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Breaking News: FDA Removes Black Box Label From Hormones For Menopause Treatment

By Alisha Ghajar, ND11/10/2025
Breaking News: FDA Removes Black Box Label From Hormones For Menopause Treatment

Finally! This morning, the FDA announced the removal of the black box cancer warning from estrogen products for hormone replacement therapy. This ends 23 years of fear mongering and misinformation. 


Watch the full announcement here. 


Because, in fact, estrogen does not cause breast cancer. 


The Women's Health Initiative in 2002 found a slight increase in breast cancer INCIDENCE, not mortality. The results were not statistically significant, but the researchers made an announcement to the media before the study results were released to physicians or other researchers. The result was widespread fear and confusion, and decades of damage to women's health, quality of life, relationships, and life expectancy.


In fact, women in the WHI trial who took estrogen alone actually had a 24% REDUCTION in breast cancer. Where was that headline? In the end, the (statistically insignificant) increase in breast cancer was found in the group who took a synthetic progestin along with estrogen - a product most of us don't prescribe any longer, because we have safer alternatives. 


Breast cancer rates have not declined since taking millions of women off hormone therapy. In fact, they've increased slightly in recent years.


And it's not just about breast cancer. The #1 killer of women is cardiovascular disease. The #1 killer of breast cancer survivors is...cardiovascular disease. Guess what prevents cardiovascular disease? 


That's right. Estrogen. 


"Hormone replacement therapy has been found to reduce cardiovascular disease and mortality by as much as 50%, Alzheimer's disease by 30%, bone fractures by 50-60%, as well as reducing cognitive decline and all-cause mortality", essentially extending the lives of women by 10 years. 


We owe deep gratitude to the expert panel of physicians who went to the FDA and petitioned for the removal of the extraordinarily harmful black box warning. They followed the science, in service of women worldwide.


You can watch the expert panel here. 

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