Distributor RFR, LLC
FDA issued a warning letter to Distributor RFR, LLC (owner Roger L. Flores, Doral, FL) regarding its product 'SANGTER Natural Male Energy Supplement,' which was found through laboratory analysis to contain undeclared sildenafil — the active ingredient in FDA-approved prescription drug Viagra. The product was marketed as a dietary supplement with drug-intent claims related to erectile dysfunction and sexual performance, making it an unapproved new drug and misbranded drug under the FD&C Act. FDA required a written response within 15 working days detailing corrective steps, and warned that failure to comply could result in seizure or injunction; the company had already initiated a voluntary nationwide recall in August 2022.
Flagged claims (4)
100% Natural Male Performance Booster
Its main use applies to erectile dysfunction and low sexual desire, but it is also used against general weakness, painfulness, spontaneous sweat.
In just 30 minutes or less after consumption you will feel its effect, more energy, more sexual desire and more power.
Damiana (turnera diffusa) It is a plant known for its aphrodisiac qualities that help stimulate the sexual appetite or libido
Required actions (3)
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these violations.
FDA acknowledges that on August 1, 2022, you initiated a voluntary nationwide recall of Lot #48656, Exp. 01/2025 of "SANGTER Energy Supplement," 3000 mg, packaged in 7-count blister packs within a carton to the consumer level.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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