In an already small market, companies that sell chest binders aren't going to let threats from Donald Trump's Food and Drug Administration stop them from serving their LGBTQ+ customers.
The FDA sent warning letters Tuesday to 11 companies — TransGuy Supply, the Fluxion, GenderBender LLC, ShapeShifter Apparel, Marli Washington Design, TomboyX, FLAVNT Streetwear, Early to Bed, TOMSCOUT, For Them, and UNTAG (formerly Trans-Missie) — threatening them with fines and seizures for not registering their binders as Class I medical devices. The companies have never been required to do so before, because binders have never been considered medical devices before.
"There are absolutely medical treatments and procedures that do treat gender dysphoria, but trying to call a chest binder a medical device, specifically because it is marketed towards trans people, in order to control it and make it inaccessible, is absurd and clearly discrimination," Xander Shephard, director of GenderBender, told The Advocate.
"Regular chest binders for pre-op use aren't a medical device in the same way that the scissors used to give someone a gender-affirming haircut aren't a medical device," they added. "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 — maybe because the people in power want to see more minor's boobs, not less."
FDA Director Michael J. Hoffmann claimed in the letters that "these products are [medical] 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." Hoffman referenced information from the companies' websites that claim the products can alleviate gender dysphoria.
Gender dysphoria, which is a specific type of stress that arises when one’s gender identity does not match their sex as assigned at birth, is classified as a medical condition. However, chest binders have no use beyond aesthetics — they only slightly flatten one's chest, and the effect disappears as soon as the binder is removed. They are frequently used for costumes in both theater and cosplay, being comparable to shapewear, compression clothing, or sports bras.
"I hadn't even used the term 'gender dysphoria' in reference to the binders on my website ... a term this administration has had no respect for until they found a way to weaponize it against us," Shephard said. "Crazily enough, I was actually cited for using the term 'gender euphoria,' which isn't even a medical term, but simply the euphoric feeling of being happy about some aspect of one's gender presentation."
Because the letter focused primarily on the language used to market the products, specifically anything that could be interpreted as medical treatment, Auston Bjorkman, owner and creative director of TransGuy Supply, said that complying with the orders meant performing an audit of the company's website and updating the product descriptions. Nothing involving how they're made or sold had to change.
Bjorkman said the company updated its language to clearly reflect that binders are compression garments, and in replying to the FDA "solidified our stance that we are not selling, as they claim," products that constitute medical devices.
"Our focus remains unchanged. We are deeply committed to supporting trans, nonbinary, gender-nonconforming, and gender-expansive people through affirming apparel and gear," Bjorkman said. "We also partner with community organizations doing direct care by providing donations and discounted access to our products. We are still designing, manufacturing, and shipping and we remain fully committed to taking care of our people. We will not allow intimidation or targeting to deter us from that work."
The letters were sent as part of the Department of Health and Human Services' recent crackdown on gender-affirming care for youth. The agency announced at a press conference Thursday that it is issuing proposals to ban the lifesaving care for those under age 18, and to prevent both Medicaid and the Children’s Health Insurance Program from covering the treatment.
While the HHS does not have the legal authority to implement either policy, a bill criminalizing gender-affirming care for trans youth and another bill banning Medicaid from covering the care were approved by the U.S. House of Representatives last week. Both bills now head to the Senate, where it is unclear if they have the support needed to pass.
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FDA Commissioner Marty Makary also announced the challenges to chest binder manufacturers at the conference, saying the supposed “Illegal marketing of these products for children is alarming. The FDA will take further enforcement action such as import alerts, seizures, and injunctions if it continues.”
Shephard noted that virtually none of GenderBender's sales come from underage customers, though the firm does "get a good number of supportive guardians buying SAFE gear for teens, which is heartwarming." The product is a popular option because it is "low impact" and not "any more risky than using a sports bra would be."
Shephard said the company is consulting with lawyers before taking action or submitting a formal response to the FDA, but that "with the way they're twisting things for the media, claiming we're marketing to children, I might add an age requirement to my website."
"I don't think there's a legal reason we can't sell compression tops to people under 18, but frankly, I'm just afraid of what the crazies who believe we're targeting children might do," Shephard said.
The companies have been given 15 days to notify the FDA of what they are doing to address the supposed "violations." If the agency is not happy with their responses, they will have to register their products to continue selling them — an expensive and lengthy process that is unattainable for most small businesses, especially with the deadline to apply for a decreased fee past. Even if they could apply, approval would be given at the discretion of the Trump administration.
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For Bjorkman, the stunt is reflective of what's become a trend in this administration, where "too often, attention is redirected toward marginalized communities instead of addressing systemic issues that require accountability and real solutions."
"Targeting people who are already 'othered' is easier than confronting uncomfortable truths," Bjorkman said. "Fear-based narratives about trans people rely on misunderstanding and a lack of empathy, while diverting attention away from harm that is overwhelmingly perpetrated by those in positions of social power. Real progress comes from addressing systemic problems, not scapegoating communities that are already vulnerable."
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