Donald Trump's Food and Drug Administration (FDA) has sent warning letters to nearly a dozen companies that sell chest binders, claiming that they have "misbranded" medical devices.
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.
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 one’s 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 — 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.
The letters were sent as part of the Department of Health and Human Services' recent crackdown on gender-affirming care for youth. The agency announced at a press conference Thursday that it is issuing proposals to ban the life-saving care for those under age 18, and to prevent both Medicaid and the Children’s Health Insurance Program (CHIP) from covering the treatment.
While the HHS does not have the legal authority to implement either policy, a bill banning gender-affirming care for trans youth and another bill banning Medicaid from covering the care were approved by the U.S. House of Representatives this week. Both bills now head to the Senate, where it is unclear if they have the support needed to pass.
FDA Commissioner Marty Makary also announced the challenges to chest binder manufacturers at the conference, saying the supposed “Illegal 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.” There is no chest binder designed for exclusively minors or using a child model on any of the sites sent warnings.
The American Medical Association, the American Psychiatric Association, the American Academy of Pediatrics, the American Academy of Child & Adolescent Psychiatry, the World Medical Association, and the World Health Organization all agree that gender-affirming care is evidence-based and medically necessary not just for adults, but minors as well.
The companies have been given 15 days to notify the FDA of what they are doing to address the supposed "violations." Brandon Wolf National Press Secretary for the Human Rights Campaign, told The Advocate that the organization will be monitoring the case.
"Everyone deserves the freedom to get the healthcare they need, support their children, and buy products that make them feel good in their own skin," Wolf said. "But this administration is trying to control every ounce of trans people's lives and dictate who they can and cannot be. As life gets harder for the American people at the hands of this cruel and incompetent administration, they are spending their time terrorizing families and harassing companies simply because their products are sometimes used by trans people. It's nothing short of a deeply un-American obsession with trans people and an allergy to freedom."
This story has been updated to include statement from HRC.
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