Does ClaimsText replace a regulatory consultant?

No. It does the search, the extraction and the disease-claim screen, and writes down what it did and how far it got. Deciding which claims to make, and signing the memo, stays with the person responsible. Many of the people it is built for are consultants running it for their clients.

Whose name is on the memo?

Whoever reviews and signs it. Each report carries its own brand name, responsible person and compliance officer, set before signing, and the memo prints all three. A consultant can run reports for several client brands from one account, with their own name as the compliance officer on each.

How does ClaimsText analyse the evidence?

ClaimsText searches PubMed for clinical trials on your ingredient, records how many matched and how many it read, and extracts what each study measured: design, population, dose, p-values and effect sizes. It keeps the findings that went against the ingredient as well as the ones in its favour, distinguishes across-group from within-group significance, checks the studied dose against the dose your product delivers, and scores confidence on eight named components with the reasoning written out.

Are the generated claims FDA-compliant?

Every claim is drafted as a structure–function claim and then screened, one criterion at a time, against the ten disease-claim criteria in 21 CFR 101.93(g)(2). The report shows each verdict and the wording that triggered it, so a reviewer can see why a claim passed rather than take it on trust. ClaimsText assists professional review; it does not replace it. The responsible person named in the memo makes the final call and signs it.

What does it say when it could not read everything?

The counts. Each search records how many records matched and how many were retrieved, and a capped search is reported as capped. Where something could not be assessed, the memo says “not assessed” rather than staying silent, because silence in a signed document reads as assurance.

What data sources does ClaimsText use?

PubMed/MEDLINE, and our internal database of PubMed studies already analysed for earlier reports, re-extracted whenever that analysis is out of date. Peer-reviewed human trials: randomised controlled trials, meta-analyses and systematic reviews. The report lists the search terms and the counts it used.

What happens to a client’s formulation?

It is used to produce the report and for nothing else on our side. We do not sell it, and our AI providers are chosen on data-processing terms that exclude training on it. The privacy policy names the processors involved and how long data is kept.

How long does a report take?

Five to fifteen minutes to produce, depending on how much literature there is. Reviewing it takes as long as a review should; the point is that the search, extraction and screen are written down, not that they were quick.

Can I export my reports?

Yes. Both documents, the clinical evidence report and the substantiation memo, export as PDF, formatted for a regulatory file or a client deliverable.

What does ‘reports a month’ mean?

Each report is one ingredient: the complete evidence report, the screened claims and the substantiation memo for that ingredient. Your monthly allowance resets on your billing date.

Can I see a report before I pay?

Yes. The sample report is a complete ashwagandha report, run by ClaimsText’s founder for his own supplement brand, BioStack Labs, with nothing edited out. For your own product, LabelScan at labelscan.claimstext.com checks the label against 21 CFR 101 free and emails the findings; choose a plan when you want full reports on your ingredients.

What is supplement substantiation?

Substantiation is the evidence behind a health claim on a supplement label or in its marketing. The FDA requires structure–function claims to be truthful, non-misleading and substantiated by competent and reliable scientific evidence, and the FTC applies the same standard to advertising. In practice that means human clinical trials, read in full, including the ones that went the other way.

Chondroitin Sulfate: Clinical Evidence & Substantiation Summary

Clinical Trials

Strongest Evidence

Joint Health

Typical Dosage

800–1,200 mg/day

Common Forms

Chondroitin sulfate (bovine)

What Is Chondroitin Sulfate?

Chondroitin sulfate is a glycosaminoglycan found naturally in cartilage. Often combined with glucosamine, chondroitin has its own substantial evidence base for joint health and osteoarthritis symptom management.

Mechanism of action: Chondroitin attracts water into cartilage matrix, maintaining viscoelastic properties. It inhibits degradative enzymes (MMPs, aggrecanases) while stimulating chondrocyte synthesis of proteoglycans and collagen type II. It has direct anti-inflammatory effects via NF-κB inhibition.

Clinical Evidence Summary

Below are 3 key clinical studies on Chondroitin Sulfate. ClaimsText analyses 53+ studies in its full clinical evidence report.

Meta-analysis2017PMID: 28611563

Chondroitin sulfate for knee osteoarthritis: updated meta-analysis

Population: 43 RCTs, 9,110 participants

Key finding: Pharmaceutical-grade chondroitin sulfate significantly reduced pain (ES: -0.63, p<0.001) and improved function. Over-the-counter products showed smaller effects.

RCT, double-blind2019PMID: 30193758

MOVES trial: chondroitin/glucosamine vs celecoxib

Population: 606 patients

Key finding: Glucosamine sulfate + chondroitin sulfate was non-inferior to celecoxib (200 mg/day) for knee pain reduction over 6 months.

Meta-analysis2019PMID: 31842879

Chondroitin sulfate and joint space narrowing

Population: 7 RCTs

Key finding: Chondroitin supplementation significantly slowed joint space narrowing (WMD: 0.13 mm, p=0.001), suggesting structural disease modification.

Evidence-Based Structure–Function Claims

Sample FDA-compliant structure–function claims generated by ClaimsText, each linked to clinical evidence and scored for confidence.

“Supports joint comfort and flexibility”

Category: Joint Health · Confidence: 8/10

“Supports healthy cartilage structure”

Category: Joint Health · Confidence: 8/10

“Supports joint mobility during physical activity”

Category: Mobility · Confidence: 7/10

Get the full substantiation report for Chondroitin Sulfate

Includes all 53+ clinical studies analysed, complete claims library, and a ready-to-file substantiation memo.

See a full sample report

Related Ingredients

Collagen Peptides

41 studies · Skin Health

Turmeric

91 studies · Inflammatory Response

Glucosamine

78 studies · Joint Health

Key Terms

Randomised Controlled Trial (RCT)Meta-Analysis Clinically Effective Dose

Frequently Asked Questions

Is chondroitin FDA approved?

Chondroitin sulfate is a dietary supplement under DSHEA. In Europe, pharmaceutical-grade chondroitin has prescription drug status for osteoarthritis.

Should I take chondroitin with glucosamine?

Clinical trials show benefits for both individual and combined supplementation. The MOVES trial showed the combination was comparable to celecoxib for knee pain.

What dosage is used in clinical studies?

The standard dose is 800–1,200 mg/day. Pharmaceutical-grade products show stronger effects than generic supplements.

Stop Spending Weeks on Substantiation

ClaimsText generates full clinical evidence reports, FDA-compliant structure–function claims, and substantiation memos in minutes — not months.

Read the sample report