Robert F Kennedy Jr and then-FDA commissioner Marty Makary announced in November that hormone therapy’s black box warning would be removed, while overstating evidence that it could prevent Alzheimer’s, slow cognitive decline and add 10 years of life.
Those claims clash with current evidence: menopause hormone therapy is mainly used to relieve hot flashes, night sweats, sleep disruption and some vaginal or bladder symptoms, not to prevent dementia, heart disease or aging.
For most women who start treatment within 10 years of their last period or before age 60, risks are considered low, with transdermal or local estrogen often seen as safer than pills because they may reduce clot-related byproducts.
The mixed messaging is landing in a fast-growing $10 billion-$15 billion menopause market, where influencers and some clinicians promote unsupported benefits even as many symptomatic women still struggle to get appropriate care.
With MHT warnings gone, are we overcorrecting for decades of fear by branding hormones as a cure-all for aging?
Is the booming menopause market a health revolution or a new form of exploitation targeting women's aging anxieties?
Historic FDA Decision in 2025: Black Box Warning Dropped from Menopausal Hormone Treatments
Overview
In November 2025, the FDA made a historic decision to remove the black box warnings from hormone treatments for menopause symptoms, acknowledging that these warnings had discouraged many women from using helpful medications. This shift was driven by new scientific evidence, especially about vaginal estrogen, which is absorbed in only minimal amounts and does not carry the same serious risks as systemic hormone therapy. FDA panelists supported revising the warnings, and the agency’s re-evaluation of risks and benefits aims to help more women manage menopausal symptoms with confidence and better information.