FDA Sends Warning Letters to Companies Promoting Sex-Rejecting Breast Binders

The Food and Drug Administration (FDA) sent warning letters to twelve companies last week ordering them to stop selling breast binders to children with wrong-sex confusion.

FDA Commissioner Marty Makary revealed the letter campaign on December 18 at the Department of Health and Human Services’ press conference denouncing sex-rejecting procedures for minors.

“These binders are not benign,” Commissioner Makary warned. “Long-term usage has been associated with pain, compromised lung function … and even difficulty breastfeeding later in life.”

Breast binders are constricting tops designed to ease swelling from some abdominal surgeries, like cancer-related mastectomies. The FDA classifies them as medical devices and regulates their sale.

Healthy women and girls with wrong-sex confusion frequently use breast binders to appear more masculine — a dangerous, off-label use with serious physical consequences.

The FDA sent warning letters to:

• TransGuy Supply
• The Fluxion
• ShapeShifter Apparel
• Marli Washington Design
• GenderBender
• TomBoyX
• FLAVNT Streetwear
• Early to Bed
• TOMSCOUNT
• For Them
• Passional Boutique
• Trans-Missie

Each company explicitly advertises breast binders to “ease,” “reduce” or “alleviate” gender dysphoria. The letters reveal none of the companies have registered their breast binders with the FDA, which means they are illegally selling “misbranded” medical devices.  

The companies must register their breast binders with the FDA and only advertise them for approved uses to avoid further legal action, the letters warn.

“The FDA is telling these companies that the illegal marketing of breast binders to children for the purpose of treating gender dysphoria commits significant regulatory violations and requires swift congressional or corrective action,” Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. weighed in at the press conference.

HHS’ inclusion of breast binding in its larger crackdown on sex-rejecting procedures for minors reflects growing awareness about physical harm breast binding causes pubescent girls.

In her peer review of HHS’ comprehensive report on sex-rejecting procedures for minors, Karleen Gribble, a professor at Western Sydney University’s School of Nursing and Midwifery, linked breast binding to adverse symptoms including chest and back pain, misshapen or deformed breasts, shortness of breath, problems breast feeding and, in extreme cases, rib fractures.

She compares breast binding to breast ironing, a “traditional practice in West Africa whereby the breasts of pubertal girls are flattened with hard objects … to discourage male sexual attention.”

The United Nations denounces breast ironing as sex-based violence and child abuse. But breast binding causes the same injuries. The U.K. Metropolitan Police even acknowledge breast binders can be used to perpetrate breast ironing.

Gribble asks the obvious question:

The answer is equally obvious: Breast binding, though functionally identical to breast ironing, belongs to a popular progressive trend. It is ideologically sanitized, such that schools are promoting improper breast binding to girls with wrong-sex identification.

In November, a top-rated Maryland middle school showed sixth-grade students a video in which a self-described “non-binary” person explained “how to bind properly.”

The young woman recommended students be “safe about it” by wearing binders for fewer than eight hours a day and taking them off to exercise.

This month, women’s rights activist Beth Bourne confronted a California school district board for providing free breast binders to girls as young as twelve years old.

“A twelve-year-old girl can get a free breast binder through CommuniCare, through this board, to flatten her breasts and pretend to be a [transgender-identified] boy,” Bourne summarized incredulously.

Schools should not promote or offer this dangerous medical device to children — with or without their parents’ consent. Commissioner Makary castigated schools for such dangerous, deceptive behavior at last week’s press conference:

“We as doctors have a duty to speak up — and that’s why we’re here against this cruel practice,” he concluded.

Commissioner Makary’s acknowledgment of school’s complicity in promoting breast binding indicate HHS and FDA may be willing to penalize public institutions, in addition to private companies, for promoting sex-rejecting medical interventions to children.

Such relief can’t come soon enough for parents and young women.

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