FDA WARNING_LETTER - Chloroquineonline.com - April 29, 2020

On May 18, 2020, the FDA issued a Warning Letter to www.chloroquineonline.com after reviewing their website on April 29, 2020. The FDA found the website was selling drug products, including "Generic Aralen" (chloroquine phosphate), claiming to mitigate, prevent, treat, diagnose, or cure COVID-19.

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 for their labeled uses. The website's claim that "Generic Aralen" is effective against COVID-19 is unsupported, and no drug is FDA-approved for COVID-19 treatment. The FDA has cautioned against using chloroquine for COVID-19 outside of hospital settings or clinical trials due to serious heart rhythm risks.

Furthermore, the products are misbranded under Section 502(f)(1) of the FD&C Act (21 U.S.C. § 352(f)(1)) because they lack adequate directions for use by a layperson. Chloroquine is a prescription drug requiring professional supervision, and its intended use for COVID-19 is not amenable to self-diagnosis or treatment.

The introduction of these unapproved and misbranded drugs