FDA WARNING_LETTER - TG Supply LLC d/b/a TransGuy Supply - December 01, 2025

The FDA issued a Warning Letter to TG Supply LLC d/b/a TransGuy Supply on December 16, 2025, following a review of their website. The agency determined that the company"s breast binders, marketed with claims such as "dysphoria relief" and affecting "the structure or any function of the body," qualify as medical devices under the Federal Food, Drug, and Cosmetic Act. A primary violation identified was the firm"s failure to comply with federal regulations requiring medical device manufacturers to annually register their establishment and list their devices with the FDA. The company"s website indicated manufacturing activities, yet records showed no registration or device listing for fiscal year 2026. Consequently, the breast binders are considered misbranded. The FDA requires TG Supply LLC to take immediate action to correct these violations. The company must provide a written response within fifteen business days detailing the specific steps taken to address the issues and prevent their recurrence. This response should include documentation of all corrective actions and a timetable for any ongoing changes. Failure to adequately resolve these violations could result in further regulatory action, including potential seizure or injunctions.