FDA WARNING_LETTER - Rat's Army - December 01, 2020

On December 2, 2020, the FDA and FTC issued a Warning Letter to the company operating rats.army, following website reviews on November 24 and December 1, 2020. The letter addresses the sale of "VIRUS BIOSHIELD," which is marketed with claims to mitigate, prevent, treat, diagnose, or cure COVID-19.

The FDA determined that "VIRUS BIOSHIELD" is 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). The introduction of this product into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The letter emphasizes the public health emergency declared for COVID-19 and the urgent need to protect consumers from unapproved products.

The company is required to immediately cease the sale of these unapproved and unauthorized products. Within 48 hours, an email must be sent to COVID-19-Task-Force-CDER@fda.hhs.gov detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction