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.

Dong Quai: Clinical Evidence & Substantiation Summary

Clinical Trials

Strongest Evidence

Women's Hormonal Balance

Typical Dosage

500–2,000 mg/day

Common Forms

Dong quai root extract

What Is Dong Quai?

Dong Quai (Angelica sinensis) is often referred to as the 'female ginseng' in Traditional Chinese Medicine. It has emerging clinical evidence for supporting women's hormonal balance and reproductive health.

Mechanism of action: Dong quai contains ferulic acid and ligustilide, which have anti-inflammatory and mild hormonal-modulating effects. It is thought to improve uterine blood flow and provide smooth muscle relaxation.

Clinical Evidence Summary

Below are 3 key clinical studies on Dong Quai. Nutra Comp analyses 16+ studies in its full clinical evidence report.

RCT2013PMID: 23558162

Dong quai and menopausal symptoms: RCT

Population: 71 postmenopausal women

Key finding: Dong quai combined with chamomile significantly reduced the frequency and intensity of hot flashes and night sweats (p<0.01) vs placebo.

Review2020PMID: 32432219

Angelic polysaccharide and blood health: clinical evidence

Population: Multiple clinical and preclinical studies

Key finding: Polysaccharides in Dong quai demonstrated support for healthy red blood cell production and provided significant antioxidant support in hematopoietic stem cells.

Review2019PMID: 31142457

Dong Quai and inflammation markers in vivo

Population: Clinical and animal data

Key finding: Dong Quai demonstrated anti-inflammatory effects through the inhibition of COX enzymes, supporting its traditional use for menstrual comfort.

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 reproductive hormones and menstrual comfort”

Category: Women's Health · Confidence: 6/10

“Supports healthy blood flow and uterine tone”

Category: Women's Health · Confidence: 6/10

“Supports a healthy response to periodic menopausal changes”

Category: Hormonal · Confidence: 7/10

Get the full substantiation report for Dong Quai

Includes all 16+ clinical studies analysed, complete claims library, and a ready-to-file substantiation memo.

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Related Ingredients

Magnesium

89 studies · Sleep & Relaxation

Black Cohosh

44 studies · Menopausal Symptom Support

Key Terms

Randomised Controlled Trial (RCT)Bioavailability Dose-Response Relationship

Frequently Asked Questions

Is Dong Quai FDA approved?

Dong Quai is sold as a dietary supplement and does not require FDA drug approval.

When should I avoid Dong Quai?

Due to its potential effects on the blood-clotting process and its traditional use in regulating menstrual flow, it should not be used during pregnancy, breastfeeding, or by individuals on blood-thinning medications.

What is the primary benefit?

Traditionally and in emerging research, it is used to support hormonal balance, PMS symptoms, and menopausal comfort.

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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