Company: BOF
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001641172-25-004712
Chunk: 450

Company: BranchOut Food Inc.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 450
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 our failure to comply
with applicable requirements could adversely affect our business and results of operations.

We
are affected by a wide range of governmental laws and regulations. Examples of regulatory agencies influencing our operations include
the United States Department of Agriculture (the “USDA”), the Food and Drug Administration (the “FDA”), the Federal
Trade Commission (the “FTC”), and the Environmental Protection Agency (the “EPA”), among others. These agencies
regulate, among other things, with respect to our products and operations:

    ●
    design, development, and manufacturing;

    ●
    testing, labeling, content, and language
    of instructions for use and storage;

    ●
    product safety;

    ●
    marketing, sales, and distribution;

    ●
    record keeping procedures;

    ●
    advertising and promotion;

    ●
    recalls and corrective actions; and

    ●
    product import and export.

These
laws and regulations affect various aspects of our business. For example, certain food ingredient products manufactured by us are regulated
under the United States Federal Food, Drug, and Cosmetic Act (“FDCA”), as administered by the FDA. Under the FDCA, pre-marketing
approval by the FDA is required for the sale of a food ingredient which is a food additive unless the substance is generally recognized
as safe, under the conditions of its intended use by qualified experts in food safety. We believe that most food ingredients in our products
are generally recognized as safe. However, this status cannot be determined until actual formulations and uses are finalized. As a result,
we may be adversely affected if the FDA determines that our food ingredient products do not meet the criteria for generally recognized
as safe.

The
regulations to which we are subject are complex and have tended to become more stringent over time. Regulatory changes could result in
restrictions on our ability to carry on or expand our operations, higher than anticipated costs or lower than anticipated sales. The
failure to comply with applicable regulations could jeopardize our ability to sell our products and result in enforcement actions and
third-party lawsuits such as:

    ●
    warning letters;

    ●
    fines;

    ●
    injunctions;

    ●
    civil penalties and civil lawsuits;

    ●
    termination of distribution;

    ●
    recalls or seizures of products;

    ●
    termination of distribution;

    ●
    delays in the introduction of products into
    the market; and

    ●
    total or partial