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.

Supplement Compliance

Glossary

Clear, practical definitions of the regulatory and scientific terms every supplement brand needs to know.

Structure–Function Claim

A statement describing the role of a nutrient or dietary ingredient in affecting the normal structure or function of the human body. This is the primary type of claim permitted on dietary supplement labels under DSHEA.

Substantiation

The process of gathering and documenting competent and reliable scientific evidence to support the health-related claims made on dietary supplement labels and marketing materials.

DSHEA (Dietary Supplement Health and Education Act)

The 1994 federal law that defines dietary supplements as a distinct regulatory category and establishes the framework for their manufacture, labelling, and marketing in the United States.

Randomised Controlled Trial (RCT)

A study design in which participants are randomly assigned to either a treatment group or a control (placebo) group, considered the gold standard for evaluating the efficacy of an intervention.

Meta-Analysis

A statistical method that combines the results of multiple independent studies addressing the same question, producing a pooled estimate of effect size with greater statistical power than any individual study.

P-Value

The probability of observing results at least as extreme as those measured, assuming the null hypothesis (no effect) is true. A p-value below the significance threshold (typically 0.05) indicates the result is statistically significant.

Effect Size

A quantitative measure of the magnitude of a treatment effect, independent of sample size. Common metrics include Cohen's d, standardised mean difference (SMD), relative risk (RR), and odds ratio (OR).

Across-Group Significance

Statistical significance measured by comparing outcomes between the treatment group and the control (placebo) group — the gold standard for demonstrating a supplement's efficacy in clinical trials.

Qualified Health Claim

An FDA-authorised claim on a food or supplement label that describes a relationship between a substance and a disease or health condition, supported by some scientific evidence but not meeting the 'significant scientific agreement' standard required for authorised health claims.

cGMP (Current Good Manufacturing Practices)

The FDA's quality standards for the manufacturing, packaging, labelling, and storage of dietary supplements, codified in 21 CFR Part 111. Compliance is mandatory for all supplement manufacturers.

New Dietary Ingredient (NDI)

A dietary ingredient that was not marketed in the United States before October 15, 1994. Manufacturers must submit a pre-market safety notification (NDI notification) to the FDA at least 75 days before marketing a supplement containing an NDI.

Bioavailability

The proportion of a dietary ingredient that enters systemic circulation and is available for biological activity when introduced into the body. Higher bioavailability means more of the ingredient reaches its target tissues.

FDA Warning Letter

An official communication from the FDA to a company or individual that identifies significant regulatory violations and demands corrective action. Warning letters are public records and can trigger marketplace delistings.

FTC Enforcement

The Federal Trade Commission's regulation of advertising claims for dietary supplements. While the FDA regulates labelling, the FTC has jurisdiction over advertising — including websites, social media, email, and paid ads.

Adverse Event Reporting

The mandatory reporting to the FDA of any serious adverse event associated with a dietary supplement. Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, manufacturers must report serious adverse events within 15 business days.

Certificate of Analysis (COA)

A document issued by a qualified testing laboratory that certifies the identity, purity, potency, and composition of a raw material or finished dietary supplement product, based on laboratory testing results.

Proprietary Blend

A mixture of dietary ingredients listed on a supplement label under a single name, where the total weight of the blend is disclosed but the individual amounts of each ingredient within the blend are not.

Daily Value (DV)

The recommended daily intake of a nutrient, established by the FDA for use on food and supplement labels. DVs are used to calculate '% Daily Value' on Supplement Facts panels and help consumers understand how a supplement contributes to their overall nutrient intake.

Supplement Facts Panel

The mandatory labelling panel on dietary supplement products that lists the product's dietary ingredients, their amounts, and their percent Daily Values. It is the supplement equivalent of the 'Nutrition Facts' panel on food products.

Standardised Extract

A botanical extract that has been processed to contain a guaranteed minimum percentage of one or more specific bioactive compounds. Standardisation ensures consistency between batches and enables more reliable comparison to clinical study dosages.

Placebo Effect

A measurable improvement in a health outcome that occurs in the control group of a clinical trial, despite receiving an inactive substance (placebo). The placebo effect must be accounted for when evaluating whether a supplement ingredient has genuine efficacy.

Dose-Response Relationship

The relationship between the amount of a substance administered and the magnitude of its effect. In supplement research, a clear dose-response relationship strengthens the evidence that an ingredient is genuinely causing the observed effect.

Informed Consent

The process by which a clinical trial participant is provided with detailed information about the study — including its purpose, procedures, risks, benefits, and alternatives — and voluntarily agrees to participate.

Clinically Effective Dose

The amount of a dietary ingredient that has been shown to produce a statistically significant health benefit in well-designed human clinical trials, typically measured as mg per day of oral supplementation.

