Claim Substantiation & FDA/FTC Risk
Know whether the evidence supports your claims before they become a problem.
Practical insights on evaluating product claims, finding evidence gaps, and understanding where weak scientific support can create FDA, FTC, legal, retailer, or commercial risk.
Strong claims begin with stronger science.
Having studies does not automatically mean your claim is supported. The evidence must match what you are selling and what you want to say. These articles help you see where problems can arise before they become costly.
Why Most Supplement Claims Won’t Survive FDA Scrutiny — And What to Do About It
Your product may have studies behind it, but that does not mean they support your claims. See the common gaps and what to check before problems arise.
5 min readLatest Articles in Claim Substantiation & FDA/FTC Risk
Your Product Has Studies. But Do They Support Your Claims?
Having studies is not the same as having evidence for the claims on your label, website, or advertising,…
The Probiotic Strain Problem: Why the Species Name on Your Label Isn’t Enough
Different probiotic strains can produce different effects, so evidence from one strain may not support another. This article…
Structure/Function Claims Under DSHEA: What’s Allowed, What’s Not, and Why It Matters
Structure/function claims may be permitted under DSHEA, but compliant wording alone is not enough. Learn where supplement claims…
Questions this topic helps answer.
What is scientific claim substantiation?
It determines whether the scientific evidence actually supports the specific claim you want to make.
Does having published studies automatically substantiate a claim?
No. The research must be relevant to your product or ingredient, dose, population, outcome, and specific claim.
Why are substantiation files important?
They show the evidence behind your claims and help you prepare for regulatory, retailer, or legal scrutiny.
How does FSC support scientific claim substantiation?
FSC reviews your claims and evidence, identifies gaps, and helps determine what the science can defensibly support.
Practical insights on claims, evidence, and risk.
Browse FSC articles on claim substantiation, evidence gaps, FDA/FTC risk, and what the science actually supports.
Need independent scientific review of your product claims?
FSC can review your claims and evidence, identify gaps, and help you understand what the science supports.