Company: BOF
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001641172-25-004712
Chunk: 310

Company: BranchOut Food Inc.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 310
---
 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 suspension of production.

Any
of these sanctions could result in higher than anticipated costs or lower than anticipated sales and harm our reputation, business, financial
condition, and results of operations. We may also be required to take corrective actions, such as installing additional equipment or
taking other actions, each of which could require us to make substantial capital expenditures. In addition, we could be required to indemnify
our employees in connection with any expenses or liabilities that they may incur individually in connection with regulatory action against
them. As a result, our future business prospects could deteriorate due to regulatory constraints, and our profitability could be impaired
by our obligation to provide such indemnification to our employees.

 17 

Our
reputation could suffer from real or perceived issues involving the labeling or marketing of our products.

Products
that we sell carry claims as to their origin, ingredients, or health benefits, including, by way of example, the use of the term “natural”,
“functional”, or “healthy”, or similar synonyms or implied statements relating to such benefits. Although the
FDA and the USDA each has issued statements regarding the appropriate use of the word “natural,” there is no single, U.S.
government regulated definition of the term “natural” for use in the food industry, which is true for many other adjectives
common in our industry. The resulting uncertainty has led to consumer confusion, distrust, and legal challenges. Plaintiffs have commenced
legal actions against several food companies that market “natural” products, asserting false, misleading, and deceptive advertising
and labeling claims, including claims related to genetically modified ingredients. In limited circumstances, the FDA has taken regulatory