6.16. 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)
6.17. 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.
6.18. 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)
6.19. 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
- 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
- 720 mg of sodium
21 CFR 101.13(h)(3)
6.20. 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)
6.21. 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)
6.22. 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)
6.23. 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.
6.24. 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)
6.25. 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)
6.26. When is a formulated food considered to be specially processed and permitted to bear a "low" or "free" claim?
If a similar food would normally be expected to contain a nutrient, such as sodium in canned peas, and the labeled food is made in such a manner that
it has little or none of the nutrient, then the food is considered specially processed and may bear a "free" or a "low" claim.
21 CFR 101.13(e)(1)
6.27. If a product is made that does not have a regular version, such as a spice mix, and salt is not included in it, may the product be labeled "sodium free"?
Yes. FDA would consider that the food was formulated so as not to include the nutrient in the food and therefore it would be eligible to bear a
"sodium free" claim if the product otherwise meets the criteria for the term "sodium free".
6.28. May a "Fat Free" claim be made even though the product is essentially 100% fat, for example, a cooking oil spray that has a very small serving size?
Although the food has less than 0.5 grams of fat per reference amount and technically qualifies to make a "fat free" claim, such a claim on a product
that is essentially 100% fat would be misleading. Under section 403(a)(1) and 201(n) of the act, the label would have to disclose that the product is
However, the terms "fat free" and "100% fat" or "all fat" are contradictory and would likely confuse consumers. FDA believes a claim such as
"for fat free cooking" is more appropriate, so long as it was not made in a misleading manner and the words "fat free" were not highlighted,
printed in a more prominent type, or otherwise set off from the rest of the statement.
6.29. May a "Less" or "Fewer" claim be made that compares ready-to-eat cereals to other breakfast options such as sausages or Danish pastries?
The agency would not object to such a claim if it were properly framed in the context of an eating occasion such as "Try a change for breakfast.
A serving of this cereal has __% less fat than a serving of Danish pastry".
21 CFR 101.13(j)(1)(i)(A)
6.30. What is an appropriate reference food for a food bearing a "Light" claim?
The reference food must be a food or group of foods that are representative of the same type as the food bearing the claim. For example, a chocolate
ice cream would use as its reference food other chocolate ice creams
21 CFR 101.13(j)(1)(i)(B).
The nutrient value for fat or calories in a reference food that is used as a basis for a "light" claim may be determined in several ways. It may be
a value in a representative valid data base, an average value determined from the top three national (or regional) brands of the food, a market basket
norm, or where its nutrient value is representative of the food type, an individual food like a market leader
21 CFR 101.13(j)(1)(ii)(A).
The nutrient value used as a basis for a 'light' claim should be similar to that calculated by averaging the nutrient values of many of the foods of
the type. It should not be the value of a single food or group of foods at the high end of the range of nutrient values for the food. When compared
to an appropriate reference food, a "light" food should be a food that the consumer would generally recognize as a food that is improved in its
nutrient value compared to other average products of its type
21 CFR 101.13(j)(1)(ii)(A).
Food and Drug Administration Center for Food Safety and Applied Nutrition
A Food Labeling Guide, September 1994 (Editorial revisions June, 1999)