FDA WARNING_LETTER - Roidsmall.net - April 17, 2020

On April 22, 2020, the FDA issued a Warning Letter to www.roidsmall.net following a website review on April 17, 2020. The FDA observed the website offering drug products for sale in the U.S. that claim to mitigate, prevent, treat, diagnose, or cure COVID-19.

These products are deemed 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). The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The FDA emphasized the public health emergency declared for COVID-19 and the inherent risks of unapproved drugs, which lack safety and effectiveness assurances.

Specific violations include the sale of oseltamivir (marketed as "Antiflu" and "Fluvir"), lopinavir + ritonavir ("Lopimune"), and ritonavir ("Ritomune") under the heading "Buy Medicines for Treating and Preventing Coronavirus." While FDA-approved versions of these active ingredients exist, the specific products offered by www.roidsmall.net lack FDA approval for any use