Reviewed by: Jose Baldazo, BSN, RN
Short answer: The FDA has approved label changes that drop the boxed warnings about heart disease, breast cancer and dementia from menopausal hormone therapy products, starting with six products in February 2026. The boxed warning for endometrial cancer on estrogen-only products stays. On October 15, 2026, ACOG also published a new menopause guideline that strongly recommends hormone therapy for hot flashes and related sleep disruption in people without contraindications. Hormone therapy is still not right for everyone, and the details of your history matter.
If you've been told for years that hormone therapy is risky, two recent developments may have you wondering whether that advice has changed. Here is what the FDA and ACOG actually said, what stayed the same, and what to ask a provider before starting.
What changed with the FDA label
On November 10, 2025, the FDA announced it was starting to remove boxed warnings from menopausal hormone therapy products. The language being removed covers cardiovascular disease, breast cancer and probable dementia. The FDA said it was not seeking to remove the boxed warning for endometrial cancer on systemic estrogen-only products, so that one remains.
The change rolls out product by product. In February 2026, the FDA approved label changes for the first six products: Prometrium, Divigel, Cenestin, Enjuvia, Estring and Bijuva. Twenty-nine manufacturers have submitted proposed labeling changes, so more approvals may follow. The FDA pointed to randomized studies in which starting hormone therapy within 10 years of menopause onset, generally before age 60, was associated with reduced all-cause mortality and fewer fractures.
Why were the warnings there to begin with? Dr. Kathryn Corelli, quoted by Harvard Health, notes that the original Women's Health Initiative findings had flaws. Participants were much older than typical hormone therapy users and had underlying risk factors, and modern formulations use lower doses and can be delivered through the skin, which may lower risks. She says the risks "were quite low and just need to be discussed on an individualized basis."
What ACOG's new guideline says
ACOG's Clinical Practice Guideline No. 13 was published October 15, 2026, in Obstetrics & Gynecology, replacing a 2014 practice bulletin. According to Contemporary OB/GYN's summary, the main points are:
Hot flashes and night sweats: Menopausal hormone therapy is strongly recommended for vasomotor symptoms and vasomotor-related sleep disturbance in people without contraindications. Estrogen plus a progestogen is used for people with a uterus, and estrogen alone when endometrial protection isn't needed.
Timing: ACOG recommends starting therapy before age 60 or within 10 years of the start of natural menopause.
Shared decision: The decision should weigh age, medical history, and cardiovascular, breast cancer and blood clot risk.
If you can't or won't take hormones: SSRIs or SNRIs and the neurokinin receptor antagonists fezolinetant and elinzanetant are strongly recommended. Gabapentin is a conditional option, and cognitive behavioral therapy, clinical hypnosis and acupuncture are conditional suggestions.
Sleep: Hormone therapy improves self-reported sleep quality but not objective sleep-lab measures.
Mood: The evidence is insufficient to recommend for or against hormone therapy for menopause-related depressive symptoms. SSRIs and SNRIs are strongly recommended for people who don't want or can't use hormones.
Who may be a good candidate, and who may not
Harvard Health lists the factors worth reviewing with a clinician: your age and years since menopause, how severe your symptoms are, personal or family history of breast cancer, blood clots or heart disease, chronic conditions such as high blood pressure, diabetes or obesity, and bone health.
Doctors may rule out systemic hormone therapy after a recent heart attack or stroke, a blood clot, a hormone-sensitive cancer, or active liver disease. Vaginal estrogen is a different case: very little is absorbed into the bloodstream, so it doesn't carry the same risks as systemic therapy.
"Bioidentical" does not mean "compounded"
"Bioidentical" describes hormones that are chemically identical to the ones your body makes. Many FDA-approved products fit that description. Per a summary of ACOG's 2023 guidance, estradiol is available in FDA-approved oral, patch, gel, spray and vaginal ring forms, micronized progesterone is available as an oral capsule, and an oral estradiol and progesterone combination is FDA-approved.
Custom-compounded preparations are a separate category. No custom compounded hormone formulation is FDA-approved. ACOG's 2023 consensus says their absorption, purity and potency may vary, high-quality long-term safety data are lacking, and clinicians should not routinely prescribe them when FDA-approved products are available. The same guidance says dosing should be adjusted to symptom relief rather than blood-level testing. The FDA's label-change announcement covers FDA-approved products and does not address compounded preparations.
That is the reason to ask any provider which products they prescribe and whether they are FDA-approved.
What about testosterone for women?
Testosterone is one of the fastest-growing add-ons to menopause care, and the evidence is thinner than the demand. The FDA has not approved testosterone for menopause, so its use is off-label. Live Science reports that a 2026 U.S. study counted more than 90,000 off-label prescriptions to women in 2025, up 58.7% from 2024, and that an FDA public workshop in September concluded more evidence is needed.
