No More Black Box!

What if one of the largest health studies in history got it wrong and millions of women paid the price?

On November 10, 2025, the U.S. Food and Drug Administration (FDA) announced it will remove the long-standing “black box” warnings from many menopause hormone therapies that had previously been inaccurately applied and caused significant fear and confusion for patients.

These warnings — put in place more than twenty years ago — warned that estrogen or combination therapies (estrogen and synthetic progestins together) increased risks of heart disease, stroke, dementia, and breast cancer. However, these findings were released before the data was fully analyzed - and have since been proven false.

It is also important to note, that these prematurely resleased warnings were based mostly on data from the Women’s Health Initiative (WHI), which studied women in their 60s and beyond using oral conjugated estrogens and synthetic progestins. These studies did not consistently evaluate newly menopausal women, and did not include the bioidentical hormones many mid-life women use today.

After a thorough review of decades of research, the FDA now acknowledges what many of us in women’s-health have known for years: this fear of estrogen was based on misinterpreted data, flawed conclusions, and a refusal to correct the record - even when the science supported a new stance. As a result of these mistakes, millions of women were denied safe, effective care.

Why does this label removal matter so much?

For far too long, fear drove a knowledge gap. Medical schools stopped teaching HRT physiology, dosing, and prescribing. Student doctors and nurses were taught that HRT is not a safe option, is dangerous, and that women's suffering does not warrant treatment.

The art and science of hormone care became a taboo topic and studies to support further learning gasped for funding and women to participate. And yet — for the women who continued to recieve HRT despite the warnings - a clear truth kept emerging. When estrogen and progesterone are dosed appropriately and properly managed, HRT can be transformative and protective — not dangerous.

Bioidentical hormones mirror the molecular structure of what the body naturally produces, which can mean better tissue response, fewer unwanted effects, and a more individualized approach to hormone care. Bio-identical hormones can be prescribed in commercially prepared (from your local pharmacy) and compounded formulas. Commercially prepared formulas are FDA approved and covered by insurance. While there are other forms of HRT, Luna Hormone Health prefers to prioritize a bio-idenital approach whenever possible.

For many mid-life women, that HRT into relief from hot flashes and night sweats, improved sleep, and stabilized mood. It also translates to cardiovascular protection, bone density support, and brain protection. Not to mention and overall better quality of life!

Now, with the FDA formally revising its stance, we have a chance to rebuild the foundation of hormone health using science — not fear. No more black box indeed!

Luna Hormone Health is here for you - with no more black box

At Luna Hormone Health, we’re proud to provide top-quality mid-life hormone care using up-to-date standards grounded in the latest science. If you’re navigating menopause or perimenopause, we offer personalized, compassionate evaluations to explore whether HRT might be right for you.

Our goal is to empower each woman to make informed choices — based on science - not fear.