FDA Removes "Black Box" Warning on Menopause Hormone Therapy: A Victory for 50 Million Women

FDA Removes "Black Box" Warning on Menopause Hormone Therapy: A Victory for 50 Million Women

In a landmark decision that advocates are calling a turning point for women's health, the U.S. Food and Drug Administration announced Monday it will remove the controversial "black box" warning from hormone therapy for menopause—ending more than two decades of fear and misinformation that kept an estimated 50 million American women from accessing life-changing treatment.

The announcement comes as Desert Harvest CEO Heather Florio attended the Advancing Women's Health speech by Health and Human Services Secretary Robert F. Kennedy Jr., where the importance of innovative women's health solutions took center stage.

"This is a watershed moment," said Florio, whose company has pioneered natural approaches to women's health for over 30 years. "For too long, women have been told to simply 'deal with' debilitating symptoms because of outdated warnings based on flawed interpretation of research. Today's FDA action acknowledges what we've known all along—women deserve access to safe, effective options backed by current science."

The 22-Year Tragedy: How a Warning Label Changed Everything

Since 2003, hormone therapy prescriptions for menopause plummeted by more than 70% after the FDA added its strongest warning label—the black box—to estrogen-containing treatments. The warning described increased risks of cardiovascular disease, stroke, breast cancer, and dementia.

The catalyst was the 2002 Women's Health Initiative study, which found higher health risks in women taking estrogen pills after menopause. However, the study's participants averaged 63 years old—many years past menopause when they started therapy, a timing now understood to be critical.

The devastating impact:

  • Prescriptions dropped from 1 in 4 postmenopausal women using HRT in the late 1990s to just 1 in 25 by 2020
  • Millions of women suffered through debilitating hot flashes, night sweats, brain fog, and bone loss unnecessarily
  • Doctors became afraid to prescribe effective treatment
  • Women's quality of life declined dramatically during what should be vibrant midlife years

FDA Commissioner Dr. Marty Makary called it "one of the greatest screw-ups of modern medicine" in his Wall Street Journal opinion piece, stating the warning "inappropriately scared women off from this life-changing, and sometimes life-saving, treatment."

What Changed: The Science Caught Up

More recent analyses of the Women's Health Initiative—emerging as early as 2010—revealed a crucial detail: timing matters. Hormone therapy started in women younger than 60, or within 10 years of menopause onset, can safely help manage symptoms without the elevated risks seen in older women.

Dr. JoAnn Pinkerton, professor of obstetrics and gynecology at the University of Virginia School of Medicine, told the FDA advisory panel in July: "I am begging the FDA, and all of us are begging, please remove the box label. And please stop harming women."

According to the CNN Health report, the FDA's action follows a wave of state-level legislation, with 19 states introducing more than 35 bills to improve menopause care, awareness, and treatment access.

What This Means for Women Today

The removal of the black box warning doesn't mean hormone therapy is risk-free or appropriate for everyone. As the FDA clarified:

Ideal candidates for HRT:

  • Women younger than age 60
  • Within 10 years of menopause onset
  • Experiencing moderate to severe symptoms
  • Without contraindications (history of breast cancer, blood clots, stroke)

What hormone therapy can address:

  • Hot flashes and night sweats
  • Sleep disruption
  • Mood changes and irritability
  • Vaginal dryness and urinary symptoms
  • Bone density loss
  • Brain fog and cognitive changes

"The fact of the matter is—estrogen is one of the primary drivers of the heart," explained Dr. Jayne Morgan, an Atlanta-based cardiologist quoted in the CNN report. "There are estrogen receptors on the heart, on the brain, in the bones, so it's like the fuel that drives our body."

Beyond HRT: The Innovation Imperative

While today's FDA action opens doors for millions of women, it also highlights a broader need: women deserve multiple evidence-based options for managing menopause symptoms and hormonal transitions.

"Not every woman is a candidate for hormone therapy, and not every woman wants it," notes Florio. "That's why innovation in natural, science-backed alternatives is so critical."

Desert Harvest has been at the forefront of this innovation, recently launching the first menopause supplement featuring human-identical lactoferrin—a breakthrough protein that works differently than traditional hormone replacement.

