FDA WARNING_LETTER - Extrapharmacy.ru - December 13, 2021

On February 15, 2022, the FDA issued a Warning Letter to www.extrapharmacy.ru following a website review on December 13, 2021. The FDA found the website offers unapproved and misbranded drug products for sale to U.S. consumers, including those claiming to mitigate, prevent, treat, diagnose, or cure COVID-19, systemic lupus erythematosus, rheumatoid arthritis, and malaria.

These products are deemed unapproved new drugs under section 505(a) of the FD&C Act [21 U.S.C. § 355(a)] because they lack FDA approval and are not generally recognized as safe and effective. Examples include "Plaquenil (Hydroxychloroquine)" by Sanofi and "Areplivir (Favipiravir)" by Promomed, neither of which has an approved application for distribution in the U.S. or for COVID-19 treatment.

Furthermore, the drugs are misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] as their labeling lacks adequate directions for use, particularly for prescription drugs requiring professional supervision. The introduction of these products into interstate commerce violates sections 301(a) and 301(d) of the FD&C Act [21 U.