Regulatory Uncertainty and Evolution: The legal and regulatory landscape for hemp-derived CBD products in the U.S. and internationally is complex, constantly evolving, and subject to significant changes, including potential stricter FDA enforcement or new federal/state laws, which could negatively impact product formulation, marketing, and sales.

Intense Competition and Market Saturation: The CBD market is highly competitive and fragmented, with a growing number of new entrants, established consumer brands, and private labels, leading to pricing pressures, increased marketing costs, and potential loss of market share for CV Sciences.

Product Safety and Efficacy Claims: CV Sciences faces risks related to the perceived or actual safety and efficacy of its CBD products, including potential adverse event reports, lack of conclusive scientific evidence for all claimed benefits, and the risk of regulatory bodies challenging health claims, which could lead to product recalls, litigation, or damage to reputation.