The FDA Just Corrected Course. Now It’s Time to Correct the Language
On November 10, 2025, the U.S. Food and Drug Administration announced it will remove the boxed (“black box”) warnings from most estrogen- and progestogen-containing therapies used for women in mid-life. The FDA will update these labels. This step is the beginning of the end of an era of “one-size-fits-all government groupthink.”
This decision marks a rare and overdue act of scientific self-correction. It acknowledges what endocrinologists have long known: when clinicians prescribe 17-beta estradiol in the proper form, dose, and timing, it supports women’s health rather than endangering it.
Beyond the M-Word (Menopause): Toward Mid-Life Primary Ovarian Insufficiency (ML-POI)
In my 2023 article, I argued that the biologic process we casually call “menopause” is not a binary event but a continuum of ovarian endocrine change. It is now best described in endocrine terms as Mid-Life Primary Ovarian Insufficiency (ML-POI).
Using the scientific term ML-POI brings the focus back to biology rather than bikini-style medical terminology. It links the physiologic waning of ovarian function in mid-life to the exact endocrine mechanisms that underlie the disorder of adolescent girls and young women known as Primary Ovarian Insufficiency – a deficiency of 17-beta Estradiol. Both exist on a continuum – one a pathologic diagnosis, one an orchestrated physiologic process.
When we shift our language, we sharpen our understanding. “Menopause” suggests finality; ML-POI recognizes a gradual process that affects bone health, brain function, cardiovascular health, mood, and overall vitality. The term invites scientific clarity and clinical compassion — two things the black box era obscured.
Why the FDA’s Move Matters
The FDA’s reversal of its early-2000s warnings corrects a categorical mistake rooted in the Women’s Health Initiative (WHI) study. Those warnings failed to distinguish between oral pharmacologic estrogen given years after ovarian shutdown and physiologic-dose, i.e., non-oral 17-beta estradiol begun earlier.
That conflation caused harm. Women and clinicians became fearful. Hormone therapy use plummeted. Bone fractures increased, cardiovascular protection was lost, and many turned to unregulated “bioidentical” products outside FDA oversight.
By removing the boxed warning, the FDA is acknowledging what the data now affirm: that risk depends on context – age, time since last menses, formulation, and route. This concept shifts the thinking and dialogue from fear to physiology.
Translating Policy into Practice
- Use physiologic routes. Transdermal and transvaginal estradiol avoids hepatic first-pass effects and carries a lower risk.
- Start earlier when appropriate. Evidence supports initiating therapy near the onset of ML-POI, before irreversible cardiovascular and skeletal changes occur.
- Provide physiological doses. The lowest effective replacement dose mimics normal ovarian output – not pharmacologic excess.
- Individualize always. Personal and family histories still guide decisions; caution and precision are not opposites.
Adolescent girls and young women present a special situation that requires utmost care. This is the endocrinologic disorder known as Primary Ovarian Insufficiency. For them, physiologic replacement matching the average daily ovarian production rate of 17-beta Estradiol, along with a cyclic progestogen, remains the standard for restoring and maintaining bone and systemic health. For women in ML-POI, the same endocrinologic logic applies, but now FDA policy no longer stands in the way.
The Deeper Correction
Science advances when it corrects itself. The FDA’s step is more than regulatory housekeeping – it is a moral acknowledgment that fear-based labeling misled a generation.
The much-needed subsequent correction must be ours: to retire outdated, culturally loaded, bikini-style medical terminology and replace it with accurate, biological endocrine language. Many women would prefer to retire the M word with its biased association with ageism and sexism. Mid-Life Primary Ovarian Insufficiency (ML-POI) captures the truth of mid-life physiology. It reframes care away from inherited hysterical myths and toward women’s actual biology.
When we speak truthfully, we restore integrity in science, in language, and in policy. And we serve women more effectively.
*Nelson, L. M. (2023). The Truth About 17-Beta Estradiol: Menopause Beyond “Old Wives’ Tales.” Frontiers in Endocrinology.
Read the full FDA Release:
We share this to educate and advocate, not to give medical advice. Always talk with your clinician about your individual situation.
Service. Truth. Heritage.
Empathy Thinking® is a registered trademark of the Mary Elizabeth Conover Foundation. All rights reserved.
