Premier Manufacturing Products, LLC – FDA Warning Letter, Jan 25, 2024

On July 2, 2024, the FDA issued a Warning Letter to Premier Manufacturing Products, LLC, specifically addressing Atofil, LLC, following an inspection from January 22 to 25, 2024. The inspection revealed that the company offers "Tianaa Red," "Tianaa White," and "Tianaa Green" products for sale in the United States.

The FDA determined these products are unapproved new drugs, violating sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). The products are considered drugs under section 201(g)(1) of the FD&C Act due to intended uses for diagnosis, cure, mitigation, treatment, prevention of disease, or affecting body structure/function, as evidenced by promotional material linking to mtbrands.com/tianaa.

These products are not generally recognized as safe and effective (GRASE) and are therefore "new drugs" under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). No FDA-approved applications exist for these products. The company must respond in writing within fifteen working days, detailing corrective actions, preventative measures, and supporting documentation, or provide