How Human-Identical Lactoferrin Complements Women's Options

Unlike hormone therapy, which directly replaces declining estrogen, human-identical lactoferrin works by supporting the body's natural systems affected by hormonal changes:

Iron regulation and energy: Research shows lactoferrin supports healthy iron absorption and utilization—addressing the fatigue many women experience as estrogen levels shift and affect iron metabolism.

Immune system modulation: As estrogen declines, inflammatory markers often increase. Lactoferrin's immunomodulatory properties, documented in over 80 years of research, help support balanced immune response during hormonal transitions.

Microbiome support: Declining estrogen disrupts both gut and vaginal microbiomes. Lactoferrin promotes beneficial Lactobacillus bacteria, supporting digestive health and urinary tract comfort—common concerns during menopause.

Bone metabolism: Preliminary research suggests lactoferrin may stimulate bone-building cells while inhibiting bone-breakdown cells, potentially supporting skeletal health as estrogen's protective effects decline.

The human-identical advantage: Desert Harvest's formula features effera™, the first human-identical lactoferrin approved for supplements. Created through precision fermentation, it matches the body's natural protein structure exactly—offering superior tolerance and bioavailability compared to bovine (cow-derived) lactoferrin.

"We're not trying to replace hormone therapy," Florio emphasizes. "For many women, HRT is appropriate and effective. But for women who can't or don't want to use hormones, or who want complementary support, human-identical lactoferrin offers a scientifically-backed alternative that addresses multiple systems simultaneously."

 

A Movement Gaining Momentum

Today's FDA action represents more than a label change—it's validation of a growing movement demanding better for women's health.

"When we think about the timing of this announcement, it's not just the FDA making a move," said Jennifer Weiss-Wolf, executive director of the Birnbaum Women's Leadership Center at NYU School of Law, in the CNN report. "It comes in the good company of now 19 states, red and blue alike, introducing more than 35 bills to improve menopause care."

Desert Harvest has been part of this advocacy for over three decades, since founder Tobi Lynn first developed Super Strength Aloe Vera to help a family member suffering with interstitial cystitis in 1993. That same commitment to addressing underserved women's health conditions continues today.

"We've seen firsthand how being dismissed or told to 'just deal with it' affects women's lives," said Florio, who attended the recent Advancing Women's Health address by Secretary Kennedy. "Whether it's bladder pain syndrome, menopause symptoms, or chronic conditions that predominantly affect women—the message is clear: women's health can no longer remain in the shadows."

What Women Should Do Now

If you've been avoiding hormone therapy due to the black box warning, or if you've been suffering through menopause symptoms unnecessarily, now is the time to reassess your options.

Steps to take:

  1. Schedule a consultation with your healthcare provider to discuss whether HRT might be appropriate for your situation, age, and health history.

  2. Ask about timing – The "window of opportunity" for safely starting HRT is within 10 years of menopause onset or before age 60.

  3. Explore comprehensive approaches – Whether or not you choose HRT, consider evidence-based supplements that support multiple systems affected by hormonal changes.

  4. Stay informed – The science of menopause care continues evolving. What you were told five or ten years ago may no longer reflect current understanding.

  5. Advocate for yourself – You don't have to accept suffering as an inevitable part of aging. Multiple effective options exist.

 

The Road Ahead: Better Care Through Innovation

While today's FDA announcement corrects a 22-year injustice, it also illuminates how much work remains. According to the CNN report, women "live about six years longer than men, but we spend about 25% of our lives in lower quality of life."

That's unacceptable—and it's why companies like Desert Harvest continue investing in research and innovation.

"Our goal has always been providing women with choices backed by rigorous science," says Florio. "Today's FDA action expands those choices for millions of women. We're proud to be part of a broader movement saying women's health matters, women's comfort matters, and women deserve better."

About Desert Harvest

Founded in 1993, Desert Harvest is a second-generation family-owned company dedicated to addressing underserved conditions in women's health. Based in Asheville, North Carolina, Desert Harvest pioneered the use of Super Strength Aloe Vera for bladder health and recently launched the first menopause supplement featuring human-identical lactoferrin.

Desert Harvest products are used by women in over 50 countries and have been the subject of multiple clinical studies. The company is the only aloe vera supplement mentioned by name in international IC/BPS treatment guidelines (IPBF 2024).

Media Contact: Amy Coffey - Amy@desertharvest.com 

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