U.S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
A Food Labeling Guide
September, 1994 (Editorial revisions June, 1999)

A Food Labeling Guide
Food Labeling CFR References

Chapter VI--Claims

Questions 1 - 25

Questions	Answers
1. What is a nutrient content claim?	It is a claim on a food product that directly or by implication characterizes the level of a nutrient in the food (e.g., "low fat" or "high in oat bran"). Nutrient content claims are also known as "descriptors". 21 CFR 101.13(b)
2. What nutrient levels must be present in a food to use nutrient content "descriptors" on food labels?	The nutrient levels needed to use nutrient content claims are shown in Appendices A and B.
3. If a nutrient content claim is not included in FDA's regulations, may it be used on a label?	If a claim is provided for an FDA regulation, then it may be used in accordance with that regulation. A firm may also submit a notification for a claim based on an authoritative statement by a U.S. government scientific body under Section 403(r)(2)(G) of the FD&C Act. All other claims are prohibited. 21 CFR 101.13(b)
4. Where are nutrient content claims specifically defined by the agency?	In 21 CFR 101.13, Subpart D of part 101, and parts 105 and 107. 21 CFR 101.13(b)
5. Are there any requirements for nutrient content claims regarding the size or style of type?	Yes. A nutrient content claim may be no more than twice as prominent as the statement of identity (the name of the food). Specifically, the type size of the claim may be no more than two times the type size of the statement of identity. If the style of the type makes the claim unduly prominent compared to the statement of identity, it will be in violation of the regulations (even if the size of the type is appropriate). 21 CFR 101.13(f)
6. Is there any additional information that is required when a claim is made?	Yes. A variety of information is required depending on the claim and what information is needed to prevent the claim from being misleading. Nutrition labeling is required for virtually all claims. 21 CFR 101.13(g) & 101.13(n)
7. What is a disclosure statement?	It is a statement that calls the consumer's attention to one or more nutrients in the food, that may increase the risk of a disease or health related condition that is diet related. The disclosure statement is required when a nutrient in a food exceeds certain prescribed levels. The disclosure statement identifies that nutrient (e.g. "See nutrition information for sodium content.") 21 CFR 101.13(h)(1)-(3)
8. When is a disclosure statement required?	It is a requirement when a nutrient content claim is made and the food contains one or more of the following nutrients in excess of the levels listed below per reference amount customarily consumed, per labeled serving, or, for foods with small serving sizes, per 50 grams (different levels apply to main dish meal-type products-see question 20): Fat                   13.0 grams Saturated Fat    4.0grams Cholesterol      60 milligrams Sodium            480 milligrams CFR 101.13(h)(1)
9. How must the disclosure statement be presented on the label?	It must be in legible boldface type, in distinct contrast to other printed or graphic matter and generally in a type size at least as large as the net quantity of contents declaration. It must also be placed immediately adjacent to the claim. 21 CFR 101.13(h)(4)(i)
10. What is meant by "immediately adjacent to"?	"Immediately adjacent to" means just that, right next to the claim. There may be no intervening material such as vignettes or other art work or graphics. However, other required information such as the statement of identity (when the claim is part of the statement of identity such as "low fat cheddar cheese"), and special disclosure statements (those required by section 403(r)(2)(A)(iii)-(v)), are permitted between the claim and the disclosure statement. 21 CFR 101.13(h)(4)(ii)
11. Could a statement of identity ever be considered "intervening material"?	Yes, if the claim and the statement of identity were separate pieces of information on the label. If the statement of identity and the claim were printed in noticeably different type styles, sizes, colors or locations, for example, if the phrase "low fat" were in a star-burst, the claim and the statement of identity would be considered separate pieces of information. In such cases the referral statement would have to be adjacent to the claim, not separated from it by the statement of identity.
12. How is the type size for the disclosure statement determined?	The type size for the disclosure statement is the same as that required for the net quantity of contents statement in 21 CFR 101.105(i); for example, for packages with a principal display panel (PDP) of five square inches or less, the disclosure statement must be at least 1/16 inch in height; for packages with a PDP of 5-25 square inches, not less than 1/8 inch; for PDP's 25-100 square inches, not less than 3/16 inch, and for packages with a PDP greater than 100 square inches, not less than 1/4 inch. 21 CFR 101.13(h)(4)(i)
