FDA WARNING_LETTER - Telos Trading Limited dba Alwinshop - May 01, 2026

On June 17, 2026, the FDA issued a warning letter to Telos Trading Limited, operating as Alwinshop, following a May 2026 review of its website and TikTok shop. The agency determined that the company’s "Prostatitis Remission Cream" is an unapproved new drug. Marketing materials for the product claimed it could treat medical conditions such as prostatitis and improve bladder control, but the product lacks the required FDA approval for safety and effectiveness for these uses. Additionally, the FDA identified misbranding violations, noting that Alwinshop’s website featured misleading imagery and statements. Specifically, the use of the FDA logo and images of agency officials falsely suggested that the product was "FDA certified" or endorsed by the agency. These practices violate the Federal Food, Drug, and Cosmetic Act, which prohibits the introduction of unapproved and misbranded drugs into interstate commerce. To comply with federal law, the company must investigate the root causes of these violations and implement corrective measures to prevent their recurrence. Alwinshop is required to submit a written response to the FDA within fifteen business days, detailing the actions taken to address the issues and providing supporting documentation. Failure to correct these violations may lead to regulatory actions, including product seizure or legal injunctions.