Legal status · United States
Is Ursolic acid legal in the United States?
Written by Aaron CuhaReviewed Sep 2026
Direct answer
Ursolic acid 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.
Ursolic acid in the United States at a glance
| Classification | Sold as a supplement |
|---|---|
| FDA approval status | Sold as a dietary supplement. Not an approved drug and not approved to prevent or treat anything. |
| Human studies cited | 1 of 2 citations on the profile |
| Reviewed | Sep 2026 |
Classification and note come from the Ursolic acid profile, checked against U.S. Food and Drug Administration (FDA) listings at the reviewed date.
What this means
- 01
Ursolic acid 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 Ursolic acid is
No effect on lifespan at the dose tested in the mouse cohort where acarbose raised male median longevity by 16 to 17 percent. The entire human record is one eight-week trial in 16 men, which reported lower body fat percentage and no change in lean body mass.
Ursolic acid is a triterpenoid found in apple peel, rosemary and holy basil, and it is sold almost entirely on the strength of one line of mouse work from a single laboratory reporting that it induced muscle hypertrophy and reduced muscle atrophy. The Interventions Testing Program tested it in the cohort built around the acarbose dose-response study.
Mechanism: A pentacyclic triterpenoid. The muscle hypothesis rests on work reporting that it enhances skeletal muscle insulin and IGF-1 receptor signalling and reduces expression of the atrophy-associated ubiquitin ligases atrogin-1 and MuRF1, shifting the balance between protein synthesis and degradation.
Regulatory history: Sold as a dietary supplement. Not an approved drug and not approved to prevent or treat anything.
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 Ursolic acid 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.
Ursolic acid in other countries
Frequently asked questions
Is Ursolic acid legal in the United States?
Ursolic acid 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.
Can I buy Ursolic acid in the United States?
Yes, in supplement or cosmetic form. In the United States Ursolic acid 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.
Is Ursolic acid FDA approved?
No. FDA status: Sold as a dietary supplement. Not an approved drug and not approved to prevent or treat anything.. 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 Ursolic acid live on its compound profile.
Ursolic acid profileThis page is general information about the regulatory status of Ursolic acid 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.