Company: JUNS
Filing Date: 2025-11-14
Form Type: 10-Q
Source: 0001493152-25-023603
Chunk: 38

Company: JUPITER NEUROSCIENCES, INC.
Filing Date: 2025-11-14
Form: 10-Q
Item: Item 8
Chunk 38
---
 or prevent the development and commercialization of our products.

Should
we fail to maintain a productive relationship with Aquanova or if Aquanova experiences operational or financial difficulties, our ability
to deliver products to market could be compromised, negatively impacting our growth prospects and competitive position.

If
the Company or its suppliers fails to comply with FDA or other regulations, it could result in enforcement actions or delays in the Nugevia
brand product launch.

The
Company is subject to various federal, state, and local laws, regulations and administrative practices that affect its business. Our
suppliers and contract manufacturers are also subject to such laws and regulations. The safety, formulation, manufacturing, processing,
packaging, importation, labeling, promotion, advertising, and distribution of the Nugevia brand products are subject to regulation by
several federal agencies, including the FDA, the FTC, the USDA, the CPSC and the EPA, as well as by various state and local agencies.
If these laws and regulations were violated by our management, suppliers or distributors, we could be subject to regulatory enforcement
action, public warning letters, product recalls, fines, penalties and sanctions, including injunctions against the future shipment and
sale of products, restitution and disgorgement of profits, operating restrictions. In addition, other public and private actors are increasingly
targeting supplement retailers and manufacturers with class action lawsuits for selling products that allegedly fail to adhere to the
requirements of FDCA, DSHEA, and other federal and state statutes and requirements, including for failing to adhere to current GPMs,
making false or misleading product statements, providing inaccurate ingredient identity and potency, and failing to control or disclose
allergens, contaminants, residues and adulterants, as well as for state common and statutory laws regarding deceptive trade practices.

We
could also be the target of claims relating to false or deceptive advertising in connection with the marketing and advertising of the
products we sell, including under the auspices of the FTC, the consumer protection statutes of some states as well as certain non-government
watchdog groups and class action law firms. In addition, the FDA has aggressively enforced its regulations with respect to structure/function
claims (e.g., “calcium builds strong bones”), nutrient content claims (e.g., “high in antioxidants”)
and other claims that impermissibly suggest therapeutic benefits In addition, the number of private consumer class actions relating to
false or deceptive advertising against cosmetic, food, beverage and nutritional supplement manufacturers has increased in recent years.
These