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.

Iodine: Clinical Evidence & Substantiation Summary

Clinical Trials

Strongest Evidence

Thyroid Function

Typical Dosage

150–300 mcg/day

Common Forms

Potassium iodide

What Is Iodine?

Iodine is an essential trace mineral required for thyroid hormone synthesis. Deficiency remains the leading preventable cause of intellectual disability worldwide, and subclinical deficiency is re-emerging in Western populations.

Mechanism of action: Iodine is incorporated into thyroid hormones T3 (triiodothyronine) and T4 (thyroxine), which regulate metabolic rate, body temperature, protein synthesis, and neurodevelopment. The thyroid gland actively concentrates iodine via the sodium-iodide symporter (NIS).

Clinical Evidence Summary

Below are 3 key clinical studies on Iodine. Nutra Comp analyses 42+ studies in its full clinical evidence report.

Systematic review2018PMID: 29099763

Iodine supplementation and thyroid function: a global review

Population: 22 studies across populations

Key finding: Iodine supplementation in deficient populations normalised thyroid function markers and significantly reduced goitre prevalence (OR 0.32, p<0.001).

Meta-analysis2019PMID: 31364729

Iodine and cognitive development in children

Population: 11 studies

Key finding: Iodine supplementation in deficient pregnant women and children significantly improved cognitive scores (SMD: 0.68, p<0.001).

Cross-sectional review2019PMID: 30193758

Subclinical iodine deficiency in Western populations

Population: National surveys

Key finding: 10–20% of women of childbearing age in the US and UK have urinary iodine concentrations indicating mild deficiency.

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: 10/10

“Supports healthy metabolic rate”

Category: Metabolism · Confidence: 9/10

“Supports cognitive development during pregnancy and early life”

Category: Cognitive · Confidence: 9/10

Get the full substantiation report for Iodine

Includes all 42+ 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

Selenium

64 studies · Thyroid Function

Key Terms

Daily Value (DV)Dietary Supplement Tolerable Upper Intake Level (UL)

Frequently Asked Questions

Is iodine FDA approved?

Iodine is an essential mineral with a DV of 150 mcg. The UL is 1,100 mcg/day. Excess iodine can worsen thyroid conditions in susceptible individuals.

What are the most studied benefits?

Iodine is essential for thyroid hormone production. Its role in cognitive development is so well established that salt iodisation is one of the most successful public health interventions globally.

What dosage is used in clinical studies?

150–300 mcg/day for general supplementation. Pregnant women need 220 mcg/day. Do not exceed 1,100 mcg/day without medical supervision.

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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