Company: KAVL
Filing Date: 2025-08-18
Form Type: 424B5
Source: 0001731122-25-001141
Chunk: 44

Company: Kaival Brands Innovations Group, Inc.
Filing Date: 2025-08-18
Form: 424B5
Chunk 44
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 and regulations may negatively impact our ability to operate. As a distributor, we are also subject
to various rules and regulations. Some of the below may not directly apply to us at this time due to the nature of our present operations.
These rules and regulations include, but are not limited to, the following:

FDA and Related Regulations Relating to ENDS Products

Effective August 8, 2016, the FDA’s regulatory
authority under The Family Smoking Prevention and Tobacco Control Act was extended to all remaining tobacco products, including: (i) certain
“new generation” products (such as electronic cigarettes, vaporizers, and e-liquids) and their components or parts (such as
tanks, coils, and batteries); (ii) cigars and their components or parts (such as cigar tobacco); (iii) pipe tobacco; (iv) hookah products;
or (v) any other tobacco product “newly deemed” by the FDA (the “Deeming Rule”). The Deeming Rule applies to all
products made or derived from tobacco intended for human consumption but excluding accessories of tobacco products (such as lighters).
Furthermore, starting in April 2022, FDA was also granted authority to regulate products containing synthetic (non-tobacco) nicotine as
tobacco products. Specifically, the Consolidated Appropriations Act of 2022 amended the definition of a “tobacco product”
in the Food, Drug and Cosmetic Act and gave the FDA authority to regulate products containing nicotine from any source, including synthetic
nicotine.

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The Deeming Rule requires (i) United States manufactured
products be registered with the FDA and that products include ingredient listings; (ii) newly deemed products be marketed only after FDA
review and authorization, subject to FDA’s compliance enforcement policy; (iii) products only make direct and implied claims of
reduced risk if the FDA authorizes after finding that scientific evidence supports the claim and that marketing the product will benefit
public health as a whole; (iv) sellers of such products refrain from distributing free samples; (v) sellers of such products implement
minimum age and identification restrictions to prevent sales to individuals under age 18 (later extended to 21); (vi) packaging of and
advertisements for products include prescribed health warnings; and (vii) sellers refrain from selling Bidi products in vending machines,
unless the machine is located in a facility that never admits youth. We, along with Bidi, must comply