13. Are there any exceptions to the disclosure statement type size requirements?	Yes. If a claim is less than two times the required size of the net quantity of contents statement, the disclosure statement may be half the size of the claim but not less than 1/16 inch--21 CFR 101.13(h)(4)(i).
14. What are the disclosure statement type size requirements for extremely small packages?	If a package has less than three square inches of available label space and is an individual serving-size package served with meals in restaurants, the disclosure statement may be 1/32 inch in height. 21 CFR 101.13(h)(4)(i)
15. Are there any situations when a referral statement is not required?	Yes. If a claim is made on the same panel as that bearing the nutrition information, no disclosure statement is required. 21 CFR 101.13(h)(4)(ii)
16. If several claims are made on one panel, is a disclosure statement required each time a claim is made?	No. Only one disclosure statement per panel is required if multiple claims are made on a panel and it must be adjacent to the claim printed in the largest type on that panel. 21 CFR 101.13(h)(4)(iii)
17. If two claims are made on one panel, both in the same size print, where is the disclosure statement placed?	The disclosure statement may be next to either claim.
18. What is a food with a small serving size?	It is a food with a reference amount of 30 g or less or 2 tablespoons or less. 21 CFR 101.13(h)(1)
19. When are disclosure statements required on meal-type products?	A meal (see 21 CFR 101.13(l) for definition of a "meal") must be labeled with a disclosure statement if it contains (per labeled serving) more than: 26 g of fat, 8 g of saturated fat, 120 mg of cholesterol, or 960 mg of sodium 21 CFR 101.13(h)(2) Likewise, a main dish (see 21 CFR 101.13(m) for the definition of a "main dish") must be labeled with a disclosure statement if it contains (per labeled serving) more than: 19.5 g of fat, 6.0 g of saturated fat, 90 mg of cholesterol, or 720 mg of sodium 21 CFR 101.13(h)(3)
20. When may a "high" or a "good source" claim be made?	A "good source" claim may be made when a food contains at least 10% of the Reference Daily Intake (RDI) or Daily Reference Value (DRV) (both declared on the label as the "Daily Value" (DV)). A "high" claim may be made when a food contains at least 20% of the DV. 21 CFR 101.54(b)(1)
21. May a "high" or a "good source" claim be made for a nutrient that does not have an established daily value?	No. "High" and "good source" claims are defined as a percentage of the DV. Therefore, nutrients that do not have an established DV are not covered by the definition and may not make "high" or "good source" claims. 21 CFR 101.54(a)
22. Is there any way that a manufacturer can let consumers know that a product contains nutrients without DV's, such as omega-3 fatty acids?	A manufacturer may make a statement about a nutrient for which there is no established daily value so long as the claim specifies only the amount of the nutrient per serving and does not imply that there is a lot or a little of that nutrient in the product. Such a claim might be "x grams of omega-3 fatty acids". Such claims must be outside the "Nutrition Facts" box. 21 CFR 101.13(i)(3)
23. May a label make statements using the words "contains" and "provides" (e.g., "Contains x grams of omega-3 fatty acids") for nutrients without DV's?	To use the words "contains" or "provides" for nutrients without DV's, the specific amount of the nutrient must be stated. The statements "Contains x grams of omega-3 fatty acids per serving" or "Provides x g of omega-3 fatty acids" are permitted. However, "Contains omega-3 fatty acids" or "Provides omega-3 fatty acids" (without the specific amount statement) would not be permitted. Such claims would be synonyms for a "good source" claim which is not permitted for nutrients that do not have established daily values.
24. Is a statement that describes the percentage of the RDI of a vitamin or mineral in a food outside the nutrition panel a nutrient content claim?	Yes, while these claims are exempt from certain labeling requirements, they are not exempt from bearing a disclosure statement when required. 21 CFR 101.13(b)(1)
25. May a food that is normally low in or free of a nutrient bear a "Low" or "Free" claim if it has an appropriate disclaimer (e.g., fat-free broccoli)?	No. Only foods that have been specially processed, altered, formulated or reformulated so as to lower the amount of nutrient in the food, remove the nutrient from the food, or not include the nutrient in the food may bear such a claim (e.g., "low sodium potato chips")--21 CFR 101.13(e)(1). Other foods may only make a statement that refers to all foods of that type (e.g., "corn oil, a sodium-free food" or "broccoli, a fat-free food") 21 CFR 101.13(e)(2)

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