FDA Threatens Companies Selling Binders
The FDA sent twelve businesses threatening letters on Tuesday, demanding that they register their chest binders as medical devices with the FDA.
by Aly Gibbs
The latest move from the federal government in their war against transgender Americans is… threatening companies that manufacture chest binders?
If you aren’t familiar, binders are shapewear designed to flatten the chests of people who have experienced breast growth to present a more typically masculine appearance. Fabric binders are most common, and are perfectly safe to wear so long as you get an appropriately sized binder, keep it clean, and try not to wear it for more than eight hours a day. Improper use of a binder can lead to skin irritation, bruising and difficulty breathing, but countless trans people wear binders in their daily lives without issue.
The Food and Drug Administration, a federal organization tasked with ensuring the safety of food, drugs, medical devices and more, has decided to take issue with companies selling chest binders. In a warning letter sent on Tuesday to Danaë Kurvers, founder of UNTAG (originally Trans-Missie), an FDA director declared that the FDA Cosmetics Act would define chest binders as 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,” and that Kurvers and UNTAG were in violation of the Cosmetics Act for failing to register the binders as medical devices with the FDA.
The FDA sent similar letters to ten other companies that sell chest binders: TransGuy Supply, the Fluxion, GenderBender LLC, ShapeShifter Apparel, Marli Washington Design, TomboyX, FLAVNT Streetwear, Early to Bed, TOMSCOUT, and For Them.
Xander Shephard, director of GenderBender LLC, told The Advocate, “[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. 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. 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.”
Auston Bjorkman, owner and creative director of TransGuy Supply, told The Advocate that his company’s website would update product language to reflect that chest binders are compression garments, not medical devices, and that they remain “deeply committed to supporting trans, nonbinary, gender-nonconforming, and gender-expansive people through affirming apparel and gear.”
These letters were initially announced at a Department of Health and Human Services press conference by FDA Commissioner Marty Makary, as part of a larger move to attack trans healthcare in America. Makary said, “We are sending warning letters to 12 manufacturers and retailers for illegal marketing of breast binders for children, for the purposes of treating gender dysphoria. Breast binders are a Class I medical device … and these binders are not benign: long-term usage has been associated with pain, compromised lung function … and even difficulty breastfeeding later in life.”
I don’t want to underplay the difficulties of binding. When you bind for too long at a time, or for many years, you can experience health problems, most often pain in the back, ribs or chest. It’s important to acknowledge that binding can be done safely, and can effectively reduce dysphoria associated with the chest area. Ultimately, binders are like very tight sports bras or shapewear. They aren’t inherently harmful devices, as long as they’re used properly.
Banning binders won’t stop trans people from binding. Instead, it will lead to more trans people binding unsafely, using materials and methods that will do more and greater harm to their bodies. Meanwhile, the HHS is trying as hard as they can to prevent anybody from receiving the surgery that would make binding unnecessary, as well as other healthcare that is vital and lifesaving for trans people.
People like Marty Makary are simply jackboot soldiers in a fascist war against trans people, uninterested in protecting the health and wellbeing of Americans. All Makary cares about, like his boss RFK, Jr., and his boss’s boss, Donald Trump, is harming trans people.
Aly Gibbs (She/They), formerly Alyssa Steinsiek, is a trans writer who reports on news important to the queer community.
