5. Claim Requirements

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General Foods
USA

This section provides information on the definition of different types of claims and any restrictions or allowance of claims as well as claim registration processes.

5.1 Overview of Claims

5.1.1 Types & Definitions

The following types of claims are defined in regulations and can be made on food under specific conditions.

Nutrient Content Claims [1]
Health Claims [2]
Descriptive Claims That Are Neither Nutrient Content Claims nor Health Claims [3]
Structure/Function Claims [4]

5.1.2 List of Prohibited Claims

Any statement that indicates a consumer food or beverage product is meant to diagnose, treat, mitigate, prevent, or cure a disease is prohibited as those claims are reserved for pharmaceutical products and medical foods.

5.2 Nutritional Claims

5.2.1 Permitted Claims

Conditions for the use of Nutrient Content Claims are described in 21 CFR Part 101 Subpart D [1].

5.2.2 Nutritional Claim Registration

(a) For nutritional claims that are already permitted for use: There is no requirement to register a label for an accepted nutritional claim.

(b) For nutritional claims that are not currently permitted for use: Outside the scope of this guidebook.

5.3 Health Claims

5.3.1 Permitted Claims

Conditions for the use of health claims are described in 21 CFR Part 101 Subpart E [2].

5.3.2 Health Claim Registration

(a) For health claims that are already permitted for use: There is no requirement to obtain pre-approval of a consumer food product that contains an FDA-accepted health claim.

(b) For nutritional claims that are not currently permitted for use: Outside the scope of this guidebook.