Legal status · United States
Is Urolithin B legal in the United States?
Written by Aaron CuhaReviewed Sep 2026
Direct answer
Urolithin B can be sold in the United States as a supplement or cosmetic ingredient, classified as "Sold as a supplement". That is not drug approval: FDA has not evaluated any health claim, and injectable or "research use only" versions fall outside supplement rules, so that label does not make human use lawful. On the evidence, 1 human study is cited on its profile.
Urolithin B in the United States at a glance
| Classification | Sold as a supplement |
|---|---|
| Note | Sold as a supplement ingredient and as a research chemical. The established mitophagy product on the market, Mitopure, is urolithin A, a different molecule with different human evidence. |
| FDA approval status | Not an approved drug. Sold as a supplement ingredient and as a research chemical. No registered human trial has administered it. |
| Human studies cited | 1 of 4 citations on the profile |
| Reviewed | Sep 2026 |
Classification and note come from the Urolithin B profile, checked against U.S. Food and Drug Administration (FDA) listings at the reviewed date.
What this means
- 01
Urolithin B can be sold in the United States as a supplement, food or cosmetic ingredient under the classification above, without drug approval.
- 02
Supplement status means FDA has not evaluated any health claim; manufacturers are responsible for safety and labeling, and quality varies by product.
- 03
Injectable or "research use only" versions are not supplements. That label does not make human use lawful, and injectables fall under medicines rules.
What Urolithin B is
Sold on the reputation of urolithin A, which has human trials. Urolithin B has none: the muscle result is C2C12 cells and mice given 10 micrograms a day through an implanted osmotic pump for 28 days.
Urolithin B is one of the compounds gut bacteria make from the ellagitannins in pomegranate, walnuts and berries. It is structurally simpler than urolithin A and has a different reported action: rather than mitophagy, the 2017 paper that put it on the map described it as a regulator of muscle protein balance acting through the androgen receptor.
Mechanism: In muscle cells and mice, an increase in protein synthesis with repression of the ubiquitin-proteasome degradation pathway, with the androgen receptor implicated genetically and pharmacologically and crosstalk to mTORC1 signalling, possibly through AMPK. This is a different proposed mechanism from urolithin A, which is sold and studied as a mitophagy activator.
Regulatory history: Not an approved drug. Sold as a supplement ingredient and as a research chemical. No registered human trial has administered it.
How FDA treats this kind of product
Approves prescription drugs by indication and polices unapproved products, including peptides sold online. Compounding pharmacies may prepare some compounds under a prescription when the FDA places them on a permitted bulk-substances category.
The classification above is the The Longevity Archive reading of U.S. Food and Drug Administration listings for Urolithin B at the reviewed date, not a legal opinion. Rules change, and importing, prescribing and possessing a compound can each be treated differently. Check the regulator directly before acting on anything here.
Urolithin B in other countries
Frequently asked questions
Is Urolithin B legal in the United States?
Urolithin B can be sold in the United States as a supplement or cosmetic ingredient, classified as "Sold as a supplement". That is not drug approval: FDA has not evaluated any health claim, and injectable or "research use only" versions fall outside supplement rules, so that label does not make human use lawful. On the evidence, 1 human study is cited on its profile. Note: Sold as a supplement ingredient and as a research chemical. The established mitophagy product on the market, Mitopure, is urolithin A, a different molecule with different human evidence.
Can I buy Urolithin B in the United States?
Yes, in supplement or cosmetic form. In the United States Urolithin B is classified as "Sold as a supplement", so oral, topical or cosmetic products can be sold under supplement rules. Injectable versions and products labeled "research use only" are not supplements and are not approved for human use. Note: Sold as a supplement ingredient and as a research chemical. The established mitophagy product on the market, Mitopure, is urolithin A, a different molecule with different human evidence.
Is Urolithin B FDA approved?
No. FDA status: Not an approved drug. Sold as a supplement ingredient and as a research chemical. No registered human trial has administered it.. Current US classification: "Sold as a supplement". On the evidence, 1 human study is cited on its profile.
Related compounds in the United States
Full research profile
Mechanism, cited studies, FDA status and the full legal summary for Urolithin B live on its compound profile.
Urolithin B profileThis page is general information about the regulatory status of Urolithin B in the United States, current as of Sep 2026. It is not legal advice, and classifications change; check U.S. Food and Drug Administration directly or consult a lawyer for a specific situation. Educational use only. This database summarizes published research. It is not medical advice and contains no dosing protocols or recommendations for personal use. The Longevity Archive has no vendor relationships and does not recommend where to buy anything.