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.

Boron: Clinical Evidence & Substantiation Summary

Clinical Trials

Strongest Evidence

Bone & Hormonal Health

Typical Dosage

3–10 mg/day

Common Forms

Sodium borate

What Is Boron?

Boron is a bioactive trace mineral that impacts the metabolism of other minerals (calcium, magnesium) and the levels of steroid hormones. It is increasingly studied for bone health, joint support, and hormonal optimization.

Mechanism of action: Boron reduces the excretion of calcium and magnesium in urine and increases the half-life of vitamin D and estrogen. It also reduces SHBG (sex hormone-binding globulin) levels, potentially increasing free testosterone. Boron has potent anti-inflammatory effects by reducing CRP.

Clinical Evidence Summary

Below are 3 key clinical studies on Boron. Nutra Comp analyses 18+ studies in its full clinical evidence report.

RCT, double-blind crossover2011PMID: 21631525

Boron supplementation and steroid hormones: RCT

Population: 8 healthy men

Key finding: 10 mg boron/day for 1 week significantly reduced CRP (anti-inflammatory) and significantly increased free testosterone by 28% (p<0.05).

RCT2018PMID: 30154332

Calcium fructoborate and joint comfort: clinical evaluation

Population: 60 adults with knee OA

Key finding: Calcium fructoborate (216 mg/day) significantly improved joint comfort and mobility and reduced inflammatory markers within 14 days (p<0.01).

Mechanism review2021PMID: 33260899

Boron and bone mineral metabolism: review

Population: Clinical and animal data

Key finding: Boron is a required co-regulator for optimal calcium and vitamin D utilization. Deficiency impairs bone recovery and mineralization.

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 bone mineral density and calcium metabolism”

Category: Bone Health · Confidence: 8/10

“Supports healthy free testosterone levels already within the normal range”

Category: Hormonal · Confidence: 6/10

“Supports joint comfort and healthy inflammatory response”

Category: Inflammation · Confidence: 7/10

Get the full substantiation report for Boron

Includes all 18+ clinical studies analysed, complete claims library, and a ready-to-file substantiation memo.

Join Waitlist for Full Access

Related Ingredients

Vitamin D3

127 studies · Bone Health & Calcium Metabolism

Magnesium

89 studies · Sleep & Relaxation

Calcium

134 studies · Bone Health

Key Terms

Randomised Controlled Trial (RCT)Bioavailability Clinically Effective Dose

Frequently Asked Questions

Is boron FDA approved?

Boron is sold as a dietary supplement. There is no established FDA Daily Value, but the Tolerable Upper Limit is set at 20 mg/day for adults.

Does boron really increase testosterone?

Clinical data shows it can reduce SHBG, which increases the percentage of 'free' (bioactive) testosterone. While significant, it is not a direct hormonal treatment and results vary by individual baseline.

What is the best form?

Calcium fructoborate is a naturally occurring plant form found in fruits and vegetables and has some of the strongest joint-health clinical data. Glycinate is also highly bioavailable.

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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