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.

Iron: Clinical Evidence & Substantiation Summary

Clinical Trials

112

Strongest Evidence

Energy & Vitality

Typical Dosage

18–65 mg/day (elemental iron)

Common Forms

Ferrous bisglycinate

What Is Iron?

Iron is an essential mineral required for oxygen transport, energy metabolism, and DNA synthesis. Iron deficiency is the most common nutritional deficiency worldwide, affecting an estimated 2 billion people. Supplementation is particularly important for premenopausal women, athletes, and vegetarians.

Mechanism of action: Iron is a critical component of hemoglobin (oxygen transport in red blood cells) and myoglobin (oxygen storage in muscles). It serves as a cofactor for cytochrome enzymes in the electron transport chain (ATP production) and is essential for DNA synthesis via ribonucleotide reductase.

Clinical Evidence Summary

Below are 5 key clinical studies on Iron. Nutra Comp analyses 112+ studies in its full clinical evidence report.

Meta-analysis2018PMID: 29543307

Iron supplementation for unexplained fatigue in non-anaemic women

Population: 8 RCTs, 1,170 women

Key finding: Iron supplementation significantly reduced fatigue in non-anaemic iron-deficient women (SMD -0.38, p<0.001).

Systematic review2019PMID: 31305906

Iron supplementation and athletic performance

Population: 22 RCTs

Key finding: Iron supplementation improved aerobic capacity (VO2max) in iron-deficient athletes, with greater effects in those with ferritin <20 μg/L.

Systematic review2018PMID: 30163680

The effect of iron on cognitive function

Population: 14 RCTs

Key finding: Iron supplementation improved attention and concentration in iron-deficient women and children (p<0.05).

RCT crossover2017PMID: 28768407

Comparative bioavailability of iron supplements

Population: 48 iron-deficient women

Key finding: Ferrous bisglycinate showed 3.4× greater bioavailability than ferrous sulfate with significantly fewer GI side effects (p<0.01).

Systematic review2020PMID: 32432219

Iron and immune function: a systematic review

Population: 19 studies

Key finding: Iron status significantly influenced immune cell function, with deficiency impairing T-cell and neutrophil activity.

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 energy levels and reduces occasional fatigue”

Category: Energy · Confidence: 8/10

“Supports oxygen transport and healthy red blood cell formation”

Category: Blood Health · Confidence: 10/10

“Supports cognitive function and mental clarity”

Category: Cognitive · Confidence: 7/10

Get the full substantiation report for Iron

Includes all 112+ clinical studies analysed, complete claims library, and a ready-to-file substantiation memo.

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Related Ingredients

Vitamin C

168 studies · Immune Function

Vitamin B12

89 studies · Nervous System Support

Folate (Vitamin B9)

94 studies · Prenatal Health

Key Terms

Bioavailability Daily Value (DV)Clinically Effective Dose

Frequently Asked Questions

Is iron FDA approved?

Iron is an essential mineral sold as a dietary supplement. The FDA has established a Daily Value of 18 mg for adults. Iron supplements do not require FDA drug approval.

What are the most studied benefits of iron?

The strongest evidence supports iron for reducing fatigue in iron-deficient individuals, supporting oxygen transport, improving athletic performance in deficient athletes, and supporting cognitive function.

What dosage of iron is used in clinical studies?

Dosage depends on iron status. For deficiency correction: 30–65 mg/day elemental iron. For maintenance: 18 mg/day. Ferrous bisglycinate offers better absorption at lower doses with fewer GI side effects.

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