FDA Targets Gender-Affirming Apparel, Warns Companies Serving Trans Customers

Gender-affirming shapewear is the latest target of the Trump administration’s attacks on trans communities.

By the end of 2025, the Food and Drug Administration warned companies that make and sell casket binders– compression garments that resemble sports bras – that their products could be seized and their sales stopped if they continued to market them as a treatment for gender dysphoria. Chest binders are often used by trans men and non-binary people to minimize the appearance of breast tissue.

The FDA classifies certain products as medical devices class 1 if they are marketed for medical use. The December 16, 2025, letter, which was sent to at least 10 manufacturers and two retailers of box binders, 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 fees $11,423plus subsequent annual fees and the costs of developing federally compliant procedures and plans.

Companies were given fifteen days to explain how they would correct these ‘violations’.

More than a month later, many of the companies that received the letter are still trying not to respond — and worry that the government will continue to target them if they do.

Who uses coffin ties?

Ring binders are not only used by transgender people; cis men with gynecomastia, a hormonal imbalance that causes enlarged breasts, also use them.

But the FDA seems particularly concerned about its use among transgender people, especially trans children. At one Press conference of December 18, 2025FDA Commissioner Marty Makary said the agency is sanctioning companies “for the illegal marketing of chest binders to children for the purpose of treating gender dysphoria.”

Makary also claimed that long-term use of chest binders has been linked to “pain, decreased lung function” and “difficulty breastfeeding later in life.”

A Study from 2025 published in the Journal of Adolescent Health found that some transgender young adults experienced back pain, chest pain, or shortness of breath while using binders. However, researchers have found no adverse long-term health effects.

Newsgroup rewiring spoke to three manufacturers and one retailer across the country who received the letters from the FDA. The letters were tailor-made for each company, but they all provoked a similar panic response.

Xander Shephard, founder of GenderBender, a gender-affirming clothing company based in California, said he “freaked out” when he the letter. It said GenderBender’s chest binders were considered medical devices because the company’s website says binders can be used after top surgery and for gynecomastia.

“Failure to adequately address this issue could result in FDA taking regulatory action without further notice,” the letter warned. “These actions include, but are not limited to, seizure and injunction.”

“I’m not sure the business would survive if we just stopped selling casket ties,” Shephard said in an interview with Newsgroup rewiring. “That’s our most popular category,” he added.

According to Shephard, binders are only classified as medical devices because they are marketed to transgender people.

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

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

“There are tons of shapewear that are sold without restrictions, including age restrictions,” Shephard said. “It’s not about the compression. It’s about who it’s being marketed to.”

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

For trans teens, finding a piece of clothing that makes them feel more at home in their bodies can be life-changing.

“Folders are a temporary way to flatten the chest until someone decides [if] they would like to have top surgery,” said Kevin, a 19-year-old transgender RNG. Kevin uses a pseudonym to protect his privacy because he has recently been released.

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

Limiting binders to adult use only “would be harmful 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 ultimately erase us.”

Although Shephard disagreed with the government’s assessment of his binders, he attempted to comply with the FDA’s requirements. Days after receiving the letter, he removed two mentions of “gender dysphoria” on GenderBender’s website, even though they did not relate 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.”

‘Dumped in the deep end’

Transguy Supply, which describes itself as a “trans-owned gender-affirming marketplace and community hub,” changed its website after receiving the FDA letterat.

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

Although the verbiage on Transguy’s website has changed, Bjorkman said, “We are deeply committed to supporting trans, non-binary, gender non-conforming and gender-expansive people through affirming clothing and gear.”

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

Shapeshifters, a Vermont binder company, has taken a different tactic and refused to remove mentions of gender dysphoria from its website. After receipt the letter from the FDAthe owners consulted a regulatory expert and concluded that binders are not medical devices and that the regulatory change is discriminatory.

“The mere fact that other companies that don’t market to transgender people … have not received a warning letter [shows] this was caused by transphobia,” says Gwen, co-owner of Shapeshifters, whose last name RNG is withheld for privacy reasons. “To take out the trans-focused language that we have would actually erode the core of who we are.”

Gwen and her wife, Bryce, purchased Shapeshifters from the company’s founder on December 18, a day before they learned of the FDA letter.

“Literally on the first day we were thrown into the deep end,” Gwen said.

Although it was an inauspicious start to their new venture, Gwen and Bryce say they are not demoralized. They see their work as an essential service for teens with gender dysphoria.

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

If teenagers are not allowed to use binders, Bryce warned, “people won’t stop binding. They will go back to unsafe methods and get hurt.”

Before commercial binders existed, people often had them layered sports bras or used dust, ACE bandages, or even duct tape to bond their breast tissue.

“It’s a bra, you know?”

The FDA is also going after small retailers who sell box binders directly to customers. Tara, an adult toy store owner in a Midwestern city who received a letter from the FDA, said she thought it was a scam until she saw the tie-down campaign in the news.

“I really panicked,” said Tara, who asked to use a pseudonym for fear of backlash. “We never marketed it as a medical device.”

Her store has been selling binders for at least 15 years, she said, including to veterans’ hospitals. According to statistics, there are an estimated 134,400 transgender veterans Williams Institutea research center.

“We have been paid by the U.S. government to provide these items to veterans for years without any problems,” she said, adding that those orders stopped coming after Donald Trump was elected to a second term as president.

Unfortunately, on the advice of the store’s lawyer, she has removed ring binders from the website. Tara doesn’t understand why her store was chosen.

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

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

“It’s a bra, you know? It just keeps your breasts hidden,” 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 place for transgender people in the Fayetteville neighborhood, where Fort Bragg is located. Many of her trans clients are military. Some come during their lunch break to try on gender-affirming clothing. Some soldiers buy binders for their children.

Tara also sees her work as a kind of public service. Ring binders make up a small percentage of what her store sells; she wouldn’t take a big financial hit if the FDA stopped her from offering them. But it would hurt her community.

“It seems to be aimed directly at an anti-trans attack,” Tara said. “It really compromises the accessibility of gender-affirming equipment” that she sees as potentially “life-saving.”

Since the start of the FDA’s anti-binder campaign, several trans customers have said this to Tara. One sent a handwritten letter describing “the joy and wholeness they felt when they put on a binder for the first time,” she recalls. “And I just started crying.”

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

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