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

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.