In a move that continues its bold experiment in regulatory minimalism, the US Food and Drug Administration announced Friday that three more menopause patches will no longer carry black-box warnings about cardiovascular disease, breast cancer, and dementia. The agency did not convene an advisory committee and offered few details on the scientific basis for the decision during a press briefing - though officials helpfully noted the evidence could be provided later, presumably in the same packet as the tooth fairy's contact information.

This follows the removal of black-box warnings from six menopause treatments in February, a decision that coincided with patients across the US struggling with shortages of the patches. "I have been concerned by the lack of transparency behind these decisions," said Reshma Ramachandran, an assistant professor and health services researcher at Yale School of Medicine. "The blanket removal of black-box warnings regarding risks of breast cancer and cardiovascular disease without clear justification can be misleading for patients and underplays real potential harms." Ramachandran also noted particular risks for certain groups, such as patients with histories of hormone-sensitive cancers - a detail that apparently didn't make the press briefing's highlight reel.

Instead, officials chose to highlight the shortage situation. "We are working with manufacturers to strengthen supply and improve access," said Dorothy Fink, deputy director of the National Institute of Child Health and Human Development, noting that manufacturing of estrogen patches has doubled over the past year. Even so, patients report stock-outs. "We know that for some patients, these past months have been frustrating," said Sarah Ibrahim, deputy center director for regulatory programs of the FDA's Center for Drug Evaluation and Research. After the February label change, demand for estradiol patches "increased significantly, and patients in many areas found it difficult to get their usual patches at their usual pharmacy," she said. "And I want you to know that we hear you." Hearing patients is, of course, a crucial first step - right after removing warnings without advisory input.

The black-box warnings "painted a broad and, in some cases, overstated pictures of risk," Ibrahim said. "Updated evidence shows that for many healthy women under 60 and within 10 years of menopause onset, the risk-benefit profile looks meaningfully different than older warnings conveyed." Estradiol patches are generally considered lower risk than synthetic oral medications because they bypass the liver, though research shows risks increase with high doses - a nuance that may or may not survive the next press briefing.

Officials in the Trump administration have made sweeping and "data-free" claims about the benefits of MHT, including improvements in longevity, which are not supported by research, menopause experts have said. While there are benefits for some women, the decision not to convene advisers or include research sets a troubling precedent, they added. The FDA bypassed its advisory committees last November when announcing it would remove the warnings; at the time, a spokesperson said committees are "bureaucratic, long, often conflicted, and very expensive." Instead, the FDA convened a panel in July 2025 featuring doctors and influencers, all vocal proponents of MHT - several with conflicts of interest with practices that market and sell hormone therapy, according to Ramachandran. "At the expert meeting, they also did not allow for public testimony," she said, including from the lead investigator of the Women's Health Initiative - research from which the MHT recommendations were formed - who was in the audience. After audience members voiced concern, the FDA opened a docket for public comment, presumably after the fact.

The FDA is also exploring the possibility of offering vaginal estrogen products over the counter, according to an agency press release on Friday - because nothing says "we've got this under control" like expanding access while declining to explain the science.