Outrage of the Month: Labeling Changes to Menopausal Hormone Therapy Products
Health Letter, March 2026
By Nina Zeldes, Ph.D., Health Researcher and Robert Steinbrook, M.D.,Director, Public Citizen's Health Research Group
If you’re not outraged, you’re not paying attention!
Read what Public Citizen has to say about the biggest blunders and outrageous offenses in the world of public health, published monthly in Health Letter.
In February 2026 the Food and Drug Administration (FDA) approved changes to the prescribing information for six menopause hormone therapy products containing estrogen. The approved changes removed risk statements related to cardiovascular disease, breast cancer and probable dementia from the boxed warning — the agency’s most prominent safety warning. The treatments are approved for vasomotor symptoms due to menopause, vulvar or vaginal atrophy due to menopause, and the prevention of postmenopausal osteoporosis.
For systemic estrogen-alone products, the boxed warning for an increased risk of endometrial cancer was retained. In the other product categories, the boxed warning was removed entirely. In the next few months, the FDA will likely approve similar labeling changes for more products
The FDA’s decision was based on opinion, not additional safety data. These medications should continue to be taken for the shortest period necessary to increase the chances that the benefits of treatment outweigh the potential risks. In November 2025, when the FDA announced the planned removal of the safety warnings, senior agency officials seemed to blatantly promote the off-label use of hormone replacement therapy for conditions for which it had not been approved, such as preventing cardiovascular disease and cognitive decline. Public Citizen’s Health Research Group criticized both the decision and the process, noting that the treatments have documented cardiovascular, cognitive and cancer safety risks that the FDA chose to ignore. Moreover, the U.S. Preventive Services Task Force has consistently recommended against hormone replacement therapy for the prevention of chronic conditions in postmenopausal women.
The boxed warning has been on menopausal hormone labels for more than 20 years. The safety warning was largely based on the results of two randomized, double-blind, placebo-controlled trials of hormone replacement therapy conducted by the federally funded Women’s Health Initiative (WHI): one of estrogen-progesterone replacement therapy in women with a uterus and the other of estrogen-only replacement therapy in women without a uterus.
The FDA’s process for requesting the labeling changes relied on what the agency described as a “comprehensive review of the scientific literature” and an ad hoc expert panel on menopause and hormone replacement therapy for women, not a formal advisory committee that followed the rules and procedures of the Federal Advisory Committee Act.
The FDA’s literature review is suspect; one reason is that as of late February 2026, it does not appear to have been made public. Although Dr. Martin A. Makary, the FDA commissioner, and other senior officials discussed the “comprehensive FDA evaluation of WHI and post-WHI publications” in an opinion article in JAMA, the article inexplicably did not include a citation to the review.
The FDA expert panel was more akin to a kangaroo court with conflicted members than an objective and diverse group of advisers. In another opinion article in JAMA, the nine living former members of the WHI Data and Safety Monitoring Board characterized the expert panel as “a group of people the FDA appears to have known supported removing the box warnings. Each panelist had 5 minutes to speak. No panelist expressed an opposing view, as all argued for the removal of boxed warnings.”
Instead of making unsubstantiated claims about improving women’s health, the FDA should encourage or fund additional research that establishes the benefits and risks of short- and long-term use of hormone replacement therapy. Regardless, the FDA should also convene a formal advisory panel, not a sham expert panel, whose fully qualified and unconflicted members would impartially evaluate the risks and benefits of menopausal hormone products containing estrogen.
Public Citizen’s Health Research Group is open to targeted updates to the safety warnings that incorporate recent medical evidence. Many of the labeling changes, however, reflect the idiosyncratic opinions of Makary and Health and Human Services Secretary Robert F. Kennedy, Jr., not evidence.