Trump Administration Delivers for Women with Major Advances in Menopause Care

WASHINGTON, D.C.-OCTOBER 30, 2026-The U.S. Department of Health and Human Services, through the Food and Drug Administration, today approved updated labeling for three additional menopausal hormone therapy (MHT) products from two applicants and provided an update on efforts to expedite appropriate manufacturing changes that can increase capacity and availability of MHT to Americans. Today's MHT labeling actions - and the agency's parallel work to help ensure adequate supply of these therapies directly supports President Trump's Executive Order, Advancing Women's Health to Improve Outcomes in All Phases of Life, signed on October 19, 2026.

First Lady Melania Trump was the impetus behind creating the Executive Order and the task force. "Now is the time for America's resources to focus on girls and women. Through my Women's Health Innovation platform, we will accelerate innovation and common-sense partnerships with the private sector to benefit America's women," said the First Lady.

"Removing outdated statements from these boxed warnings marks a major victory for women's health," said HHS Secretary Robert F. Kennedy, Jr. "Under President Trump's leadership, we are changing how the federal government approaches menopause care. We are updating labels to reflect current science, confronting barriers to treatment, and working with manufacturers to expand supply."

"Today's announcement is an important step forward in supporting women's health," said CMS Administrator Dr. Mehmet Oz. "I applaud the First Lady for spearheading her Women's Health Innovation platform, as well as Secretary Kennedy and Acting Commissioner Diamantas for their commitment to ensuring agency actions reflect current science."

In February 2026, FDA approved labeling changes to clarify benefit-risk considerations for six menopausal hormone therapy products. Today's action expands this effort by approving the removal of the same outdated risk statements regarding cardiovascular disease, breast cancer, and probable dementia from the boxed warning section of three additional menopausal hormone therapy products. The three products with updated labeling changes are for estradiol transdermal patches.

These changes reflect a thorough re-examination of the scientific literature and updated information that characterizes the relevant benefit-risk profile of these therapies.

In November 2025 FDA began engaging companies to submit proposed supplemental revisions to their MHT product labeling. To date, 29 drug companies have submitted proposed labeling changes. FDA is working expeditiously with applicants to take action on labeling changes for these MHT products.

"FDA's actions today are grounded in, and consistent with, a sustained commitment to women's health as a cross-cutting agency priority," said Acting FDA Commissioner Kyle Diamantas, J.D. "We are equally committed to ensuring that when women and their doctors determine hormone therapy is right for them, they can access it. That means advancing both the most up-to-date labeling and access to treatment."

Recognizing that updating the labeling of these products would likely encourage more women to seek treatments they had previously been cautioned to avoid, the FDA anticipated a significant increase in demand and has been proactively taking steps to help ensure adequate supply.

The Agency is in close contact with manufacturers of all FDA-approved MHT formulations and, based on current information, is not aware of an imminent risk of a nationwide shortage. In addition, FDA continues engaging with all six manufacturers of FDA-approved estradiol transdermal patches to address access challenges driven by a significant rise in demand. Manufacturers have and continue to actively scale up, with measures including expanded production capacity, additional manufacturing shifts, and prioritized output of estradiol patch products. These efforts have resulted in an overall doubling of market output in the last 12 months. Patches are only one option for treatment, and FDA continues to monitor supply for other dosage forms, such as gels and creams.

The FDA is also utilizing available regulatory flexibilities, such as the agency's interim policy on compounding using bulk drug substances by 503B outsourcing facilities, estradiol and estradiol-containing combinations are listed as Category 1 bulk drug substances. This means the FDA does not intend to take action against outsourcing facilities compounding drugs with such substances even though they do not appear on FDA's list of bulk drug substances for which there is a clinical need or on FDA's shortage list, so long as certain conditions are met. This provides another potential channel for supply for certain estradiol products.

In addition, 503A pharmacy compounding remains available to meet the individualized needs of patients under certain conditions, including that a valid prescription exists for an identified individual patient.

To further expand access, the FDA, in addition to approving generic menopausal hormone therapies, is working with sponsors to explore the potential for over-the-counter availability of vaginal estrogen products. Any transition from prescription to nonprescription status would require FDA approval, supported by evidence that consumers can appropriately select and use the product safely and effectively without the supervision of a healthcare professional.

FDA has heard directly from patients and consumers who have reported localized challenges in finding their usual MHT products, and we take those reports seriously. Women who are having difficulty finding their usual patch product are encouraged to speak with their pharmacist or healthcare provider, who may be able to identify an available alternative or equivalent option appropriate for their individual needs. Availability can vary by brand, strength, formulation (once-weekly versus twice-weekly), and geographic location. The FDA continues to actively monitor the supply chain across approved MHT products and is taking appropriate data driven action within the agency's current authorities to mitigate supply disruptions.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.