Bioidentical Hormone Therapy: 2026 FDA Updates
What Changed, What Didn't
At the clinic we care for many women in perimenopause and menopause, providing evidence-based, individualized treatment including hormone replacement therapy. Today, we’re sharing an important update in women’s health.
On November 10, 2025, the U.S. Food and Drug Administration announced it was beginning to remove the “black box” warnings from hormone replacement therapy products used for menopause. The first labels actually changed on February 12, 2026.
At the same time, a separate and longer-standing FDA caution about compounded “bioidentical” preparations is still in circulation. Both are real, both come from the same regulator, and they get confused constantly — but they cover different products.
That distinction is the whole question if you’re holding a prescription. Bioidentical describes the molecule — this can include both compounded and some traditional pharmaceutical hormones. Compounded describes customized hormones made in a pharmacy. They’re two separate things, and only one of them is what the caution is about.
Even though we practice in Canada and the FDA is the United States regulator, this matters for bioidentical hormone replacement therapy, which is a focus of our practice. Below we go through what changed, what didn’t, and which statement applies to which prescription.
The November 2025 Action and the February 2026 Label Changes
On November 10, 2025, the FDA announced it was beginning to remove the broad “black box” warnings from hormone therapy products for menopause, and that it would work with manufacturers to update the labelling.
The FDA’s announcement names three warnings that will be removed:
- risks of cardiovascular disease
- risks of breast cancer
- risks of probable dementia
Stroke appeared in some secondary reporting, and stays on the label.
One warning remains, with a precise scope. The FDA “is not seeking to remove the boxed warning for endometrial cancer for systemic estrogen-alone products.” That covers systemic estrogen used on its own.
The FDA gave three reasons: a review of the scientific literature, an expert panel in July, and a public comment period. It points to a specific window — randomized studies show that women who begin hormone therapy within 10 years of the onset of menopause, generally before age 60, have a reduction in all-cause mortality and fractures.
On February 12, 2026, the FDA approved labelling changes to six menopausal hormone therapy products, removing the cardiovascular disease, breast cancer and probable dementia statements from the boxed warning.
Those six span all four categories of menopausal HRT: systemic combination therapy, systemic estrogen-alone therapy, systemic progestogen-alone therapy for women with a uterus using systemic estrogen, and topical vaginal estrogen. All six are FDA-approved products, a category that includes bioidentical hormone therapy in its FDA-approved forms.
At the FDA’s request, 29 drug companies have submitted proposed labelling changes. The first labels have changed and the rest are pending.
All of this concerns FDA-approved products. The FDA’s guidance on compounded preparations is a separate matter, covered below.
On November 10, 2025, the FDA announced it was beginning to remove the broad “black box” warnings from hormone therapy products for menopause, and that it would work with manufacturers to update the labelling.
The FDA’s announcement names three warnings that will be removed:
- risks of cardiovascular disease
- risks of breast cancer
- risks of probable dementia
Stroke appeared in some secondary reporting, and stays on the label.
One warning remains, with a precise scope. The FDA “is not seeking to remove the boxed warning for endometrial cancer for systemic estrogen-alone products.” That covers systemic estrogen used on its own.
The FDA gave three reasons: a review of the scientific literature, an expert panel in July, and a public comment period. It points to a specific window — randomized studies show that women who begin hormone therapy within 10 years of the onset of menopause, generally before age 60, have a reduction in all-cause mortality and fractures.
On February 12, 2026, the FDA approved labelling changes to six menopausal hormone therapy products, removing the cardiovascular disease, breast cancer and probable dementia statements from the boxed warning.
Those six span all four categories of menopausal HRT: systemic combination therapy, systemic estrogen-alone therapy, systemic progestogen-alone therapy for women with a uterus using systemic estrogen, and topical vaginal estrogen. All six are FDA-approved products, a category that includes bioidentical hormone therapy in its FDA-approved forms.
