FDA WARNING_LETTER - Emedkit.com - April 17, 2020

On April 22, 2020, the FDA issued a Warning Letter to emedkit.com after reviewing their website and social media on April 17, 2020. The FDA observed that emedkit.com was offering drug products for sale in the United States, claiming to mitigate, prevent, treat, diagnose, or cure COVID-19.

The FDA determined these products are unapproved new drugs, violating section 505(a) of the FD&C Act, and misbranded drugs under section 502 of the FD&C Act. The introduction of these products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act.

Specifically, emedkit.com offered "Lopikast" (lopinavir 200 mg + ritonavir 50 mg), claiming it treats COVID-19 symptoms and is effective against coronaviruses like SARS and MERS. While FDA-approved versions of lopinavir + ritonavir exist, "Lopikast" from emedkit.com lacks FDA approval for any use, and no drug has been approved by the FDA for COVID-19.

The FDA emphasized the risks of unapproved drugs, including contamination, counterfeiting, and inconsistent active ingredients. The company was ordered to immediately cease selling these unapproved and unauthorized products for COVID-19. Within