FDA targeting breast binder manufacturers over use by trans people

By Jane Migliara Brigham

The Food and Drug Administration (FDA) has issued legal notices to every major manufacturer and distributor of chest binders and tucking underwear stating that these devices will have to register as medical devices because they are used to treat symptoms of gender dysphoria.  

The notices, which were sent on Tuesday, tell the affected companies that they have 15 days to address the FDA’s concerns.  If they do not comply, the letter states that the FDA would have the right to seize these products and prevent them from being sold to the public.

This was announced at the HHS press conference yesterday as part of a wider push against trans healthcare.  While the stated scope of that meeting was to target trans youth healthcare, these notices make no distinction between usage by children and adults.

If you support our coverage, consider subscribing to The Needle as a Gold tier supporter, at $20 a month- you'll get access to all content! For a limited time, you can get half off your first three months!

Become Gold!

The letters explicitly state that the garments are being targeted because they are used to treat the medical condition of gender dysphoria, and that this is being done outside of clinical settings.

Quoting from the letter sent to TomboyX, 

Per your firm’s website: “Many individuals who identify as transgender, non-binary, or gender-fluid utilize chest binding as a way to help manage their own dysphoria”

In other words, because gender dysphoria exists as a recognized mental disorder, and the products in question are advertised as alleviating the symptoms of gender dysphoria, the FDA is claiming the authority to regulate all products associated with alleviating gender dysphoria.  

The notice also stated that “Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts.”  In other words, noncompliance in this matter could be used to prevent these companies from accessing federal funds in unrelated matters.

The twelve companies that received these notices were Trans-Missie B.V., Philadelphia 7, Inc d/b/a Passional Boutique, For Them, Inc., TOMSCOUT, Early to Bed, Inc., FLAVNT Streetwear, LLC, TomboyX, PBC, GenderBender LLC, Marli Washington Design, LLC, ShapeShifter Apparel, LLC, Flux Lab Pte. Ltd. d/b/a The Fluxion, and TG Supply LLC d/b/a TransGuy Supply.

These threats represent a broad expansion of the government’s power to regulate non-medical products that are used by trans people.  In the words of Giovanna Esposito, a doctor of law, activist, and former Congressional staffer, "This is absolutely an overreach and  a failure to differentiate these garments as medical devices. Is one of these binders still a medical device if a cis actress uses it to portray a small-chested role? Are sports bras that provide compression medical devices now? Is a jock strap? What about tucking underwear? Does a push-up bra become a medical device when a trans woman uses it? This is basically begging for litigation."

Chest binders in particular are used by most transmascs, and have at various times been used by nearly every transsexual man.  This is the first time in decades that the federal government has attempted to regulate the clothing used by trans people directly, with no regard to the context in which it is used.