FDA WARNING_LETTER - Foxroids.com - April 17, 2020

On April 22, 2020, the FDA issued a Warning Letter to www.foxroids.com after reviewing its website on April 17, 2020. The FDA found the company was unlawfully selling unapproved and misbranded drug products online, claiming they could mitigate, prevent, treat, diagnose, or cure Coronavirus Disease 2019 (COVID-19) during a declared public health emergency. Specific products cited include "Lopimune 200mg/50 mg," "Ritomune 100 mg," "Fluvir 75 mg," and "Antiflu 75mg," all marketed under a "Coronavirus Treatment" heading. These products are deemed unapproved new drugs, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), as no approved applications exist for their COVID-19 related uses, and they are not generally recognized as safe and effective. Additionally, they are misbranded drugs under section 502 (21 U.S.C. § 352). The introduction or delivery of these prohibited products into interstate commerce violates sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The FDA stressed the inherent risks of unapproved drugs, which lack assurances of safety and effectiveness. The company must immediately cease selling these products and respond within 48 hours via email to COVID-19-Task-Force-CDER@fda.hhs.gov, detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply could result in legal action, including seizure and injunction, and products may be refused admission into the U.S.