Legal status · United States
Is (R/S)-1,3-Butanediol legal in the United States?
Written by Aaron CuhaReviewed Sep 2026
Direct answer
(R/S)-1,3-Butanediol can be sold in the United States as a supplement or cosmetic ingredient. Its legal category is "Sold as a dietary supplement". That is not approval as a drug. FDA has not checked any health claim made for it. Versions you inject, and "research use only" versions, fall outside supplement rules, so that label does not make them legal to use in people. On the evidence, 1 completed human trial is cited on its profile.
- People given it
- 0
- Found nothing
- 0
Legal category
Sold as a dietary supplement
FDA approval and compounding status, from the (R/S)-1,3-Butanediol profile.
Reviewed Sep 2026. This is a legal category, not legal advice.
A "research use only" label on a vial does not make it legal to use on people.
(R/S)-1,3-Butanediol in the United States at a glance
| Legal category | Sold as a dietary supplement |
|---|---|
| FDA approval status | Not a drug. Allowed in US food as a liquid that carries flavourings. Sold in ketone supplement products. Not approved for any use. The lifespan result from the Interventions Testing Program (ITP), a US government-funded mouse study, is unclear. Females lived 2 percent longer by the standard test, but only at some test sites. Males lived 9 percent longer, but only by one other test (the Gehan test). The mice got it as 10 percent of their diet. |
| Studies in people | 3 of 6 sources on the profile |
| Reviewed | Sep 2026 |
The legal category and note come from the (R/S)-1,3-Butanediol profile. We checked them against U.S. Food and Drug Administration (FDA) listings on the reviewed date.
What this means
- 01
(R/S)-1,3-Butanediol can be sold in the United States as a supplement, food or cosmetic ingredient, under the legal category above. It has no approval as a drug.
- 02
Being sold as a supplement means FDA has not checked any health claim. The makers are responsible for safety and labels, and quality varies from product to product.
- 03
Versions you inject, and "research use only" versions, are not supplements. That label does not make them legal to use in people, and anything you inject falls under the rules for medicines.
What (R/S)-1,3-Butanediol is
In people, it raises blood ketones for a few hours. In 9 cyclists, it gave 5 of them moderate to severe gut problems and did not make them faster. In mice, it gave the NIA lifespan program's most shaky result. Females gained 2 percent in typical lifespan, but only when one lab was counted. Males gained 9 percent, but only by a test that counts early deaths more. The mice ate it as 10 percent of their food by weight.
1,3-butanediol is a small alcohol. The liver turns it into beta-hydroxybutyrate (BHB), a ketone.
How it works: The liver breaks down 1,3-butanediol, the same way it breaks down alcohol, into BHB, the main ketone in the blood. The (R) form of the molecule makes the natural D form of BHB.
Approval history: Not a drug. Allowed in US food as a liquid that carries flavourings. Sold in ketone supplement products. Not approved for any use. The lifespan result from the Interventions Testing Program (ITP), a US government-funded mouse study, is unclear. Females lived 2 percent longer by the standard test, but only at some test sites. Males lived 9 percent longer, but only by one other test (the Gehan test). The mice got it as 10 percent of their diet.
How FDA treats this kind of product
Approves prescription drugs, each for a named use. It also acts against unapproved products, including peptides sold online. Compounding pharmacies, which mix drugs to order, may make some compounds with a prescription. That only applies when the FDA puts the compound in a category of bulk ingredients it allows.
The legal category above is how The Longevity Archive reads U.S. Food and Drug Administration listings for (R/S)-1,3-Butanediol on the reviewed date. It is not a legal opinion. Rules change. Bringing a compound into the country, prescribing it and owning it can each be treated differently. Check with the agency before you act on anything here.
(R/S)-1,3-Butanediol in sport and the military
Whether (R/S)-1,3-Butanediol is banned in sport is set by the World Anti-Doping Code and by military rules, not by its legal status in the United States. Before you compete or get tested, look up (R/S)-1,3-Butanediol by name on the Prohibited List, or look up a named product in Global DRO. Under the World Anti-Doping Code, category S0 bans, at all times, any drug-like substance that meets two tests. No other section of the List covers it. And no government health regulator anywhere has a current approval for it as a treatment in people. Many substances that are approved somewhere are banned by name in another section. So approval does not mean a substance is allowed in sport.
- WADA Prohibited List
- Global DRO (check a named product)
- USADA (US athletes)
- Operation Supplement Safety (US service members)
The rules you compete or serve under decide this, not this page.
(R/S)-1,3-Butanediol in other countries
Frequently asked questions
Is (R/S)-1,3-Butanediol legal in the United States?
(R/S)-1,3-Butanediol can be sold in the United States as a supplement or cosmetic ingredient. Its legal category is "Sold as a dietary supplement". That is not approval as a drug. FDA has not checked any health claim made for it. Versions you inject, and "research use only" versions, fall outside supplement rules, so that label does not make them legal to use in people. On the evidence, 1 completed human trial is cited on its profile.
Can I buy (R/S)-1,3-Butanediol in the United States?
Yes, as a supplement or cosmetic. In the United States, (R/S)-1,3-Butanediol has the legal category "Sold as a dietary supplement". So products you swallow, put on your skin or use as a cosmetic can be sold under supplement rules. Versions you inject, and products labeled "research use only", are not supplements. They are not approved for use in people.
Is (R/S)-1,3-Butanediol FDA approved?
No. FDA status: Not a drug. Allowed in US food as a liquid that carries flavourings. Sold in ketone supplement products. Not approved for any use. The lifespan result from the Interventions Testing Program (ITP), a US government-funded mouse study, is unclear. Females lived 2 percent longer by the standard test, but only at some test sites. Males lived 9 percent longer, but only by one other test (the Gehan test). The mice got it as 10 percent of their diet.. Current US legal category: "Sold as a dietary supplement". On the evidence, 1 completed human trial is cited on its profile.
Related compounds in the United States
Full research profile
How (R/S)-1,3-Butanediol works, the studies we cite, FDA status and the full legal summary are all on its compound profile.
(R/S)-1,3-Butanediol profileThis page is general information about the legal status of (R/S)-1,3-Butanediol in the United States, current as of Sep 2026. It is not legal advice. Legal status changes. For your own situation, check with U.S. Food and Drug Administration or ask a lawyer. Educational use only. This database summarizes published research and is not medical advice. Where a dose appears it is a record of what a trial or clinic ran, or what people describe doing, with its source attached. Nothing here is a recommendation for personal use. Sellers named on the price pages are ranked by certificate tier, then price, and any affiliate income is disclosed there. Naming a seller is not a recommendation to buy or use anything.