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
Hi there. I’m Lisa Capote, an FDA compliance attorney. Let’s talk about claims — specifically, what you can and can’t say about your dietary supplement.
The FDA recognizes three categories of claims for dietary supplements.
First, nutrient content claims. These describe the level of a nutrient in a product — terms like “high in fiber,” “low in sodium,” or “excellent source of vitamin D.” These are tightly defined by FDA regulations and you can only use them if your product meets specific criteria.
Second, health claims. These link a nutrient or dietary ingredient to a reduced risk of a disease or health condition. Health claims require either significant scientific agreement or FDA authorization. The bar is high — these aren’t something you can create on your own.
Third, structure/function claims. These are the most commonly used by supplement brands. They describe the role of a nutrient or ingredient in the normal structure or function of the body — for example, “supports heart health” or “helps maintain healthy blood sugar levels already in the normal range.” You don’t need FDA pre-approval, but you must have substantiation, and you must include the required disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Get your claims right before your product goes to market. We can help review your label and marketing materials. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.