Built on21 CFR 101.93·FTC 255 disclosure guidance·21 CFR Part 111·DSHEA claim categories
See it in action
The full platform in under three minutes.
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 screens every claim against the same criteria regulators apply. 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
- •For every “can we say this?”
- •Talks through the gray areas
- •Citations in every answer
- •Built on the regulations, current through live search
No callbacks required
Answers in seconds, citations in every response. Or pass a borderline question to your regulatory consultant with the full context attached.
Substantiate Smarter
SubstantiatePro keeps every claim, its supporting research, and the decisions behind it in one structured record. Develop, launch, and market your products with confidence, knowing the messaging is compliant and backed by evidence.
Before
After
A product profile in SubstantiatePro
Pricing
Claims you can
stand behind.
The full platform on every plan.
Individual
$299/mo
For one person who owns compliance.
1 user
The full platform, from label upload to retailer-ready dossier
Unlimited products
Audit-ready dossiers and defensibility reports
Real human support
Live onboarding
Monthly AI capacity included
Team
$499/mo
For regulatory, quality, and marketing on one record.
5 users included
The full platform, from label upload to retailer-ready dossier
Unlimited products
Audit-ready dossiers and defensibility reports
Real human support
Live onboarding
50% more monthly AI capacity
Approval workflow with team sign-off
Add users anytime, $49/mo each
7 days free. No credit card required.
Need more room? One-time Standard and Pro Pack data packages add capacity and carry over until used. Pricing in your dashboard.
Larger or multi-brand operation? Contact us for custom capacity and users.
From the founder
Built from inside the supplement industry.
SubstantiatePro was created by Corey Friese, co-founder of Vital Proteins (acquired by Nestlé Health Science in 2020) and founder of Friese Regulatory, a dietary supplement regulatory consulting practice in Chicago.
Knowing firsthand the challenge brands face maintaining compliance across their product line and marketing channels, he built SubstantiatePro to give them one platform for substantiating and defending their claims.
Corey Friese, FounderLinkedIn