What is supplement substantiation?

Substantiation is the process of gathering and documenting scientific evidence that supports the health claims you make on your supplement labels and marketing materials. The FDA requires that all structure–function claims be truthful, non-misleading, and substantiated by competent and reliable scientific evidence — typically clinical trials on healthy human subjects.

How does Nutra Comp's AI analysis work?

Nutra Comp searches PubMed for clinical trials relevant to your ingredient, filters for studies on healthy human subjects with oral administration, and uses AI to extract key data: p-values, effect sizes, study design, population details, and conclusions. It distinguishes between across-group and within-group significance and ranks evidence strength with a confidence scoring system.

What data sources does Nutra Comp use?

Nutra Comp primarily searches PubMed/MEDLINE, the world's largest biomedical literature database maintained by the U.S. National Library of Medicine. We focus on peer-reviewed clinical trials, randomised controlled trials (RCTs), meta-analyses, and systematic reviews.

Are the generated claims FDA-compliant?

Yes. Nutra Comp generates structure–function claims in strict accordance with the FDA Small Entity Compliance Guide. All claims avoid explicit and implicit disease references. However, we recommend having your legal/regulatory team review the final output before use, as Nutra Comp is a tool to assist — not replace — professional compliance review.

How long does a typical ingredient search take?

Most ingredient searches complete within 5–15 minutes, depending on the volume of clinical literature available. Compare this to the typical manual process which can take 40–100+ hours per ingredient when done by a human compliance expert.

Can I export my reports?

Absolutely. All clinical evidence reports, structure–function claims, and substantiation memos can be exported as professional PDF documents. These are formatted for easy sharing with your legal team, regulatory reviewers, or business partners.

What does 'ingredient searches per month' mean?

Each search is one ingredient analysis — for example, searching 'Ashwagandha' or 'Vitamin D3'. The search generates a complete evidence report, claims, and substantiation memo for that ingredient. Your monthly allowance resets on your billing date.

When will Nutra Comp be available?

We're currently in private beta. Join the waitlist to get early access and be notified when we launch. Early waitlist members will receive priority access and special launch pricing.

Quercetin: Clinical Evidence & Substantiation Summary

Clinical Trials

Strongest Evidence

Immune & Anti-inflammatory

Typical Dosage

500–1,000 mg/day

Common Forms

Quercetin dihydrate

What Is Quercetin?

Quercetin is a flavonoid antioxidant found in fruits, vegetables, and grains. It has broad biological activity including anti-inflammatory, antihistamine, and immune-modulating effects, with growing clinical evidence for exercise performance and immune support.

Mechanism of action: Quercetin inhibits multiple inflammatory mediators including NF-κB, COX-2, and LOX. It stabilises mast cells (reducing histamine release), scavenges reactive oxygen species, inhibits viral replication pathways, and activates AMPK and SIRT1 for metabolic benefits.

Clinical Evidence Summary

Below are 5 key clinical studies on Quercetin. Nutra Comp analyses 36+ studies in its full clinical evidence report.

RCT2019PMID: 31142457

Quercetin supplementation and upper respiratory tract infections

Population: 1,002 participants

Key finding: Quercetin (1,000 mg/day for 12 weeks) significantly reduced the severity and duration of URTIs in adults over 40 (p<0.05).

Systematic review2018PMID: 30368550

Quercetin and allergic rhinitis: systematic review

Population: 6 studies

Key finding: Quercetin supplementation reduced nasal allergy symptoms via mast cell stabilisation and histamine inhibition.

Meta-analysis2020PMID: 32914701

Quercetin and exercise performance: a meta-analysis

Population: 11 RCTs

Key finding: Quercetin supplementation showed small but significant improvements in VO2max (+2.3%, p=0.03) and endurance performance.

Meta-analysis2018PMID: 29543307

Anti-inflammatory effects of quercetin supplementation

Population: 9 RCTs

Key finding: Quercetin significantly reduced CRP (WMD: -0.33 mg/L, p=0.04) in doses ≥500 mg/day for 8+ weeks.

Meta-analysis2021PMID: 33260899

Quercetin and blood pressure: meta-analysis

Population: 7 RCTs, 587 participants

Key finding: Quercetin supplementation (≥500 mg/day) significantly reduced systolic BP by 3.04 mmHg (p=0.01).

Evidence-Based Structure–Function Claims

Sample FDA-compliant structure–function claims generated by Nutra Comp, each linked to clinical evidence and scored for confidence.

“Provides antioxidant and flavonoid support”

Category: Antioxidant · Confidence: 8/10

“Supports a healthy immune response”

Category: Immune · Confidence: 7/10

“Supports a healthy inflammatory response”

Category: Anti-inflammatory · Confidence: 7/10

Get the full substantiation report for Quercetin

Includes all 36+ clinical studies analysed, complete claims library, and a ready-to-file substantiation memo.

Join Waitlist for Full Access

Related Ingredients

Zinc

92 studies · Immune Function

Vitamin C

168 studies · Immune Function

Elderberry

14 studies · Immune Function

Key Terms

Randomised Controlled Trial (RCT)Meta-Analysis Bioavailability

Frequently Asked Questions

Is quercetin FDA approved?

Quercetin is sold as a dietary supplement and has GRAS status. It does not require FDA approval.

What are the most studied benefits?

The strongest evidence supports quercetin for immune support (reducing URTI severity), antioxidant/anti-inflammatory effects, and modest exercise performance improvements.

What dosage is used?

Most studies use 500–1,000 mg/day. Phytosome and glycoside forms have significantly better bioavailability than standard quercetin dihydrate.

Stop Spending Weeks on Substantiation

Nutra Comp generates full clinical evidence reports, FDA-compliant structure–function claims, and substantiation memos in minutes — not months.

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