FDA WARNING_LETTER - Pharmacy2Home/LandiCom Holding LTD - December 13, 2021

On February 3, 2022, the FDA issued a Warning Letter to www.pharmacy2home.com following a December 13, 2021, review of their website. 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 and other diseases.

The FDA determined these products are unapproved new drugs, violating section 505(a) of the FD&C Act [21 U.S.C. § 355(a)], and misbranded drugs under section 502 of the FD&C Act [21 U.S.C. § 352]. Specific examples include "Chloroquine (CoronaVirus Covid-19)," "Antiflu 75 mg (Oseltamivir)," a "CoronaVirus pack" containing oseltamivir, ribavirin, and lopinavir + ritonavir, and "Ivermectin 12mg (Covid/Corona)." These drugs are not FDA-approved for their advertised uses, particularly for COVID-19, and lack adequate directions for layperson use, as they are prescription drugs.

The introduction of these products into interstate commerce is prohibited under sections 301(a) and 301(d) of the FD&C Act [21 U.S.C. §