FDA Issues Warning Letters to Chest Binder Companies Over Medical Device Classification

On December 18, 2025, the Trump administration's Food and Drug Administration announced the issuance of warning letters to eleven companies that manufacture and sell chest binders, marking an escalation in federal regulatory action against gender-affirming products and services. The targeted companies include TransGuy Supply, the Fluxion, GenderBender, ShapeShifter Apparel, Marli Washington Design, TomboyX, FLAVNT Streetwear, Early to Bed, TOMSCOUT, For Them, and UNTAG .

The FDA's warning letters contend that chest binders should be classified as Class I medical devices because manufacturers market them for alleviating gender dysphoria, which the agency argues falls under the definition of treating a medical condition. FDA Director Michael J. Hoffmann stated in the letters that "these products are 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."

The companies have been given 15 days to notify the FDA of corrective actions they plan to take. FDA Commissioner Marty Makary warned at the Department of Health and Human Services press conference that the agency will pursue "further enforcement action such as import alerts, seizures, and injunctions if it continues."

Chest binders have never before been classified as medical devices by the FDA. These compression garments are commonly used in theatrical costumes, cosplay, and are comparable to shapewear, compression clothing, or sports bras. The sudden reclassification represents a significant shift in regulatory approach.

Notably, three of the eleven targeted companies are not even located in the United States, raising questions about the FDA's jurisdictional authority. Additionally, none of the companies' websites feature chest binders designed exclusively for minors or using child models, contradicting claims of illegal marketing to children.

The warning letters have drawn swift condemnation from major medical organizations. 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 all recognize gender-affirming care as evidence-based and medically necessary for both adults and minors.

This regulatory action forms part of a comprehensive Department of Health and Human Services initiative announced on the same day to restrict gender-affirming care for transgender and non-binary youth under age 18. The administration has proposed bans on such care and is seeking to prevent Medicaid and the Children's Health Insurance Program from covering gender-affirming treatments.

Human Rights Campaign National Press Secretary Brandon Wolf characterized the actions as alarming, emphasizing that the regulatory reclassification of chest binders represents an unprecedented intervention in personal health decisions for transgender people.