The latest version of this document issued in April 2008. Below is an earlier version.
A Food Labeling Guide
Food Labeling
CFR References
(see update at end of document)
| Questions | Answers | ||||||||||||||||||||||||||||||||||||
| 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) | ||||||||||||||||||||||||||||||||||||
| 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". | ||||||||||||||||||||||||||||||||||||
| 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 100% fat. 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. | ||||||||||||||||||||||||||||||||||||
| 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) | ||||||||||||||||||||||||||||||||||||
| 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). | ||||||||||||||||||||||||||||||||||||
| 31. What is considered to be an "average nutrient value"? | It might be a value in a data base that is appropriate for the
food, or an average of nutrient levels in several of the leading brands
of that type of food. It might also be a market basket norm. In
determining an average nutrient value for a particular type of food, a
manufacturer should take into account the nutrient variability of the
product--21 CFR 101.13(j)(1)(ii)(A). Some types of products are fairly uniform; others, such as chocolate chip cookies, are not. Obviously, in products in which there is wide variability among different versions of the same food type, more products should be considered in arriving at an accurate nutrient level. | ||||||||||||||||||||||||||||||||||||
| 32. How will anyone know what the reference food is and how it was derived? | The type of food used as a reference food must be identified on the
label as part of the accompanying information. In addition, the
regulation requires that manufacturers using calculated nutrient values
(averages, norms, etc.) as the basis for a claim be able to
provide specific information on how the nutrient values were derived.
This information must be available on request to consumers and to
appropriate regulatory officials. 21 CFR 101.13(j)(2)(i) & 101.13(j)(1)(ii)(A) | ||||||||||||||||||||||||||||||||||||
| 33. How would a label state the identity of a reference food when the nutrient value used as a reference for the claim was from a data base or was an average of several foods? | The label might state "50% less fat than regular Italian salad
dressing" (on a light Italian dressing) or "half the fat of the average
creamy Italian salad dressing" (on a light creamy Italian salad
dressing). The label is not required to state that the reference value
came from a data base. 21 CFR 101.13(j)(2)(i). | ||||||||||||||||||||||||||||||||||||
| 34. What is the appropriate reference food for a nutrient content claim on a product that substitutes for a food and bears a name that is significantly different from that food? | Examples are vegetable oil spreads that substitute for margarine or
butter, and mayonnaise spreads that substitute for mayonnaise. To bear a
claim, the labeled food, for example, vegetable oil spread, must be "not
nutritionally inferior" to the food that it resembles and for which it
substitutes (e.g., margarine). The reference food on which the claim is
based should be the food that it resembles and for which it substitutes
(e.g., margarine). Definition of "substitute food"-21 CFR 101.13(d), 101.13(j)(1)(i)(A)-(B) | ||||||||||||||||||||||||||||||||||||
| 35. Is there any information that must be placed on the label when making a "Light" claim? | When making "light" claims, as with other relative claims such as
"reduced," "less," "fewer," "more," or "added," the label must state each
of the following (these are called "accompanying information"):
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| 36. Where must the accompanying information be placed? | The percentage or fraction by which the food is modified and the
identity of the reference food must be immediately adjacent to the most
prominent claim on the label--21 CFR 101.56(b)(3)(i), 101.13(j)(2)(ii). The actual amount of the nutrient in the labeled food and the reference food may be adjacent to the most prominent claim or on the same panel as the nutrition label--21 CFR 101.56(b)(3)(ii), 101.13(j)(2)(iv)(B). | ||||||||||||||||||||||||||||||||||||
| 37. What is the most prominent claim? | In order, the most prominent claims are: (1) A claim on the principal display panel as a part of or adjacent to the statement of identity;21 CFR 101.13(j)(2)(iii) | ||||||||||||||||||||||||||||||||||||
| 38. How large must the accompanying information be? | Generally the type size must be at least 1/16 of an inch in height.
However, there are certain exemptions from this type size requirement
for packaged foods that meet certain size requirements. Generally,
the minimum type size is 1/32 inch for products with a total surface
area available to bear labeling of less than 12 square inches. 21 CFR 101.2(c), 101.2(c)(3)(iii) | ||||||||||||||||||||||||||||||||||||
| 39. What does "Fresh" mean? | When used in a manner which suggests that a food is unprocessed, the
term "fresh" means that the food is in a raw state and has not been
frozen or subjected to any form of thermal processing or preservation,
except:
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| 40. What do the terms "Fresh Frozen" and "Quickly Frozen" mean? | FDA's regulation specifies that "fresh frozen" or "frozen fresh"
means the food has been quickly frozen while still fresh (i.e., recently
harvested when frozen). Appropriate blanching before freezing is
permitted. "Quickly frozen" means freezing using a system such as
blast-freezing (i.e., sub-zero Fahrenheit temperature with high-speed
forced air directed at the food) for a sufficient length of time to
freeze quickly to the center of the food with virtually no
deterioration. 21 CFR 101.95(b) | ||||||||||||||||||||||||||||||||||||
| 41. What health claims are permitted on food labels? | If a claim is provided for in a FDA regulation, then it may be
used in accordance with that regulation. A firm may also submit a health claim based on
an authoritative statement by a U.S. government scientific body under section 403(r)(3)(c)
of the FD&C Act. The qulifications necesary to use health claims provided for by FDA are
summarized in Appendix C. 21 CFR 101.9(k)(1), 101.14(c)-(d) & 101.70 | ||||||||||||||||||||||||||||||||||||
| 42. If health symbols (hearts, etc.) are used on food labels, are special statements needed? | The requirements are the same for labels with health symbols and for
written health claims. For each, the health claim must be permitted
under a regulation in 21 CFR Subpart E, and the food must meet the
criteria for health claims for total fat, saturated fat, cholesterol,
and sodium content. In addition to the symbol,
the label must include the same complete health
claim information (such as, including the appropriate model claim
information next to the health symbol). 21 CFR 101.14(a)(1), 101.14(a)(5) and 101.14(d)(2)(iv) | ||||||||||||||||||||||||||||||||||||
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43. What are the requirements to use the word
"Healthy"? To be labeled as "Healthy," a food must meet the definition of "low" for fat and saturated fat, and neither cholesterol nor sodium may be present at a level exceeding the disclosure levels in 21 CFR 101.13(h). In addition, the food must comply with definitions and declaration requirements for any specific nutrient content claims. (See updated information) 21 CFR 101.65(d)(2)-(4)
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Chapter VI: Questions 1 - 25
Appendix A Definitions of Nutrient Claims
Appendix B Relative (or Comparative) Claims
Appendix C Health Claims
Updated Information:
September 29, 2005: Final Rule: Food Labeling, Nutrient Content Claims Definition of Sodium Levels for The Term "Healthy".