Breaking News: A Win for Women’s Health
FDA Challenges the Black Box Warning on Estrogen Products — and Why It Matters
By Loopwell · November 10, 2025
A landmark moment in women’s health has arrived.
The U.S. Food and Drug Administration (FDA) has announced it will remove the long-standing black box warning on many hormone therapies used during menopause — a historic shift in how this life stage is understood, treated, and discussed.
For Loopwell — New Jersey’s women-led well-being social club and community hub — this decision is profoundly meaningful. It affirms years of collective advocacy, education, and community-building that Loopwell and our founder, Deb Looney, have championed across New York and New Jersey.
Since opening in 2022, Loopwell has worked to shift the narrative around menopause by bringing women trusted experts, evidence-based education, and safe spaces to talk openly about their health. This FDA decision underscores what our community has long deserved: access to accurate information, compassionate care, and the ability to make empowered choices.
What’s Changing — and Why It’s Big
For decades, hormone therapies containing estrogen and progestin carried the FDA’s most serious safety label: the black box warning.
It cautioned patients about risks of stroke, heart disease, and dementia — and for many women and clinicians, it created fear, confusion, and hesitation.
But today, the science looks different.
Updated analyses show that much of the earlier data — primarily gathered from women long past menopause — didn’t accurately reflect modern, personalized approaches to hormone therapy.
What we now know:
Timing matters. Women who initiate hormone therapy at the onset of menopause face significantly lower risks.
Dosage and delivery matter. Low-dose and localized therapies, particularly vaginal estrogen, have been shown to be safe and effective.
Access matters. The prior warning may have discouraged countless women from exploring treatment options that could have improved their quality of life.
The removal of the black box warning opens the door to more accurate counseling, more individualized care, and a more compassionate era of menopause support.
Loopwell’s Role in the Menopause Movement
This national milestone is also a moment of recognition for the work happening locally — especially at Loopwell.
Since 2022, Loopwell has:
Hosted 17 transformative menopause events, workshops, and community gatherings
Educated and involved more than 2,000 women
Collaborated with 50+ visiting doctors, researchers, and experts
Celebrated 7 major menopause-focused book launches and panel discussions
Loopwell didn’t just join the conversation — we helped fuel it. Through thoughtful programming, expert partnerships, and a community-first approach, we’ve helped take menopause from a quiet, stigmatized topic to a movement gaining momentum across New York and New Jersey.
“We created Loopwell as a space where the menopause conversation doesn’t just exist — it sparks a ripple effect,” says Founder Deb Looney.
“We couldn’t have done this without the incredible doctors, thought leaders, organizations, and companies who have partnered with us. This win belongs to every woman who showed up, asked questions, and demanded better.”
Why This FDA Decision Matters for Every Woman
Whether you’re approaching menopause, navigating it now, or supporting someone who is, this policy shift has wide-reaching implications.
It means:
Validation. Women’s experiences are finally being met with nuance and updated science.
Honest conversations. Clinicians and patients can now speak more openly about hormone therapy as one of many viable options.
Empowerment. With reduced stigma and clearer guidance, more women can make informed, confident health decisions.
Community. As always, Loopwell believes connection is a powerful catalyst for well-being and change.
This isn’t just a regulatory update — it’s a cultural turning point.
Looking Ahead
While the FDA’s decision marks real progress, the work continues. We need ongoing research, better access to care, and more inclusive spaces where women can learn, connect, and advocate for their well-being.
“Empowering women to take back their health has always been my passion,” says Deb Looney.
“Menopause is just the beginning. We still have more work to do.”
Loopwell remains committed to leading that work — through education, meaningful conversation, and community-driven change.
About Loopwell
Loopwell is a women-led well-being social club and community hub based in Montclair, New Jersey. Dedicated to making women’s health more accessible, Loopwell creates spaces where education, connection, and care come together.
Since 2022, Loopwell has proudly hosted:
17 transformative experiences
2,000+ women
50+ experts
7 menopause-focused books and panels
Together, we continue to advocate, educate, and celebrate every phase of womanhood.
💛 Together, we Gather for Good.