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What This Page Explains
Urolithin A supplements are available as dietary supplements, with the most clinically studied form being Mitopure® (synthetic crystalline UA) by Amazentis SA. This page covers regulatory status, forms and formulations, clinical dosing context, quality markers to evaluate, and cost considerations — with transparency about what supplements can and cannot legally claim.
The Science on This Page Points to One Conclusion
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Detailed Evidence
REGULATORY STATUS Urolithin A (as Mitopure®) received FDA GRAS (Generally Recognized As Safe) status in 2018 (GRN 000833) for use as a food ingredient. It also received EFSA Novel Food approval in the EU in 2022. These designations confirm safety for human consumption — they do NOT confirm efficacy for any health condition. As a dietary supplement, UA products are regulated under DSHEA (1994), which does not require pre-market efficacy proof. FORMS AND FORMULATIONS UA supplements are available primarily in capsule/softgel form. The most clinically studied form is Mitopure® (synthetic crystalline UA) by Amazentis SA, used in nearly all published clinical trials. Other forms include UA derived from fermentation or chemical synthesis. Key formulation factors include: (1) Purity — pharmaceutical-grade UA vs food-grade, (2) Bioavailability — absorption characteristics may vary between formulations, (3) Dose standardization — consistency of UA content per serving. Not all forms have equivalent clinical data. CLINICAL DOSING CONTEXT Published clinical trials have used UA at 250–2000 mg/day. The doses showing the most consistent functional benefits were 500–1000 mg/day over 4 months (Singh 2022, Liu 2022). The first-in-human trial (Andreux 2019) confirmed safety at up to 2000 mg/day for 28 days. There is no established RDA or official dosing recommendation. Commercial products typically offer 250–1000 mg per serving. QUALITY MARKERS TO EVALUATE When evaluating any UA supplement, consider: (1) Third-party testing — independent verification (USP, NSF, ConsumerLab) of identity, purity, and potency, (2) Clinical backing — whether the specific formulation has been used in published trials, (3) Certificate of Analysis (CoA) — batch-level documentation of UA content and contaminant testing, (4) Manufacturing standards — cGMP (current Good Manufacturing Practice) certification, (5) Transparency — clear labeling of active ingredient amount, other ingredients, and allergen information. COST CONSIDERATIONS UA supplements are premium-priced — typically $1.50–3.00/day for clinical doses (500–1000 mg). For comparison: CoQ10 costs ~$0.15–0.50/day, creatine ~$0.05–0.10/day, and pomegranate extract ~$0.10–0.50/day. The higher cost reflects limited manufacturers, patented formulations, and the relatively small market. Consumers should weigh cost against the current evidence level (promising but early-stage). WHAT SUPPLEMENTS CANNOT DO No UA supplement can legally claim to treat, cure, or prevent any disease. Marketing claims should use structure/function language (e.g., "supports mitochondrial health") rather than disease claims. Be cautious of products making exaggerated claims about reversing aging, curing conditions, or guaranteed results — these are red flags for poor-quality products.
Evidence Hierarchy
Systematic Reviews & Meta-Analyses
Multiple high-quality trials combined
Randomized Controlled Trials (RCTs)
Gold standard for treatment efficacy
Observational Studies
Can show associations, not causation
Case Reports & Expert Opinion
Hypothesis-generating only
Preclinical (Lab/Animal) Studies
Should NOT be extrapolated to humans
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Study Quality Indicators
Higher Quality Indicators
- Large sample size (hundreds to thousands)
- Randomized and blinded design
- Placebo-controlled comparison
- Published in peer-reviewed journals
- Replicated in multiple studies
- Registered trial protocol before starting
Lower Quality Indicators
- Small sample size (under 100)
- No control group or blinding
- Manufacturer-funded with conflicts
- Only animal/cell studies
- Never replicated
- Published in predatory journals
Important Limitations
- • Supplement research often has methodological limitations
- • Results from one study may not generalize to all people
- • Marketing claims often exceed what research supports
- • Absence of evidence is not evidence of absence
- • Individual response to supplements varies widely
Quick Answers
What is the best Urolithin A supplement?
