In the latest installment of our Ask the Scientists blog, we sat down with our resident experts to answer some of the most commonly asked questions concerning the use of Pregnenolone.
What is Pregnenolone?
Pregnenolone is a hormone naturally produced in the body by the adrenal gland. Pregnenolone is also made from cholesterol, and is the starting material in the production of testosterone, progesterone, cortisol, estrogen and other hormones. Because the body uses it biochemically as starting material, pregnenolone is sometimes referred to as a “precursor” or “pro-hormone”.
What about Pregnenolone in dietary supplements?
The legal status of pregnenolone in dietary supplements has not been explicitly stated by the FDA, and is often determined on a case by case basis. If pregnenolone is present in a dietary supplement as a constituent or extract of adrenal glands, then the FDA may conclude it qualifies as a dietary supplement ingredient. On the other hand, the FDA may have a different opinion on synthetically produced pregnenolone. The FDA issued a warning letter to a compounding pharmacy for illegally compounding with pregnenolone (to see the warning letter, go to FDA.gov and search for “American Hormones Warning Letter”)[1]. In this warning letter, the FDA makes it clear that it considers pregnenolone an unapproved new drug [2]. Furthermore, it appears it was once an approved topical drug, which may also preclude it from use in dietary supplements.
What is Pregnenolone used for?
There has been interest in pregnenolone for a long time as an anti-aging compound, for hormone replacement and to treat a myriad of medical conditions. Since pregnenolone is a precursor in the synthesis of other hormones, sometimes it is advertised to boost the production of other hormones and may make people feel more energetic and younger. There is no clear scientific evidence that pregnenolone is effective for this purpose.
Is Pregnenolone a banned substance?
Pregnenolone is not on the World Anti-Doping Agency (WADA) Prohibited List. However, WADA reviews and updates the List annually and substances can be added to the List at any time. Therefore, you should always double check the current status of any substance on GlobalDRO.com before using it.
Since Pregnenolone is not prohibited, can I go ahead and use it?
Yes, you may use pregnenolone without incurring an anti-doping rule violation. However, by doing so you also must accept all risks inherent to the supplement and compounding industry. USADA considers the use of any dietary supplement that claims to deliver or “boost” hormones to be especially risky. To learn more about risks associated with the supplement industry, visit Supplement Connect. You can also read more about compound pharmacies.
Can I get a Therapeutic Use Exemption for a compounded formulation of Pregnenolone?
No. A TUE is not required for pregnenolone because it is not prohibited.
[1] http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm155170.htm
[2]See section 201(ff)(3)(B)(i) of the Federal Food, Drug, and Cosmetic Act
*Original article posted September 2, 2015. This article was amended on June 14, 2017, and again on 6/29/2019.
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