Medication-house.com – FDA Warning Letter, Aug 10, 2020

On September 2, 2020, the FDA issued a Warning Letter to www.medication-house.com after reviewing their website on August 10, 2020. 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 Arbidol, claimed to inhibit influenza and coronavirus, and unapproved versions of amoxicillin and azithromycin, which are prescription drugs in the U.S. and require adequate directions for use not provided for laypersons. The letter notes that some drug labeling is not in English, indicating they are not intended for the U.S. market.

The FDA emphasized the inherent risks of unapproved and misbranded drugs, including potential contamination, counterfeiting, and incorrect active ingredient amounts. The company is required to immediately cease selling all such unapproved and misbranded products. Within 48 hours, www.medication-house.com must email FDAInternetPharmacyTaskForce-CDER@fda.