At the FDA’s request, 29 drug companies have submitted proposed labelling changes. The first labels have changed and the rest are pending.
All of this concerns FDA-approved products. The FDA’s guidance on compounded preparations is a separate matter, covered below.
What the WHI Study Actually Showed About HRT Risk
The warnings now coming off date back to the early 2000s. In the FDA’s own account, hormone therapy use “plummeted” once the boxed warnings went on, following a Women’s Health Initiative study — a study whose breast cancer finding the FDA now describes as “a statistically non-significant increase in the risk of breast cancer diagnosis.”
Three things separate that trial from how we prescribe now:
Who was studied. From the FDA’s release: “The average age of women in the study was 63 years — over a decade past the average age of a woman experiencing menopause.” Those trials also enrolled many women with existing cardiovascular disease, and many who smoked. The baseline risk of that population shaped the results.
What they were given. Participants, in the FDA’s words, “were given a hormone formulation no longer in common use.” Those trials used oral estrogen with synthetic progestins. Modern bioidentical protocols use transdermal estrogen with natural progesterone. Those are different drugs with different profiles.
How it was taken. This distinction comes from pharmacology rather than the FDA’s release. Oral estrogen used in old studies passes through the liver and produces clotting metabolites; transdermal estrogen bypasses this problem altogether as it doesn’t turn into these metabolites. The clotting risk in those older trials tracked the oral route specifically.
Even though it was found that HRT does not cause cancer, it’s important to understand that screening is important. A cancer that develops incidentally can still feed off hormones, which is why keeping up with the breast screening guidelines for your age range matters throughout.
And for anyone with a history of breast cancer, hormone receptor status matters. Though low dose vaginal estrogens are approved for those with a history of hormone positive breast cancer, other forms are contraindicated. Always consult with your oncology team before considering HRT if you have a personal history of breast cancer.
When it comes to family history of breast cancer, this is rarely a contraindication except for a few situations. BRCA genes, though rare, have very specific implications. However, even with a family history of breast cancer it is rare to have BRCA genetics.
The FDA's Compounded Bioidentical Hormone Therapy Warning: Which Menopause Prescriptions It Covers
Two words, two properties. Bioidentical describes the molecule — the hormone in the preparation is identical to the one your body makes. Compounded describes how it was produced — made up by a compounding pharmacy for one patient, rather than manufactured at scale. Conventional pharmaceutical HRT is bioidentical too.
The regulator draws the line the same way. In the FDA’s words: “FDA has approved drugs containing hormones that are identical to the hormones made naturally by women in their reproductive years.” Approved products contain the same molecules your body makes, so “bioidentical” describes the molecule in both compounded and pharmaceutical forms.
The American College of Obstetricians and Gynecologists says the same from the specialist side. Its Clinical Consensus No. 6 (November 2023) notes that many compounding pharmacies use “bioidentical hormone” “as a marketing term to imply that these preparations are natural and, thus, safer and more effective than U.S. Food and Drug Administration (FDA)–approved menopausal medications that use bioidentical or synthetic hormones or both.”
Compounding can be used when indicated, however. We work with compounding pharmacies that we trust and have validated their products through lab testing. For some hormonal needs, like progesterone cream, there’s no commercial product on the market, so a prescription for one is compounded by necessity. Every other prescribed form has both compounded and pharmaceutical bioidentical options.
Despite this, our naturopathic doctors are experienced with compounded hormones, from our trusted compounding pharmacies. These are options which are always available for those who prefer specific forms, need customized doses or want to avoid fillers.
The FDA’s second statement, from its consumer guidance on menopause: “Many marketed products that are called ‘bioidentical hormones’ are compounded drugs, which are not FDA-approved. FDA does not have evidence that compounded ‘bioidentical hormones’ are safe and effective, or safer or more effective than FDA-approved hormone therapy.” The same document adds: “FDA recommends that women use hormone therapies that are FDA-approved.” In fact, this is a sweeping statement because the FDA cannot know which compounding pharmacies are compounding high quality products that can be trusted.
