Christopher Rhodes, co-owner of local streetwear brand FLAVNT, received a letter from the U.S. Food and Drug Administration’s Center for Devices and Radiological Health on Dec. 16. The reason for the correspondence? FLAVNT’s BareSkin binders, which the FDA believe fall under the definition of medical devices.
“Receiving a federal warning during the busiest week of the year for a small business felt like a very deliberate choice in timing,” said Rhodes, citing the pre-Christmas email delivery date. “My first thought was that it had to be a scam, receiving a federal medical warning via email felt surreal. But looking at the current political climate, the ‘scam’ wasn’t the email, the real issue is the government trying to claim that an everyday compression undergarment is a medical device just because a trans person is wearing it.”
FLAVNT wasn’t the only queer-owned and -focused business to receive this particular warning. Similar letters were sent from the FDA to 11 other companies, including TransGuy Supply, The Fluxion, GenderBender, ShapeShifter Apparel, Marli Washington Design, TomboyX, Early to Bed, For Them, TOMSCOUT, UNTAG, and Passional Boutique. In the letter, the FDA states that the garments fall under the definition of medical devices intended to be used “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.”
Prior to this notice, Rhodes says FLAVNT’s only federal interaction was through tax filings and various small business operations. At no point did it cross his mind that the FDA would be reaching out to put an end to the sale of the company’s breast binders.
“We are a clothing line,” he says. “We don’t make medical devices or anything that falls under the FDA’s traditional jurisdiction. The sudden decision to reclassify everyday compression garments as ‘medical devices’ – specifically when marketed to our community – is an unprecedented shift in how clothing is regulated.”
In a press conference held two days after the letter was issued, FDA Commissioner Marty Makary stated these products were marketed toward children and are Class I medical devices. However, in FLAVNT’s case, the BareSkin binders have no marketing materials specifically directed at children. The binders were originally designed by Rhodes, Courtney, and their mother using fabric and an old pillowcase, with Rhodes acting as the test model prior to his top surgery, Rhodes says.
“We took inspiration from athletic compression garments and sports bras, consulting with fashion designers on stitching that would hold up to daily wear,” he recalls. To call FLAVNT’s products medical devices, Rhodes says, “is a total mischaracterization of what we do; we make clothes.”
This is not the FDA’s first action taken against a local queer-owned company. On March 13, 2025, Austin-based isobutyl nitrite, or “poppers,” brand Double Scorpio had their offices subjected to a search and seizure by the FDA. Since then, the brand has shut down all operations with their final message being “Thanks for everything… and remember keep supporting queer businesses, creators, and your local queens.”
As far as the FLAVNT Streetwear folks are concerned, Rhodes says, “the FDA and the administration are deeply affecting the livelihood of queer people and queer businesses.” He points to bigger companies like Amazon, who offer compression binders and vests from international entities, seemingly exempt from the warning letters as evidence of the FDA focusing on LGBTQ businesses. “The fact that the FDA bypassed those giants to target 12 small community brands, many of whom are trans-owned, makes the political nature of this crackdown impossible to ignore,” he says.
FLAVNT remains in active dialogue with the FDA in order to avoid what the warning letter describes as “regulatory action” following failure to address its concerns. The binders remain available for purchase, albeit with modified sales copy such as the removal of the term “dysphoria” from product descriptions.
“At the end of the day,” Rhodes says, “FLAVNT has always been about visibility and the right for our community to have access to apparel that reflects who they are. We’ve spent 12 years building a brand based on joy and self-expression, and we aren’t going to let a politically motivated regulatory hurdle change that. We are a small business, but we are a resilient one, and we will continue to stand in solidarity with our community and the other brands fighting this same fight.”