Episode 12: FDA Black Box Warning Removal — Progress or Performance?
The FDA removed the black box warning from estrogen—an announcement packaged as a major win for women’s health. But behind the headlines lies a different story. In this episode, Marie Hoäg breaks down what the FDA actually changed, what they left untouched, and why women must look deeper than the surface-level celebration.
Marie and Maggie examine the coordinated media tour by FDA Commissioner Dr. Marty Makary, the inaccuracies and contradictions in his messaging, and why the science has not changed—only the narrative has. This symbolic shift opens the door for more low-dose prescribing, more confusion, and another generation of women being underdosed, misled, and medically underserved.
Marie explains the real differences between low-dose HRT and therapeutic-dose restoration, what women can expect from each generation of hormone therapy, and how the system continues to profit from the symptoms of estrogen deficiency. This is a critical episode for every woman who refuses to settle for the status quo and wants clarity on what true hormone restoration really looks like.
What You’ll Learn
- Why the FDA removed the visual black box, but kept the warning
- The industry motives behind the timing of this announcement
- The contradictions in Dr. Makary’s messaging
- Why low-dose HRT protocols cannot restore physiology
- How four generations of HRT differ in their clinical outcomes
- Why “talk to your doctor” is dangerous advice when doctors aren’t trained
- How women can identify real hormone restoration vs. symptom management
- What women should do now if they want true hormone replacement
Listener Questions We Address
- “If estrogen doesn’t cause cancer, why did the FDA keep the warning at all?”
- “Why are doctors still pushing low-dose protocols?”
- “What’s the real difference between an FDA-approved patch and therapeutic-dose HRT?”
- “Should women still trust menopause guidelines if the data is incomplete?”
- “What should women look for in a doctor who knows how to dose estrogen correctly?”
If today’s episode made you question whether you need HRT—or whether your current therapy is truly serving you—trust that instinct. Your brain, your body, your family, and your long-term mental and physical health depend on you getting this right.
To discover hormonal balance as you are supposed to experience it, book a complimentary discovery session at: advancedhormonebalancing.com
Disclaimer
The views expressed on the MeNoPause Moxie Podcast are based on over two decades of clinical observation, research, education, training, and personal experience by Marie Hoäg, MBA. It is presented for educational, informational, and entertainment purposes, and is not intended as medical, nutritional, or hormone replacement therapy (HRT) advice. Viewers and listeners are strongly encouraged to consult with a trained HRT professional before making any hormone-balancing decisions.