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Ravenscroft Apothecary, Inc. was selling four products—"Air Purify Aromamist," "Healer's Chai Aromatea & Breath Drops," "Elevation of Mind Aromamist," and "Rose Frequency Tongue Tincture"—with claims that they could mitigate, prevent, treat, diagnose, or cure COVID-19, violating section 505(a) of the FD&C Act by marketing unapproved new drugs. The products were also misbranded under section 502 of the FD&C Act, and their sale constituted prohibited introduction of drugs into interstate commerce under sections 301(a) and (d). The FDA conducted its review during the COVID-19 pandemic emergency declaration period, when the agency was implementing urgent enforcement measures to prevent false or unsubstantiated claims about disease treatments.