FDA WARNING_LETTER - Pharmaboosters.com - June 23, 2020

On July 9, 2020, the FDA issued a Warning Letter to www.pharmaboosters.com following a June 23, 2020, review of their website. The FDA found the website was selling unapproved and misbranded drugs to U.S. consumers, including products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19, major depressive and anxiety disorders, early-stage Parkinson’s disease, and opioid dependence.

Specifically, the website offered "Arbidol" with claims of efficacy against coronaviruses, and unapproved versions of prescription drugs like amitriptyline and naltrexone. These products are considered unapproved new drugs under Section 505(a) of the FD&C Act [21 U.S.C. § 355(a)] because they lack FDA approval and are not generally recognized as safe and effective for their labeled uses. Their introduction into interstate commerce violates Sections 301(d) and 505(a) of the FD&C Act.

Furthermore, these drugs are misbranded under Section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] as they lack adequate directions for use by a layperson, and as prescription drugs, they require professional supervision. Selling these misbranded drugs violates Section 30