News and Events => Political and Legal News => Topic started by: Sarah B on December 25, 2025, 07:00:04 PM Return to Full Version
Title: Chest binder vendors respond to 'absurd' FDA warning letter:
Post by: Sarah B on December 25, 2025, 07:00:04 PM
Post by: Sarah B on December 25, 2025, 07:00:04 PM
Title: Chest binder vendors respond to 'absurd' FDA warning letter: 'Clearly discrimination'.
Link To: Article (https://www.advocate.com/exclusives/chest-binder-fda-letter-response)
Author: Ryan Adamczeski
Date: 22 December 2025
Brief summary of the article
The FDA warned 11 chest binder companies to register as medical devices, threatening fines and seizures. The companies argue binders are simple compression garments not medical devices and say the action targets trans communities. Some are changing marketing language while pledging to keep serving customers amid broader federal efforts to restrict gender-affirming care for youth.
"The FDA sent warning letters Tuesday to 11 companies threatening them with fines and seizures for not registering their binders as Class I medical devices."
"trying to call a chest binder a medical device, specifically because it is marketed towards trans people, in order to control it and make it inaccessible, is absurd and clearly discrimination"
"these products are medical 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."
"solidified our stance that we are not selling, as they claim, products that constitute medical devices."
"The companies have been given 15 days to notify the FDA of what they are doing to address the supposed violations."
"they will have to register their products to continue selling them an expensive and lengthy process that is unattainable for most small businesses."
"Targeting people who are already othered is easier than confronting uncomfortable truths."
"Real progress comes from addressing systemic problems, not scapegoating communities that are already vulnerable."
Best Wishes Always
Sarah B
Global Moderator
Link To: Article (https://www.advocate.com/exclusives/chest-binder-fda-letter-response)
Author: Ryan Adamczeski
Date: 22 December 2025
Brief summary of the article
The FDA warned 11 chest binder companies to register as medical devices, threatening fines and seizures. The companies argue binders are simple compression garments not medical devices and say the action targets trans communities. Some are changing marketing language while pledging to keep serving customers amid broader federal efforts to restrict gender-affirming care for youth.
"The FDA sent warning letters Tuesday to 11 companies threatening them with fines and seizures for not registering their binders as Class I medical devices."
"trying to call a chest binder a medical device, specifically because it is marketed towards trans people, in order to control it and make it inaccessible, is absurd and clearly discrimination"
"these products are medical 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."
"solidified our stance that we are not selling, as they claim, products that constitute medical devices."
"The companies have been given 15 days to notify the FDA of what they are doing to address the supposed violations."
"they will have to register their products to continue selling them an expensive and lengthy process that is unattainable for most small businesses."
"Targeting people who are already othered is easier than confronting uncomfortable truths."
"Real progress comes from addressing systemic problems, not scapegoating communities that are already vulnerable."
Best Wishes Always
Sarah B
Global Moderator