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.

Milk Thistle: Clinical Evidence & Substantiation Summary

Clinical Trials

Strongest Evidence

Liver Health & Detoxification

Typical Dosage

140–420 mg/day (silymarin equivalent)

Common Forms

Milk thistle extract (standardised to 80% silymarin)

What Is Milk Thistle?

Milk Thistle (Silybum marianum) is a botanical extract containing silymarin, a complex of flavonolignans with potent antioxidant and hepatoprotective properties. It is the most studied herbal supplement for liver support.

Mechanism of action: Silymarin acts as a radical scavenger and inhibits lipid peroxidation. It also increases ribosomal RNA synthesis, stimulating liver cell regeneration, and inhibits the binding of toxins to hepatocyte cell membrane receptors.

Clinical Evidence Summary

Below are 3 key clinical studies on Milk Thistle. Nutra Comp analyses 58+ studies in its full clinical evidence report.

Systematic review and meta-analysis2017PMID: 28612110

Milk thistle for liver health: meta-analysis

Population: 19 RCTs

Key finding: Milk thistle supplementation significantly reduced liver enzymes ALT and AST (p<0.01) in patients with NAFLD and hepatitis populations.

Meta-analysis2020PMID: 32432219

Silymarin and metabolic parameters in diabetes

Population: 7 RCTs

Key finding: Silymarin supplementation significantly reduced fasting glucose and HbA1c (p=0.03) in type 2 diabetes patients, likely through improved hepatic insulin sensitivity.

RCT crossover2019PMID: 31142457

Phytosome technology and silybin bioavailability

Population: 12 healthy adults

Key finding: Silybin phytosome (Siliphos) showed 4–5x higher bioavailability compared to standardized 80% silymarin extracts.

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 liver function and detoxification”

Category: Liver Health · Confidence: 9/10

“Provides potent antioxidant support for hepatocyte integrity”

Category: Antioxidant · Confidence: 8/10

“Supports healthy metabolic parameters already within the normal range”

Category: Metabolism · Confidence: 7/10

Get the full substantiation report for Milk Thistle

Includes all 58+ clinical studies analysed, complete claims library, and a ready-to-file substantiation memo.

Join Waitlist for Full Access

Related Ingredients

NAC (N-Acetyl Cysteine)

53 studies · Antioxidant & Detoxification

Berberine

47 studies · Blood Sugar Support

Turmeric

91 studies · Inflammatory Response

Key Terms

Randomised Controlled Trial (RCT)Bioavailability Standardised Extract

Frequently Asked Questions

Is milk thistle FDA approved?

Milk thistle is sold as a dietary supplement. In Europe, silymarin extracts (Legalon) are used as drugs for toxic liver damage and cirrhosis. It is not FDA approved as a drug in the US.

How long should I take milk thistle?

Most clinical studies for liver enzyme reduction last 8 to 24 weeks. It is considered safe for long-term use.

Does milk thistle help with skin?

By supporting hepatic detoxification and providing systemic antioxidant support, some users notice improvements in skin clarity, though direct clinical evidence for acne is limited.

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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