Finally, labeling will reflect the truth and reverse decades of misplaced fear
(originally published Nov. 10, 2025)
The FDA today announced it will remove the “black box” warning label on hormone replacement therapies (estrogen and progesterone), a first step toward finally reducing the fear and misinformation surrounding the use of bioidentical hormone therapy for women.
This is HUGE news—the FDA is righting a major wrong that has harmed an entire generation of women.
The false flag that misled a generation
For years, every estrogen product on the market has carried an ominous “black box” warning label that claimed it causes cancer, blood clots, stroke and “probable dementia.” This false labeling is the result of the flawed and misleading (and now mostly debunked) Women’s Health Initiative study in 2002. (Read why the WHI was a huge mistake here.)
Because of this erroneous labeling, doctors were afraid to prescribe estrogen, and women were afraid to use it. I’ve heard many providers say that even though THEY knew it was safe, when they prescribed estrogen to their patients, many, many women threw it in the trash or never used it after picking up their prescription because the “black box” warning label scared them.
One small step for estrogen, a giant leap for women’s health
Removing this warning label is a MAJOR step forward for women’s health. Finally, the FDA is admitting that the WHI got this all wrong.
“Estrogen is a key hormone for women’s health. Every single part of a woman’s body depends on estrogen to operate at its best—including the brain, bones, heart, and muscles,” said Advanced Research Projects Agency for Health Director Alicia Jackson, Ph.D. “The removal of the black box warning, based on the best science and data, is an incredible step forward to empower millions of women to live longer, healthier lives.”
Estrogen and progesterone are VITAL hormones for health and longevity. For anyone suffering from genitourinary symptoms of low estrogen, vaginal estrogen alone can be a godsend to:
Alleviate vaginal dryness that contributes to discomfort, itching, unusual odor and the development of yeast infection and/or bacterial vaginosis.
Reduce the incidence of recurrent UTIs by over 50%. This is huge! Did you know that UTIs kill roughly 13,000 Americans every year, predominantly older women? And that prescribing vaginal estrogen to women could save BILLIONS of dollars a year in the treatment of chronic/recurrent UTIs? Hopefully, with this FDA news, vaginal estrogen will become the standard of care.
Prevent or reverse vaginal/labia atrophy. Did you know that your labia minora (inner labia) can actually disappear in menopause? I KNOW! This is not only disturbing and upsetting from a mental and sexual wellness perspective, but it also contributes to vaginal infections—those labia are there for a reason and when they go away, that protective barrier is gone.
Treat or prevent urinary incontinence and potentially interstitial cystitis. The bladder and urethra are full of estrogen receptors, and when estrogen drops, it causes urinary urgency, frequency (which disturbs sleep by forcing you to get up multiple times to pee), pelvic pain, and UTI-like symptoms with no sign of infection. While interstitial cystitis can have other causes, it’s often mistaken for and/or complicated by genitourinary syndrome of menopause and vaginal estrogen can dramatically reduce or eliminate IC symptoms.
Prevent or resolve pain with sex. The lack of estrogen in the vaginal tissues not only causes dryness but also loss of elasticity. That can cause burning and pain with sex that no amount of lube can help. This, plus the loss of libido that’s common in perimenopause and menopause, is a recipe for disaster.
And that’s to say nothing of the benefits of systemic estrogen for protecting against osteoporosis, heart attacks, cancer and dementia.
From the HHS press release:
“Randomized studies show that women who initiate HRT within 10 years of the onset of menopause (generally before age 60) have a reduction in all-cause mortality and fractures. Women may also reduce their risk of cardiovascular diseases by as much as 50%, Alzheimer’s disease by 35%, and bone fractures by 50 to 60%. Though the starting time of HRT and duration of use are decisions made between the prescriber and the individual patient, the FDA’s labeled recommendation will be to start HRT within 10 years of menopause onset or before 60 years of age for systemic HRT.”
Beyond all of these benefits, I find it absolutely absurd that for years women have been told that the hormones our body naturally produces throughout our entire lives until this point are harmful. It makes ZERO evolutionary sense that hormones that fuel reproduction would also be trying to kill us. (Again: I’m referring here to bioidentical estradiol and micronized progesterone, not synthetic estrogens like Premarin or birth control pills, which DO carry risks worth consideration.)
Hopefully, today’s announcement alleviates some of those misguided fears and is a catalyst for broader access to this vital treatment for women. Fingers crossed!
**This is not medical advice, and I am not a doctor. The information here is based on my personal experience and research.
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