FDA Approves New Menopausal Hormone Therapy Labels (2026)

Table of Contents

1. What the FDA Announced on 12 February 2026
2. What a Boxed Warning and a Drug Label Are
3. What the FDA Asked to Be Removed
4. What the FDA Asked to Be Added or Kept
5. The Four Categories the First Six Labels Cover
6. The Background: The Women’s Health Initiative Trials and the 2003 Warnings
7. The Reasons the FDA Gives for the Change
8. What the Action Does Not Do
9. Dates and Status as of 11 October 2026
10. The 2026 Workshop on Testosterone in Menopausal Women
11. How the Action Fits the FDA’s Earlier Handling of Hormone Therapy
12. Primary Documents
13. Key Research Papers
14. Connections

1. What the FDA Announced on 12 February 2026

The FDA news release, “FDA Approves Labeling Changes to Menopausal Hormone Therapy Products,” is dated 12 February 2026. It states that the agency “has approved drug labeling changes to six menopausal hormone therapy products” in order “to clarify risk considerations for these drugs,” and that “risk statements related to cardiovascular disease, breast cancer and probable dementia were removed from the ‘boxed warning.’”

The release says the FDA initiated the removal of these warnings in November 2025 “following a comprehensive review of the scientific literature,” and that, at the FDA’s request, 29 drug companies have submitted proposed labeling changes. It describes the six approved labels as a “first batch” that includes products from each of the four categories of hormone therapy for menopausal women (listed in section 5). The release does not name the six products, and neither does this page.

The release quotes two officials. The Secretary of Health and Human Services, Robert F. Kennedy, Jr., said the decision “reflects our commitment to follow the science wherever it leads and to correct course when the evidence demands it,” and that removing the boxed warnings is meant to ensure “that women receive accurate information about hormone therapy.” The FDA Commissioner, Marty Makary, M.D., M.P.H., said the action delivers on a promise “to make sure women have accurate, scientifically grounded information about the potentially life-changing benefits of HRT,” adding that the agency’s efforts “will help these women make well-informed medical decisions.”

The release closes by stating that the action will allow women, working with their health care professionals, to make better-informed decisions about treatment of menopause symptoms, and that women are encouraged by the agency to consult the drug label for more detailed information on benefits and risks.

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2. What a Boxed Warning and a Drug Label Are

Every prescription drug approved in the United States comes with official prescribing information, usually called the “label” or “package insert.” It is the document, approved by the FDA, that sets out what the drug is approved to treat, how it is given, and its known risks. The label belongs to the company that holds the approval (the “application holder”), so a change to it is normally made by that company submitting new wording and the FDA approving it. That is why the FDA’s November 2025 step took the form of a request to application holders, and the February 2026 step took the form of approvals of the labels they sent in.

A boxed warning (often called a “black box warning”) is a warning printed inside a border at the top of the label. The FDA’s documents call it “the agency’s most prominent safety-related warning.” Moving a risk out of the box does not by itself delete it from the label: the FDA’s request distinguishes between what is in the boxed warning and what is in “the labeling as a whole,” and section 4 lists the risk information the agency asked to keep elsewhere in the label.

Some other terms used in the FDA’s documents:

• Menopausal hormone therapy (MHT): estrogen, sometimes combined with a progestogen, used for menopause symptoms; the FDA notes it is also commonly called hormone replacement therapy (HRT).
• Progestogen: the general term for progesterone and progesterone-like drugs (progestins). In women who still have a uterus, a progestogen is given alongside systemic estrogen; the FDA’s product categories reflect this (section 5).
• Systemic products act throughout the body (for example tablets, patches or gels); local vaginal products are applied in the vagina for symptoms there.
• Vasomotor symptoms (VMS): the FDA’s term for hot flashes and night sweats.
• Genitourinary syndrome of menopause (GSM): changes to the vagina, vulva and urinary tract caused by lower estrogen, formerly called vulvovaginal atrophy (VVA).
• Endometrial cancer: cancer of the lining of the uterus.

