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.

Tongkat Ali: Clinical Evidence & Substantiation Summary

Clinical Trials

Strongest Evidence

Vitality & Hormonal Health

Typical Dosage

200–600 mg/day

Common Forms

Root extract (standardised to eurycomanone)

What Is Tongkat Ali?

Tongkat Ali (Eurycoma longifolia) is a Southeast Asian medicinal herb with emerging clinical evidence for supporting endogenous testosterone production, reducing stress, and improving vitality and sexual health.

Mechanism of action: Tongkat Ali compounds (quassinoids) modulate the conversion of pregnenolone to DHEA and testosterone and reduce SHBG (sex hormone-binding globulin). It also modulates the HPA axis to reduce cortisol levels, fostering an optimal anabolic environment.

Clinical Evidence Summary

Below are 3 key clinical studies on Tongkat Ali. Nutra Comp analyses 24+ studies in its full clinical evidence report.

RCT, double-blind2013PMID: 23754792

Tongkat Ali and stress hormones: RCT

Population: 63 individuals with moderate stress

Key finding: 200 mg/day of Tongkat Ali significantly reduced cortisol (-16%) and increased testosterone (+37%) and significantly improved tension scores (p<0.05).

RCT2019PMID: 31398862

Tongkat Ali and testosterone in older men

Population: 105 men (50–70 years)

Key finding: Tongkat Ali supplementation significantly increased total and free testosterone levels and improved erectile function scores over 12 weeks (p<0.01).

Review2021PMID: 33992294

Eurycomanone and ergogenic effects: systematic review

Population: Clinical and animal data

Key finding: Tongkat Ali extract enhanced muscle strength and lean body mass when combined with resistance training, likely through direct hormonal modulation and cortisol reduction.

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 free testosterone levels already within the normal range”

Category: Hormonal · Confidence: 7/10

“Supports a healthy response to everyday stress and cortisol levels”

Category: Recovery · Confidence: 8/10

“Supports energy, vitality, and sexual health”

Category: Vitality · Confidence: 8/10

Get the full substantiation report for Tongkat Ali

Includes all 24+ clinical studies analysed, complete claims library, and a ready-to-file substantiation memo.

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Related Ingredients

Ashwagandha

34 studies · Stress & Anxiety

Zinc

92 studies · Immune Function

Boron

18 studies · Bone & Hormonal Health

Key Terms

Randomised Controlled Trial (RCT)Bioavailability Standardised Extract

Frequently Asked Questions

Is Tongkat Ali safe?

Human clinical trials using standardized extracts at doses of 200–600 mg show a very high safety profile. It should not be used by individuals with hormone-sensitive cancers.

How fast do I feel the effects?

Stress reduction (cortisol) can be felt within 2–4 weeks. Changes in testosterone and vitality typically require 8–12 weeks of consistent use.

What is eurycomanone?

Eurycomanone is the primary active quassinoid in Tongkat Ali. Look for extracts standardized to at least 0.5%–2% eurycomanone to ensure clinical potency.

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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