FDA WARNING_LETTER - Fusion Health and Vitality LLC - April 28, 2020

On May 11, 2020, the FDA issued a Warning Letter to Pharmorigins after reviewing their websites (www.pharmorigins.com, http://www.freecoreoffer.online, and http://www.immune-shot.com) on April 28, 2020. The FDA found that Pharmorigins offered "CORE" and "IMMUNE SHOT" products for sale in the U.S., claiming they could mitigate, prevent, treat, diagnose, or cure COVID-19.

These products were deemed unapproved new drugs, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and misbranded drugs under section 502 (21 U.S.C. § 352). Their introduction into interstate commerce violated sections 301(a) and (d) of the FD&C Act (21 U.S.C. § 331(a) and (d)). The FDA emphasized the public health emergency declared for COVID-19.

While the FDA noted that "Immune Shot" was no longer marketed and "Core" claims were removed as of the letter's date, they stressed the importance of preventing recurrence of these violations. Pharmorigins was instructed to email COVID-19-Task-Force-CDER@fda.hhs.