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FDA Regulations on Food Health Claims

How to design food labeling to communicate food and nutrition information.


FDA Basics for Industry

FDA Basics for Industry


Are You Confused About FDA Allowed Label Claims?

Food health claims are tightly regulated by The Food and Drug Administration (FDA). There are 3 basic FDA health claims that are guidelines for consumer packaged goods brands to accurately communicate health claims on food labels. The regulations are complex and can be found at the FDA Label Claims Web Site. Here is a broad overview and if you are in the stages of developing packaging, you should spend some time on the FDA Label Claims web site. You should also check out the FDA for Industry pages which has basic information regulations affecting the food industry and is also user-friendly format.

Health Claims Meeting Significant Scientific Agreement (SSA). Essentially these are claims that have solid scientific backing. FDA has a very specific list as well as the wording allowed on the label. You are surely familiar with ... "adequate calcium and vitamin D intake, throughout life, in a healthful diet, are essential to reduce osteoporosis risk" and " diets low in saturated fat and cholesterol "may" or "might" reduce the risk of heart disease"

Structure/Function Claims . These describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans. An example we all have seen and heard "calcium builds strong bones", "fiber maintains bowel regularity" or "antioxidants maintain cell integrity". The FDA says they may describe general well-being from consumption of a nutrient or dietary ingredient.

Qualified Health Claims. These are the most recent and have been driven by new product development in the area of Better for You foods and Functional Foods. These claims characterize a relationship between a specific food component and a disease (e.g., lung cancer or heart disease) or health-related condition (e.g., high blood pressure), and are supported by scientific evidence. Important: These make statements about diet/disease relationships when the science supporting the claim did not meet the significant scientific agreement standard. The caveat: the claim about the relationship was stated or "qualified" in such a way as to not mislead consumers. According to FDA, these "... differ from SSA health claims in that they must be accompanied by a disclaimer or otherwise qualified."

The driver for Qualified Health Claims comes from food brands petitioning the FDA based on their own research and ostensibly to give the brand a competitive edge during new product launch. Of course other brands who meet the criteria will qualify as well.

The Future of Health Claims

As Functional Foods, Better For You and Natural foods continue to grow, expect more Qualified Health Claims to come down from FDA. Expect new product development to center more and more on products that can meet these FDA guidelines.

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