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3. What the FDA Asked to Be Removed

The FDA statement of 10 November 2025, “FDA Requests Labeling Changes Related to Safety Information to Clarify the Benefit/Risk Considerations for Menopausal Hormone Therapies,” records that the agency informed application holders that day of the changes it was requesting. For all menopausal hormone therapies, systemic and local vaginal alike, the requested changes to the boxed warning were:

• remove the language related to cardiovascular diseases, breast cancer and probable dementia;
• remove language related to endometrial cancer, except in the systemic estrogen-alone drugs;
• remove the recommendation to use the lowest effective dose for the shortest amount of time.

In the labeling as a whole, for all of these products, the FDA asked that the probable dementia warning be removed.

The February 2026 press release describes the approved changes for the first six products in terms of the first of these items: the risk statements on cardiovascular disease, breast cancer and probable dementia “were removed from the ‘boxed warning.’”

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4. What the FDA Asked to Be Added or Kept

The November 2025 request also set out changes that differ by product type.

For systemic products, in the labeling as a whole, the FDA asked companies to:

• add consideration of starting hormone therapy for moderate to severe vasomotor symptoms in women younger than 60 or within 10 years of menopause;
• add Women’s Health Initiative data in women aged 50 to 59;
• retain the boxed warning about endometrial cancer in the systemic estrogen-alone products;
• retain information about cardiovascular diseases and breast cancer warnings.

For local vaginal estrogen products, in the labeling as a whole, the FDA asked companies to condense safety information and prioritize the information most relevant to the local vaginal formulation. The site’s background on these products is on the Genitourinary Syndrome of Menopause and Vaginal Estrogen page.

Read together, sections 3 and 4 show that for systemic products the cardiovascular and breast-cancer information was moved out of the box rather than out of the label, while the dementia warning was taken out of the label entirely.

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5. The Four Categories the First Six Labels Cover

According to the February 2026 release, the first six approved labels include products from each of the four categories of hormone therapy for menopausal women:

1. Systemic combination therapy (estrogen and progestogen);
2. Systemic estrogen-alone therapy;
3. Systemic progestogen-alone therapy for women with a uterus who are using systemic estrogen;
4. Topical vaginal estrogen therapy.

The release does not say how many of the six fall in each category. For the second category, the November 2025 request is the one that keeps a boxed warning in place: the endometrial-cancer warning is retained for systemic estrogen-alone products. The differences between progesterone and synthetic progestins are covered on the site’s Micronized Progesterone vs Synthetic Progestins page.

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6. The Background: The Women’s Health Initiative Trials and the 2003 Warnings

The November 2025 statement traces the original warnings to two long-term, large studies of the Women’s Health Initiative (WHI). One tested estrogen plus progestin (“WHI EP”) in women with a uterus; the other tested estrogen alone (“WHI E”) in women without a uterus. Both looked at whether hormone therapy prevents heart disease, cancer and bone fractures in postmenopausal women aged 50 to 79.

The FDA’s account of what happened:

• Both studies began in the 1990s and were stopped early, WHI EP in 2002 and WHI E in 2004.
• WHI EP was stopped because investigators reported an increased risk of breast cancer, after an average of about five years of follow-up.
• WHI E was stopped because investigators reported an increased risk of stroke and a lack of evidence that it prevented coronary artery disease, after an average of about seven years.
• Two further WHI studies, testing estrogen plus progestin or estrogen alone for dementia prevention in women aged 65 to 79, reported an increased risk of probable dementia.

Based on the WHI findings, the statement says, the FDA began approving class-wide labeling changes in 2003 for estrogen plus progestogen and estrogen-alone products approved for vasomotor symptoms, vulvovaginal atrophy and prevention of postmenopausal osteoporosis. Those changes “would eventually include a Boxed Warning for increased risk of serious adverse events, including cardiovascular disorders, invasive breast cancer, and probable dementia.” The published WHI reports behind these events are listed under Key Research Papers below; the longer history of hormone therapy is on the site’s Menopause and HRT: History and Discovery page.

