FDA WARNING_LETTER - Greater Peoria Physical Medicine & Rehabilitation, S.C. d.b.a. Joseph Health Group - September 04, 2020

On August 10, 2020, the FDA and FTC issued a Warning Letter to Joseph Health Group after reviewing their website on April 22, 2020, and August 6, 2020. The company was found to be selling "Basic Immune Support Kit," "Enhanced Immune Support Kit," and "Ultra Immune Support Kit" with claims to mitigate, prevent, treat, diagnose, or cure COVID-19.

These products are considered unapproved new drugs under 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). The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)).

Examples of violative claims include "Inhibit Viral Acquisition," "Inhibit Viral Replication," and "Support Your Cell’s Systems." The letter demands immediate cessation of sales for these unapproved products. Joseph Health Group must respond within 48 hours via email to COVID-19-Task-Force-CFSAN@fda.hhs.gov, detailing corrective actions and providing supporting documentation. Failure to comply may lead to legal action, including seizure and injunction.