Built onFDA § 101.93(c)·FTC §255 disclosure guidance·21 CFR Part 111·DSHEA claim categories
Before & After
From scattered to substantiated.
Four things that change the moment your team starts using SubstantiatePro.
claims_v2_FINAL.xlsx
claims_v2_FINAL_v3.xlsx
study_USE_THIS_ONE.pdf
RE: RE: FW: compliance.eml
label_DRAFT_3_LATEST.docx
which one is current??
Invoice#INV-0847
Reg. consulting
18 hrs @ $400/hr
Due$7,200.00
Compliance Health
94%
Claim · Joint HealthStrong
“Supports joint health”
Strong
Strong
Moderate
Label extractedSFP + claims
Marketing reviewed3 pieces
FDA monitoring0 alerts
Substantiation lives in spreadsheets
Claims linked to studies in one system
No grade on defensibility
FDA-aligned grade on every claim
Issues caught after launch
Marketing reviewed before publish
Hourly consultants, weeks per review
Real-time review at predictable cost
Audit
Catch the claims that trigger warning letters.
- •Every claim classified as structure/function, disease, nutrient content, or borderline
- •Disease claims evaluated against the 10 criteria from 21 CFR 101.93(g)
- •High-risk language flagged with the specific regulatory reference
- •Suggested fix on every flagged claim
- •Works on claims from your label, your marketing, or claims you add directly
✓ Disease claims are where enforcement starts
FDA warning letters routinely cite disease claim language as the basis for action. SubstantiatePro classifies every claim against 21 CFR 101.93(g) the same way regulators do. You see the problem before they do.
Substantiate
Every claim, backed by your research.
- •Drag-and-drop study PDFs onto any product profile
- •AI extracts metadata, methodology, and key findings
- •Per-claim support analysis with rationale grounded in the study
- •Suggested additional claims you could make based on the evidence
✓ FTC requires evidence
FTC’s substantiation standard requires competent and reliable scientific evidence for every objective claim. The studies you already have are evidence. They just need to be matched to the claims they support.
Create
Every piece of marketing, reviewed, approved, and audit-ready.
- •Text content: ad copy, emails, product descriptions
- •Image content: product photos, social graphics, ad creative
- •Scheduled scans of live websites, social feeds, and email archives
- •Net-new copy drafted within regulatory constraints
- •Submit drafts for approval with timestamped sign-off history
✓ Why it matters
FTC enforcement actions against supplement brands frequently originate in marketing copy, not labels. Approval workflows mean every published asset has a documented sign-off chain. Useful for retailer reviews, FTC inquiries, and any conversation that starts with ‘who approved this?’
Ask Pro
Regulatory expertise, on demand.
- •Structure/function rewrites
- •Ingredient FDA status and limits
- •Whether a claim needs a qualifier
- •Citations in every answer, not hand-waved hedges
- •Grounded in current FDA, FTC, and USDA rules
✓ No callbacks required
Answers in seconds, citations in every response. Or pass a borderline question to your regulatory consultant with the full context attached.
Pricing
$399a month
Built for regulatory and marketing teams.
Add teammates for $99/mo each.
Request access 14 days free. No credit card required.
Every label parsed
Supplement Facts panel, ingredients, and claims extracted from PDFs and images into structured product records.
Every claim graded
PubMed evidence analysis with FDA-aligned grading on study type, sample size, dose alignment, and peer review.
Marketing reviewed
Pre-publication compliance review for websites, emails, social posts, and ad copy.
Ask Pro on demand
AI regulatory advisor trained on FDA guidance, FTC rules, and supplement industry precedents.
Audit-ready dossiers
Customer-branded substantiation dossiers ready for retailer audits and regulatory inquiries.
FDA & FTC monitoring
Warning letter trends and enforcement actions tracked across your category.
Unlimited products. Full FDA + FTC coverage. Email support included.
Enterprise plans available for multi-brand portfolios. Contact sales