FDA WARNING_LETTER - TomboyX, PBC - December 01, 2025

The FDA issued a Warning Letter to TomboyX, PBC on December 16, 2025, after reviewing the company"s website. The agency identified that TomboyX, PBC"s breast binders, such as the "Compression Top" and "Racerback Compression Top," are marketed with claims indicating their use for managing dysphoria. Due to these intended uses, the FDA classifies these products as medical devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which pertains to products intended to affect the structure or function of the body, or for the cure, mitigation, or treatment of disease. The main violation is TomboyX"s failure to comply with regulatory requirements for medical device manufacturers. Specifically, the company has not registered its establishment or listed these breast binders with the FDA for fiscal year 2026, as mandated by section 510 of the FD&C Act. This omission renders the devices "misbranded" under section 502(o) of the Act. The FDA requires TomboyX, PBC to take prompt action to rectify these violations. The company must submit a comprehensive written response within fifteen business days from the letter"s receipt, outlining the specific corrective steps taken, providing supporting documentation, and detailing how similar violations will be prevented in the future. Failure to adequately address these issues could result in further FDA enforcement actions, including product seizure or injunctions.