Systematic Review

A comprehensive, structured review of all available research on a specific question, using pre-defined criteria to identify, evaluate, and synthesise relevant studies. Distinguished from a meta-analysis in that it does not necessarily involve statistical pooling of data.

Amazon Supplement Compliance

Amazon's specific policies and requirements for listing dietary supplements on its marketplace, including prohibited claims, required documentation, and enforcement actions like listing suppression and account suspension.

Clinical Endpoint

The specific health outcome measured in a clinical trial to evaluate the effect of an intervention. Endpoints can be primary (the main outcome the study was designed to assess) or secondary (additional outcomes of interest).

Third-Party Testing

Independent laboratory testing of a dietary supplement by an organisation with no financial relationship to the manufacturer. Third-party testing provides unbiased verification of a product's identity, potency, purity, and safety.

Allergen Declaration

The mandatory disclosure on a supplement label of the presence of any of the major food allergens defined by the FALCPA and FASTER Act, including milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame.

GRAS (Generally Recognised as Safe)

A designation meaning a substance is generally recognised by qualified experts as safe for its intended use in food or supplements, based on a history of common use or adequate scientific evidence.

Confidence Interval (CI)

A statistical range that estimates where the true effect of an intervention likely falls, typically expressed as a 95% CI — meaning there's a 95% probability the true value lies within that range.

PubMed

A free searchable database maintained by the National Library of Medicine (NLM) containing over 36 million citations and abstracts from biomedical and life sciences journals.

MEDLINE

The premier bibliographic database of the National Library of Medicine, containing over 29 million references to journal articles in the biomedical and health sciences, indexed with MeSH controlled vocabulary.

Nutrient Content Claim

A claim that characterises the level of a nutrient in a food or supplement, such as 'high in calcium,' 'good source of vitamin C,' or 'low sodium.' These claims are regulated by FDA and must meet specific quantitative criteria.

Clinical Trial

A research study conducted with human participants to evaluate the safety, efficacy, or optimal dosage of a treatment, intervention, or supplement ingredient under controlled conditions.

FDA Small Entity Compliance Guide

FDA publications designed to help small businesses understand and comply with specific regulations, written in plain language with practical examples and step-by-step guidance.

Health Claim

A claim that describes a relationship between a food substance and a disease or health-related condition. Health claims require FDA pre-approval (authorised) or must meet the 'significant scientific agreement' standard.

Disease Claim

A claim that a product can diagnose, treat, cure, mitigate, or prevent a disease. Disease claims are prohibited on dietary supplement labels unless they meet the stringent requirements for authorised health claims.

30-Day Notification (Structure-Function Claim)

The legal requirement under DSHEA to notify FDA within 30 days of first marketing a dietary supplement bearing a structure-function claim. The notification includes the text of the claim and the disclaimer.

Dietary Supplement

A product intended to supplement the diet that contains one or more dietary ingredients (vitamins, minerals, herbs, amino acids, or other substances) and is intended for ingestion as a tablet, capsule, powder, softgel, liquid, or other form.

Label Claims (Types Overview)

An overview of the four main claim types that can appear on dietary supplement labels: structure-function claims, health claims, qualified health claims, and nutrient content claims — each governed by different FDA regulations.

In Vitro Study

A scientific study conducted outside a living organism, typically in test tubes, cell cultures, or petri dishes. In vitro studies test how a substance interacts with cells or tissues in controlled laboratory conditions.

Observational Study

A study that observes the relationship between variables without any experimental manipulation, such as tracking health outcomes in people who already consume a particular supplement versus those who don't.

NMR Identity Testing

Nuclear Magnetic Resonance (NMR) spectroscopy used to verify the identity and purity of raw ingredients, detecting adulterants and ensuring that what's on the label matches what's in the product.

Tolerable Upper Intake Level (UL)

The maximum daily intake of a nutrient that is likely to cause no adverse health effects in the general population. Established by the National Academies' Food and Nutrition Board for vitamins and minerals.

Botanical Ingredient

A plant-derived substance used as a dietary ingredient in supplements, including whole herbs, herbal extracts, essential oils, and plant-derived compounds. Botanicals are the most complex and variable category of supplement ingredients.

Post-Market Surveillance

The ongoing monitoring of a dietary supplement's safety profile after it has been marketed, including tracking adverse event reports, consumer complaints, and emerging scientific evidence.

FTC Substantiation Doctrine

The Federal Trade Commission's requirement that advertisers must have a 'reasonable basis' for advertising claims BEFORE making them. For health claims about supplements, FTC typically requires 'competent and reliable scientific evidence' — usually meaning at least one well-designed human clinical study.

Equivalence Principle (Substantiation)

The principle that evidence from clinical studies on a specific ingredient form, dosage, and population can only substantiate claims for products that are substantially similar to what was studied.

Put This Knowledge to Work

Nutra Comp automates clinical evidence analysis and generates FDA-compliant structure–function claims in minutes.

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