Distributor RFR, LLC – FDA Warning Letter, Jun 14, 2022

On January 9, 2023, the FDA issued a Warning Letter to Mr. Flores regarding "SANGTER Natural Male Energy Supplement" following an inspection from June 2-14, 2022, and a review of www.sangter.com.

The FDA's laboratory analysis confirmed the product contains undeclared sildenafil, an active pharmaceutical ingredient (API) in Viagra, an FDA-approved prescription drug for erectile dysfunction. This renders "SANGTER Energy Supplement" an unapproved new drug and a misbranded drug.

Violations include: 1. **Unapproved New Drug:** The product is a drug under section 201(g)(1) of the FD&C Act due to its intended use (e.g., "100% Natural Male Performance Booster," "help stimulate the sexual appetite or libido," "erectile dysfunction and low sexual desire"). It is a "new drug" under section 201(p) as it's not generally recognized as safe and effective. Its introduction into interstate commerce without FDA approval violates sections 505(a) and 301(d). 2. **Misbranded Drug:** * **Lack of Adequate Directions (502(f)(1)):** As a prescription drug containing sildenafil, it requires supervision by a licensed practitioner, making adequate directions for lay use impossible. * **False or