This status update of the U.S. Food and Drug Administration’s (FDA) actions toward eliminating compounded bioidentical hormone replacement therapy (cBHRT) continues the alerts we started reporting three years ago. It is interesting to observe the broad range of groups and individuals who are protesting the FDA’s apparent anti-cBHRT goals.

Click here to refresh your memory of our 11/22/19 alert and our 8/14/20 alert and learn why some individuals are concerned about possibly losing the only HRT product that their system can tolerate.

Links below include one to the full NASEM report that has triggered the controversy.

Issue: Which research on the safety and efficacy of compounded bioidentical hormone replacement therapy (cBHRT) do you view as the most truthful?

AHHA strives to maintain a neutral position on issues and views knowledge as power. For those interested in this month’s issue, the articles below were selected to expand your understanding of what has been unfolding and what are the various factions trying to influence the FDA’s final decision.

What are we talking about?
First educate yourself about what bioidentical hormones are and their various versions.
Why You Need Bioidentical Hormones (updated 11/3/20)
Christiane Northrup, MD

FDA 2018 announcement of two studies assigned to National Academies of Science, Engineering & Medicine
(1) To examine the clinical utility of treating patients with compounded bioidentical hormone replacement therapy (BHRT) products.
(2) To examine available evidence of the safety and effectiveness of multi-ingredient compounded topical pain creams
FDA announces new and expanded compounding research projects (9/26/18)
U.S. Food and Drug Administration 

FDA 2020 announcement of NASEM study results stating that there was a lack of rigorous evidence of safety and effectiveness from well-designed or properly controlled clinical studies.
National Academies of Science, Engineering, and Medicine (NASEM) Study on the Clinical Utility of Treating Patients with Compounded “Bioidentical” Hormone Therapy (7/1/20)
U.S. Food and Drug Administration

Actual NASEM report
Clinical Utility of Treating Patients with Compounded “Bioidentical Hormone Replacement Therapy” (2020)
The National Academies of Sciences Engineering and Medicine

Rebuttal comments about NASEM report by coalition of traditional compounding pharmacies
Supplement to August 17, 2020 Comment to FDA Regarding the National Academies of Sciences, Engineering, and Medicine Report on the Clinical Utility of Treating Patients with Compounded “Bioidentical Hormone Replacement Therapy”  (3/4/21)
Reed Smith LLP

Advocacy groups point out bias with FDA using NASEM
Bias in Government Group Ruling Against Women’s Health (10/7/21)
Alliance for Natural Health USA

Healthcare professionals registered concerns about NASEM recommendations and offered opposing research results
If We Lose Compounded Bioidentical Hormone Replacement Therapy (May 2021)
Townsend Letter

You are encouraged to post your comments.

To review past ISSUES, visit the Special Updates Archives.