Our clinic does have this information as we have standing relationships with the best compounding pharmacies in Toronto and regularly test levels in our patients to confirm potency and accuracy.
What Decides Between Compounded and Pharmaceutical
Compounded and pharmaceutical-grade preparations are both effective as long as the pharmacy produces products of high quality. Once this is considered, the differences are simply practical.
Coverage. Pharmaceutical-grade bioidentical hormones are often covered by standard prescription insurance. Coverage for compounded preparations varies.
Fillers and additives. Some people prefer to avoid the fillers used in pharmaceutical-grade products, and choose compounding for that reason.
Dose flexibility. Pharmaceutical-grade HRT comes in a set range of doses. Compounding allows the dose to be tailored more precisely, which matters when the standard increments don’t fit.
Outside progesterone cream, where compounding is the only option, this choice exists for every prescribed form. It’s your decision, made on the factors that matter in your case: coverage, additives, and the dose you need. We provide all of these options so you can choose.
Does the FDA's HRT Label Change Apply in Canada?
This label change is a US labelling decision, on products approved for the US market. Health Canada is a separate regulator with its own process.
One Canadian source establishes something useful. On November 12, 2025, the Canadian Menopause Society issued a media release saying it “welcomes the FDA’s removal of the ‘Black Box’ warning from menopausal hormone therapy (MHT) labels,” and that it “will continue to engage with Health Canada and other Canadian interested parties to ensure labelling and guidance reflect up-to-date evidence.” That’s where a Canadian specialist body stood in November 2025.
The Menopause Society, a US body, responded to the FDA announcement this way: “We agree with the FDA’s decision to remove the boxed warning on low-dose vaginal estrogen therapies used to treat genitourinary symptoms associated with menopause.” And in the same statement: “Systemic estrogen still comes with potential risks in certain individuals that should be reviewed in detail with women initiating therapy.”
Common Questions
Is estrogen bioidentical?
The estradiol in FDA-approved menopausal hormone products is the same molecule the body makes — bioidentical in the literal sense. “Bioidentical” is a property of the molecule, not of where the preparation was made. The FDA states it “has approved drugs containing hormones that are identical to the hormones made naturally by women in their reproductive years.” The full distinction between molecule and production method is drawn in the compounded-warning section above.
Is bioidentical hormone therapy safe?
“Safe” isn’t one question. It resolves into three — which drug, given by which route, to which population — and the WHI section above works through all three, with the breast-screening caveat that travels with them. Two limits remain: The Menopause Society’s position is that “medical comorbidities, personal and family histories, symptoms, and personal preferences all need to be reviewed with patients considering the use of hormone therapy,” and this page doesn’t state Health Canada’s position on the US labelling change.
Is compounded bioidentical hormone therapy FDA-approved?
No. In the FDA’s words, many marketed products called “bioidentical hormones” “are compounded drugs, which are not FDA-approved.” That is a fact about production method and regulatory status: compounded preparations are made individually by a pharmacy and aren’t evaluated through the FDA’s approval process. The labelling changes of November 2025 and February 2026 concern FDA-approved products, so they neither extend to nor speak about compounded preparations.
When was this page last updated?
The most recent development this page carries is the FDA’s approval of the first six revised labels on February 12, 2026. The publication date and the medical-review date for the page itself are shown with the byline below.
