Hormone replacement therapy is a key component of regenerative medicine. It is particularly useful in the management of menopausal changes. The Food and Drug Administration has published a new recommendation that will make it easier for providers to offer this treatment.

Hormone replacement medication containing estrogen and progesterone will no longer be required by the FDA to carry a black warning label. The label was first placed on these medications in 2003 due to concerns about an increased risk of breast cancer, stroke, and heart attack. This warning has presented difficulties to patients in obtaining the medications, as well as possibly deterring others from starting the treatment.

Why the Label Was Removed

FDA Commissioner Marty Makary and researchers cited those concerns in an editorial published to JAMA on November 10.  “Clinicians then only infrequently offered hormone therapy to perimenopausal and postmenopausal women because of the black box warnings,” the editorial explains. The black box warning remained on the medications despite that formulation no longer being in use. Recent studies have not shown the same correlations, according to the FDA announcement. 

Makary believes the harsh label created an “outsized fear that has prevented approximately 50 million women from the short- and long-term health benefits of this therapy.” Along with the change in label, the FDA is making a recommendation for women to begin the treatment within 10 years of the onset of menopause.

What Will Change

The new FDA indications for estrogen and progesterone-based hormone medications will include

• Removal of boxed warnings for cardiovascular disease, stroke, breast cancer, and probable dementia. Exception for the boxed warning in systemic estrogen labels for endometrial cancer with unopposed estrogen in women with a uterus, in those cases the recommendation will be to include progesterone.
• Removal of the recommendation to prescribe hormone therapy at the lowest effective dose for the shortest duration, this will now be left to the discretion of the provider.
• Change from including identical class-based language across all hormone therapy labels to safety data reflecting the risks most relevant to each specific type of hormone therapy product (eg, combined estrogen plus progestogen vs estrogen alone).
• For the topical hormone medication, the emphasis will be on the safety findings most relevant to topical use and not the broader warnings associated with systemic exposure.
• Labels will include updated guidance on initiating treatment in women younger than 60 years or within 10 years of menopause onset to optimize the benefit-risk balance.

The Impact on Medical Spas

These new recommendations coincide with the increasing interest in regenerative medicine as a service and discipline. This topic was explored in great depth at Medical Spa Show 2025 through the Biohacking Beauty educational track and additional presentations. As Dr. Kay Durairaj explains, it’s “taking your inner health and wellness, elevating it, and projecting it into outer beauty.” 

Regenerative treatments go beyond and below the skin to focus on the roots of the changes brought on by aging. Hormone replacement medication and biostimulators can have positive effects on skin health and sexual wellness. The updated FDA indications will make this treatment more accessible, particularly for women under 60. 

Learn More About Regenerative Medicine

The Science of Aging Skin

Why Biostimulators Are a Go-To Non-Surgical Treatment

Medical Spa Insider: Whole Body Beauty (ft Dr. Rahi Sarbahiza)