FDA Takes Action Against Illegal Marketing of Breast Binders for Children

The U.S. Food and Drug Administration (FDA) is committed to protecting the health and well-being of all individuals, particularly vulnerable populations such as children. As part of this effort, the FDA is taking decisive action against companies that are illegally marketing breast binders for children, alleging that these products can be used to treat gender dysphoria.

Warning Letters Issued to 12 Manufacturers and Retailers

The FDA is issuing warning letters to 12 manufacturers and retailers who are marketing breast binders for children in violation of federal law. These companies are making unsubstantiated claims that their products can be used to treat gender dysphoria, a serious medical condition that requires proper diagnosis and treatment by a qualified healthcare professional.

The FDA is concerned that these products are being marketed to children and adolescents without adequate evidence to support their safety and effectiveness for this use. Furthermore, the use of breast binders can pose serious health risks, including respiratory problems, skin irritation, and other complications.

Protecting the Health and Well-being of Children

The FDA is committed to protecting the health and well-being of children and ensuring that medical products are safe and effective for their intended use. They are taking this action to prevent harm to children and to ensure that companies comply with federal laws and regulations.

They urge parents, caregivers, and healthcare professionals to be cautious of products that claim to treat gender dysphoria without scientific evidence to support their claims. It is essential to consult with a qualified healthcare professional before using any medical product, especially for a serious medical condition like gender dysphoria.

The potential health risks associated with using breast binders for gender dysphoria include a wide range of physical symptoms, from mild discomfort to severe, long-term damage.

Common Physical Symptoms and Risks

Many individuals who bind their chests experience at least one negative physical symptom. A 2017 study found that 97% of people who bound their chest daily experienced at least one negative symptom. Common risks include:

• Respiratory Issues: Breathing restriction and shortness of breath are frequently reported. In extreme cases, binding too tightly can lead to collapsed lungs if a fractured rib punctures the lung.
• Musculoskeletal Problems: Back pain, chest pain, and altered rib cage alignment are prevalent. Prolonged pressure can cause changes to normal spine alignment, resulting in chronic pain . Rib fractures and bruising are also possible, especially with improper binding methods.
• Skin and Tissue Issues: Skin irritation, itching, scarring, and fungal infections are common due to friction, sweat buildup, and lack of air circulation. Wearing a wet binder can also lead to skin irritation. Long-term binding can also affect the overall appearance of the chest and may impact the skin’s elasticity, which can be a concern for those considering top surgery.
• Circulatory Problems: Circulation compromise and nerve compression can occur if binding is too tight. Damaged blood vessels and an increased risk of blood clots are also potential consequences.
• Overheating: Binders can trap heat, leading to overheating, especially in warmer weather or during physical activity.
• Other Symptoms: General aches and pains, reduced exercise tolerance, and difficulty speaking have also been reported.

Factors Increasing Risk

Several factors can increase the risk of experiencing these health complications:

• Improper Sizing: Wearing a binder that is too small or too tight is a primary cause of many adverse effects. If a binder is too big, it won’t compress enough, but if it’s too small, it can be uncomfortable and damaging.
• Binding Duration: Binding for more than 8 hours a day, or sleeping in a binder, significantly increases the risk of injury and discomfort.
• Inappropriate Materials: Using materials not designed for chest binding, such as duct tape, plastic wrap, or elastic bandages, is highly dangerous. These materials can constrict breathing, cause skin damage, and even lead to rib fractures. Kinetic tape, while medical, is not designed for chest compression and can restrict breathing.
• Underlying Health Conditions: Individuals with pre-existing conditions affecting the chest, lungs, heart, or skin (e.g., asthma, Ehlers-Danlos syndrome, chronic pain, scoliosis, sensitive skin) should consult a doctor before binding, as it can exacerbate these conditions. Binding while sick can also be dangerous, potentially leading to fluid buildup in the lungs.
• Exercise and Physical Activity: Exercising in a binder, especially one that is too tight, can restrict breathing and movement. If exercising, a larger size binder or a high-compression sports bra is recommended.

.@DrMakaryFDA: “Today the FDA is taking action. We are sending warning letters to 12 manufacturers and retailers for illegal marketing of breast binders for children, for the purposes of treating gender dysphoria.” pic.twitter.com/6JNAy36223

— HHS Rapid Response (@HHSResponse) December 18, 2025

The FDA is committed to taking enforcement action against companies that violate federal laws and regulations. They will continue to monitor the market and take action against companies that make unsubstantiated claims about their products.

They are also working with other government agencies, healthcare professionals, and patient advocacy groups to ensure that medical products are safe and effective for their intended use.

Ref:

1. What Is Chest Binding. [ https://www.webmd.com/a-to-z-guides/what-is-chest-binding ]
2. Chest binding: Tips and risks. [ https://www.sharp.com/health-news/chest-binding-tips-and-risks ]
3. Chest binding and care seeking among transmasculine adults: a cross-sectional study. [ https://pmc.ncbi.nlm.nih.gov/articles/PMC6298447/ ]
4. Health Consequences of Chest Binding. [ https://www.topsurgery.ca/blog/health-consequences-chest-binding ]
5. Breast binding: What to know. [https://www.medicalnewstoday.com/articles/breast-binding ]
6. Breast Binding: Self Harm or Gender Care. [ https://www.bayswatersupport.org.uk/breast-binding-self-harm-or-gender-care/ ]
7. There is an array of negative health effects associated with chest binding. [ https://statsforgender.org/in-one-survey-68-of-transmen-who-bound-their-breasts-were-concerned-about-negative-health-effects/ ]

Also Read: