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Sensory Cloud, Inc was cited for marketing an unapproved COVID-19 product called FEND through its website and social media channels in violation of the Federal Food, Drug, and Cosmetic Act. The product was deemed an unapproved new drug under section 505(a) and a misbranded drug under section 502 of the FD&C Act because it claimed to mitigate, prevent, treat, diagnose, or cure COVID-19 without FDA approval. The company had not obtained the required premarket approval before introducing this product into interstate commerce, which FDA explicitly prohibited during the COVID-19 public health emergency.