BIOLabs PRO® Welcomes FDA’s November 10 Decision: A Major Step Forward for Women’s Health
Earlier this week, on November 10, 2025, the U.S. Food and Drug Administration (FDA), in coordination with the U.S. Department of Health and Human Services (HHS), announced its plans to remove misleading and overly broad “black box” warnings from hormone replacement therapies (HRT) used to treat menopause symptoms. This landmark move represents a long-overdue correction of decades-old misinformation that stigmatized hormone therapy and discouraged millions of women from exploring safe, effective options for symptom relief.
As the leading U.S. manufacturer of bioidentical, over-the-counter hormone wellness products, BIOLabs PRO® has championed accurate education, clean formulations, and evidence-based science for years, often in contrast to the outdated, fear-driven narratives that dominated public conversation.
A Victory for Science and for Women Everywhere
The FDA’s announcement acknowledges that the original warnings were based largely on data from the Women’s Health Initiative (WHI), a study involving older women using synthetic, non-bioidentical formulations that do not reflect modern therapies. The FDA now recognizes what hormone experts have long understood: timing, formulation, and dosage matter.
For women beginning hormone therapy within 10 years of menopause onset, research shows improved quality of life and potential benefits related to cardiovascular health, bone density, and cognitive aging.
The removal of these broad warnings represents a return to nuance, accuracy, and evidence-based care.
BIOLabs PRO® Was Built for This Moment
Long before the national narrative began shifting, BIOLabs PRO® invested in the principles now coming to the forefront of women’s health:
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Bioidentical, plant-derived ingredients, not the synthetic or animal-derived compounds that informed outdated fears.
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OTC, cosmetic, and supplement formulations, not prescription drug positioning, ensuring safety, compliance, and consumer trust.
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Clean formulas and transparent labeling, backed by FDA-registered manufacturing practices and rigorous quality standards.
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A business model rooted in private-label manufacturing and clinician partnerships, designed to scale responsibly as demand for hormone-support products accelerates.
While the regulatory landscape is rapidly evolving, our mission has not.
As public perception shifts, BIOLabs PRO® is already steps ahead, offering brands, practitioners, and consumers premium, compliant, plant-derived bioidentical products supported by both science and integrity.
CEO Matthew Skamser’s Statement
“For over a decade, we’ve known that the blanket fear surrounding hormone therapy was rooted in incomplete science and based on synthetic animal hormones not plant-derived bioidentical hormones,” said Matt Skamser, CEO of BIOLabs PRO®.
“This week’s FDA action is not only validation of what women’s health advocates have said for years it’s a rebirth of confidence in hormone wellness. BIOLabs PRO® was founded on the principle that balanced hormones are essential to vibrant health. We’re thrilled to see regulators finally align with what the science has long shown.”
What This Means for Women and Their Providers
This regulatory shift opens new doors for women and the professionals who support them:
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Women can now explore hormone wellness options with renewed confidence and fewer outdated warnings clouding the conversation.
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Healthcare practitioners gain clarity to discuss evidence-based approaches to menopause and hormone balance.
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Private-label partners and retailers aligned with BIOLabs PRO® can confidently expand hormone-support offerings, backed by compliant manufacturing and responsible positioning.
About BIOLabs PRO®
BIOLabs PRO® is the USA’s premier manufacturer of bioidentical over-the-counter hormone wellness products, trusted nationwide by integrative health clinics, clinicians, private-label partners, and consumers. BIOLabs PRO® adheres to the highest standards of quality, safety, transparency, and scientific integrity, producing hormone creams, oils, supplements, and skincare designed to support natural hormonal balance.
Looking Ahead
While the FDA’s updated stance primarily applies to prescription hormone therapies, its impact will ripple across the broader landscape of women’s wellness. More women will feel empowered to pursue balanced, evidence-based options, and BIOLabs PRO® will continue leading this shift with innovation, education, and unwavering integrity.
References for further reading:
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FDA Expert Panel on Menopause & Hormone Replacement Therapy – FDA.gov U.S. Food and Drug Administration
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“Updated Labeling for Menopausal Hormone Therapy” — JAMA Network JAMA Network
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“Bioidentical hormones: Are they safer?” — Mayo Clinic Mayo Clinic
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“RFK Jr says FDA taking ‘black box’ warnings off menopause hormone therapy drugs” — The Independent The Independent
