Clomiphene and Enclomiphene: Drugs, Not Dietary Supplements
ProhibitedWhat is clomiphene?
- Clomiphene is a selective estrogen receptor modulator (SERM), which is a synthetic substance designed to alter how estrogen functions in the body.
- It is a prescription fertility medication approved by the Food and Drug Administration (FDA) to induce ovulation in women desiring pregnancy.
- Clomiphene is not FDA-approved to treat any condition in men. However, it is sometimes prescribed off-label for male infertility and other conditions.
- Clomiphene is listed in Section 4 (Hormone and Metabolic Modulators) of the World Anti-Doping Agency (WADA) Prohibited List and the DoD Prohibited Dietary Supplement Ingredients List .
What is enclomiphene?
- Enclomiphene (also a SERM) is a component of clomiphene.
- It has been studied in clinical trials as a treatment for conditions including low testosterone, hypogonadism, and type 2 diabetes. However, as of 2021, development of enclomiphene as a drug has been discontinued for all medical purposes. By itself, enclomiphene has not been approved by FDA for any use .
- As an unapproved drug, enclomiphene is on the DoD Prohibited List and as a component of clomiphene, it also falls under Section 4 of the WADA Prohibited List.
How are these substances being marketed in health and wellness products?
It is illegal for clomiphene and enclomiphene to be sold as dietary supplement ingredients. However, these substances are still listed on product labels and marketed as testosterone boosters. These products may be dietary supplements with a Supplement Facts label. Or, they may be sold as “research chemicals” with a “Research Facts” label and carry statements such as “for research use only” or “not for human consumption.”
Can enclomiphene be legally prescribed?
While enclomiphene itself is not an FDA-approved drug, as mentioned above, it is a component of the approved medication clomiphene. Under Section 503A of the Federal Food, Drug, and Cosmetic Act, drug substances that are components of FDA-approved products are eligible for use in compounding. This enables access to lawfully compounded drugs for those who have a medical need and a valid prescription . For more information, read the guidance from FDA .
What should I do if I have been prescribed clomiphene or enclomiphene?
Speak with your military healthcare provider who can determine whether you can take either of these drugs. Service Members should use providers at their installation’s Medical Treatment Facility (MTF) whenever possible. These providers will be more knowledgeable about their service-specific policies regarding the use of these medications. Service Members should ensure all their medications are recorded in their military health record and work with their military Primary Care Provider to ensure their record is updated to reflect any missing prescription medications.
Content current as of 12 January 2026
