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FDA's Regulatory Actions on Chest Binders: Implications for Transgender Health

2/21/2026, 12:16:40 AM

Overview of the FDA's Actions

The U.S. Food and Drug Administration (FDA) has initiated regulatory actions against manufacturers and retailers of chest binders, which are commonly used by transgender individuals to alleviate gender dysphoria. FDA Commissioner Marty Makary announced that the agency would send warning letters to 12 companies for allegedly marketing these products illegally to children, asserting that binders qualify as medical devices that must be registered with the FDA. This move has raised concerns among advocates and users about the potential impact on access to safe binding options.

Historical Context of Chest Binding

Historically, transgender individuals have utilized various methods for chest binding, often resorting to unsafe practices due to a lack of accessible, safe products. Jamison Green, a trans health expert, recalls using girdles and ACE bandages in the 1980s, which were uncomfortable and posed health risks. Sean Ebony Coleman, founder of the nonprofit Destination Tomorrow, shared similar experiences, noting that many in his generation used electrical tape and bandages, leading to long-term physical issues. The evolution of binders over the past 15 years has provided safer alternatives, but the FDA's recent actions threaten to limit these options.

Criticism of FDA's Position

Critics argue that the FDA's stance reflects a disconnect from the realities faced by transgender individuals. Coleman emphasized that the agency's approach does not consider the historical context of binding and the necessity of these products for many in the community. The FDA's warning letters have been described as inconsistent with its own policies regarding low-risk devices, prompting legal experts to question the rationale behind targeting products that support gender-affirming care.

Official Statements and Responses

The FDA maintains that binders are medical devices intended to treat gender dysphoria, citing evidence from manufacturers' marketing materials. However, advocates like Aydian Dowling of the nonprofit Point of Pride argue that binders are essentially clothing items rather than medical devices. Dowling noted that many individuals seeking binders are low-income and rely on organizations like Point of Pride for assistance, highlighting the ongoing demand for accessible gender-affirming products.

On-the-Ground Perspectives

Transgender individuals express a profound need for binders as part of their gender identity exploration. Dowling pointed out that the average age of those requesting free binders is 22, with many being younger and living in poverty. For these individuals, binders represent a critical step in affirming their gender identity. Green emphasized that regardless of federal restrictions, the need for binding will persist, stating, “They better take away duct tape if they really want to stop us.”

What's Next for Transgender Health and Binding

As the FDA continues to enforce its regulations, organizations like Point of Pride plan to support binder manufacturers and maintain their distribution programs. The ongoing dialogue surrounding the FDA's actions and their implications for transgender health care will likely evolve, as advocates push for greater understanding and access to safe binding options.

Verbatim Quotes

  • “Having a flat chest was really important, because if people couldn’t see who I was, it was devastating,” — Jamison Green, Trans Health Expert
  • “You just endure it because you need to,” — Sean Ebony Coleman, Founder of Destination Tomorrow
  • “They’re a part of gender-affirming care. They’re not medical devices. They’re really just clothing that anyone can wear,” — Aydian Dowling, Co-founder of Point of Pride
  • “They better take away duct tape if they really want to stop us,” — Jamison Green, Trans Health Expert