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Blue Willow Biologics was warned for marketing an unapproved non-alcohol-based nasal antiseptic product intended to mitigate, prevent, treat, or cure COVID-19 without FDA approval, violating section 505(a) of the Federal Food, Drug, and Cosmetic Act. The product was found to be misbranded under sections 502(a) and (ee) of the FD&C Act and was being sold through the company's websites and retail partners including CVS. These violations—introducing an unapproved new drug into interstate commerce—were particularly serious given the concurrent public health emergency declaration for COVID-19, which prompted FDA to take urgent enforcement measures against unauthorized products making pandemic-related claims.