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7. The Reasons the FDA Gives for the Change

Questions about the warnings. The FDA writes that in the years after 2003 it “received questions about whether the Boxed Warnings resulting from the WHI findings were warranted, particularly for local vaginal estrogen-only products.” It reports that some groups questioned how well the WHI methods and interpretations applied to menopausal women for whom hormone therapy is warranted, and that the women’s health community raised concern that many symptomatic women decline or are not prescribed hormone therapy because of the boxed warnings.

The age of the WHI participants. The FDA states that the primary aim of the WHI trials was to evaluate the effect of hormone therapy on cardiovascular disease and other chronic conditions in postmenopausal women of all ages, with an average participant age of 63. By contrast, it says, bothersome hot flashes typically occur much earlier, between about 45 and 55, and the average age of menopause in the U.S. is 51, so “the age-related health conditions in the WHI population did not match the typically younger and healthier women who may start MHT for bothersome VMS.” To address this, the FDA says it considered multiple additional analyses and long-term follow-up of WHI participants. On dementia specifically, it notes that the WHI dementia studies enrolled women aged 65 to 79, “a population much older than women starting MHT.”

Mortality and fractures. In the February 2026 release the FDA states that “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.” This is the agency’s statement; the release does not name the studies. Bone effects are covered on the site’s Postmenopausal Osteoporosis and Hormone Therapy page.

How many women use it. Both documents cite U.S. Census Bureau data that about 41 million U.S. women were aged 45 to 64 in 2020, and the FDA’s review of outpatient prescription data that about 2 million women aged 46 to 65 received a prescription for systemic estrogen-alone or combined estrogen plus progestogen that year. The November 2025 statement adds a 2021 study (Nappi and colleagues, listed below) that put the prevalence of moderate to severe vasomotor symptoms in women aged 45 to 65 at about 34%, and concludes that “such drug use data suggest MHT may be under-utilized among women likely to benefit from MHT.”

The 2025 expert panel and public input. The FDA held an Expert Panel on 17 July 2025 focused on the risks and benefits of menopausal hormone therapy, and afterwards requested broad public input on the same question. The November 2025 statement says the requested changes follow “the agency’s comprehensive assessment of relevant literature” since the WHI publications, an updated drug utilization review and that public input, and that the FDA “has re-considered the benefit/risk balance of these drugs.”

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8. What the Action Does Not Do

• It does not remove every boxed warning. Under the November 2025 request, the boxed warning about endometrial cancer is retained in systemic estrogen-alone products.
• It does not remove the cardiovascular and breast-cancer information from systemic product labels. The request asks that this information be retained in the labeling as a whole; what changes is that it is no longer in the boxed warning. The site’s summary of these risks is on the HRT Risks: Breast Cancer, Clots, and Stroke page.
• It did not change every label at once. As of the 12 February 2026 announcement, new labels had been approved for the first six products; the release says 29 companies had submitted proposed changes, and the rest were still pending at that date.
• It does not approve any new hormone product or any new use. The action changes the wording of labels for drugs that were already approved. The February release lists the uses for which the FDA has approved hormone therapies as moderate-to-severe hot flashes, vaginal dryness and discomfort, and preventing bone loss.
• It does not approve testosterone for menopausal women. The later workshop notice states that there are no FDA-approved indications for testosterone therapy for menopausal women (section 10).

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9. Dates and Status as of 11 October 2026

• 17 July 2025: FDA Expert Panel on the risks and benefits of menopausal hormone therapy, followed by a request for public input.
• 10 November 2025: FDA informs application holders of the requested labeling changes.
• 12 February 2026: FDA announces approval of new labels for the first six products; 29 companies had submitted proposed changes.
• 18 August 2026: Federal Register notice of the public workshop “Testosterone Use in Menopausal Women” (91 FR 53417, Docket No. FDA-2026-N-5479).
• 17 September 2026: the workshop, held as a hybrid event at the FDA White Oak Campus in Silver Spring, Maryland, and by webcast.
• 19 October 2026: closing date for comments to the workshop docket.

