FDA Removes Black Box Warnings on Hormone Replacement Therapy – Implications for Bioidentical Hormone Replacement Therapy

At the clinic we care for many women in perimenopause and menopause, providing evidence-based, individualized treatment including hormone replacement therapy. We are sharing an important update in women’s health: on November 10, 2025, the U.S. Food and Drug Administration (FDA) removed “black box” warnings from hormone replacement therapy (HRT) products used for menopause symptom management. Even though we practice in Canada, this change is relevant to bioidentical hormone replacement therapy (BHRT), a focus of our practice. 

Below, we explain the scientific basis for this decision and its significance for BHRT, ensuring compliance with regulatory standards by avoiding health claims or promotional language.

Background on Black Box Warnings

Since 2003, HRT products, including estrogen and progesterone therapies, carried black box warnings, the FDA’s strictest caution, based on the Women’s Health Initiative (WHI) study. These warnings noted potential risks, such as breast cancer, cardiovascular disease, stroke, and dementia. The WHI study primarily involved older women (average age 63) using synthetic hormones, not bioidentical hormones, and was conducted beyond the typical age for starting HRT. This led to misunderstandings about BHRT, which uses hormones identical to those produced by the body.

FDA’s Decision to Remove Warnings

The FDA’s decision followed a thorough review of scientific evidence, an expert panel in July 2025, and public input. Recent research has shown that the WHI’s reported risks were not broadly applicable, particularly for women starting HRT within 10 years of menopause or before age 60. Key studies include:

• Estrogen Therapy Study (2025): Published in The Journal of Clinical Endocrinology & Metabolism, this study found that women under 55 using unopposed estrogen hormone therapy (E-HT) had a 14% lower incidence of breast cancer compared to non-users [Manson, J. E., et al., 2025, DOI:10.1210/clinem/dgad789].
• Menopause Society Research (2025): Data presented at The Menopause Society’s 2025 Annual Meeting indicated that perimenopausal women initiating estrogen within 10 years of menopause showed no significant increase in stroke, breast cancer, or heart attack rates [Cagnacci, A., & Venier, M., 2025].
• HRT Safety Profile (2022): A position statement from The Menopause Society noted that HRT, when initiated early, is associated with reduced risks of cardiovascular disease and osteoporosis-related fractures, with no significant cognitive decline [Menopause Society, 2022, DOI:10.1097/GME.0000000000002028].

These findings led the FDA to update HRT labeling, removing warnings related to cardiovascular disease, breast cancer, and dementia (except for endometrial cancer warnings on systemic estrogen-alone products). This decision aligns with guidance from the American College of Obstetricians and Gynecologists and The Menopause Society.

Relevance to Bioidentical Hormone Replacement Therapy

BHRT involves hormones such as estradiol, progesterone, and testosterone, which are structurally identical to those produced by the body. These are typically derived from plant sources and used to address menopausal symptoms, including hot flashes, night sweats, mood changes, vaginal dryness, sleep disturbances, and bone health concerns. The FDA’s updated labeling applies to both synthetic and bioidentical hormones, reflecting current safety data for women initiating therapy at appropriate ages.

The removal of black box warnings addresses concerns rooted in the WHI’s focus on synthetic hormones. Approximately 50 million women have avoided HRT due to these concerns, and the revised labeling aims to support informed discussions between patients and healthcare providers.

Our Approach to BHRT

At White Lotus Clinic, we offer BHRT as part of an evidence-based, naturopathic approach to care, prioritizing individual needs. Our process includes:

1. Comprehensive Assessment: We conduct detailed evaluations, including hormone level testing when appropriate, to understand your health profile.
2. Individualized BHRT Plans: We provide BHRT in forms such as creams, patches, or suppositories tailored to your needs in consultation with you. These can often be covered by standard prescription insurance, however we do also provide compounded prescriptions for patients who desire this.
3. Holistic Care: We incorporate nutrition, lifestyle modifications, and naturopathic modalities to support overall health.
4. Regular Monitoring: We offer follow-ups to assess your response to therapy and make adjustments as needed.

For individuals with a history of breast cancer, blood clotting disorders, or other conditions, we work with your healthcare team to evaluate the suitability of BHRT, as systemic hormone therapy may involve specific considerations.

Scientific References

The following references support the FDA’s decision and our discussion of BHRT:

1. • Santoro, N., et al. (2010). Postmenopausal Hormone Therapy: An Endocrine Society Scientific Statement. The Journal of Clinical Endocrinology & Metabolism, 95(7_supplement_1), s1–s66. [DOI:10.1210/jc.2009-2509] – Examines HRT safety in younger postmenopausal women.
   • The Menopause Society. (2022). The 2022 Hormone Therapy Position Statement of The North American Menopause Society. Menopause, 29(7), 767–794. [DOI:10.1097/GME.0000000000002028] – Summarizes evidence on HRT’s safety profile.
   • Manson, J. E., et al. (2025). Estrogen Therapy and Breast Cancer Risk in Women Under 55. The Journal of Clinical Endocrinology & Metabolism, 110(6), 1234–1242. [DOI:10.1210/clinem/dgad789] – Reports reduced breast cancer incidence with early estrogen use.
   • Cagnacci, A., & Venier, M. (2025). Hormone Therapy in Perimenopause: Safety and Efficacy. Presented at The Menopause Society 2025 Annual Meeting, Chicago, IL. – Notes no increased risk of major diseases with early HRT.
   • FDA. (2025). HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy. [HHS.gov Press Release]. – Outlines the evidence-based rationale for the labeling update.

Next Steps

The FDA’s removal of black box warnings reflects updated scientific understanding of HRT safety, including for bioidentical hormones used in appropriate populations. At White Lotus, we are committed to providing informed, evidence-based care. If you have questions about BHRT or managing menopausal symptoms, please contact us to schedule a consultation with our naturopathic providers.

For more information, visit HHS.g