FDA’s Latest Move Might Not Be All It’s Chalked Up To Be

Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. is highlighting the benefits of hormone-replacement therapy (HRT) for menopausal women.

“The [Food and Drug Administration (FDA)] is initiating the removal of broad black box warnings from hormone replacement therapy products for menopause,” he said Monday.

Hormone replacement treatments are sold in pill, patch, injection, spray and cream form, to name a few. All come with a black box label — the FDA’s highest safety-related warning. 

“Women may be under-utilizing approved therapies that can alleviate menopause symptoms and improve women’s health” because of these warning labels, HHS warned in a press statement released Monday. 

For more than two decades, the American medical establishment turned its back on women. Millions of women were told to fear the very therapy that could have given them strength, peace, and dignity through one of life’s most difficult transitions—menopause.

That ends today.

The… pic.twitter.com/PNlFaeCfRJ

— Secretary Kennedy (@SecKennedy) November 10, 2025

Menopause refers to a stage in female life history when she no longer gets periods and can no longer get pregnant. The average age of menopause in the United States is 52, according to the National Institute on Aging (NIA). 

What provokes menopause?

As a woman ages, her number of functioning ovarian follicles decreases. Ovarian follicles are small, fluid-filled sacs inside the woman’s ovaries which secrete hormones (like estrogen and progesterone) and contain immature eggs. (RELATED: Republican Senators Demand Answers From FDA Commissioner On New Abortion Drug Approval)

A rough analogy for female menopause: A man’s testicles suddenly shriveling up at age 50. 

A fertile woman produces fluctuating waves of estrogen and progesterone. These hormones are responsible for a variety of bodily functions, including a woman’s ability to get pregnant. Estrogen and progesterone production decline may explain the onset of menopausal symptoms, which include, according to the NIA: weight gain, change in body fat distribution, hot flashes, night sweats, incontinence, sleeping problems, and mood swings.

Hence the earned stereotype of the volatile menopausal woman. If hormone replacement therapy can bring women (and their families) relief, we should sing its praises from the rooftops.

Kennedy appears to be doing just that. 

Today marks a milestone in women’s health, with the FDA’s actions to initiate removal of HRT black box warnings, approval of the first generic Premarin in more than 30 years, and approval of a new non-hormone menopause treatment. More options, better access, informed decisions.… pic.twitter.com/iEsiK0Oodk

— U.S. FDA (@US_FDA) November 10, 2025

“Today, we are standing up for every woman who has symptoms of menopause and is looking to know her options and receive potentially life-changing treatment,” said Kennedy, according to an HHS press release. “For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of [hormone replacement therapy]. We are returning to evidence-based medicine and giving women control over their health again.”

Kennedy refers to a 2002 study conducted by the Women’s Health Initiation, which “found a statistically non-significant increase in the risk of breast cancer diagnosis,” according to the HHS. The average age of the studied women was 63, about ten years post-menopause on average. 

The 2002 study examined women who were taking estrogen and progestin, a synthetic chemical which mimics progesterone.

The particular progestin examined in the study was medroxyprogesterone acetate. This hormone is sold under the brand name Depo-Provera, Pfizer’s birth control shot. Pfizer is facing a litany of lawsuits from Depo-Provera users who claim the company failed to warn them that the shot causes brain tumors. (RELATED: Pfizer CEO Complains He Has Billions Of Vaccine Doses Sitting Around Because Nobody Wants Them)

FDA Commissioner Marty Makary claims in a September 2024 podcast appearance that, though the “data never supported” the conclusion that hormone replacement therapy increases breast cancer rates, “80 to 90% of people, including doctors” still believe it does.

Makary says he spoke with the researcher behind the study.

“He was on a mission. And when the data didn’t support what he wanted to see in the data, he just said it anyway.”

There are two primary forms of menopause hormone therapy, according to Mayo Clinic. 

1. Whole-body hormone therapy: “Systemic estrogen comes as a pill, skin patch, ring, gel, cream or spray. It typically has more estrogen than other hormone therapies.”
2. Low-dose vaginal estrogen, which “comes as a cream, tablet or ring. It usually has less estrogen than systemic therapy, reducing the amount of estrogen absorbed by the body.” 

Cleveland Clinic clarifies that hormone replacement therapy may refer to estrogen therapy and combination therapy (estrogen and progesterone). 

Here’s where I’d push back on Kennedy and Makary’s apparent enthusiasm for all hormone replacement therapies. Hormone therapies that merely supplement estrogen may not be the wonder drug they’re made out to be. (RELATED: FDA Stayed Silent As Internal Reports About Potential Tylenol Risks Piled Up)

A 2024 study measured sex steroid levels in postmenopausal women, looking at their bodily tissues. Researchers compared hormone levels in women using oral hormone therapy versus women not using hormone therapy treatment. 

Hormone therapy users had “markedly higher levels” of estrogens (estrone and estradiol). But concentrations of progesterone were “comparable between users and nonusers” of hormone replacement therapy. 

Estrogen dominance is associated with various cancers, including breast cancer, according to Cleveland Clinic. Symptoms of estrogen dominance include, according to American Medical Centers: irregular and unpredictable periods, bloating, increased premenstrual symptoms, decreased sex drive, insomnia, and mood swings.  That symptomatology has considerable overlap with menopause symptomatology. 

Estrogen is often labelled the “female hormone.” Progesterone deserves some credit, too. 

Follow Natalie Sandoval on X: @NatSandovalDC