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.

Valerian Root: Clinical Evidence & Substantiation Summary

Clinical Trials

Strongest Evidence

Sleep & Relaxation

Typical Dosage

300–600 mg (before bed)

Common Forms

Valerian root extract (0.8% valerenic acid)

What Is Valerian Root?

Valerian (Valeriana officinalis) is a traditional sedative herb used for centuries to improve sleep quality and reduce mild anxiety. It is one of the most studied herbal sleep aids in modern pharmacology.

Mechanism of action: Valerenic acid and other compounds in Valerian act on GABA-A receptors, increasing GABA release and inhibiting GABA reuptake in the synaptic cleft. This increases the availability of the body's primary inhibitory neurotransmitter, fostering relaxation and sleep onset.

Clinical Evidence Summary

Below are 3 key clinical studies on Valerian Root. Nutra Comp analyses 48+ studies in its full clinical evidence report.

Meta-analysis2012PMID: 20590480

Valerian root for sleep quality: meta-analysis

Population: 16 RCTs

Key finding: Valerian supplementation significantly improved subjective sleep quality (p<0.01) and reduced the time to fall asleep (sleep latency) vs placebo.

RCT2013PMID: 23320030

Valerian vs. placebo for occasional anxiety

Population: 36 adults with GAD

Key finding: Valerian root extract (100 mg TID) significantly reduced anxiety scores (p=0.04) and was well tolerated without daytime sedation.

RCT2016PMID: 27471106

Valerian root and menopausal sleep disturbances

Population: 100 postmenopausal women

Key finding: 530 mg valerian BID significantly improved sleep quality and reduced hot flash frequency (p<0.05) over 8 weeks.

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 restfulness”

Category: Sleep · Confidence: 8/10

“Supports a calm and relaxed mood”

Category: Mood · Confidence: 7/10

“Supports healthy sleep quality during times of occasional stress”

Category: Sleep · Confidence: 8/10

Get the full substantiation report for Valerian Root

Includes all 48+ 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

L-Theanine

28 studies · Relaxation & Focus

Melatonin

112 studies · Sleep

Key Terms

Randomised Controlled Trial (RCT)Meta-Analysis Standardised Extract

Frequently Asked Questions

Does valerian have a hangover effect?

Unlike some pharmaceutical sleep aids, valerian is typically not associated with 'morning grogginess' or daytime sedation when used at recommended doses.

Is valerian FDA approved?

Valerian is sold as a dietary supplement. In many European countries, it is an approved over-the-counter medicine for sleep and anxiety. It is not FDA approved as a drug in the US.

Why does it smell so bad?

The characteristic pungent smell of valerian root is due to its valerenic acid and volatile oils. This is a marker of its potency and authenticity.

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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