# FDA WARNING_LETTER - Trinity Natural Health & Pain Management, Inc. - April 01, 2021

Source: https://www.keypedia.com/records/warning_letter/trinity-natural-health-pain-management-inc/10ab9d11-5257-4b5f-beda-03d57fa6abc0

> FDA WARNING_LETTER for Trinity Natural Health & Pain Management, Inc. on April 01, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Trinity Natural Health & Pain Management, Inc.
- Inspection Date: 2021-04-01
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA and FTC issued a Warning Letter to Trinity Natural Health on April 13, 2021, following reviews of their websites (trinity-naturalhealth.com and Facebook page) on March 26 and April 1, 2021. The agencies found that Trinity Natural Health was offering "COVID-19 Formula" for sale, claiming it could mitigate, prevent, treat, diagnose, or cure COVID-19.

This product is deemed an unapproved new drug, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and a misbranded drug under section 502 (21 U.S.C. § 352). The introduction of this product into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The letter emphasizes the ongoing public health emergency related to COVID-19.

Trinity Natural Health is required to immediately cease selling all unapproved and unauthorized COVID-19-related products. Within 48 hours, the company must email COVID-19-Task-Force-CDER@fda.hhs.gov detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction.

## Related Officers

- [Director](https://www.keypedia.com/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)
- [Associate Director](https://www.keypedia.com/people/serena-viswanathan/7d1b292d-1f22-42ff-8452-0bc9673b8326)

Company: https://www.keypedia.com/companies/trinity-natural-health-pain-management-inc/68363e5a-c908-4508-be53-1705a35011d2

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c