In this short video, FDA compliance attorney Lisa Capote of Capote Law Firm covers key FDA compliance guidance. Watch below, then read the full transcript.
Video Transcript
Hey there. I’m Lisa Capote, an FDA compliance attorney. Let’s talk about health claims on dietary supplements — and the science that needs to back them up.
There are three types of claims you can make on a dietary supplement: nutrient content claims, health claims, and structure/function claims. The type of claim you use determines how much scientific evidence you need.
Health claims — which link a specific nutrient or ingredient to a reduced risk of a disease — require prior FDA authorization. They need to be supported by significant scientific agreement among qualified experts.
Structure/function claims are the most commonly used. These describe how a nutrient affects the normal structure or function of the body — for example, “calcium builds strong bones” or “vitamin C supports immune function.” You don’t need FDA pre-approval for these, but you do need competent and reliable scientific evidence to support them.
Here’s the critical point: the FTC and FDA both have the authority to go after unsupported claims. “Competent and reliable scientific evidence” isn’t just two studies you found online — it means well-designed studies that show your specific product or ingredient produces the claimed effect.
Before you put a claim on your label, make sure you can back it up. We help clients evaluate their evidence and structure compliant claims. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.