FDA WARNING_LETTER - Corona-cure.com - March 26, 2020

On March 26, 2020, the FDA and FTC issued a Warning Letter to Corona-Cure regarding their website, corona-cure.com, which offered "Corona-Cure Coronavirus Infection Prevention Nasal Spray." The FDA determined this product was marketed to mitigate, prevent, treat, diagnose, or cure COVID-19.

The product is cited as an unapproved new drug, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and a misbranded drug under section 502 (21 U.S.C. § 352). Its introduction into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). This action is part of urgent measures to protect consumers during the COVID-19 public health and national emergencies declared in January and March 2020, respectively.

The letter demands immediate cessation of sales for these unapproved and unauthorized products. The company must email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction. The firm will be added to FDA's public list of