Estradiol and progesterone are available as FDA-approved products that are chemically identical to the body's hormones. Biest is a compounded cream that mixes estriol with estradiol; it is not FDA-approved, and expert bodies advise using it only when an approved product will not work.
Estradiol and progesterone are both available as FDA-approved prescription products that contain hormones chemically identical to the ones your body makes. Biest is different: it is a compounded preparation (offered through NewDay Wellness as a cream) that combines estriol with estradiol, and it is not FDA-approved. The National Academies, The Menopause Society and the American College of Obstetricians and Gynecologists all recommend approved hormone products first, and reserve compounded hormones for specific situations, such as an allergy to an ingredient in an approved product or a need for a dosage form that is not available.
The term causes a lot of confusion. The Menopause Society's 2022 hormone therapy position statement explains that both government-approved and compounded bioidentical hormones exist. FDA-approved bioidentical hormones include estradiol, estrone and micronized progesterone, which are regulated and monitored for purity and efficacy and come with package inserts based on clinical trials. The FDA makes the same point on its menopause page: it has approved drugs containing hormones identical to those women make naturally in their reproductive years, and it has no evidence that compounded "bioidentical hormones" are safer or more effective than FDA-approved hormone therapy.
So the real question is not whether a hormone is bioidentical. It is whether the specific product has been tested and approved.
| Estradiol (approved forms) | Progesterone (approved oral capsules) | Biest cream | |
|---|---|---|---|
| What it contains | Estradiol | Micronized progesterone | Estriol plus estradiol, mixed by a pharmacy |
| FDA-approved | Yes, for labeled uses | Yes, for labeled uses | No, compounded |
| Standardized label with risks | Yes | Yes | No FDA-approved label |
| Main role in menopause care | Treats hot flashes, night sweats and vaginal symptoms; some forms approved to prevent bone loss | Protects the uterine lining in women with a uterus who use estrogen | Marketed for menopause symptoms; clinical utility not established |
The label for an FDA-approved estradiol patch lists four uses: moderate to severe hot flashes and night sweats due to menopause, moderate to severe vaginal and vulvar symptoms due to menopause, low estrogen due to certain ovarian conditions, and prevention of postmenopausal osteoporosis. For vaginal symptoms alone, the label advises first considering topical vaginal products. For bone protection alone, it advises first considering non-estrogen medicines.
Route can matter. ACOG's 2023 clinical consensus notes that FDA-approved patches provide more consistent delivery and a relatively steady estradiol level, and may carry a lower risk of blood clots than oral hormones. Your prescriber chooses the form and dose.
Estrogen alone can thicken the lining of the uterus. The label for Prometrium, an FDA-approved micronized progesterone capsule, is indicated to prevent endometrial hyperplasia (overgrowth of the uterine lining) in postmenopausal women with a uterus who are taking conjugated estrogens, and for certain missed periods. In a three-year randomized trial of 358 postmenopausal women described in the label, hyperplasia occurred in 6 percent of women taking progesterone with estrogen, compared with 64 percent of women taking estrogen alone.
Two practical label details are worth knowing. The capsules contain peanut oil and should not be used by people allergic to peanuts, and the label notes that some women become very drowsy or dizzy after taking them.
A 2012 committee opinion from ACOG and the American Society for Reproductive Medicine explains that "Biest" commonly refers to a preparation of 20 percent estradiol and 80 percent estriol by weight, and that these ratios are based on milligram amounts rather than on each hormone's estrogenic strength. Ratios vary between pharmacies; the Biest cream available through NewDay Wellness is a 50:50 formulation, offered with or without progesterone. Like all compounded hormone preparations, it is not FDA-approved.
Estriol is the key difference. The FDA states that there are no FDA-approved drugs containing estriol, that marketed drugs containing estriol are compounded, and that it does not have evidence that estriol is a "safer form of estrogen."
Expert reviews raise several concerns about compounded hormones in general:
The National Academies recommends restricting compounded bioidentical hormones to two circumstances: a documented allergy to an ingredient in an FDA-approved product, or a documented need for a dosage form that approved products do not offer. The committee chair added that providers have an obligation to educate patients about the potential risks and to present a clear rationale if they prescribe them. The Menopause Society states that patient preference alone should not be used to justify compounded bioidentical hormones, and ACOG advises that compounded menopausal hormone therapy should not be prescribed routinely when FDA-approved formulations exist.
If a compounded product is suggested, it is reasonable to ask why an approved product will not work for you.
In February 2026 the FDA announced that it had approved labeling changes for six menopausal hormone therapy products, removing risk statements about cardiovascular disease, breast cancer and probable dementia from the boxed warning. Those updated labels belong to FDA-approved products. Compounded preparations such as Biest do not carry an FDA-approved label at all, so the updated benefit and risk language does not travel with them. For the broader background on symptoms and timing, see understanding perimenopause and menopause hormone therapy options.
Yes. Estradiol is chemically identical to the estrogen the ovaries make, and The Menopause Society lists estradiol and micronized progesterone among FDA-approved bioidentical hormones. Being approved means the product has been tested and comes with a standardized label.
If you have a uterus and use systemic estrogen, a progestogen is generally used to protect the uterine lining, as the Prometrium label trial illustrates. Whether and how you use it is a decision your prescriber makes based on your history.
There is no evidence that it is. The FDA says it has no evidence that compounded bioidentical hormones or estriol are safer or more effective than approved therapy, and the National Academies found insufficient evidence for their clinical utility. Biest cream is compounded and not FDA-approved.
The Menopause Society states that salivary and urine hormone testing to determine dosing is unreliable and not recommended, and that serum hormone testing is rarely needed. Ask your prescriber how they will judge whether treatment is working.
A licensed provider can review your symptoms, uterine status, medical history and preferences, explain the approved estradiol and progesterone options, and tell you clearly if and why a compounded product like Biest is being considered. If you have sudden chest pain, trouble breathing, or signs of a stroke, call 911. This article is educational and does not determine eligibility for any treatment.
Written by the NewDay Wellness editorial team from the sources above and checked against them before publication, and medically reviewed by Dr. Sean Arora and Dr. Shannon Arora of Arora Health & Aesthetics; see our editorial standards. This article is educational and does not diagnose conditions, establish eligibility for any medication, or replace care from a licensed provider. Compounded medications are not FDA-approved.
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