FDA Targets Gender-Affirming Garments, Warning Companies that Serve Trans Customers
Gender-affirming shapewear is the latest target of the Trump administration’s attacks on trans communities.
In late 2025, the Food and Drug Administration warned companies that make and sell chest binders—compression garments resembling sports bras—that their products could be seized and their sales could be halted if they continued to market them as a treatment for gender dysphoria. Chest binders are commonly used by trans men and nonbinary people to minimize the look of breast tissue.
The FDA classifies certain products as class 1 medical devices if they are marketed for medical uses. The Dec. 16, 2025 letter, which was sent to at least ten manufacturers and two chest binder retailers, stated that companies must register with the FDA because their devices “are intended for use in the diagnosis of disease” when marketed to “reduce gender dysphoria.” FDA registration costs $11,423, plus subsequent annual fees and the expense of developing federally compliant procedures and plans.
Companies were given 15 days to explain how they’d correct these “violations.”
More than a month later, many of the businesses that received the letter are still scrambling to respond—and worrying that the government will continue targeting them if they do.
Binders are not just used by trans people; cis men with gynecomastia, a hormone imbalance that causes enlarged breasts, also use them.
But the FDA seems to primarily be concerned about their use among trans people, particularly trans kids. At a Dec. 18, 2025 press conference, FDA Commissioner Marty Makary said the agency was sanctioning companies “for the illegal marketing of breast binders to children for the purposes of treating gender dysphoria.”
Makary also claimed that long-term use of chest binders has been associated with “pain, compromised lung function” and “difficulty breastfeeding later in life.”
A 2025 study published in the Journal of Adolescent Health found that some transgender young adults did experience back pain, chest pain, or shortness of breath while using binders. However, researchers found no long-term ill health effects.
Rewire News Group spoke to three manufacturers and one retailer across the country who received the FDA’s letters. The letters were custom tailored to each business, but they all elicited a similar panicked reaction.
Xander Shephard, founder of GenderBender, a gender-affirming clothing company based in California, said he was “freaked out” when he received the letter. It said that GenderBender’s chest binders were considered medical devices because the company’s website says binders could be used after top surgery and for gynecomastia.
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