Wholesale Peptide — FDA Warning Letter, June 17, 2026: Unapproved New Drugs/Misbranded

FDA Warning Letter — Violations FDA cited at Wholesale Peptide

WARNING LETTER Wholesale Peptide MARCS-CMS 729447 — June 17, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED Product: Drugs Recipient: Wholesale Peptide 7394 Broad Street Brooksville , FL 34601 United States service@wholesalepeptide.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States June 17, 2026 WARNING LETTER Reference Number: 729447 To Wholesale Peptide: This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. FDA Review Violations were identified and documented during a review of your website https://www.wholesalepeptide.com in May 2026. Based on our review, “Prostamax” and “Gonadorelin” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). These products are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users. Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions. Violations of the Federal Food, Drug, and Cosmetic Act The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations. Unapproved New Drug Violations Based on a review of your website, “Prostamax” and “Gonadorelin” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. 1 Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following: Prostamax On the webpage https://wholesalepeptide.com/buy-peptides/prostamax-20mg/: “Prostamax reduces chronic inflammation in the prostate, swelling and vascular hyperemia.” “Prostamax for Enlarged Prostate” “Research shows Prostamax can improve bladder control, reducing frequency and urgency of urination.” “Prostamax benefits BPH [benign prostatic hyperplasia], for better daily living and comfort, and reducing the risk of complications.” “Prostatitis, inflammation of the prostate gland, can affect prostate health. 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.” “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.” Gonadorelin On the webpage https://wholesalepeptid