FDA WARNING_LETTER - TOMSCOUT - December 01, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to TOMSCOUT, addressed to Partner Lim Tong Moi, on December 16, 2025. Following a review of the company"s website (tomscout.com), the FDA determined that TOMSCOUT"s breast binders, marketed with claims such as "help reduce gender dysphoria" and "alleviate distress associated with gender dysphoria," meet the definition of medical devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act. The primary violation cited is that TOMSCOUT, as a manufacturer of these medical devices, failed to comply with regulatory requirements. Specifically, the company has not annually registered its establishment with the FDA nor listed its devices for fiscal year 2026, as mandated by section 510 of the Act. Consequently, these devices are deemed misbranded under section 502(o) of the Act. The FDA requires TOMSCOUT to take prompt action to rectify these violations. The firm must provide a written response within fifteen business days, detailing specific corrective steps, explaining how similar violations will be prevented, and including supporting documentation. Failure to adequately address these concerns may result in further regulatory action, such as seizure or injunction.