Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Per your firm’s website: “A binder works by pressing the breasts flat against the chest, spreading the mass of the breasts. This makes the breasts appear flatter and less present, which can help reduce gender dysphoria or any other uncomfortable feelings that you might have about your chest.”
Passage 2Per your firm’s website: “Most people wear a binder because it helps reduce any gender dysphoria that they experience about their breasts. Binders can be worn by … people who have just had breast surgery, people who suffer from gender dysphoria.”
Passage 3Per your firm’s website: “A binder can greatly help to reduce body dysphoria and promote gender euphoria”
Passage 4Per your firm’s website: “Reduced dysphoria: Binding alleviates the distress associated with a chest that does not align with one’s gender identity…Improved mental health: Participants in multiple studies reported reduced anxiety and depression, increased confidence, and greater comfort in public spaces”
Passage 5Per your firm’s website: “Gender affirming garments can help you alleviate gender dysphoria by compressing or enhancing body parts that cause you negative feelings. As you can imagine, some of these gender affirming practices (like wearing binders) are not entirely without risk.”
Passage 6Our records indicate that you have not registered or listed these devices for fiscal year 2026.