How much Urolithin A should I take daily?
Is Urolithin A FDA approved?
Are Urolithin A supplements safe?
What should I look for in a Urolithin A supplement?
Can I get Urolithin A from food instead of supplements?
Why are Urolithin A supplements so expensive?
What forms do Urolithin A supplements come in?
How long does Urolithin A take to work?
Should I take Urolithin A with food?
Can I take Urolithin A with other supplements?
Is synthetic Urolithin A the same as natural?
Do I need a prescription for Urolithin A?
What is Mitopure?
Are there side effects of Urolithin A supplements?
Key Research Facts
Urolithin A (as Mitopure®) received FDA GRAS status in 2018 (GRN 000833) and EFSA Novel Food approval in 2022, confirming safety for human consumption.
Strong EvidenceFDA/EFSA regulatory filings — GRN 000833; EFSA-Q-2021-00513
Only approximately 40% of people efficiently produce Urolithin A from dietary ellagitannins, making direct supplementation the only reliable delivery method for the majority.
Strong EvidenceEspín et al., Evid Based Complement Alternat Med — doi:10.1155/2013/270418
Clinical trials used UA doses of 250–2000 mg/day, with 500–1000 mg/day over 4 months showing the most consistent functional improvements in muscle endurance.
Strong EvidenceSingh et al., 2022; Liu et al., 2022 — Multiple DOIs
Nearly all published human clinical trials (~8–10) have used one specific formulation: Mitopure® by Amazentis SA (Switzerland).
Strong EvidencePublished clinical trial literature — PubMed analysis, 2026
The first-in-human safety trial confirmed UA tolerability at up to 2000 mg/day for 28 days, with adverse events comparable to placebo.
Strong EvidenceAndreux et al., Nature Metabolism — doi:10.1038/s42255-019-0073-4
UA supplements cost approximately $1.50–3.00/day for clinical doses (500–1000 mg), making them 30–60x more expensive than creatine monohydrate.
Strong EvidenceMarket pricing analysis — Accessed March 2026
Dietary supplements in the US are regulated under DSHEA (1994), which does not require pre-market proof of efficacy — only safety and truthful labeling.
Strong EvidenceFDA regulatory framework — DSHEA, Public Law 103-417
Synthetic crystalline UA is chemically identical to the metabolite produced by gut bacteria from ellagitannins — the difference is in delivery method, not molecular structure.
Strong EvidenceAmazentis manufacturing data — Product characterization studies
Third-party certification (USP, NSF, ConsumerLab) is voluntary for dietary supplements — absence does not mean a product is unsafe, but presence provides additional quality assurance.
Moderate EvidenceSupplement industry standards — USP/NSF certification guidelines
The longest published UA supplementation trial lasted 4 months — long-term safety and efficacy data beyond this timeframe do not exist.
Strong EvidenceLiu et al., JAMA Network Open — doi:10.1001/jamanetworkopen.2021.44279
Continue Your Research
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Citations & External Resources
FDA GRAS Notice GRN 000833 — Urolithin A
EFSA Novel Food Catalogue — Urolithin A
FDA — Dietary Supplement Information
USP — Dietary Supplement Verification Program
NSF International — Supplement Certification
ClinicalTrials.gov — Search: Urolithin A
PubMed — Urolithin A clinical trials
Nature Metabolism — Andreux et al. 2019 (Safety Trial)
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Related Reading
Urolithin A Brands: Comparison & Quality Assessment
Urolithin A: Foods vs Supplements — What You Need to Know
Urolithin A: The Complete Evidence-Based Guide
References (3)
Written by
ReCellence™ Editorial Team
Health Content Specialists
Medically reviewed by
Medical Review Board
MD, PhD
Last updated: March 8, 2026
Last medical review: March 8, 2026