Trinity Natural Health & Pain Management, Inc.

Warning LetterOpen

Trinity Natural Health & Pain Management, Inc. 1100 NE 125th Street, Suite #203A North Miami , FL 33161 United States amarc37@ymail.comIssued Apr 13, 2021Center for Drug Evaluation and Research

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateApr 13, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Trinity Natural Health & Pain Management, Inc.
Location: Trinity Natural Health & Pain Management, Inc. 1100 NE 125th Street, Suite #203A North Miami , FL 33161 United States amarc37@ymail.com
FEI Number: N/A
Country: United States
Issue Date: April 13, 2021
Issuing Office: Center for Drug Evaluation and Research
Product Type: Drugs
Status: Open

Summary

Trinity Natural Health & Pain Management, Inc. was cited for selling an unapproved new drug called "COVID-19 Formula" that claimed to mitigate, prevent, treat, diagnose, or cure COVID-19, violating section 505(a) of the Federal Food, Drug, and Cosmetic Act. The product was also found to be misbranded under section 502 of the FD&C Act and was marketed through the company's website and Facebook page without FDA approval or authorization. The FDA and FTC jointly reviewed the company's marketing claims during the COVID-19 public health emergency, determining that introduction of this product into interstate commerce was prohibited under sections 301(a) and (d) of the FD&C Act.

Trinity Natural Health & Pain Management, Inc. FDA Warning Letter, April 13, 2021