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 B3 (Niacin): Clinical Evidence & Substantiation Summary

Clinical Trials

112

Strongest Evidence

Lipid & DNA Support

Typical Dosage

16–1,000 mg/day

Common Forms

Nicotinic acid

What Is Vitamin B3 (Niacin)?

Niacin (Vitamin B3) is a water-soluble vitamin that is converted into nicotinamide adenine dinucleotide (NAD+), a coenzyme essential for hundreds of metabolic reactions, DNA repair, and cellular energy production.

Mechanism of action: NAD+ and its phosphate form (NADP+) are critical for redox reactions in glycolysis, the Krebs cycle, and electron transport. Niacin also acts on specific G-protein coupled receptors in adipose tissue and skin (causing the characteristic 'flush').

Clinical Evidence Summary

Below are 3 key clinical studies on Vitamin B3 (Niacin). Nutra Comp analyses 112+ studies in its full clinical evidence report.

Post-hoc analysis of large RCT2017PMID: 28612110

Niacin and cardiovascular risk: AIM-HIGH re-analysis

Population: 3,414 participants

Key finding: While niacin effectively raises HDL and lowers triglycerides, adding it to intensive statin therapy did not further reduce major vascular events in this population.

RCT (ONTRAC)2015PMID: 26466134

Niacinamide and skin cancer prevention

Population: 386 adults with skin cancer history

Key finding: 500 mg niacinamide BID significantly reduced the rate of new non-melanoma skin cancers by 23% (p=0.02) after 12 months.

Meta-analysis2020PMID: 32268543

Niacin and triglycerides: meta-analysis

Population: 22 RCTs

Key finding: Niacin supplementation significantly reduced triglycerides (WMD: -33.4 mg/dL, p<0.001) and increased HDL cholesterol.

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 cellular energy and NAD+ levels”

Category: Metabolism · Confidence: 9/10

“Supports healthy cholesterol and triglyceride levels already within the normal range”

Category: Cardiovascular · Confidence: 9/10

“Supports healthy DNA repair and skin integrity”

Category: Skin · Confidence: 8/10

Get the full substantiation report for Vitamin B3 (Niacin)

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

Join Waitlist for Full Access

Related Ingredients

Vitamin B12

89 studies · Nervous System Support

Quercetin

36 studies · Immune & Anti-inflammatory

Resveratrol

41 studies · Cardiovascular & Anti-ageing

Key Terms

Substantiation Daily Value (DV)Standardised Extract

Frequently Asked Questions

What is the 'niacin flush'?

Nicotinic acid causes blood vessels to dilate (vasodilation) near the skin surface, causing redness and warmth. This is harmless but can be uncomfortable. Niacinamide does not cause flushing.

Is niacin FDA approved?

Niacin is an essential nutrient with a DV of 16 mg. High-dose niacin (Niaspan) is also an FDA-approved prescription drug for lipid disorders.

What is the difference between niacin and niacinamide?

Both provide B3 activity, but only nicotinic acid (niacin) significantly affects cholesterol levels and causes flushing. Niacinamide is used primarily for skin health and DNA repair support without flushing.

Stop Spending Weeks on Substantiation

Nutra Comp generates full clinical evidence reports, FDA-compliant structure–function claims, and substantiation memos in minutes — not months.

Join the Waitlist