Related Reading
The regulatory change is the whole of what’s above. The questions it hands off — suitability, cost, process, and symptom care — live on these pages:
- Bioidentical hormone therapy in Toronto — whether this approach fits an individual, cost and insurance, and what a first appointment involves
- Progesterone for heavy menstrual bleeding — one place the choice of progesterone formulation has clinical consequences
- Hot flashes in perimenopause — treatment options when the question is the symptoms themselves
- Menopause care at the clinic — how perimenopause and menopause are treated here, beyond the hormone-therapy question
- Hormone health topics — the full hormones hub
References
- “HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy.” U.S. Food and Drug Administration / Department of Health and Human Services, November 10, 2025. fda.gov
- “FDA Approves Labeling Changes for Menopausal Hormone Therapy Products.” U.S. Food and Drug Administration, February 12, 2026. fda.gov
- “Menopause” (consumer health topic). U.S. Food and Drug Administration. Content current as of December 14, 2023. fda.gov
- The Menopause Society. Statement on the FDA announcement on hormone therapy. November 10, 2025. menopause.org
- Canadian Menopause Society. “Canadian Menopause Society welcomes FDA decision to remove ‘Black Box’ warning from menopausal hormone therapy labels.” Media release, November 12, 2025. canadianmenopausesociety.org
- American College of Obstetricians and Gynecologists. “Compounded Bioidentical Menopausal Hormone Therapy.” Clinical Consensus Number 6, November 2023. Obstetrics & Gynecology 2023;142(5):1266–1273. acog.org
- Zeeshan F, Saqlain A. “FDA’s 2025 removal of black box warnings on menopausal hormone therapy.” Annals of Medicine and Surgery (London), 2026. DOI: 10.1097/MS9.0000000000004749. PMID: 41675753.
Written by Dr. Fiona McCulloch, ND
Medically reviewed by Dr. Fiona McCulloch, ND — review date: [PLACEHOLDER — pending Dr. Fiona’s final review; date must be filled at Checkpoint C before publication]
Published November 20, 2025
Last reviewed: 2026-08-18. This page reflects the FDA’s November 10, 2025 announcement and its February 12, 2026 approval of the first revised labels.
Talking Through Cyclic Progesterone With a Naturopathic Doctor
Two naturopathic doctors see patients for these consultations. Dr. Alex currently has immediate availability; Dr. Fiona typically books two to three weeks out. Fee details and booking links are in each card below.
Meet our Practitioners
Both Dr. Fiona and Dr. Alex see PCOS patients at White Lotus Clinic using the same clinical framework. Fees differ by practitioner.
Fees for Dr Alexandra Triendl-Dimitriu, ND
Perimenopause care using the same clinical framework as Dr. Fiona. For complex or challenging cases, Dr. Alex has direct access to Dr. Fiona's guidance — so you benefit from that depth of expertise regardless of which practitioner you see.
| Time | Description | Price |
|---|---|---|
| Up to 90 mins | Initial Naturopathic Consultation | $350 |
| 30m | Followup Naturopathic Consultation | $110 |
Fees for Dr Fiona McCulloch, RAc, ND
Author of 8 Steps to Reverse Your PCOS. Treating Menopause for 20+ years with a clinical focus in hormonal health, thousands of patients assessed.
| Time | Description | Price |
|---|---|---|
| Up to 90 min | Initial Naturopathic Consultation | $420 |
| 45m | Followup Naturopathic Consultation | $215 |
Click Links in description to see booking options. All new patents must start with an initial consultation.
Dr. Fiona McCulloch is a naturopathic doctor and the founder of White Lotus Clinic in Toronto. Her clinical focus is hormone health, with over 20 years of practice.
- Received the fellow of the American Board of Naturopathic Endocrinology designation
- Author of 8 Steps to Reverse Your PCOS (Greenleaf Publishing)
- Peer reviewer of the 2023 International Evidence-Based PCOS Guidelines
- Board member of the Endocrinology Association of Naturopathic Physicians (EndoANP) from 2018-2026
Insurance Coverage
Insurance is not provided by OHIP but is typically included on most extended insurance plans.
Prescribing note
Licensed naturopathic doctors (NDs) in Ontario have regulated prescribing authority for bioidentical hormones under the College of Naturopaths of Ontario (CONO). This is an authorized scope of practice, not an alternative pathway or a workaround. BHRT prescriptions issued by Ontario NDs are filled at standard pharmacies and compounding pharmacies. Naturopathic menopause care, including hormone prescribing, is a regulated option in Ontario.
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