FDA Targets Gender-Affirming Garments, Warning Companies that Serve Trans Customers

At least 12 companies received letters from the agency stating that chest binders, a compression garment, are medical devices and require compliance with strict federal regulations. The post FDA Targets Gender-Affirming Garments, Warning Companies that Serve Trans Customers appeared first on Rewire News Group.

FDA Targets Gender-Affirming Garments, Warning Companies that Serve Trans Customers
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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. 

Who uses chest binders?

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. 

“Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice,” the letter warned. “These actions include, but are not limited to, seizure and injunction.”

“I’m not sure by business would survive if we only stopped selling chest binders,” Shephard said in an interview with Rewire News Group. “That’s our most popular category,” he added.

In Shephard’s view, binders are only being classified as medical devices because they are marketed to trans people. 

“Push-up bras, which can be a gender-affirming garment and also temporarily shift breast tissue into one’s desired shape, would never get called a medical device,” Shephard said.

Meanwhile, Shephard said, a sports bra carries similar compression-related risks.

“There’s tons of shapewear that is being sold with no restrictions, including no age restrictions,” Shephard said. “It’s not about the compression. It’s about who it’s being marketed toward.” 

Shephard emphasized that his company does not market to children and “very few people under the age of 18 purchase binders.” However, parents and guardians do purchase binders for their children. He said he knows that because many thank the company for helping their kids.  

For trans teens, finding a garment that allows them to feel more at home in their body can be life-changing.

“Binders are a temporary way to flatten the chest until someone decides [if] they would like to get top surgery,” Kevin, a transgender 19-year-old, told RNG. Kevin is using a pseudonym to protect his privacy because he is newly out. 

Kevin first purchased a binder when he was 14 from gc2b, a gender-affirming garment company that also received an FDA letter. He doesn’t think the legislation is really about consumer safety. 

Restricting binders to adult use only “would be detrimental to transgender youth,” Kevin said, adding: “I think they are simply trying to further oppress transgender people, and [it] is part of the plan to eventually erase us.” 

Though Shephard disagreed with the government’s assessment of his binders, he has tried to comply with the FDA’s demands. Days after receiving the letter, he removed two mentions of “gender dysphoria” on GenderBender’s website, even though they were not in reference to binders. 

For good measure, he also added a legal disclaimer that the company’s products “are not intended to diagnose, treat, cure, or prevent any disease or physical health condition.” 

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‘Dumped in the deep end’

Transguy Supply, which describes itself as a “trans-owned gender-affirming marketplace & community hub,” altered its website after receiving the FDA letter, too. 

“We updated our language to clearly reflect that binders are compression garments, similar to shapewear or athletic compression apparel,” owner Auston Bjorkman told RNG.  

Though Transguy’s website verbiage changed, Bjorkman said, “we are deeply committed to supporting trans, nonbinary, gender-nonconforming, and gender-expansive people through affirming apparel and gear.” 

“We will not allow intimidation or targeting to deter us from that work,” he added. 

Shapeshifters, a Vermont binder company, has taken a different tactic, refusing to remove mentions of gender dysphoria from its website. After receiving the FDA’s letter, its owners consulted with a regulatory expert and decided that binders are not medical devices and that the regulatory change is discriminatory.  

“The mere fact that other companies that do not market to trans folks … did not receive a warning letter [shows] this was transphobia driven,” said Shapeshifters co-owner Gwen, whose last name RNG is withholding for privacy. “Pulling out the trans-focused language that we have would really be gutting the core of who we are.” 

Gwen and her spouse, Bryce, bought Shapeshifters from the company’s founder on Dec. 18—a day before learning about the FDA’s letter. 

“Literally day one, we were dumped in the deep end,” Gwen said.

Though it was an inauspicious start to their new endeavor, Gwen and Bryce say they aren’t demoralized. They see their work as an essential service for teenagers with gender dysphoria. 

During our interview, Bryce and Gwen pointed the camera at the thank you notes from parents tacked to the wall of the company’s office. 

If teens are prevented from getting binders, Bryce warned, “people aren’t going to stop binding. They’re going to go back to unsafe methods and get hurt.”

Before commercial binders existed, people often layered sports bras or used fabric, ACE bandages, or even duct tape to bind their breast tissue. 

‘It’s a bra, you know?’

The FDA is also going after small retailers that sell chest binders directly to customers. Tara, an adult toy store owner in a Midwest city who received an FDA letter, said she thought it was a scam—until she saw the binders campaign in the news. 

“I really freaked out,” said Tara, who asked to use a pseudonym due to fear of backlash. “We never marketed it as a piece of medical equipment.”  

Her store has been selling binders for at least 15 years, she said, including to veterans’ hospitals. There are an estimated 134,400 transgender veterans, according to the Williams Institute, a research center. 

“We have been paid by the U.S. government to provide these items for veterans with no issues for years,” she said, adding that those orders stopped coming in after Donald Trump election to a second term as president.

Following advice from the store’s lawyer, she has unhappily removed binders from its website. Tara doesn’t understand why her store was singled out. 

“Literally dozens of retail stores” sell these products, she said. “TomboyX binders were sold at Target.” 

Drea Walker’s lingerie store, Up4Drea Lingerie and Romance Boutique in Fayetteville, North Carolina, also sells binders, among many other products. She hasn’t heard from the FDA, but she’s worried she will—and that she will no longer be able to carry what she sees as basic shapewear. 

“It’s a bra, you know? It just keeps your boobs under wraps,” Walker said. 

The binder company whose products she stocks, Gender Fluid, is on the FDA’s target list. 

Walker sees her store as a safe space for trans people in the Fayetteville area, which is home to Fort Bragg. Many of her trans customers are members of the military. Some come on their lunch break to try on gender-affirming clothing. Some servicemembers purchase binders for their children. 

Tara also sees her work as a kind of public service. Binders are a small percentage of what her store sells; she would not take a huge financial hit if the FDA stopped her from offering them. But it would hurt her community. 

“It seems directly targeted as an anti-trans attack,” Tara said. “It really puts at risk the accessibility of gender-affirming gear” that she sees as potentially “lifesaving.”

Since the FDA’s anti-binders campaign began, several trans customers have told Tara as much. One sent a handwritten letter describing “the joy and the wholeness that they felt when putting on a binder for the first time,” she recalled. “And I started just bawling.” 

Tara worries that the FDA’s letter is only the beginning of a broader government campaign against gender-affirming garments.

“They’re going to come after everybody eventually,” she said.

 

 

The post FDA Targets Gender-Affirming Garments, Warning Companies that Serve Trans Customers appeared first on Rewire News Group.

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