WASHINGTON, D.C. — The Department of Health and Human Services announced Friday that the Food and Drug Administration has approved updated labeling for three additional menopausal hormone therapy products, removing certain longstanding boxed warnings, while also detailing steps to expand manufacturing capacity amid rising demand.
The products are estradiol transdermal patches from two applicants. The changes remove outdated risk statements about cardiovascular disease, breast cancer and probable dementia from the boxed warning section. Officials described the revisions as reflecting a re-examination of the scientific literature and a clearer characterization of the benefit-risk profile for these therapies. The move expands on labeling changes the FDA approved in February for six other menopausal hormone therapy, or MHT, products.
The actions align with President Donald Trump’s Oct. 19 executive order, Advancing Women’s Health to Improve Outcomes in All Phases of Life. First Lady Melania Trump championed the order.
“Now is the time for America’s resources to focus on girls and women,” the First Lady said. “Through my Women’s Health Innovation platform, we will accelerate innovation and common-sense partnerships with the private sector to benefit America’s women.”
HHS Secretary Robert F. Kennedy Jr. called the labeling updates a significant shift.
“Removing outdated statements from these boxed warnings marks a major victory for women’s health,” Kennedy, Jr. said. “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.”
CMS Administrator Dr. Mehmet Oz described the announcement as “an important step forward in supporting women’s health.” He credited the first lady’s Women’s Health Innovation platform and the work of Kennedy and Acting FDA Commissioner Kyle Diamantas.
“FDA’s actions today are grounded in, and consistent with, a sustained commitment to women’s health as a cross-cutting agency priority,” Diamantas said. “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.”
The FDA began engaging companies in November 2025 about proposed supplemental labeling revisions. To date, 29 drug companies have submitted proposals, and the agency said it is working expeditiously with applicants on additional changes.
Officials noted that clearer labeling could increase interest in therapies some women had previously been advised to avoid. In anticipation, the FDA has been in close contact with manufacturers of all approved MHT formulations. Based on current information, the agency is not aware of an imminent risk of a nationwide shortage.
For estradiol transdermal patches specifically, the FDA continues working with all six manufacturers to address access issues tied to higher demand. Manufacturers have expanded production capacity, added shifts and prioritized output of these products. Those steps have roughly doubled overall market output over the past 12 months. The agency is also monitoring other forms such as gels and creams. Patches remain only one treatment option.
The FDA is using available regulatory flexibilities, including an interim policy that lists estradiol and certain estradiol-containing combinations as Category 1 bulk drug substances for compounding by 503B outsourcing facilities under specified conditions. Traditional 503A pharmacy compounding also remains available when a valid prescription exists for an identified patient.
In addition to previously approving generic MHT options, the agency is exploring with sponsors the potential for over-the-counter availability of vaginal estrogen products. Any shift from prescription to nonprescription status would require separate FDA approval based on evidence that consumers can safely and effectively select and use the products without a healthcare professional’s supervision.
Women who have reported localized difficulties finding their usual products are encouraged to speak with a pharmacist or healthcare provider, who may identify an available alternative or equivalent option suited to their needs. Availability can differ by brand, strength, formulation—once-weekly versus twice-weekly—and location. The FDA said it continues to monitor the supply chain and take data-driven steps within its authorities to limit disruptions.
Author: Lynnwood Times Staff
