What Claims Are Permitted on U.S. Food Labels?

In the US, three categories of claims can be used on food and dietary supplements labels, these include:

• nutrient content claims,
• health claims, and
• structure/function claims.

Nutrient Content Claims

Nutrient content claims refer to any claim that expressly or implicitly characterizes the level of a nutrient of the type required to be in nutrition labeling (that is, a nutrient content claim) made on the label or in labeling of foods (21 CFR 101.13(b)). It applies to conventional foods and dietary supplements (21 CFR 101.13(a)). Nutrient content claims describe the level of a nutrient in the product, using terms such as free, high, and low, or they compare the level of a nutrient in a food to that of another food, using terms such as more, reduced, and lite.

Refer to 21 CFR 101 Subpart D for specific requirements. Examples are given below:

Health Claims

Health claim means any claim made on the label or in labeling of a food, including a dietary supplement, that expressly or by implication, including “third party” references, written statements (e.g., a brand name including a term such as “heart”), symbols (e.g., a heart symbol), or vignettes, characterizes the relationship of any substance to a disease or health-related condition.

Health claims:

• must contain the elements of a substance and a disease or health-related condition;
• are limited to claims about disease risk reduction;
• cannot be claims about the diagnosis, cure, mitigation, or treatment of disease; and
• are required to be reviewed and evaluated by FDA prior to use.

There are two types of health claims: “authorized” and “qualified” health claims.

To be approved by the FDA as an authorized health claim, there must be significant scientific agreement (SSA) among qualified experts that the claim is supported by the totality of publicly available scientific evidence for a substance/disease relationship. The SSA standard is intended to be a strong standard that provides a high level of confidence in the validity of the substance/disease relationship.

The FDA permits the use of 12 specific health claims that are supported by significant scientific evidence, as specified. Refer to 21 CFR 101 Subpart E for specific requirements. Examples are provided below:

Qualified health claims are supported by some scientific evidence, but do not meet the significant scientific agreement standard. To ensure that they are not false or misleading to consumers, qualified health claims must be accompanied by a disclaimer or other qualifying language to accurately communicate the level of scientific evidence supporting the claim.

Different levels of evidence will result in different qualifying language:

1) Second Level: ... “although there is scientific evidence supporting the claim, the evidence is not conclusive.”

2) Third Level: “Some scientific evidence suggests ... however, FDA has determined that this evidence is limited and not conclusive.”

3) Fourth Level: “Very limited and preliminary scientific research suggests... FDA concludes that there is little scientific evidence supporting this claim.”

Companies must submit specific details and supporting evidence to the FDA, following the requirements outlined in 21 CFR 101.70 for health claims, at least 120 days before marketing the product.

Structure/Function Claims

Structure/function claims may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body, for example, “calcium builds strong bones.” In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, “fiber maintains bowel regularity,” or “antioxidants maintain cell integrity.” Structure/function claims may not explicitly or implicitly link the claimed effect of the nutrient or dietary ingredient to a disease or state of health leading to a disease.

Structure/function claims can be used in conventional foods and dietary supplements, and are not pre-approved by FDA. However, the manufacturer must submit a notification with the text of the claim to FDA no later than 30 days after marketing the dietary supplement with the claim, and it must state in a “disclaimer” that: “This (These) statement (s) has (have) not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” FDA does not require conventional food manufacturers to notify FDA about their structure/function claims, and disclaimers are not required for claims on conventional foods.

It is crucial to understand the relevant food laws to successfully export food to the U.S. and ensure compliance with regulations. Click here to learn more about our US Food Label/Advertisement Information Review service.

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