In this short video, FDA compliance attorney Lisa Capote 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 food label claims — because getting these wrong can put your entire business at risk.
The FDA regulates what you can say about your food product on the label. There are three main categories of claims for food.
Nutrient content claims describe the level of a nutrient in the food — terms like “low fat,” “high fiber,” “reduced sodium,” or “excellent source of vitamin C.” These terms have specific definitions under FDA regulations at 21 CFR Part 101. You can’t use them unless your product meets the specific criteria for that claim.
Health claims link a food or nutrient to a reduced risk of a disease or health-related condition. These require either FDA authorization based on significant scientific agreement, or they can be qualified health claims with appropriate disclaimers.
Structure/function claims for food describe how a nutrient or ingredient maintains normal structure or function — for example, “calcium builds strong bones.” These are permitted for conventional foods but cannot imply treatment, cure, or prevention of a disease.
Here’s the big risk: if your claim crosses the line from a food claim into drug territory — if it implies your food treats or prevents a disease — your food may be regulated as a drug, which triggers an entirely different set of requirements.
Review every claim on your label and in your marketing materials before you go to market. We help food brands structure compliant claims. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.