Legal status. The labeling changes for the first six products are approved, final FDA actions on those products’ labels. How many of the remaining submitted labels have been approved since February was not found in a primary FDA document, so this page does not give a number. The testosterone workshop docket (FDA-2026-N-5479) is open for comments until 11:59 p.m. Eastern Time on 19 October 2026; the notice states that late comments will not be considered.

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10. The 2026 Workshop on Testosterone in Menopausal Women

On 18 August 2026 the FDA published a notice in the Federal Register (91 FR 53417–53418, FR Doc. 2026-16829) announcing a public workshop titled “Testosterone Use in Menopausal Women,” organized by the FDA’s Office of Women’s Health and its Center for Drug Evaluation and Research. A Federal Register notice is the government’s official public announcement; the “docket” is the public file, kept on regulations.gov under a number, where comments and background documents are collected. The workshop was scheduled for 17 September 2026, 9:00 a.m. to 4:30 p.m. Eastern Time.

The notice says the workshop’s purpose was “to examine the current scientific evidence and critical knowledge gaps related to testosterone use in menopausal women to help inform future research and potential drug development of testosterone products for menopausal women.” Its background section states:

• Testosterone in women declines with age: levels in the late 40s are about half those in the early 20s, reaching a low point in the late 50s, followed by stabilization or modest increases from the 60s.
• How declining ovarian testosterone relates to frailty, depressive symptoms, sleep, sexual function, cognition and musculoskeletal health is “not well understood.”
• “Unlike estrogen-containing products, there are no FDA approved indications for testosterone therapy for menopausal women,” although off-label use (use for a purpose not on the approved label) in women nearing or after menopause has increased over the past decade.
• Testosterone is approved for hypoactive sexual desire disorder (HSDD, persistently low sexual desire that causes distress) in women in Australia, New Zealand, the UK and South Africa; beyond HSDD there are limited data on its treatment effect for other uses.
• Short-term safety data exist for physiologic doses, but long-term safety data beyond 24 months are limited, “particularly regarding cardiovascular and breast cancer risks,” and there are challenges in measuring testosterone and relating blood levels to clinical outcomes.

Sessions were to cover testosterone physiology across a woman’s life, measurement challenges, clinical guidelines and practice perspectives, and regulatory considerations for drug approval, including clinically meaningful endpoints, with the patient perspective also explored. The notice approves nothing; it gathers evidence and comments. The site’s background is on the Testosterone Therapy for Women page.

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11. How the Action Fits the FDA’s Earlier Handling of Hormone Therapy

2002–2004: the WHI trials stop early. The estrogen-plus-progestin trial stopped in 2002 and the estrogen-alone trial in 2004, as the FDA recounts (section 6).

From 2003: class-wide warnings. The FDA began approving class-wide labeling changes in 2003, which eventually included the boxed warning covering cardiovascular disorders, invasive breast cancer and probable dementia. “Class-wide” means the same warning was applied across a whole group of similar products rather than one product at a time.

The years after. The FDA reports receiving continued questions about whether the boxed warnings were warranted, “particularly for local vaginal estrogen-only products.”

2025: reassessment. The Expert Panel of 17 July 2025, a public-input request, and then the 10 November 2025 request to application holders.

2026: approvals and a new question. The first six new labels were approved in February 2026. In August the FDA turned to a related, unapproved therapy, announcing the September workshop on testosterone in menopausal women.

Read together, the documents show the agency removing the main element of its 2003 class labeling (the boxed warning on heart disease, breast cancer and dementia), keeping the endometrial-cancer box for estrogen-alone systemic products, and then opening a separate evidence-gathering step on testosterone, a hormone for which, by its own account, there is no approved menopausal indication.

