Grade your claims against clinical evidence. Review your labels for regulatory compliance. Create marketing content you can defend.
Co-founder of Vital Proteins (acquired by Nestlé Health Science, 2020). Fifteen years in FDA/DSHEA dietary supplement compliance. Founder of Friese Regulatory Partners in Chicago.
“Regulatory scrutiny on supplement claims is only going up. The brands that can show their work are going to be fine. This is the tool for showing it.”
Claims Assessment, Label Review, and Content Studio are the core. Everything else supports them.
Add your product and its claims. SubstantiatePro searches PubMed and Google Scholar, then grades each claim against the clinical evidence using FDA’s substantiation framework.
You’ll see exactly which claims are ✓ Strong, Moderate, or Weak, with revision suggestions for anything that needs work. Export a retailer-ready evidence dossier when you’re done.
Upload any supplement label and get a full compliance audit. Structure/function language, required disclaimers, Supplement Facts formatting, allergen declarations, and implied disease claims from your product name.
Every finding cites a specific CFR section, so you’re never left to interpret vague advice.
Paste ad copy, email drafts, or product descriptions. The platform flags disease claims, unsubstantiated superlatives, and implied efficacy your legal team would catch on a good day and miss on a bad one.
Or draft new copy from scratch, constrained to what you can actually say given your evidence. Every suggestion cites the regulation behind it.
Every plan includes the full suite. No feature gating on the tools that matter.
Ask any regulatory question. Answers use your actual products and cite specific CFR sections every time.
Evidence-based research for formulation decisions. Dose-response data, form comparisons, safety profiles.
Track stability data and monitor your live website for compliance drift. Alerts when a spec trends off.
Cross-product evidence sharing. Build a reusable library that re-grades automatically as new studies publish.
| Auto re-grading | Updates when new studies publish |
| Compliance dashboard | Portfolio status at a glance |
| Intel Feed | FDA warning letters, cross-referenced to your claims |
| Substantiation Spotlight | Your best-backed claims, highlighted for marketing reuse |
| Export dossiers | Retailer-ready PDF at one click |
| Audit trail | Full revision history on every product, claim, and label |
Co-founder of Vital Proteins (acquired by Nestlé Health Science, 2020). Founder of Friese Regulatory Partners. Fifteen years of FDA and DSHEA compliance practice out of Chicago.
“The real work of substantiating a claim is tedious: searching the literature, grading studies, cross-checking the regulation, writing up what you found. Most brands skip it — not because they want to cut corners, but because doing it properly across a full product line is too expensive to justify.”
I spent fifteen years in dietary supplement compliance. I co-founded Vital Proteins, sat through FDA audits, wrote CAPAs after Form 483s, and told a lot of founders things they didn’t want to hear about their marketing copy. The pattern was usually the same: the claims were too aggressive, the evidence was thinner than the team believed, and by the time anyone asked a serious question, the budget for answering it was already gone.
The real work of substantiating a claim is tedious: searching the literature, grading studies, cross-checking the regulation, writing up what you found. Most brands skip it, and not because they want to cut corners. Doing it properly across a full product line is just too expensive to justify.
SubstantiatePro is the tool I wish I’d had fifteen years ago. It does the tedious part quickly, ties every answer back to the actual regulation, and leaves you with a record you can hand to a regulator, a retailer, or your own legal team. It won’t replace your lawyer, but it will make their job a lot easier.
Regulatory scrutiny on supplement claims is only going up. The brands that can show their work are going to be fine. This is the tool for showing it.
Every plan includes the full compliance platform, unlimited products, and a 14-day free trial. No credit card required to start.
No contracts · No setup fees · Cancel anytime · Questions? corey@frieseregulatory.com
Start a 14-day free trial. Assess your claims, review your labels, generate content you can defend. No credit card required.