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.

Lutein: Clinical Evidence & Substantiation Summary

Clinical Trials

Strongest Evidence

Eye Health

Typical Dosage

10–20 mg/day

Common Forms

Free lutein

What Is Lutein?

Lutein is a carotenoid pigment concentrated in the macula and retina of the eye. The landmark AREDS2 trial established its role in eye health, and emerging research supports cognitive benefits through its presence in brain tissue.

Mechanism of action: Lutein filters high-energy blue light in the macula, protecting photoreceptors from oxidative damage. It quenches reactive oxygen species and singlet oxygen. In the brain, it accumulates preferentially and supports neural efficiency and processing speed.

Clinical Evidence Summary

Below are 3 key clinical studies on Lutein. Nutra Comp analyses 44+ studies in its full clinical evidence report.

RCT, multi-centre2013PMID: 23527038

AREDS2: Lutein/zeaxanthin for age-related macular degeneration

Population: 4,203 participants

Key finding: Lutein/zeaxanthin (10 mg/2 mg) reduced progression to advanced AMD by 18% in participants with low dietary intake (p=0.03).

Systematic review2017PMID: 28756447

Lutein and cognitive function: a systematic review

Population: 8 studies

Key finding: Higher lutein status was consistently associated with better cognitive performance, particularly in memory and processing speed.

Meta-analysis2018PMID: 30465716

Lutein supplementation and macular pigment optical density

Population: 20 RCTs

Key finding: Lutein supplementation significantly increased macular pigment optical density (MPOD) in a dose-dependent manner (p<0.001).

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 vision and eye function”

Category: Eye Health · Confidence: 9/10

“Supports macular health by filtering blue light”

Category: Eye Health · Confidence: 9/10

“Supports cognitive function and processing speed”

Category: Cognitive · Confidence: 6/10

Get the full substantiation report for Lutein

Includes all 44+ clinical studies analysed, complete claims library, and a ready-to-file substantiation memo.

Join Waitlist for Full Access

Related Ingredients

Omega-3 Fatty Acids

214 studies · Cardiovascular Health

Vitamin C

168 studies · Immune Function

Key Terms

Randomised Controlled Trial (RCT)Dose-Response Relationship Clinical Endpoint

Frequently Asked Questions

Is lutein FDA approved?

Lutein is a dietary supplement under DSHEA. The AREDS2 formula (including lutein/zeaxanthin) is one of the most evidence-backed supplement formulations.

What are the most studied benefits?

The AREDS2 trial established lutein's role in eye health. Emerging research supports cognitive benefits through brain carotenoid accumulation.

What dosage is used in clinical studies?

The AREDS2 trial used 10 mg lutein + 2 mg zeaxanthin daily. Most eye health studies use 10–20 mg/day.

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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