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.

Elderberry: Clinical Evidence & Substantiation Summary

Clinical Trials

Strongest Evidence

Immune Function

Typical Dosage

300–600 mg/day (extract) or 15 mL/day (syrup)

Common Forms

Standardised elderberry extract

What Is Elderberry?

Elderberry (Sambucus nigra) extract is one of the most popular immune-support botanicals, with clinical evidence supporting its use for reducing the duration and severity of upper respiratory infections, particularly colds and influenza.

Mechanism of action: Elderberry's anthocyanins and other flavonoids exhibit direct antiviral activity by inhibiting viral adhesion and entry into host cells. They also stimulate cytokine production (IL-6, IL-8, TNF-α), enhancing innate immune response, while modulating pro-inflammatory pathways.

Clinical Evidence Summary

Below are 5 key clinical studies on Elderberry. Nutra Comp analyses 14+ studies in its full clinical evidence report.

Meta-analysis2019PMID: 30670267

Black elderberry supplementation for upper respiratory symptoms: a meta-analysis

Population: 4 RCTs, 180 participants

Key finding: Elderberry supplementation significantly reduced upper respiratory symptom duration (mean reduction: 2.1 days, p<0.001) and severity.

RCT, double-blind2017PMID: 28515951

Elderberry extract and influenza: a randomised trial

Population: 312 air travellers

Key finding: Elderberry extract significantly reduced cold episode duration (4.75 vs 6.88 days, p=0.02) and severity in travellers.

Laboratory study + clinical review2018PMID: 30163680

In vitro antiviral activity of elderberry extract

Population: Multiple viral strains

Key finding: Elderberry extract demonstrated inhibition of influenza A and B virus replication at extract concentrations achievable with standard supplementation.

RCT2017PMID: 29099763

Elderberry and immune biomarkers in humans

Population: 52 healthy adults

Key finding: Elderberry extract (600 mg/day for 10 days) significantly increased antibody titers against influenza following vaccination (p=0.04).

Systematic review2019PMID: 31691193

Safety and tolerability of elderberry supplementation

Population: All available clinical data

Key finding: Elderberry supplementation demonstrated excellent safety and tolerability at standard doses, with adverse events comparable to placebo.

Evidence-Based Structure–Function Claims

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

“Supports healthy immune system function”

Category: Immune · Confidence: 8/10

“Provides antioxidant support through anthocyanin content”

Category: Antioxidant · Confidence: 7/10

“Supports upper respiratory health during seasonal challenges”

Category: Respiratory · Confidence: 7/10

Get the full substantiation report for Elderberry

Includes all 14+ clinical studies analysed, complete claims library, and a ready-to-file substantiation memo.

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Related Ingredients

Vitamin D3

127 studies · Bone Health & Calcium Metabolism

Zinc

92 studies · Immune Function

Vitamin C

168 studies · Immune Function

Key Terms

Structure–Function Claim Randomised Controlled Trial (RCT)Meta-Analysis

Frequently Asked Questions

Is elderberry FDA approved?

Elderberry is sold as a dietary supplement and does not require FDA approval. Raw elderberries should never be consumed uncooked due to cyanogenic glycoside content; commercial extracts are heat-processed.

What are the most studied benefits?

The strongest evidence supports elderberry for reducing the duration and severity of upper respiratory infections, particularly colds and influenza.

What dosage is used?

Most studies use 300–600 mg/day of standardised extract or 15 mL/day of syrup for prevention, with higher doses (4× daily) during acute symptoms.

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