Greater Peoria Physical Medicine & Rehabilitation, S.C. d.b.a. Joseph Health Group – FDA Warning Letter, Apr 22, 2020
On August 10, 2020, the FDA and FTC issued a Warning Letter to Joseph Health Group after reviewing their website, josephhealthgroup.com, on April 22, 2020, and August 6, 2020. The letter states that the company offers "Basic Immune Support Kit," "Enhanced Immune Support Kit," and "Ultra Immune Support Kit" for sale, claiming they mitigate, prevent, treat, diagnose, or cure COVID-19.
The FDA determined these products are unapproved new drugs, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and are 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 claims from a video titled "Boost Your Immune System" suggesting the products prevent or lessen COVID-19 symptoms.
The letter demands immediate cessation of sales for these unapproved and unauthorized products. Joseph Health Group must email COVID-19-Task-Force-CFSAN@fda.hhs.gov within
- Inspection date
- April 22, 2020
- Product type
- Food
ID · 0c7472d7-cb68-46ba-acf4-bfa64bf031c7
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