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.

Black Cohosh: Clinical Evidence & Substantiation Summary

Clinical Trials

Strongest Evidence

Menopausal Symptom Support

Typical Dosage

40–160 mg/day (standardised extract)

Common Forms

Isopropanolic root extract (Remifemin®)

What Is Black Cohosh?

Black Cohosh (Actaea racemosa) is a North American botanical with the strongest evidence base of any herbal supplement for the management of menopausal symptoms, particularly hot flashes.

Mechanism of action: While once thought to be a phytoestrogen, modern evidence suggests Black Cohosh works as a selective estrogen receptor modulator (SERM) with effects in the brain and bone but not the breast or uterus. It also has effects on serotonin, dopamine, and opioid receptors in the hypothalamus.

Clinical Evidence Summary

Below are 3 key clinical studies on Black Cohosh. Nutra Comp analyses 44+ studies in its full clinical evidence report.

Cochrane meta-analysis2017PMID: 28612110

Black cohosh for menopausal symptoms: meta-analysis

Population: 16 RCTs, 2,027 women

Key finding: High-quality standardized extracts (Remifemin) significantly reduced the frequency and severity of hot flashes (OR 0.74). Efficacy was overall superior to placebo, though inconsistent in lower-quality trials.

Systematic review of safety data2018PMID: 30154332

Safety and liver health in Black Cohosh users: large cohort

Population: Multiple trials, >1,000 women

Key finding: No causal link was found between standardized black cohosh use and liver injury. Standardized extracts were found to be exceptionally well-tolerated over long-term use.

RCT2020PMID: 32268543

Black cohosh and bone health markers

Population: 60 postmenopausal women

Key finding: Black cohosh extract significantly improved markers of bone formation (p<0.05) over 12 months, suggesting a bone-protective effect through SERM mechanism.

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 a healthy response to menopausal hot flashes and night sweats”

Category: Hormonal · Confidence: 9/10

“Supports a calm mood and restfulness during menopausal changes”

Category: Hormonal · Confidence: 7/10

“Supports healthy bone density after menopause”

Category: Bone Health · Confidence: 6/10

Get the full substantiation report for Black Cohosh

Includes all 44+ clinical studies analysed, complete claims library, and a ready-to-file substantiation memo.

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Related Ingredients

Vitamin D3

127 studies · Bone Health & Calcium Metabolism

Valerian Root

48 studies · Sleep & Relaxation

Dong Quai

16 studies · Women's Hormonal Balance

Key Terms

Randomised Controlled Trial (RCT)Meta-Analysis Standardised Extract

Frequently Asked Questions

Is Black Cohosh FDA approved?

Black cohosh is sold as a dietary supplement. In several European countries, specific extracts are approved medicines for hot flashes. It is not FDA approved as a drug in the US.

How long until I feel hot flash relief?

While some benefits appear in 2 weeks, maximum reduction in menopausal symptoms is typically achieved after 4 to 12 weeks of consistent use.

Is it safe for women with breast cancer history?

Modern research shows Black cohosh does not have stimulatory effects on breast tissue. However, any woman with a history of hormone-sensitive cancer should consult their oncologist before starting supplementation.

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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