WASHINGTON, D.C. — The Food and Drug Administration approved revised safety labeling for three additional menopausal hormone therapy products last week while working with manufacturers to expand production of estradiol patches, responding to rising treatment demand and localized supply constraints.
The changes remove statements concerning cardiovascular disease, breast cancer and probable dementia from the boxed warning sections of three estradiol transdermal patch products submitted by two applicants. The agency said the revisions follow a reassessment of scientific evidence concerning the therapies’ benefits and risks.
The action expands a labeling initiative that began in February 2026, when the FDA approved similar revisions for six menopausal hormone therapy products.
Since November 2025, 29 pharmaceutical companies have submitted proposed labeling changes, according to the agency. Additional applications remain under review.
The revisions do not establish that hormone therapy is free of cardiovascular, cancer or cognitive risks. Rather, the FDA is changing how certain risks are presented in product labeling based on its evaluation of the available evidence.
The regulatory effort follows President Donald Trump’s Oct. 19 executive order, Advancing Women’s Health to Improve Outcomes in All Phases of Life, which directs federal attention toward women’s healthcare and treatment access.
First Lady Melania Trump helped initiate the executive order and an associated women’s health task force through her Women’s Health Innovation platform.
“Removing outdated statements from these boxed warnings marks a major victory for women’s health,” Health and Human Services Secretary Robert F. Kennedy Jr. stated.
The labeling changes coincide with increased demand for estradiol transdermal patches, prompting the FDA to work with manufacturers to prevent broader supply disruptions.
The agency reported that manufacturers have doubled overall market output of estradiol patches during the past 12 months through expanded production capacity, additional manufacturing shifts and increased prioritization of patch manufacturing.
All six manufacturers of FDA-approved estradiol transdermal patches are working with regulators to address availability concerns.
Despite reports of localized shortages, the FDA said current information does not indicate an imminent nationwide shortage of menopausal hormone therapies.
Availability remains uneven across individual brands, strengths, geographic markets and dosing schedules, including once-weekly and twice-weekly patches.
“That means advancing both the most up-to-date labeling and access to treatment,” Acting FDA Commissioner Kyle Diamantas stated, describing the agency’s approach to menopause care.
The FDA is also monitoring supplies of alternative formulations, including estrogen gels and creams, while using existing regulatory authorities to support additional production.
One measure involves the agency’s interim policy governing certain drugs compounded by facilities registered under Section 503B of the Federal Food, Drug, and Cosmetic Act.
Estradiol and estradiol-containing combinations are classified as Category 1 bulk drug substances under that policy, allowing qualifying outsourcing facilities to compound certain products without FDA enforcement action for specified regulatory requirements, provided applicable conditions are met.
Traditional pharmacy compounding under Section 503A also remains available for individualized patient needs when statutory requirements are satisfied, including a valid prescription for an identified patient.
Separately, the FDA is working with pharmaceutical sponsors to evaluate whether certain vaginal estrogen products could become available without a prescription.
Any transition to over-the-counter status would require FDA approval supported by evidence that consumers can select and use the products safely and effectively without medical supervision.
The agency continues to approve generic menopausal hormone therapies as another means of supporting treatment availability.
For patients experiencing difficulty obtaining their usual estradiol patches, the FDA recommends consulting a pharmacist or healthcare provider about appropriate alternatives, which may differ by formulation, strength or dosing frequency.
The agency said it will continue monitoring manufacturer output and regional availability while reviewing additional labeling applications and potential regulatory changes affecting access to menopausal hormone therapy.
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