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.

Vitamin B2 (Riboflavin): Clinical Evidence & Substantiation Summary

Clinical Trials

Strongest Evidence

Energy & Headache Support

Typical Dosage

1.3–400 mg/day

Common Forms

Riboflavin

What Is Vitamin B2 (Riboflavin)?

Riboflavin (Vitamin B2) is an essential water-soluble vitamin required for energy production, cellular function, and the metabolism of fats, drugs, and steroids. It is a key component of the coenzymes FAD and FMN.

Mechanism of action: FAD and FMN serve as hydrogen carriers in mitochondrial electron transport (energy production). Riboflavin is also required for the recycling of glutathione and for the conversion of B6 and folate into their active coenzyme forms.

Clinical Evidence Summary

Below are 3 key clinical studies on Vitamin B2 (Riboflavin). Nutra Comp analyses 34+ studies in its full clinical evidence report.

Systematic review and meta-analysis2017PMID: 26780877

Riboflavin for migraine prophylaxis: systematic review

Population: 11 RCTs

Key finding: High-dose riboflavin (400 mg/day) significantly reduced migraine frequency and duration (p<0.001) with minimal side effects.

Systematic review2018PMID: 30368550

Riboflavin status and iron metabolism

Population: 7 studies

Key finding: Riboflavin status directly correlates with iron status. Supplementation improved hemoglobin levels in individuals with subclinical riboflavin deficiency.

Review2019PMID: 31142457

B2 and oxidative stress markers

Population: Clinical data

Key finding: Riboflavin is a required cofactor for glutathione reductase, directly supporting the body's primary antioxidant system.

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 cellular energy production”

Category: Energy · Confidence: 10/10

“Supports healthy iron metabolism”

Category: Blood Health · Confidence: 8/10

“Supports a healthy response to periodic headaches”

Category: Neurological · Confidence: 7/10

Get the full substantiation report for Vitamin B2 (Riboflavin)

Includes all 34+ clinical studies analysed, complete claims library, and a ready-to-file substantiation memo.

Join Waitlist for Full Access

Related Ingredients

Magnesium

89 studies · Sleep & Relaxation

Folate (Vitamin B9)

94 studies · Prenatal Health

Coenzyme Q10 (CoQ10)

68 studies · Cardiovascular Health

Key Terms

Daily Value (DV)Dose-Response Relationship Clinically Effective Dose

Frequently Asked Questions

Why does B2 turn my urine bright yellow?

Riboflavin is naturally neon-yellow. The excess your body doesn't need is excreted in urine, causing a harmless bright yellow color (flavinuria).

Is riboflavin FDA approved?

Riboflavin is an essential vitamin with a Daily Value of 1.3 mg. It does not require FDA drug approval.

Is B2 good for headaches?

Clinical studies use high doses (400 mg/day) as a evidence-backed approach for migraine prevention, though results can take 3 months to manifest.

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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