FDA WARNING_LETTER - www.ivermectin4covid.com - March 21, 2023

On March 16, 2023, the FDA issued a Warning Letter to www.ivermectin4covid.com for unlawfully selling unapproved and misbranded drugs to U.S. consumers over the internet, specifically in relation to COVID-19. The FDA observed the website introducing into interstate commerce misbranded and unapproved new drugs, violating sections 301(a), 301(d), and 505(a) of the FD&C Act.

The primary violation involves the sale of "Iverheal 12mg" manufactured by Healing Pharma, marketed for "Covid 19 care." This product is an unapproved new drug under section 201(p) and 505(a) of the FD&C Act, as no approved applications are in effect for it. While FDA-approved ivermectin exists for specific parasitic infections, it is prescription-only and not approved for COVID-19.

Additionally, the drugs are misbranded under section 502(f)(1) of the FD&C Act because their labeling lacks adequate directions for use by a layperson, and they are prescription drugs intended for conditions not amenable to self-diagnosis and treatment.

The FDA requires www.ivermectin4covid.com to cease the sale of all unapproved and misbranded products. The company must email FDA within 48 hours, detailing specific steps taken