# FDA WARNING_LETTER - Distributor RFR, LLC - June 14, 2022

Source: https://www.keypedia.com/records/warning_letter/distributor-rfr-llc/428c58bc-0fb5-4b98-bb84-7c85d06acf13

> FDA WARNING_LETTER for Distributor RFR, LLC on June 14, 2022. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Distributor RFR, LLC
- Inspection Date: 2022-06-14
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Officers

- [Director](https://www.keypedia.com/people/tina-smith/5d590654-a270-4f3f-833f-d6fe13ca8c05)

Company: https://www.keypedia.com/companies/distributor-rfr-llc/bf70d6ac-340b-40b3-8d1f-a3a6cda93680

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