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.

Potassium: Clinical Evidence & Substantiation Summary

Clinical Trials

145

Strongest Evidence

Cardiovascular Health

Typical Dosage

2,000–4,700 mg/day (total diet + supplements)

Common Forms

Potassium citrate

What Is Potassium?

Potassium is an essential mineral and electrolyte that maintains intracellular fluid balance, supports nerve conduction, and enables muscle contraction. It is a critical counterpart to sodium in blood pressure regulation.

Mechanism of action: The Na+/K+-ATPase pump maintains high intracellular potassium levels, creating the electrical gradient necessary for action potentials in neurons and myocytes. High potassium intake promotes sodium excretion (natureisis) and relaxes vascular smooth muscle.

Clinical Evidence Summary

Below are 3 key clinical studies on Potassium. Nutra Comp analyses 145+ studies in its full clinical evidence report.

Meta-analysis2013PMID: 23558162

Potassium intake and blood pressure: meta-analysis

Population: 33 RCTs

Key finding: Increased potassium intake (≥3,500 mg/day) significantly reduced systolic BP by 3.49 mmHg and diastolic BP by 1.96 mmHg (p<0.001).

Systematic review2017PMID: 27773926

Potassium and stroke risk: systematic review

Population: 12 prospective cohort studies

Key finding: Highest vs. lowest potassium intake was associated with a 24% reduction in stroke risk (p=0.002).

RCT2018PMID: 30154332

Potassium citrate and bone mineral density

Population: 201 postmenopausal women

Key finding: Potassium citrate (60 mEq/day) significantly reduced urinary calcium excretion and improved BMD markers over 2 years (p<0.05).

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 blood pressure levels already within the normal range”

Category: Cardiovascular · Confidence: 10/10

“Supports healthy electrolyte balance and muscle function”

Category: Electrolytes · Confidence: 9/10

“Supports healthy nervous system signaling”

Category: Neurological · Confidence: 9/10

Get the full substantiation report for Potassium

Includes all 145+ clinical studies analysed, complete claims library, and a ready-to-file substantiation memo.

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Related Ingredients

Magnesium

89 studies · Sleep & Relaxation

Calcium

134 studies · Bone Health

Taurine

33 studies · Cardiovascular & Anti-ageing

Key Terms

Qualified Health Claim Daily Value (DV)Dose-Response Relationship

Frequently Asked Questions

Is potassium FDA approved?

Potassium is an essential mineral. The FDA has authorised a health claim linking potassium-rich diets to reduced stroke and heart disease risk. The Daily Value is 4,700 mg.

Why are potassium supplements limited to 99 mg?

The legacy FDA regulation limits individual supplement doses of potassium salts (like chloride) due to concerns about intestinal lesions from concentrated potassium. Potassium-rich foods and powders have no such limit.

What is the best form?

Potassium citrate and gluconate are typically better tolerated and more bioavailable than potassium chloride. Citrate also provides an alkalizing effect that supports kidney health.

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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