Full Breakdown
FDA Targets Chest Binder Manufacturers Amid New Rules on Gender-Affirming Care
12/23/2025, 2:17:36 AM
Overview of the FDA's Actions
The U.S. Food and Drug Administration (FDA) has issued warning letters to twelve companies selling chest binders, asserting that these products must be registered as Class I medical devices. This action, announced on December 16, 2025, coincides with new proposals from the Department of Health and Human Services (HHS) aimed at restricting gender-affirming care for minors. The companies targeted include TransGuy Supply, ShapeShifter Apparel, The Fluxion, GenderBender, Marli Washington Design, Tomboy X, FLAVNT Streetwear, Early to Bed, TOMSCOUT, For Them, Passional Boutique, and UNTAG (formerly Trans-Missie).
Claims and Justifications
FDA Commissioner Marty Makary stated that the binders were being marketed illegally for children to treat gender dysphoria, a claim that has been met with skepticism. Critics note that none of the companies market binders specifically for children, nor do they use child models in their promotional materials. The letters assert that these products are medical devices because they are intended to affect the structure or function of the body, a classification that has not been applied to chest binders in the past.
Industry Response
The affected companies have expressed their commitment to serving the LGBTQ+ community despite the FDA's threats. Xander Shephard, director of GenderBender, criticized the FDA's characterization of binders as medical devices, arguing that such a classification is discriminatory and absurd. Shephard emphasized that binders are akin to compression garments and should not be subjected to medical device regulations. Similarly, Auston Bjorkman, owner of TransGuy Supply, stated that the company is updating its website language to clarify that binders are compression garments, not medical devices.
Criticism and Opposition
Brandon Wolf, national press secretary for the Human Rights Campaign, condemned the FDA's actions as an attempt to control the lives of transgender individuals. He described the administration's focus on regulating products used by trans people as a "deeply un-American obsession." Critics argue that the FDA's actions reflect a broader trend of targeting marginalized communities rather than addressing systemic issues.
Broader Implications
The FDA's crackdown on chest binder manufacturers is part of a larger initiative by the HHS to limit gender-affirming care for minors. Recent proposals include banning Medicaid and the Children’s Health Insurance Program from covering such treatments. While the HHS lacks the legal authority to enforce these proposals, they have gained traction in Congress, with bills aimed at criminalizing gender-affirming care for youth recently passing the U.S. House of Representatives.
Conflicting Reports & Gaps
There is a notable discrepancy between the FDA's claims regarding the marketing of binders to children and the lack of evidence supporting these assertions. No marketing materials from the targeted companies indicate that binders are intended for minors. Additionally, the classification of chest binders as medical devices remains contested, with many arguing that they serve primarily aesthetic purposes.
Verbatim Quotes
- “But this administration is trying to control every ounce of trans people's lives and dictate who they can and cannot be.” — Brandon Wolf, National Press Secretary, Human Rights Campaign
- “Our focus remains unchanged. We are deeply committed to supporting trans, nonbinary, gender-nonconforming, and gender-expansive people through affirming apparel and gear,” — Auston Bjorkman, Owner, TransGuy Supply
- “Pushing transgender ideology in children is predatory, it’s wrong, and it needs to stop,” — Marty Makary, FDA Commissioner
The FDA's actions against chest binder manufacturers highlight ongoing tensions surrounding gender-affirming care and the rights of transgender individuals in the United States.