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12. Primary Documents

1. U.S. Food and Drug Administration (2026). FDA Approves Labeling Changes to Menopausal Hormone Therapy Products. FDA News Release, 12 February 2026 — fda.gov press announcement
2. U.S. Food and Drug Administration (2025). FDA Requests Labeling Changes Related to Safety Information to Clarify the Benefit/Risk Considerations for Menopausal Hormone Therapies. Drug Alerts and Statements, 10 November 2025 (page updated 12 February 2026) — fda.gov drug statement
3. Food and Drug Administration, HHS (2026). Testosterone Use in Menopausal Women; Public Workshop; Request for Comments. Federal Register 91:53417–53418, 18 August 2026. FR Doc. 2026-16829, Docket No. FDA-2026-N-5479 — federalregister.gov 2026-16829
4. Public docket FDA-2026-N-5479 on regulations.gov (comments and background documents for the testosterone workshop; open for comments until 19 October 2026)

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Key Research Papers

1. Rossouw JE, Anderson GL, Prentice RL, et al. (2002). Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative randomized controlled trial. JAMA 288(3):321-333 — PubMed PMID: 12117397
2. Shumaker SA, Legault C, Rapp SR, et al. (2003). Estrogen plus progestin and the incidence of dementia and mild cognitive impairment in postmenopausal women: the Women’s Health Initiative Memory Study: a randomized controlled trial. JAMA 289(20):2651-2662 — PubMed PMID: 12771112
3. Anderson GL, Limacher M, Assaf AR, et al. (2004). Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women’s Health Initiative randomized controlled trial. JAMA 291(14):1701-1712 — PubMed PMID: 15082697
4. Rossouw JE, Prentice RL, Manson JE, et al. (2007). Postmenopausal hormone therapy and risk of cardiovascular disease by age and years since menopause. JAMA 297(13):1465-1477 — PubMed PMID: 17405972
5. Manson JE, Chlebowski RT, Stefanick ML, et al. (2013). Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women’s Health Initiative randomized trials. JAMA 310(13):1353-1368 — PubMed PMID: 24084921
6. Manson JE, Aragaki AK, Rossouw JE, et al. (2017). Menopausal hormone therapy and long-term all-cause and cause-specific mortality: the Women’s Health Initiative randomized trials. JAMA 318(10):927-938 — PubMed PMID: 28898378
7. Nappi RE, Kroll R, Siddiqui E, Stoykova B, Rea C, Gemmen E, Schultz NM (2021). Global cross-sectional survey of women with vasomotor symptoms associated with menopause: prevalence and quality of life burden. Menopause 28(8):875-882 — PubMed PMID: 34033602

Papers 1–3 are the published WHI results for the trial stoppages the FDA describes in section 6; papers 4–6 are later WHI analyses by age, years since menopause and long-term follow-up (the FDA’s statement says it considered additional analyses and long-term follow-up of WHI participants but does not name them); paper 7 is the 2021 study cited in the FDA’s November 2025 statement.

PubMed Topic Searches

1. PubMed: menopausal hormone therapy and the timing hypothesis
2. PubMed: Women’s Health Initiative long-term follow-up
3. PubMed: vaginal estrogen safety after menopause
4. PubMed: testosterone in postmenopausal women

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Connections

• FDA and Regulation
• Menopause and Hormone Replacement Therapy
• Menopause and HRT: History and Discovery
• Genitourinary Syndrome of Menopause and Vaginal Estrogen
• HRT Risks: Breast Cancer, Clots, and Stroke
• Testosterone Therapy for Women
• Hot Flashes and Night Sweats
• Menopause
• Postmenopausal Osteoporosis and Hormone Therapy
• Breast Cancer
• Dementia
• FDA Proposal on Compounded Semaglutide and Tirzepatide (2026)
• FDA Review of Compounded Peptides Including BPC-157 (2026)
• FDA Ibogaine Research Notice (2026)

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