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.

Selenium: Clinical Evidence & Substantiation Summary

Clinical Trials

Strongest Evidence

Thyroid Function

Typical Dosage

55–200 mcg/day

Common Forms

Selenomethionine

What Is Selenium?

Selenium is an essential trace mineral that functions primarily through selenoproteins — a family of at least 25 proteins with antioxidant, immune, and thyroid-related functions. Both deficiency and excess carry health risks, making appropriate dosing critical.

Mechanism of action: Selenium is incorporated into selenoproteins as the amino acid selenocysteine. Key selenoproteins include glutathione peroxidases (antioxidant defence), thioredoxin reductases (redox regulation), and iodothyronine deiodinases (thyroid hormone conversion of T4 to T3).

Clinical Evidence Summary

Below are 5 key clinical studies on Selenium. Nutra Comp analyses 64+ studies in its full clinical evidence report.

Systematic review and meta-analysis2015PMID: 26362110

Selenium supplementation and thyroid function: a systematic review

Population: 16 RCTs

Key finding: Selenium supplementation (200 mcg/day) significantly reduced thyroid peroxidase antibodies in thyroiditis patients (WMD: -271 IU/mL, p<0.001).

Meta-analysis2018PMID: 30411529

Selenium and immune response: a meta-analysis

Population: 9 RCTs

Key finding: Selenium supplementation enhanced immune response to vaccination and improved lymphocyte function in selenium-deficient populations.

Meta-analysis of observational studies2018PMID: 29610056

Selenium status and cancer risk: an updated meta-analysis

Population: 69 studies

Key finding: Higher selenium status was associated with reduced risk of several cancers, but supplementation trials showed mixed results suggesting a U-shaped relationship.

Systematic review2019PMID: 31496068

Selenium and male fertility: systematic review

Population: 11 studies

Key finding: Selenium supplementation improved sperm motility and morphology in selenium-deficient men (p<0.05).

Meta-analysis2020PMID: 32432219

Selenium supplementation and antioxidant capacity

Population: 12 RCTs

Key finding: Selenium supplementation significantly increased glutathione peroxidase activity (p<0.001) and total antioxidant capacity.

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 thyroid function”

Category: Thyroid · Confidence: 9/10

“Provides antioxidant support through selenoprotein activity”

Category: Antioxidant · Confidence: 8/10

“Supports healthy immune system function”

Category: Immune · Confidence: 7/10

Get the full substantiation report for Selenium

Includes all 64+ 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

Iodine

42 studies · Thyroid Function

Key Terms

Bioavailability Daily Value (DV)Dose-Response Relationship

Frequently Asked Questions

Is selenium FDA approved?

Selenium is an essential trace mineral sold as a dietary supplement. The FDA has established a Daily Value of 55 mcg. It does not require FDA drug approval.

What are the most studied benefits of selenium?

The strongest evidence supports selenium for thyroid function (particularly autoimmune thyroiditis), antioxidant defence, and immune function. Evidence shows a U-shaped curve — both deficiency and excess are harmful.

What dosage of selenium is used?

Most studies use 55–200 mcg/day. The tolerable upper limit is 400 mcg/day. Selenomethionine is the preferred form for general supplementation due to superior bioavailability.

Stop Spending Weeks on Substantiation

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