The US Food and Drug Administration (FDA) has announced they will remove the “black box warning” from hormone therapy (HRT) products used for menopause. This warning was the strongest kind the FDA can give, and for years it scared many women away from treatment that could actually help them feel better.

Let’s break down what this change means, in simple terms.

What Did the FDA Change?

1. The Big Scary Warning Is Gone

For a long time, hormone therapy came with a bold black box warning about heart disease, breast cancer, and dementia.

But this warning was based on uutdated and misunderstood research, including data that wasn’t statistically significant.

Now the FDA points out what many of us have been saying for a long time - current knowledge shows the risks are different (and much less) than was once thought. And, thus, the black box warning is being removed.

This is a huge step toward giving women clearer, more accurate information and more options when it comes to addressing symptoms of perimenopause and menopause.

2. One Warning Is Still There

The warning about endometrial cancer (cancer of the uterine lining) will stay—but only for whole body (systemic) estradiol-alone products.

This is not new. It simply reminds women who still have a uterus that systemic estradiol (i.e. the patch or pill) should be used with oral progesterone to stay safe.

Note that progesterone does NOT have to be used when using vaginal estrogens as directed.

3. New Age-Based Guidance

The labels will now explain that hormone therapy works best and is safest when women start it within 10 years of menopause or before age 60.

4. Doctors Encouraged to Talk With Patients

The labels will remind women to talk openly with their doctor about the risks and benefits.

This is important because hormone therapy is not one-size-fits-all. Your body and symptoms are unique.

Why Did the FDA Make This Change?

Science Has Changed

Over the last 20 years, researchers have learned a lot more about hormone therapy. New studies show that, when started at the right time, HRT can be safe and very helpful to manage the symptoms that come with menopause as well as supporting bone health.

Too Many Women Were Scared Away

The old black box warning frightened women and even some doctors.

This led to fewer women getting treatment that could ease hot flashes, improve sleep, protect bones, support the brain, and improve quality of life.

Women Deserve Balanced Information

The new labels will give women both the benefits and the risks—without fear-based language.

This helps every woman make choices that match her health, her symptoms, and her goals.

Your body deserves options.
Your symptoms deserve solutions.
And you deserve the freedom to make informed choices without fear.