Company: JUNS
Filing Date: 2025-11-26
Form Type: S-1
Source: 0001493152-25-025204
Chunk: 147

Company: JUPITER NEUROSCIENCES, INC.
Filing Date: 2025-11-26
Form: S-1
Chunk 147
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 such as contamination or inconsistent ingredient potency, could
lead to product recalls, fines, or reputational damage. Given Nugevia’s pharmaceutical-grade positioning, any lapses in quality
control could undermine consumer trust and weaken its competitive edge in the $451.7 billion nutraceutical market.

Compliance with U.S. FDA Regulations

In the United States, Nugevia
products, classified as dietary supplements, fall under the Dietary Supplement Health and Education Act (DSHEA) of 1994, enforced by the
FDA. The FDA requires that all health claims be substantiated with credible scientific evidence, and any claims related to Nugevia’s
benefits—such as mitochondrial support, mental clarity, or skin vitality—must avoid implying treatment or prevention of diseases,
which would classify the products as drugs subject to stricter pre-market approval. Non-compliance, such as misleading labeling or unsubstantiated
claims, could result in warning letters, product seizures, or injunctions. Additionally, Jupiter must ensure that JOTROL™, its proprietary
resveratrol delivery system, complies with FDA’s New Dietary Ingredient (NDI) notification requirements if deemed novel, a process
that can take months and delay the Q3 2025 launch if not initiated early.

International Regulatory Variations

Global expansion introduces
regulatory complexities. In the European Union, the European Food Safety Authority (EFSA) oversees nutraceuticals under the Novel Food
Regulation (EU) 2015/2283. If JOTROL™ or other ingredients like NovaSOL® Astaxanthin are considered novel foods (not consumed
in the EU before May 15, 1997), Jupiter must submit a detailed safety dossier, a costly and time-intensive process that could delay market
entry. In markets like China or Japan, stringent pre-market approvals and ingredient restrictions may require reformulation or additional
clinical studies. Failure to navigate these variations could limit Nugevia’s global reach or result in costly reformulations, impacting
Jupiter’s revenue projections.

Post-Market Surveillance and Adverse Event Reporting

After launch, Nugevia products
are subject to post-market surveillance, particularly in the U.S., where manufacturers must report serious adverse events to the FDA within
15 days under DSHEA. Even rare side effects linked to resveratrol or other ingredients like astaxanthin could trigger investigations,
negative publicity, or product withdrawals. Jupiter must establish robust adverse event reporting systems and ensure transparency to mitigate