Legal status · United States
Is Urolithin A legal in the United States?
Urolithin A can be sold in the United States as a supplement or cosmetic ingredient, classified as "Sold as a dietary 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. Human evidence: Moderate.
Urolithin A in the United States at a glance
| Classification | Sold as a dietary supplement |
|---|---|
| FDA approval status | Sold as a supplement (GRAS); not an approved drug |
| Evidence level | Moderate (research strength: Moderate) |
| Reviewed | Sep 2026 |
Classification and note come from the Urolithin A profile, checked against U.S. Food and Drug Administration (FDA) listings at the reviewed date.
What this means
- 01
Urolithin A 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 A is
A gut-derived compound that triggers mitophagy and has improved muscle function in older adults in human trials, one of the better-evidenced longevity supplements.
Urolithin A is a compound the gut microbiome makes from ellagitannins found in pomegranate and berries, though many people do not produce much of it. It triggers mitophagy, the recycling of damaged mitochondria, and human trials have shown improvements in mitochondrial function and muscle endurance and strength in older adults.
Mechanism: Induces mitophagy, clearing damaged mitochondria and improving the quality of the cellular energy supply, especially in muscle.
Regulatory history: Sold as a supplement (GRAS); not an approved drug
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 A 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 A in other countries
Frequently asked questions
Is Urolithin A legal in the United States?
Urolithin A can be sold in the United States as a supplement or cosmetic ingredient, classified as "Sold as a dietary 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. Human evidence: Moderate.
Can I buy Urolithin A in the United States?
Yes, in supplement or cosmetic form. In the United States Urolithin A is classified as "Sold as a dietary 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.
Is Urolithin A FDA approved?
No. FDA status: Sold as a supplement (GRAS); not an approved drug. Current US classification: "Sold as a dietary supplement". Evidence level: Moderate.
Related compounds in the United States
Full research profile
Mechanism, cited studies, FDA status and the full legal summary for Urolithin A live on its compound profile.
Urolithin A profileThis page is general information about the regulatory status of Urolithin A 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.