FDA Cites JJLBRO in June 17, 2026 Warning Letter — Unapproved New Drugs/Misbranded

FDA Warning Letter — Violations FDA cited at JJLBRO

WARNING LETTER JJLBRO MARCS-CMS 729873 — 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: JJLBRO Romvy E-Ticaret Limited Sirketi Oba Başaranlar Sk. No: 16 07400 / Antalya Turkey eroxoninmed@gmail.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States June 17, 2026 WARNING LETTER Reference Number: 729873 To JJLBRO and Romvy E-Ticaret Limited Sirketi: 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://jjlbro.com/ in May 2026. We also reviewed your Amazon storefront in May 2026. 1 Based on our review, “Men’s Foreskin Repair Gel,” “Size’Up Chrono Erect,” “Penile Health Cream,” “Men’s External Delayed Spray,” and “Men’s Penis XXL Care Cream” 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). 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, “Men’s Foreskin Repair Gel,” “Size’Up Chrono Erect,” “Penile Health Cream,” “Men’s External Delayed Spray,” and “Men’s Penis XXL Care Cream” 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. 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: Men’s Foreskin Repair Gel On the webpage https://jjlbro.com/products/mens-extra-power-foreskin-repair-enhancement-gel?variant=41998671478878: “DOUBLE LINE CARE, DIRECT HIT PHIMOSIS” “ABSORPTION OF INTERNAL ADHESIONS” “TO PROMOTE THE VITALITY OF PRIVATE CELLS FROM THE CONGENITAL PHIMOSIS” Size’Up Chrono Erect On the webpage https://jjlbro.com/products/mens-size-up-chrono-erect-enlargement-cream-extra-power-massage-gel-oil-for-huge-thickness-strength-and-prolonged-performance?variant=41998765916254: “Proven Size Enhancement: Clinically . . . shown to help promote blood flow and stimulate cell growth, leading to visible results in size enhancement with consistent use.” “Prolonged Performance: Men’s Size Up Chrono Erect Enlargement Cream supports prolonged performance by stimulating circulation and energy flow, improving stamina and endurance.” Penile Health Cream On the webpage https://jjlbro.com/products/male-performance-med3000-enhancement-gel?variant=41998765850718: “BOOST MUSCLE STRENGTH” “ENHANCES LIBIDO AND PLEASURE” “INCREASE ENERGY AND STAMINA” “IMPROVE MALE REPRODUCTIVE HEALTH” “Naturally Boosts Energy, Libido, Fertility, Mood, and Hormonal Balance.” “Enhances intim