FDA Warning Letter to Telos Trading Limited dba Alwinshop (June 17, 2026) — Unapproved New Drugs/Misbranded

FDA Warning Letter — Violations FDA cited at Telos Trading Limited dba Alwinshop

WARNING LETTER Telos Trading Limited dba Alwinshop MARCS-CMS 729062 — 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: Telos Trading Limited dba Alwinshop 61 Bridge Street Kington Herefordshire HR5 3DJ United Kingdom support@alwinshop.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States June 17, 2026 WARNING LETTER Reference Number: 729062 To Telos Trading Limited dba Alwinshop: 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://alwinshop.com in May 2026. We have also reviewed your TikTok shop at https://www.tiktok.com/shop/store/alwin-shop/7495713729295518702, where you offer the product to consumers for purchase. Based on our review, “Prostatitis Remission Cream” is an unapproved new drug and a misbranded drug under sections 505(a) and 502(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 352(a). As explained further below, introducing or delivering this product for introduction into interstate commerce violates sections 301(a), 301(d), and 505(a) of the FD&C Act, 21 U.S.C. 331(a), 331(d), and 355(a). 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 and TikTok shop, “Prostatitis Remission Cream” is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is 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. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of this product as a drug include, but may not be limited to, the following: On the webpage https://alwinshop.com/products/mens-treatment-cream-mens-body-treatment-relieves-discomfort-and-itching-daily-massage-treatment-cream-gentle-glycerin: “Improved Bladder Control” “Better Bladder Emptying” “Support Prostate Functions” On your TikTok shop page, https://www.tiktok.com/shop/store/alwin-shop/7495713729295518702: “Treatment for Prostatitis Symptom Relief” “Improved Bladder Control” “Prostatitis Remission Cream” is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates