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

Source: https://www.keypedia.com/records/warning_letter/holistic-health-international-llc/638c6868-a7b5-452a-8f2a-708b8a9d6051

> FDA WARNING_LETTER for Holistic Health International, LLC on May 13, 2020. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Holistic Health International, LLC
- Inspection Date: 2020-05-13
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

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Company: https://www.keypedia.com/companies/holistic-health-international-llc/099b9c3f-523b-4300-9fb4-cf327003b56b

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7