What the trials show so far:
Placebo-controlled trials have not shown a benefit for brain fog, mood, bone density or muscle function.
A review of 36 randomized trials found skin-patch testosterone was associated with 0.85 additional satisfying sexual events per month versus placebo, an effect one expert called "not huge."
Doses designed for men may be too high for women and can cause voice deepening, hair thinning and facial hair growth.
A large UK trial of testosterone cream in menopausal women is expected to report by 2028.
What to ask at a hormone therapy visit
Whether you are in Dallas or anywhere else, these questions make the visit more useful:
Is the product you're recommending FDA-approved, and in which form (patch, gel, pill, vaginal)?
Am I within 10 years of menopause or under 60? If not, what is the reasoning for starting?
What does my personal risk picture look like for breast cancer, blood clots and heart disease?
How will the dose be adjusted, and when will we check in?
What are my options if I can't or don't want to take hormones?
When will we decide together whether to continue?
At Regen Wellness in Dallas, hormone care starts with a free info call, followed by lab testing and a review of your symptoms and history, with plans overseen by our medical director. You can read more about hormone replacement therapy for women or our overall bioidentical hormone replacement therapy approach. Not sure where to start? Take the free Root Cause Score assessment.
The bottom line
The FDA's label changes and ACOG's new guideline both point the same way: for many healthy women who start within the window, hormone therapy is a reasonable, evidence-supported option for hot flashes and sleep disruption, and the decision belongs in an individualized conversation. Neither one says hormone therapy is risk-free, and neither settles the questions around compounded products or testosterone. A good provider will tell you what is well supported, what isn't, and which product they are recommending and why.
This article is educational and is not medical advice. Talk with a qualified clinician about your own health history before starting or stopping any treatment.
Frequently Asked Questions
Did the FDA remove the black box warning on HRT? The FDA is removing the boxed warnings about cardiovascular disease, breast cancer and probable dementia from menopausal hormone therapy labels. It began with six products in February 2026, and more may follow. The boxed warning for endometrial cancer on estrogen-only systemic products remains.
Is hormone replacement therapy safe? For many healthy women who start within 10 years of menopause or before age 60, current FDA labeling and ACOG's 2026 guideline support hormone therapy for hot flashes and related sleep disruption. It is not safe for everyone. Recent heart attack or stroke, a blood clot, a hormone-sensitive cancer or active liver disease may rule it out, so the decision should be individualized.
What is the best age to start HRT? The FDA's labeled recommendation and ACOG's guideline both point to starting before age 60 or within 10 years of menopause onset, in people without contraindications.
Is bioidentical hormone therapy FDA-approved? Some bioidentical hormones are. Estradiol patches, gels, sprays and vaginal rings, oral micronized progesterone and an estradiol and progesterone capsule are FDA-approved. Custom-compounded preparations are not FDA-approved, and ACOG advises against routinely prescribing them when approved options exist.
Does testosterone help women in menopause? The FDA has not approved testosterone for menopause. Trials have not shown a benefit for mood, brain fog, bone or muscle, and the best evidence is a modest effect on sexual desire. More research is under way.
Sources & Further Reading
U.S. Food and Drug Administration — HHS Advances Women's Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy (November 10, 2025). https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy
Urology Times — FDA approves label changes for first batch of menopausal hormone therapy products (February 2026). https://www.urologytimes.com/view/fda-approves-label-changes-for-first-batch-of-menopausal-hormone-therapy-products
Harvard Health Publishing — FDA removes menopause hormone therapy black box warnings. https://www.health.harvard.edu/womens-health/fda-removes-menopause-hormone-therapy-black-box-warnings
Contemporary OB/GYN — ACOG guideline expands menopause VMS, sleep, and mood recommendations (October 2026). https://www.contemporaryobgyn.net/view/acog-guideline-expands-menopause-vms-sleep-and-mood-recommendations
American College of Obstetricians and Gynecologists — ACOG Expands Recommendations for Management of Menopause Symptoms (October 2026). https://www.acog.org/news/2026/10/acog-expands-recommendations-for-management-of-menopause-symptoms/
The ObG Project — ACOG recommendations on compounded bioidentical menopausal hormone therapy (2024 summary of ACOG's 2023 consensus). https://www.obgproject.com/2024/01/03/acog-recommendations-compounded-bioidentical-menopausal-hormone-therapy/
Live Science — Experts caution that testosterone for menopause lacks clear evidence. https://www.livescience.com/health/reproductive-health/testosterone-for-menopause-the-treatment-is-rising-in-popularity-but-does-it-work