FDA WARNING_LETTER - JJLBRO - May 01, 2026

In June 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to JJLBRO (Romvy E-Ticaret Limited Sirketi), a company based in Turkey, following a review of its website and Amazon storefront conducted in May 2026. The FDA found that several products, including "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 being marketed as unapproved new drugs. The investigation revealed that the company’s labeling and online descriptions make unauthorized medical claims, such as treating physical conditions like phimosis, improving reproductive health, and stimulating cell growth for physical enhancement. Under the Federal Food, Drug, and Cosmetic Act, any product intended to treat a disease or change the structure of the body is classified as a drug and must undergo FDA evaluation for safety and effectiveness. Because these products lack the required federal approvals, their sale and distribution are illegal. JJLBRO is required to take immediate action to correct these violations and ensure future compliance. The company must submit a written response to the FDA within 15 business days, detailing the specific steps taken to address the issues and prevent their return. Failure to comply may result in serious legal consequences, including the seizure of products or an injunction against the company.