FDA WARNING_LETTER - www.wellerectile.com - February 07, 2022

On April 6, 2022, the FDA issued a Warning Letter to www.wellerectile.com following a website review on February 7, 2022. 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 like malaria.

The primary violations identified are the sale of unapproved new drugs and misbranded drugs. Specifically, products like "Hydroxychloroquine Tablets IP HCQS-200" manufactured by IPCA are cited. These products are considered unapproved new drugs under section 505(a) of the FD&C Act [21 U.S.C. § 355(a)] because no approved applications are in effect for them, and they are not generally recognized as safe and effective for their labeled uses. The website's claim that HCQS 200 mg is "Proven Effective with Covid-19 Treatment" is false, as hydroxychloroquine is not FDA-approved for COVID-19.

Furthermore, these products are deemed misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] because their labeling lacks adequate directions for use by a layperson. As prescription drugs, they require professional supervision for safe use, and