Trump's FDA sends warning letters to companies selling chest binders

"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."

"The FDA sent the letters on Tuesday to 11 companies - TransGuy Supply, the Fluxion, GenderBender, ShapeShifter Apparel, Marli Washington Design, TomboyX, FLAVNT Streetwear, Early to Bed, TOMSCOUT, For Them, and UNTAG (formerly Trans-Missie) - 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."

The Food and Drug Administration sent warning letters to 11 companies selling chest binders for failing to register products as Class I medical devices for fiscal year 2026. The letters name companies including TransGuy Supply, TomboyX, FLAVNT Streetwear, and UNTAG, noting that three are not based in the United States. FDA Director Michael J. Hoffmann stated that the products are devices because companies' websites claim they can alleviate gender dysphoria. Gender dysphoria is classified as a medical condition, but chest binders only temporarily flatten the chest and have uses comparable to shapewear or sports bras. The letters were issued amid a Department of Health and Human Services initiative targeting gender-affirming care for minors.

Read at Advocate.com