The Regulatory Pivot — Removal of Boxed Warnings
The most significant shift in early 2026 is the removal of broad "Black Box" warnings from many systemic HRT products. For decades, these warnings, which stemmed from the 2002 Women’s Health Initiative (WHI) study, created a culture of hesitancy among both physicians and patients.
Evidence-Based Correction: Regulatory agencies now acknowledge that the original WHI data was based on a specific, older, and often asymptomatic demographic.
The Timing Hypothesis: New consensus emphasizes that the "window of opportunity"—initiating HRT within ten years of menopause or before age 60—is critical. In this window, the benefits for heart and bone health significantly outweigh the risks for most women.
Refining the Risks: Updated labeling now differentiates between the low risk of modern bioidentical micronized progesterone and the slightly higher risks historically associated with synthetic progestins.