FDA WARNING_LETTER - Hydroxychloroquine-online.com - June 23, 2020

On July 9, 2020, the FDA issued a Warning Letter to www.hydroxychloroquine-online.com after reviewing their website on June 23, 2020. The FDA found the website was illegally selling unapproved and misbranded drug products to U.S. consumers, specifically those claiming to mitigate, prevent, treat, diagnose, or cure COVID-19 and other diseases like malaria.

The products, including "Generic Aralen" (chloroquine phosphate), are considered unapproved new drugs under Section 505(a) of the FD&C Act because they lack FDA approval for their labeled uses and are not generally recognized as safe and effective. Their introduction into interstate commerce violates Sections 301(d) and 505(a). The FDA noted that while approved chloroquine exists for malaria and amebiasis, it is prescription-only, and there are no approved applications for the specific products offered. Furthermore, the FDA had cautioned against using hydroxychloroquine or chloroquine for COVID-19 outside of hospital settings or clinical trials due to serious heart rhythm risks, and no drug is FDA-approved for COVID-19.

The drugs are also misbranded under Section 502(f)(1) of the FD&C Act because they lack adequate directions for use by a layperson, as they are prescription drugs requiring professional supervision. Selling these misbranded drugs violates Section