FDA WARNING_LETTER - Extrapharma.com - September 02, 2020

On August 10, 2020, the FDA reviewed www.extrapharma.com and found it offering drug products for sale in the U.S. These products claim to mitigate, prevent, treat, diagnose, or cure COVID-19 and various bacterial infections, including sexually-transmitted ones. The FDA determined these products are unapproved new drugs, violating section 505(a) of the FD&C Act, and misbranded drugs under section 502. Their introduction into interstate commerce is prohibited under sections 301(a) and (d). Specific examples cited include Arbidol, marketed for COVID-19 and other respiratory infections, and Amoxil and Zithromax, marketed for bacterial infections, none of which have FDA approval for sale by extrapharma.com. Furthermore, these prescription drugs are misbranded under section 502(f)(1) because their labeling lacks adequate directions for use by a layperson, as required by 21 CFR 201.5. The sale of these unapproved and misbranded drugs poses inherent risks to consumers, as they lack assurances of safety and effectiveness and may be contaminated or counterfeit. The FDA demands immediate cessation of all such sales. The firm must respond within 48 hours via email, detailing corrective actions and preventative measures, with supporting documentation. Failure to comply could lead to legal action, including seizure and injunction, and products may be detained upon U.S. importation.