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fabulousblasphemer.bsky.social
@fabulousblasphemer.bsky.social
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Reposted
kodyisover.com
It's not just TomboyX, by the way! Trump's FDA has sent these warning letters to 11 companies that sell Binders.

- TransGuy Supply
- ShapeShifter Apparel
- GenderBender
- gc2b
- TomboyX
- FLAVNT Streetwear
- Early to Bed
- TOMSCOUT
- For Them
- Fluxion
- UNTAG

www.fda.gov/inspections-...
List of recently issued FDA warning letters, all from 12/18/2025. For all of them, the Issuing Office is Center for Devices and Radiological Health and the reason for the issuances are "Failure to Register and List/Misbranded." The offending companies are TG Supply LLC d/b/a TransGuy Supply, ShapeShifter Apparel, LLC, GenderBender LLC, Marli Washington Design, LLC, TomboyX, PBC, FLAVNT Streetwear, LLC, Early to Bed, Inc., TOMSCOUT, For Them, Inc., and Philadelphia 7, Inc d/b/a Passional Boutique. The final few companies issued warnings do not appear because the page only lists 10 entries.
December 19, 2025 at 12:44 AM
Reposted
kodyisover.com
It's been pointed out that this paragraph about the FDA issuing warnings to binder manus is now missing from The Seattle Times article from which I took this screenshot this morning; the FDA website DOES have its warning letter to TomboyX publicly viewable, however.

www.fda.gov/inspections-...
Our review of your firm’s website revealed statements that these breast binders (example trade names: “Compression Top - Black”, “Racerback Compression Top - Chai”, “V Neck Compression Top - White”) are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body, including: 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” Our review also revealed statements that you manufacture these devices within the meaning of section 510 of the Act (21 U.S.C. § 360) (e.g., “We pay obsessive attention to every design aspect, leaving no detail overlooked so that our community can live and experience a life unbound.”). Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that you have not registered or listed these devices for fiscal year 2026.
December 18, 2025 at 11:58 PM