FDA WARNING_LETTER - rxmedkart.com - May 12, 2021

On July 20, 2021, the FDA issued a Warning Letter to www.rxmedkart.com following a May 12, 2021, review of their website. The FDA found the website was illegally selling unapproved and misbranded drugs to U.S. consumers, specifically products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19, strongyloidiasis, onchocerciasis, and lymphatic filariasis.

The primary violation cited was the sale of "unapproved new drugs" under Section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. An example given was the "Ziverdo Kit" (Zinc Acetate, Doxycycline, Ivermectin), marketed for COVID-19 treatment, for which no FDA approval exists. While individual components are FDA-approved for other conditions (e.g., zinc acetate for Wilson's disease, doxycycline for infections, ivermectin for parasitic infections), their combination and use for COVID-19 are unapproved.

Additionally, the products were deemed "misbranded drugs" under Section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] because they lacked adequate directions for use by a layperson. As prescription drugs, they require