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Talk to a SpecialistTalk to a SpecialistSalvacion USA Inc. was cited for distributing Covixyl Nasal Spray, an unapproved new drug in violation of section 505(a) of the Federal Food, Drug, & Cosmetic Act. The company made disease-prevention and antiviral efficacy claims on its website and social media platforms (Twitter and Facebook) without FDA approval, including statements that the product "safely and effectively create[s] a barrier in the nasal passages that helps block airborne viruses" against SARS-CoV-2, influenza, RSV, and rotavirus. These marketing claims established the product's intended use as a drug, yet no new drug application had been submitted or approved by the FDA.