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.

Melatonin: Clinical Evidence & Substantiation Summary

Clinical Trials

112

Strongest Evidence

Sleep

Typical Dosage

0.5–5 mg/day (30–60 min before bedtime)

Common Forms

Immediate-release melatonin

What Is Melatonin?

Melatonin is a hormone naturally produced by the pineal gland that regulates circadian rhythm and sleep-wake cycles. It is the most widely used sleep supplement globally, with strong evidence for sleep onset, jet lag, and shift work support.

Mechanism of action: Melatonin binds to MT1 and MT2 receptors in the suprachiasmatic nucleus (SCN), the brain's master circadian clock. It promotes sleep onset by lowering core body temperature and reducing alerting signals. It also has antioxidant properties and can modulate immune function.

Clinical Evidence Summary

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

Meta-analysis2019PMID: 30681787

Melatonin for primary sleep disorders: a meta-analysis

Population: 19 RCTs, 1,683 participants

Key finding: Melatonin significantly reduced sleep onset latency (-7.06 min, p<0.001), increased total sleep time (+8.25 min), and improved sleep quality.

Cochrane systematic review2020PMID: 32182294

Melatonin and jet lag: systematic review

Population: 10 RCTs

Key finding: Melatonin (0.5–5 mg at bedtime at destination) significantly reduced jet lag symptoms, particularly for eastward travel crossing 5+ time zones.

Meta-analysis2021PMID: 33992294

Low-dose melatonin for sleep in older adults

Population: 14 RCTs

Key finding: Low-dose melatonin (0.5–2 mg) significantly improved sleep onset and quality in adults over 55 with minimal side effects.

Systematic review2019PMID: 31305906

Melatonin and circadian rhythm disorders

Population: 12 RCTs

Key finding: Melatonin was significantly more effective than placebo for delayed sleep-wake phase disorder (DSWPD) and shift work sleep problems.

Review2018PMID: 29473879

Antioxidant properties of melatonin: clinical evidence

Population: Clinical studies

Key finding: Melatonin demonstrated antioxidant effects at physiological doses, scavenging free radicals and stimulating antioxidant enzyme 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 sleep onset and quality”

Category: Sleep · Confidence: 9/10

“Helps maintain a healthy circadian rhythm”

Category: Sleep · Confidence: 9/10

“Supports adjustment to jet lag and time zone changes”

Category: Sleep · Confidence: 8/10

Get the full substantiation report for Melatonin

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

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Related Ingredients

Ashwagandha

34 studies · Stress & Anxiety

Magnesium

89 studies · Sleep & Relaxation

L-Theanine

28 studies · Relaxation & Focus

Key Terms

Randomised Controlled Trial (RCT)Dose-Response Relationship Clinically Effective Dose

Frequently Asked Questions

Is melatonin FDA approved?

In the US, melatonin is sold as a dietary supplement and does not require FDA approval. In many European countries, it is sold as a prescription medication (Circadin®).

What are the most studied benefits?

The strongest evidence supports melatonin for improving sleep onset latency, managing jet lag, and supporting circadian rhythm in shift workers and older adults.

What dosage is used?

Most studies use 0.5–5 mg taken 30–60 minutes before bedtime. Lower doses (0.5–1 mg) may be more physiological and cause fewer next-day grogginess issues. More is not necessarily better.

Stop Spending Weeks on Substantiation

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