesses had declined to single digits as of February 9, 2020. The CDC also reconfirmed
that (i) Vitamin E acetate, which was found in some THC-containing ENDS cartridges for non-ENDS ENDS products that were mostly obtained
illegally, was