The FDA sent the letters on Tuesday to 11 companies β TransGuy Supply, the Fluxion, GenderBender, ShapeShifter Apparel, Marli Washington Design, TomboyX, FLAVNT Streetwear, Early to Bed, TOMSCOUT, For Them, and UNTAG (formerly Trans-Missie) β for not registering their products as Class I medical devices for the 2026 fiscal year. The companies have never been required to do so before, and three of them are not located in the United States.
In the letters, FDA Director Michael J. Hoffmann claimed that "these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body." Hoffman referenced information from the companies' websites that claim the products can alleviate gender dysphoria.
Gender dysphoria, which is a specific type of stress that arises when oneβs gender identity does not match their sex as assigned at birth, is classified as a medical condition. However, chest binders have no use beyond aesthetics β they only slightly flatten one's chest and the effect disappears as soon as the binder is removed.
Chest binders have never before been considered medical devices. They are frequently used for costumes in both theatre and cosplay, being comparable to shapewear, compression clothing, or sports bras. [...]
FDA Commissioner Marty Makary also announced the challenges to chest binder manufacturers at the conference, saying the supposed βIllegal marketing of these products for children is alarming. The FDA will take further enforcement action such as import alerts, seizures, and injunctions if it continues.β There is no chest binder designed for exclusively minors or using a child model on any of the sites sent warnings.
