FDA Makes Big Changes

On November 11, 2025, the FDA removed the message “estrogen causes cancer” from HRT prescriptions. We’re going to split the difference on some of the messaging yet let’s just for a moment be grateful that the tide is turning on supporting women through menopause and life beyond. Unwinding the 23-year negative messaging on Hormone Replacement Therapy (HRT) use will take some time…but a start has been made.

What is the Women's Health Initiative?

The Women’s Health Initiative (WHI) was a study started in 1995 to investigate the impacts of hormone replacement on women’s health. The study was halted suddenly in 2002 when early results analysis seemed to indicate that HRT significantly increased a woman’s risk for developing breast cancer and cardiovascular incidents. Despite the fact that even then, right at the time, a group of scientists actively involved in the study tried to say “hey, hang on, we’re wrong here, the results are NOT significant”, the message of harm was rolled out in a press statement. When the study was actually published a few days later, many researchers read the report and agreed that the data did NOT support the claim that HRT causes cancer.

It was too late – the rogue cat was out of the bag. The media had its frenzy and as quick as you can shout “not it” doctors stopped prescribing HRT and women chucked their prescriptions in the trash. Hormonal chaos and mayhem ensued. Most US doctors did not do what their European counter parts did and prescribe bioidentical hormones, they simply shrugged their shoulders and said, “HRT is risky, use it to get through menopause and then stop, and it’s not a good idea if you are ten years from menopause.” The data from this study has been reevaluated over and over in the intervening 20 plus years and, far from being the gold standard study on hormone replacement, the WHI has been shown repeatedly to have a flawed framework with analysts making incorrect interpretations of data.

NAMS Guideline Changes

In 2017 the North American Menopause Society incorporated some of the reevaluations of the data and stated that “Hormone therapy (HT) remains the most effective treatment for vasomotor symptoms (VMS) and the genitourinary syndrome of menopause (GSM) and has been shown to prevent bone loss and fracture”.

By 2022 the North American Menopause Society again updated its guidelines and clearly stated that vaginal use of bioidentical estriol has a strong safety protocol for women experiencing genitourinary symptoms of menopause – what we at Parlor Games call out as vaginal dryness, vaginal itching, painful sex, incontinence, increased urinary urgency, frequent UTI’s. By this time Parlor Games had been providing Silky Peach Cream with estriol for over 2 years knowing SOMETHING had to be done to help women.

And here we are November 2025 and finally, further studies and further reevaluation of that initial WHI as resulted in a wrong being righted. Hormones are recognized as critical for women’s health both during and after the menopausal transition. The actual quote is “With the exception of antibiotics and vaccines, there may be no medication in the modern world that can improve the health outcomes of older women on a population level more than hormone therapy.” Yes, you read that right - hormones are right up there at the top of the list of essential items for women’s health.

This is a Big Hurray Moment!

Women who have been using hormones for years have been saying they help, practitioners using bioidentical hormones with their patients for years have been saying they help, finally, the FDA is saying it – hormones are critical for women’s health. Woo hoo – biochemistry for the win!

What is even more important is the recognition that not only are hormones critical for breast health and cardiovascular health – it’s the shared understanding that hormones are critical for so many aspects of women’s health.

Here is a direct quote from the FDA paper: “Current evidence suggests that hormone therapy initiated within a decade of the onset of perimenopause has been associated with numerous long-term health benefits, including reduced vasomotor symptoms, without significantly affecting atherosclerotic cardiovascular disease among younger postmenopausal women aged 50 to 59 years. Hormone therapy has also been associated with a 25% to 50% reduction in fatal cardiovascular events (the leading cause of death in women), a 50% to 60% reduction in bone fractures, a 64% reduction in cognitive decline, and a 35% decreased risk of Alzheimer disease.”

You can read more in our blogs . YOU can celebrate because you now have additional validation that everything you have been reading and telling your doctor about was right all along! You can continue to feel confident using Parlor Games’ bioidentical hormone products in a way that works for you. Yeah you!

What Now?

