FDA WARNING_LETTER - Antroids.com - April 17, 2020

The FDA issued a Warning Letter to www.antroids.com on April 22, 2020, following a review on April 17, 2020, which found the website offering drug products for sale in the United States with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. This action was taken during a declared public health and national emergency related to COVID-19. The FDA determined these products are unapproved new drugs, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and misbranded drugs under section 502 (21 U.S.C. § 352). Their introduction into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). Specific examples cited include "Lopimune 200mg/50mg," "Ritomune 100 mg," "Fluvir 75 mg," and "Antiflu 75mg," all marketed for "Coronavirus Treatment" without FDA approval for COVID-19 uses. The FDA emphasized the inherent risks of unapproved drugs, such as contamination, counterfeiting, and inconsistent active ingredients. The firm was directed to immediately cease sales of these products and, within 48 hours, email COVID-19-Task-Force-CDER@fda.hhs.gov detailing corrective actions, recurrence prevention, and supporting documentation. Failure to comply could result in legal action, including seizure and injunction, and potential detention of products offered for importation.