Over the past year, there have been significant changes to how gender-affirming health care is treated at the federal level in the United States. These changes have understandably caused confusion and concern within trans and gender-diverse communities — particularly around access, safety, and what is still allowed.
This article explains, in clear and practical terms:
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What has changed at the federal level
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Who is affected
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How these changes relate to gender-affirming apparel such as chest binders and packers
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Practical guidance for safely accessing affirming products
Our goal is to provide clarity, not alarm — and to reassure our community with accurate, up-to-date information.
What Has Changed at the Federal Level?
Recent federal policy changes have focused on healthcare coverage and funding, particularly within federally administered or funded programs. These changes primarily affect:
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Certain federal employee health plans
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Some federally funded healthcare programs
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How gender-affirming medical care is defined and covered at a federal level
These policy updates are about healthcare coverage and regulation — not about personal identity, expression, or apparel.
Who Is Most Directly Affected?
People most likely to feel the immediate impact of these changes are those who rely on:
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Federal health insurance plans
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Federally administered healthcare programs
Even within these groups, the situation can vary depending on:
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State-level protections
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Court challenges and injunctions
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Individual healthcare providers and insurers
This is why experiences can differ widely from one person to another.
How State Laws Still Matter
In the US, state laws play a major role in how healthcare is delivered and protected.
Many states:
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Continue to protect access to gender-affirming care
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Have anti-discrimination laws that apply regardless of federal changes
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Regulate healthcare independently of federal policy shifts
This means federal policy changes do not automatically determine what care is available in every state.
Understanding Chest Binders and FDA Regulation
It’s important to clarify the current regulatory situation around chest binders in the US.
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In late 2025, the FDA issued warning letters to some companies selling binders, saying certain marketing claims may make binders subject to Class I medical device regulation.
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This classification is based on products being described as intended to treat or mitigate gender dysphoria, which is considered a medical condition.
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These actions do not ban binders. Companies can still sell binders if they market them as apparel or compression garments, without medical treatment claims.
Key takeaway: Whether a binder is treated as a medical device depends on how it is marketed, not on the product itself.
What This Means for Gender-Affirming Apparel
Gender-affirming products like:
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Chest binders (marketed as apparel)
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Compression garments
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Packing underwear and packers
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Gender-affirming swimwear
are still available and legal in the US as long as they are described as clothing or personal garments, rather than medical treatments.
At Transform Transwear, our products are designed for comfort, expression, and confidence — not for medical treatment. This approach keeps our offerings safe under current US regulations while continuing to serve the community.
Our Commitment to the Community
Transform Transwear was founded to support trans and gender-diverse people through thoughtfully designed, affirming clothing.
We continue to:
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Monitor regulatory developments carefully
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Ensure our products are clearly positioned as apparel, not medical devices
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Provide transparent, accurate information to our customers
Most importantly, we remain committed to serving the US community with care, respect, and honesty.
Looking Ahead
Policy landscapes can change — and we know that uncertainty can be stressful.
We will continue to share updates, explain changes in plain language, and answer common questions as they arise.
You are not alone — and you deserve clarity, dignity, and support.