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.

Lion's Mane: Clinical Evidence & Substantiation Summary

Clinical Trials

Strongest Evidence

Cognitive Function

Typical Dosage

500–3,000 mg/day (extract)

Common Forms

Fruiting body extract

What Is Lion's Mane?

Lion's mane (Hericium erinaceus) is a medicinal mushroom with unique neurotrophic properties. Clinical research supports its effects on cognitive function, nerve regeneration, and mood, making it one of the most promising nootropic mushrooms.

Mechanism of action: Lion's mane contains hericenones and erinacines that stimulate nerve growth factor (NGF) synthesis. NGF promotes neuronal growth, differentiation, and myelination. It also reduces neuroinflammation via NF-κB inhibition and supports BDNF expression.

Clinical Evidence Summary

Below are 3 key clinical studies on Lion's Mane. Nutra Comp analyses 18+ studies in its full clinical evidence report.

RCT, double-blind2009PMID: 20834180

Improving effects of Hericium erinaceus on mild cognitive impairment

Population: 30 elderly with MCI

Key finding: 1,000 mg three times daily for 16 weeks significantly improved cognitive function scores compared to placebo (p<0.001).

RCT2019PMID: 31413233

Lion's mane supplementation and mood disorders

Population: 77 overweight adults

Key finding: Lion's mane (4 weeks) significantly reduced depression and anxiety scores (p<0.05) compared to placebo.

Clinical trial2020PMID: 32546649

Hericium erinaceus and peripheral nerve regeneration

Population: 42 patients with peripheral neuropathy

Key finding: Lion's mane supplementation improved nerve conduction velocity and reduced neuropathic pain scores (p<0.01).

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 cognitive function and mental clarity”

Category: Cognitive · Confidence: 7/10

“Supports healthy nerve function”

Category: Nervous System · Confidence: 7/10

“Supports a positive mood”

Category: Mood · Confidence: 6/10

Get the full substantiation report for Lion's Mane

Includes all 18+ clinical studies analysed, complete claims library, and a ready-to-file substantiation memo.

Join Waitlist for Full Access

Related Ingredients

Phosphatidylserine

24 studies · Cognitive Function

Bacopa Monnieri

46 studies · Memory & Cognitive Function

Ginkgo Biloba

122 studies · Brain Health & Circulation

Key Terms

Randomised Controlled Trial (RCT)Placebo Effect Clinical Endpoint

Frequently Asked Questions

Is lion's mane FDA approved?

Lion's mane is a dietary supplement sold under DSHEA. It does not require FDA approval. It is also consumed as a culinary mushroom.

What are the most studied benefits of lion's mane?

The strongest evidence supports lion's mane for cognitive function improvement, nerve regeneration support, and mood enhancement.

What dosage of lion's mane is used in clinical studies?

Most studies use 500–3,000 mg/day of fruiting body extract. The landmark MCI study used 3,000 mg/day.

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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