The Food & Drug Administration (FDA) have sent warnings out to 11 companies selling chest binders, claiming they are mislabeling medical devices.
The FDA sent warning letters to companies TransGuy Supply, the Fluxion, GenderBender, ShapeShifter Apparel, Marli Washington Design, TomboyX, FLAVNT Streetwear, Early to Bed, TOMSCOUT, For Them, and UNTAG (Trans-Missie). These letters detailed that the companies “misbranded” medical devices, saying that chest binders should be registered as Class I devices because of their “prevention of disease”—alleviating gender dysphoria. Though gender dysphoria is a medical diagnosis, chest binders in the past have not had to be registered as medical devices with the FDA prior to the current administration. Since they are predominantly for aesthetic changes, and are very temporary and removable, they didn’t need this. However, FDA Director Michael J. Hoffman states in his letters that legal action can and will be taken if the companies do not register binders as medical devices now.
This administration has been noticeably cracking down on trans-related healthcare and resources. Trans healthcare for those under 18 has been targeted for a ban at a recent press conference, and there is a threat of Medicaid not covering the care in general anymore. FDA Commissioner Marty Makary discussed the chest binders and warning letters at this conference, saying that the believed “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.” None of the 11 companies sell or provide binders for children, or use children at all on their sites for advertising.
Chest binder companies receive support from 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. These groups all agree that trans healthcare is life-saving and very necessary for both trans adults and trans youth. The Human Rights Campaign has actually stated that they will be monitoring the cases. The 11 companies have 15 days to respond to the letters with how they are going to resolve the “violations.” It is so disheartening to see the way that this administration is focused on tearing down the trans community. We can, however, hold onto hope that the support for trans people through these other organizations will keep a safety net available and the community in tact.
