FDA WARNING_LETTER - Holistic Health International, LLC - May 13, 2020

The FDA issued a Warning Letter to Holistic Heal on July 23, 2020, following a May 13, 2020 review of their websites, www.holisticheal.com and https://www.ch3nutrigenomics.com/, and product listings on Amazon.com. The letter addresses the sale of the "SARS-COV-2 STOOL TEST (SCV)," an at-home stool sample collection kit for COVID-19 PCR testing, manufactured by Diagnostic Solutions Laboratory, LLC.

The FDA determined this product is a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h), intended for COVID-19 mitigation, prevention, treatment, diagnosis, or cure. The product is deemed adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because it was offered for sale without required marketing approval, clearance, or authorization (PMA or IDE). It is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), as the firm failed to notify the Agency of its intent to introduce the device into commercial distribution, as required