Let’s be really clear with this message in particular and celebrate it, estrogen does not cause cancer. In fact, recent studies which have tracked women for many years have found out that statistically, those women who did develop breast cancer had better outcomes if they were taking estrogen compared to those who were not taking estrogen. Now, every woman’s health and hormone profile is different, and cancer development is complex and has multiple causes, to understand more about this – read our

While we are hooting, and cheering, and maybe saying, “I told you so”, we want to call out a couple of points from the recent announcement...

A Deep Dive into the FDA Changes

First – once again, all the messaging is still only referring to the pharmaceutical synthetic hormones with no reference made to bioidentical hormones. There is still no widespread large-scale study that looks at bioidentical hormone use in the long term – this is primarily because no entity is prepared to fund such research. There are, however, thousands of practitioners who have been using bioidentical hormones with their patients for decades and report that their patients are thriving.

Second – the message from the FDA still puts limitations on use of hormones stating that it is best to start use early and starting late has more risks than benefits. There are studies that give a very different opinion on this – see the list of references at the end of this article. Even if hormone replacement is started well after menopause, there will be benefits – the trick is to go slowly and allow the body to gradually adjust to having these important chemical messengers available again.

When we lose estrogen, progesterone, testosterone and DHEA through age related decline – including the menopausal transition, that’s when an increase in symptoms starts. Now you can feel doubly confident in using Parlor Games products:

Silky Peach Cream with estriol for vaginal dryness, painful sex, incontinence, vaginal itching,

Vibrant Third Progesterone Cream for tender breasts, forgetfulness, foggy thinking, mood swings, trouble sleeping, bloating.

ReBounce DHEA for ladies 55+ for fatigue, inflammation, aches and pains, cognitive changes, concentration and focus.

What Can I Do?

Share this important information. Many practitioners have fewer than 5 hours of training on menopause and many doctors who graduated since 2002 heard the message “don’t prescribe HRT”. It will take all of us to help this message spread out to friends, family, doctors, that hormones are critical and approved for use. Spread the word ladies, spread the word, share this article with your friends of all ages.

References

1. Gersh FL, O'Keefe JH, Lavie CJ. Postmenopausal hormone therapy for cardiovascular health: the evolving data. Heart. 2021 Jul;107(14):1115-1122. Epub 2021 Feb 22. PMID: 33619206.
2. Iorga, A., et al., “Rescue of pressure overload-induced heart failure by estrogen therapy,” Jour Amer Heart Assoc 2016; 5(1):e002482.
3. Shwaery GT, Vita JA, Keany JF. Antioxidant protection of LDL by physiologic concentrations of 17Beta Estradiol. Circulation 1997 Mar 18;95(6):1378 -85
4. L M Kaemmle, A Stadler, H Janka, M von Wolff, P Stute The impact of micronized progesterone on cardiovascular events - a systematic review. Climacteric 2022 Aug;25(4):327-336.
5. Whitney Wharton, Carey E. Gleason, et al. Potential role of estrogen in the pathobiology and prevention disease. Am J Transl Res. 2009; 1(2): 131–147
6. E.B. Engler-Chiurazzi, C.M. Brown, J.M. Povroznik, and J.W. Simpkinsa, Estrogens as neuroprotectants: Estrogenic actions in the context of cognitive aging and brain injury. Prog Neurobiol. 2017 Oct; 157: 188–211.
7. Berent-Spillson A, Briceno E, Pinsky A, Simmen A, Persad CC, Zubieta JK, Smith YR. Distinct cognitive effects of estrogen and progesterone in menopausal women. Psychoneuroendocrinology. 2015 Sep;59:25-36.
8. Fatemeh Abdia et al., The Effects of Transdermal Estrogen Delivery on Bone Mineral Density in Postmenopausal Women: A Meta-analysis. Iranian Journal of Pharmaceutical Research (2017), 16 (1): 380-38
9. Could transdermal estradiol + progesterone be a safer postmenopausal HRT? A review. https://pubmed.ncbi.nlm.nih.gov/18775609/