Please remember that the American Holistic Health Association (AHHA) supports you in your efforts to be well educated about what you can do in your daily life to enhance the quality of your health. Should symptoms of an illness arise, we encourage you to be well-informed about all of your treatment options, both pharmaceutical and natural. We want you to research healthcare options until you feel well-prepared to confidently and effectively make your health decisions. We also alert you when we hear rumblings that there might be a threat to your access to any of your desired treatment options.

This month we are updating past alerts to the potential loss of access to compounded bioidentical hormone therapies.

Issue: How serious is the threat to continued access to compounded bioidentical hormone therapies?

AHHA strives to maintain a neutral position on issues and viewsknowledge as power. For those interested in this month’s issue and wanting to learn more about this topic, the articles cited below were selected to offer you some resources to begin your research to better understand what might impact you and your loved ones.

The AHHA Issue in our 5/10/19 Special Updates Report was Proposed regulation changes for custom meds. We reported that the FDA can classify a substance as Demonstrably Difficult to Compoundand then forbid your pharmacist from compounding your formulation with that substance.”

The AHHA Issue in our 11/22/19 Special Updates Report was Possible threat to compounded bioidentical hormones? We reported thatbioidentical hormones had been nominated to be added to the Food and Drug Administration’s Demonstrably Difficult to Compound List. And that the fate of compounded bioidentical hormones appeared to have been turned over by the FDA to the Clinical Utility of Treating Patients with Compounded “Bioidentical Hormone Replacement Therapy”study committee of the National Academies of Science, Engineering, and Medicine (NASEM).

This month we report that the NASEM special committee report was published July 1, 2020. The recommendations could severely restrict access to compounded bioidentical hormone therapies.

Because the FDA position has been consistently against natural forms of hormone therapy products, the negative NASEM report on cBHT was not a surprise. Here is what is currently on the FDA website…
Menopause: Medicines to Help You (updated 8/22/19)
U.S. Food & Drug Administration
[We did not find any mention of natural or bioidentical hormone therapy options.]
links to
Menopause & Hormones: Common Questions
U.S. Food & Drug Administration
[“Are herbs and other ‘natural’ products useful in treating symptoms of menopause?
At this time, FDA does not know if herbs or other “natural” products are helpful or safe.”
“Are compounded ‘bioidentical hormones’ safer or more effective than FDA-approved hormone therapy for menopause?
Many marketed products that are called ‘bioidentical hormones’ are compounded drugs, which are not FDA-approved. FDA does not have evidence that compounded ‘bioidentical hormones’ are safe and effective, or safer or more effective than FDA-approved hormone therapy.”]

There is a specific Office of Women’s Health (OWH) within the FDA…
Office of Women’s Health (updated 12/2/19)
U.S. Food & Drug Administration
links to
For Women: Office of Women’s Health (updated 8/3/20)
U.S. Food & Drug Administration
[Mission and Goals: OWH serves as the principal advisor to the Commissioner and other key Agency officials to protect and promote the health of women through policy, science, education, and outreach.]
links to
Office of Women’s Health Strategic Priorities; Establishment of a Public Docket; Request for Comments (7/10/20)
Federal Register
[This Request for Comments is seeking suggestions and information during development of OWH’s scientific, educational, and outreach priorities. Deadline 9/8/20.]

The FDA Request for Comments mentioned above is related to…
Clinical Utility of Treating Patients with Compounded “Bioidentical Hormone Replacement Therapy”
Consensus Study Report: Publication (7/1/20)
National Academies of Sciences, Engineering, and Medicine

Because accessing the full July 1 NASEM report is difficult, here are some sources for key points…
Prescribers Should Restrict the Use of Non-FDA-Approved Compounded Bioidentical Hormones, Except for Specific Medical Circumstances (7/1/20)
National Academies of Sciences, Engineering, and Medicine
[“Bioidentical” hormone therapies (BHTs) contain hormones that are chemically and structurally identical to those produced by the human body. They are available as FDA-approved products or non-FDA-approved compounded preparations. Unlike FDA-approved BHT products, compounded preparations have not been subjected to regulatory oversight or rigorous safety, efficacy, and quality control testing. Further, because cBHTs are custom-blended in different doses and forms — such as pills, creams, or pellets — the lack of standardization can increase the possibility of overdosing, underdosing, or contamination, says The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use.”
“The report recommends that the FDA’s Pharmacy Compounding Advisory Committee review 10 BHTs as candidates for the agency’s Difficult to Compound list, which prohibits pharmacies from compounding certain products that are complex in terms of formulation, delivery mechanism, and bioavailability (the extent to which the drug is absorbed by the body and has an active effect). These 10 candidates are: estradiol, estrone, estradiol cypionate, estriol, dehydroepiandrosterone, pregnenolone, progesterone, testosterone, testosterone cypionate, and testosterone propionate.”]

July 2020 – The Clinical Utility of Compounded Bioidentical Hormone therapy (cBHT): A Review of Safety, Effectiveness, and Use: Recommendations
PCCA – Professional Compounding Centers of America
[“Recommendation 1: Restrict the use of cBHT preparations. Recommendation 2: Review select bioidentical hormone therapies and dosage forms as candidates for the FDA Difficult to Compound List. Recommendation 3: Improve education for prescribers and pharmacists who market, prescribe, compound, and dispense cBHT preparations. Recommendation 4: Additional federal and state-level oversight is needed to better address public health and clinical concerns regarding the safety and effectiveness of cBHT.”]

There are groups that identify serious omissions in the research referenced in NASEM report. They also disagree strongly with many of the report’s recommendations…
NASEM, FDA, and the cBHT study (7/2/20)
Alliance for Pharmacy Compounding

NASEM Report on the Clinical Utility of Compounded Bioidentical Hormones (7/1/20)
Womens Hormone Network

FDA Turns Its Back on Women (7/23/20)
Alliance for Natural Health USA

For those who wish to share a comment with the FDA…
The FDA has set up a site where individuals and organizations can submit comments online related to Office of Women’s Health Strategic Priorities. Deadline September 9, 2020.
Request for Comments

Note that these priorities are directly related to how the FDA will handle compounded bioidentical hormone therapies in the future.

If you currently using or anticipate using any of these hormones–estradiol, estrone, estradiol cypionate, estriol, dehydroepiandrosterone, pregnenolone, progesterone, testosterone, testosterone cypionate, and testosterone propionate–you may want to consult with your physician and local pharmacist to explore other potential options in case you may need them in the future. Unfortunately, as you do your own research on natural/ bioidentical vs. synthetic/ chemical hormone products, you may find that information documenting the safety of compounded bioidentical hormone therapies (cBHT) that formerly was easily available is currently more challenging to locate online.

To review past ISSUES, visit the Special Updates Archives.