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Legal status · United States

Is Bergamot legal in the United States?

Written by Reviewed Sep 2026

Not approvedMetabolicNo human studies cited

Direct answer

Bergamot 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, no human study is cited on its profile.

Bergamot in the United States at a glance

ClassificationSold as a supplement
FDA approval statusSold as a dietary supplement. Not approved to treat dyslipidaemia or anything else.
Human studies cited0 of 1 citations on the profile
ReviewedSep 2026

Classification and note come from the Bergamot profile, checked against U.S. Food and Drug Administration (FDA) listings at the reviewed date.

What this means

  • 01

    Bergamot 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 Bergamot is

Fourteen randomised trials show large lipid changes, including LDL down 55 mg/dL. The effect sizes are implausibly large for a food extract, the trials are small and regionally concentrated, and no outcome trial exists.

Bergamot is a citrus fruit whose polyphenol extract has a randomised literature on blood lipids, and the honest reading of that literature is that it is both real and hard to believe. 7 mg/dL.

Mechanism: The bergamot polyphenolic fraction is rich in flavanones, notably brutieridin and melitidin, which carry a side chain structurally similar to the statin pharmacophore. That has led to the hypothesis of partial HMG-CoA reductase inhibition, which would make it a weak statin rather than a generic antioxidant.

Regulatory history: Sold as a dietary supplement. Not approved to treat dyslipidaemia or anything else.

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 Bergamot 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.

Bergamot in other countries

Frequently asked questions

Is Bergamot legal in the United States?

Bergamot 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, no human study is cited on its profile.

Can I buy Bergamot in the United States?

Yes, in supplement or cosmetic form. In the United States Bergamot 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 Bergamot FDA approved?

No. FDA status: Sold as a dietary supplement. Not approved to treat dyslipidaemia or anything else.. Current US classification: "Sold as a supplement". On the evidence, no 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 Bergamot live on its compound profile.

Bergamot profile

This page is general information about the regulatory status of Bergamot 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.