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HHS

Dec 22 2025

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:

Why [is] breast binding as part of a West African tradition child abuse or self-harm but breast binding to support a transgender identification is apparently not?

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:

How is it that a child cannot get an ibuprofen without their parents’ consent at school, yet states like California are arguing that children should be able to make irreversible choices without their parents’ knowledge?

“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.

Additional Articles and Resources

Transgender Resources

Counseling Consultation & Referrals

Chloe Cole: Gender Reassignment Surgery Regret

HHS Will Block Hospitals From Performing Sex-Rejecting, Mutilating Procedures on Children

Maryland School Teaches Sixth Graders About Being ‘Transgender’ and ‘Nonbinary’

House Passes Bill banning Sex-Rejecting Procedures for Minors

HHS Finalizes Report Finding Sex-Rejecting Procedures Harm Minors

President Trump Signs Order Protecting Children From Transgender Medical Interventions

Transgenderism and Minors: What Does the Research Really Show?

The WPATH Files – Transgender Interventions Are ‘Unethical Medical Experiments’

Written by Emily Washburn · Categorized: Culture · Tagged: breast binding, FDA, HHS, transgender

Dec 18 2025

HHS Will Block Hospitals From Performing Sex-Rejecting, Mutilating Procedures on Children

The U.S. Department of Health and Human Services announced it will block hospitals from performing sex-rejecting, mutilating procedures on children.

A press release from the department stated that procedures to be barred “include pharmaceutical or surgical interventions of specified types that attempt to align a child’s physical appearance or body with an asserted identity different from their sex.”

The department is working to fulfill President Trump’s Executive Order, signed on January 28, 2025, Protecting Children from Chemical and Surgical Mutilation.

In a press conference, HHS Secretary Robert F. Kennedy said he has now taken action to follow that order, directing health care providers to follow science – not transgender dogma:

This morning, I signed a declaration: Sex-rejecting procedures are neither safe nor effective treatment for children with gender dysphoria.

.@SecKennedy: "This morning, I signed a declaration: Sex-rejecting procedures are neither safe nor effective treatment for children with gender dysphoria… This declaration is a clear directive to providers to follow the science and the overwhelming body of evidence that these… https://t.co/B5rIe6ajcl pic.twitter.com/OKZKdUbE1N

— Rapid Response 47 (@RapidResponse47) December 18, 2025

Secretary Kennedy used strong language to condemn hospitals, health care professionals, and medical organization that irreversibly damage children. He called these procedures “junk science” and “malpractice,” stating:

Doctors assume a solemn obligation to protect children. Yet doctors across the country now provide needless and irreversible sex-rejecting procedures that violate their sacred Hippocratic Oath by endangering the very lives that they are sworn to safeguard.

The Secretary explained that medical organizations like the American Medical Association and the American Academy of Pediatrics “peddled the lie that chemical and surgical sex-rejecting procedures could be good for children who suffer from gender dysphoria” – betraying more than 300,000 young people who were “conditioned to believe that sex can be changed.”

🚨 BREAKING: @SecKennedy announces "six decisive actions" to protect children from chemical and surgical mutilation:

"So-called 'gender affirming care' has inflicted lasting physical and psychological damage on vulnerable young people… we’re done with junk science, driven by… pic.twitter.com/q4iWbmSNEj

— Rapid Response 47 (@RapidResponse47) December 18, 2025

HHS’ press release detailed steps it would take to protect children:

The Centers for Medicare & Medicaid Services (CMS) will release a notice of proposed rulemaking to bar hospitals from performing sex-rejecting procedures on children under age 18 as a condition of participation in Medicare and Medicaid programs.
Nearly all U.S. hospitals participate in Medicare and Medicaid and this action is designed to ensure that the U.S. government will not be in business with organizations that intentionally or unintentionally inflict permanent harm on children.

The department was also “moving to reverse the Biden administration’s attempt to include gender dysphoria within the definition of a disability”; proposing new rules “to prohibit federal Medicaid funding for sex-rejecting procedures on children under age 18”; and “issuing warning letters to 12 manufacturers and retailers for illegal marketing of breast binders to children for the purposes of treating gender dysphoria.”

Pro-child activists were quick to applaud the HHS’ actions. Erin Lee, who is spearheading a ballot effort in Colorado to protect children from these horrific procedures, said, “The White House and HHS have taken HUGE steps to crack down on irreversible sex-rejecting procedures for children … “

At the same time, she noted that many states, with leaders in thrall to deceptive transgender ideology, would fight the Trump administration’s actions, adding, “That’s why we MUST *ban* this child butchery in the blue states.”

The @WhiteHouse and @HHSGov have taken HUGE steps to crack down on irreversible sex-rejecting procedures for children…

But as this @FoxNews reporter points out: the blue states aren’t going to roll over. They will keep mutilating children by any means necessary — they’re in… pic.twitter.com/na5tJwTwUe

— Erin for Parental Rights (@Erin4Parents) December 18, 2025

Chloe Cole, who’s body was damaged by transgender medical interventions and has fought to protect sexually confused children, praised HHS’ newly proposed rules, saying the day was “incredible” and “uplifting.”

Her moving and eloquent words at the press conference show why it’s so good and vitally important that our government is taking steps to safeguard children:

Every boy and every girl deserves to be loved – the way that they were beautifully created in their mother’s womb.
And to the young people out there who are struggling with this mental illness, I want you to know that there is a better way out, and it’s not too late to accept the beautiful way that God has created you.

NEW: Chloe Cole, who detransitioned when she was a teenager, praises the Trump administration’s efforts to protect children:

“Every boy and every girl deserves to be loved the way that they were beautifully created in their mother’s womb.” pic.twitter.com/CXiB1iCBti

— Fox News (@FoxNews) December 18, 2025

Related articles and resources:

Daily Citizen:

DOJ Targets Those Mutilating Children with ‘Transgender’ Drugs and Surgeries

Florida Sues Medical Groups for Promoting ‘Transgender’ Mutilation of Children

HHS Releases Report on Harms of ‘Transgender’ Medical Interventions for Minors

President Trump Signs Order Protecting Children From Transgender Medical Interventions

Sign These Three Ballot Petitions to Protect Kids and Parental Rights in Colorado

Transgenderism and Minors: What Does the Research Really Show?

The WPATH Files – Transgender Interventions Are ‘Unethical Medical Experiments’

Focus on the Family:

Chloe Cole: Gender Reassignment Surgery Regret

Counseling Consultation & Referrals

God’s Amazing Grace in a Transgendered Person’s Life

Transgender Resources

Understanding “Transgenderism”

Written by Jeff Johnston · Categorized: Culture · Tagged: HHS, transgender

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