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FDA Warns Chest-Binder Companies Amid Transgender Care Debate

12/23/2025

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Story summary
  • The U.S. Food and Drug Administration (FDA) issued warning letters to 12 chest-binder companies for not registering binders as medical devices.
  • The action coincides with proposed Department of Health and Human Services rules restricting gender-affirming care for minors.
  • Critics including Brandon Wolf of the Human Rights Campaign say the move targets transgender lives.
  • Companies have 15 days to respond and contend binders are not medical devices but compression garments.