Wholesale Peptide
FDA's Center for Drug Evaluation and Research issued a warning letter to Wholesale Peptide (Brooksville, FL) in June 2026 after reviewing their website and finding that two injectable products — 'Prostamax' and 'Gonadorelin' — are being marketed as unapproved new drugs under section 505(a) of the FD&C Act. The products' labeling included claims about treating benign prostatic hyperplasia, prostatitis, spermatogenesis, and cancer, establishing intended human drug use despite 'research use only' disclaimers. FDA warned that continued interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, and that failure to correct violations may result in seizure or injunction.
Flagged claims (8)
Emerging research is investigating gonadorelin's applications in cancer research, particularly in hormone-dependent cancers. While this research is in early stages, scientists have explored: o Prostate Cancer Models: Studies on prostate cancer cell growth and progression in laboratory settings.
Prostamax for Enlarged Prostate
Research shows Prostamax has shown to reduce inflammation caused by prostatitis which is a key factor in managing the condition. This reduction in inflammation will alleviate symptoms like swelling and hyperemia, improve overall prostate health and reduce swelling.
Prostamax reduces chronic inflammation in the prostate, swelling and vascular hyperemia.
Research shows Prostamax can improve bladder control, reducing frequency and urgency of urination.
Studies have shown Prostamax can inhibit sclerotic and atrophic changes associated with chronic prostatitis. Prostamax's ability to restore tissue specific gene expression and maintain cellular health is unique among prostatotropic agents.
Spermatogenesis Research: Investigations show how gonadorelin affects testosterone production and supports testes function in experimental subjects.
Prostamax benefits BPH [benign prostatic hyperplasia], for better daily living and comfort, and reducing the risk of complications.
Required actions (2)
Send your written response to [email protected] within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
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