Built onFDA § 101.93(c)·FTC §255 disclosure guidance·21 CFR Part 111·DSHEA claim categories
Before & After
From scattered to substantiated.
Five things that change the moment your team starts using SubstantiatePro.
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
Sign-offs lost in email threads
Approval trail on every published claim
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.
- •Knows your products, claims, and the studies behind them
- •Structure/function rewrites
- •Ingredient FDA status and limits
- •Whether a claim needs a qualifier
- •Citations in every answer
- •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.
Substantiation Records
The file your records should already look like.
Regulators and retailers expect organized records of the evidence behind every claim. Most brands keep theirs in scattered PDFs and email threads. SubstantiatePro keeps it in a structured file you can produce on request.
A substantiation file per claim
Every claim is tied to the studies that support it, with grading, dose alignment, and a methodology summary. Indexed by ingredient and product.
Timestamped audit trail
Every approval, override, and revision is logged with the user, the time, and the rationale. The record shows who made each compliance decision and when.
Automatic re-evaluation on reformulation
When a dose or ingredient changes, the platform flags which substantiation grades may no longer apply. Records stay current with the product.
Excerpt from a SubstantiatePro substantiation dossier
Pricing
Built for regulatory and marketing teams.
Entry
$299/mo
$99/mo per additional seat
10 products For a focused catalog
1 seat included Add seats at $99/mo each
Email support Help when you need it
Add products, $12/mo each Scale your catalog anytime
Pro
$599/mo
$99/mo per additional seat
50 products For an active portfolio
1 seat included Add seats at $99/mo each
Priority support and onboarding Guided setup call, priority response
Add products, $8/mo each Scale your catalog anytime
Enterprise
Custom
Custom pricing for large portfolios
Unlimited products Across all your brands
Multi-brand portfolios Manage every label in one place
Dedicated onboarding and support A direct line to our team
14 days free. No credit card required.
Every plan includes
Substantiation dossiers
Customer-branded, audit-ready evidence reports
All features
Audit, Substantiate, Create, Ask Pro, approval workflows
Intel feed
FDA enforcement signals, early
Substantiation that holds
Weak claims filtered out
Consistent messaging
Aligned across every channel
Compliance health
Portfolio status at a glance
Audit trail and re-evaluation
Every change logged, grades flagged on reformulation
Email support
Direct help when you need it