6.31. 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.
6.32. 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
21 CFR 101.13(j)(2)(i) & 101.13(j)(1)(ii)(A)
6.33. 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
21 CFR 101.13(j)(2)(i).
6.34. 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
21 CFR 101.13(d), 101.13(j)(1)(i)(A)-(B)
6.35. 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"):
- The percentage or fraction by which the food has been modified
- The reference food
- The amount of nutrient (that is the subject of the claim) that is in the labeled food and in the reference food
1/3 fewer calories and 50% less fat than our regular cheese cake.
Lite cheese cake - 200 calories, 4g fat;
Regular cheese cake - 300 calories, 8g fat per serving;
21 CFR 101.56(b)(3)(i)-(ii), 101.13(j)(1) & (2)
6.36. 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
21 CFR 101.56(b)(3)(ii), 101.13(j)(2)(iv)(B)
6.37. What is the most prominent claim?
In order, the most prominent claims are:
- A claim on the principal display panel as a part of or adjacent to the statement of identity
- A claim elsewhere on the principal display panel
- A claim on the information panel
- A claim elsewhere on the label or in labeling
21 CFR 101.13(j)(2)(iii)
6.38. 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)
6.39. 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:
- Waxing raw fruits or vegetables with a wax approved by FDA as a food additive
- Use of approved pesticides before or after harvest
- Pasteurization of milk
- Treatment of raw foods with ionizing radiation in accordance with 21 CFR 179.26 (not exceeding 1 kiloGray when this booklet was prepared)
- Treatment with mild chlorine wash or mild acid wash on produce
- Refrigeration is also permitted
21 CFR 101.95(c)
6.40. 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)
6.41. 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
6.42. 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)
6.43. 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)
CONDITIONS FOR THE USE OF "HEALTHY"
||< 5 g fat/RA & 100g
||low sat fat
||< 2 g sat fat/RA & 100g
||low sat fat
||≤ 360 mg/RA, /l.s. and /50 g if small RA
||≤ 360 mg/RA & l.s. and /50 if small RA
||≤ 480 mg/l.s.
||< 95 mg/RA & 100 g
||≤ 90 mg/l.s.
||Contains at least 10% of DV/RA for vitamins A, C, calcium, iron, protein, or fiber. Except raw fruits and vegs.;
frozen or canned single ingredient fruits and vegs., except that ingredients whose addition does not change the
nutrient profile of the fruit or veg. may be added; enriched cereal-grain products that conform to a standard of
identity in 21 CFR 136, 137, or 139.
||Contains 10% DV/l.s. of 2 nutrients (vit. A, C, calcium, iron, protein, or fiber) for main dish, 3 nutrients for meal
||Per 21 CFR 104.20
||Per 21 CFR 104.20
||Per 21 CFR 104.20
||Food complies with established definition and declaration requirements for any specified nutrient content claim.
l.s. = label serving
RA = Reference Amount
RA small = 30 g or less, or 2 tablespoons or less
Food and Drug Administration Center for Food Safety and Applied Nutrition
A Food Labeling Guide, September 1994 (Editorial revisions June, 1999)