Food Regulation. Neal D. Fortin

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СКАЧАТЬ any such quantitative statement must be truthful and nonmisleading.

      Similarly, nutrient descriptions that only indicate the function of a nutrient without characterizing the level are not nutrient content claims. For example, “Calcium helps build strong bones” is a structure–function claim not a nutrient content claim. (Of course, one must be mindful of potential implied nutrient content claims if a nutrient is mentioned on a label.)

      4.7.4 Meals and Main Dishes

      Claims that a meal or main dish is “free” of a nutrient, such as sodium or cholesterol, must meet the same requirements as those for individual foods. Other claims can be used under special circumstances. For example, “low‐calorie” means the meal or main dish contains 120 calories or less per 100 grams. “Low‐sodium” means the food has 140 mg or less per 100 grams. “Low‐cholesterol” means the food contains 20 mg cholesterol or less per 100 grams and no more than 2 grams saturated fat. “Light” means the meal or main dish is low‐fat or low‐calorie.

      4.7.5 Modifications of Standardized Foods

Any nutrient level descriptor, such as “reduced fat,” “low calorie,” and “light,” may be used in conjunction with a standardized food name, if the new product has been specifically formulated to meet FDA’s criteria for that claim, if the product is not nutritionally inferior to the traditional standardized food, and the new product complies with certain compositional requirements set by FDA.⁸⁷ A new product bearing a claim must also have performance characteristics similar to the referenced traditional standardized food. If the product does not meet the performance characteristics, and the differences materially limit the product’s use, its label must state the differences (for example, “not recommended for baking”) to inform consumers.⁸⁸

Note, however, that modifications of standardized foods that are nutritionally inferior to the standardized food must be labeled “imitation.” (See Chapter 8 for more details on standardized food and labeling as imitation.) For the purposes of naming a food with a standardized name plus a nutrient content claim, “nutritionally inferior” has a defined meaning that excludes a reduction in the caloric or fat content.⁸⁹ Other essential nutrients cannot be reduced.

4.7.6 Disclosure Statements⁹⁰

      When a food bearing a nutrient content claim contains a macronutrient at a level that is associated with an increased risk of disease or health problems, the food must bear a disclosure statement, “See nutrition information for ____ content” with the blank filled in with the identity of the nutrient exceeding the specified level; e.g., “See nutrition information for sodium content.” The disclosure must be immediately adjacent to the nutrient content claim without intervening material.

      The basic threshold levels for triggering a disclosure statement are more than 15.0 grams of fat, 4.0 grams of saturated fat, 60 mg of cholesterol, or 460 mg of sodium per RACC or per labeled serving. Main dish meal products are allowed higher trigger amounts. Foods with a RACC of 30 grams or less or 2 tablespoons or less are based on a per 50 grams amount. Food intended specifically for use by infants and children less than 2 years of age is exempt from this requirement.

      The disclosure must be in easily legible, boldface print, in distinct contrast to other printed or graphic matter, and in a size no less than that required for the net quantity of contents statement. However, when the nutrient content claim is less than two times the required size of the net quantity statement, the disclosure statement may be no less than one‐half the size of the claim but no smaller than one‐sixteenth of an inch.

      4.7.7 Foods Intended for Infants

A statement listing the percentage of a vitamin or mineral may be made on the labeling of food intended for infants and children less than 2 years of age.⁹¹ However, no other nutrient content claims are permitted on food intended for infants and children less than 2 years of age.⁹² In particular, statements about the saturated fat, polyunsaturated fat, monounsaturated fat, cholesterol, calories from fat, or calories from saturated fat are prohibited.

      4.7.8 Exemptions

       Brand Names

Undefined nutrient descriptors used in brand names established before October 21, 1989, can continue to be used in the name until FDA may define the term.⁹³ Any brand names first used after 1989 must comply with nutrient content claim rules, and undefined nutrient descriptors are prohibited.

       Diet Soft Drinks

A soft drink that used the term “diet” as part of its brand name before October 25, 1989 (and in compliance with other FDA rules) may continue to use diet as part of its brand name, provided that its use of the term is not false or misleading.⁹⁴ “Diet” is not an approved nutrient descriptor, and therefore, is not permitted in other uses.

       Terms in Standardized Food Names

Where a statement of identity established a descriptor in the standardized name of a food, the statement of identity rule applies rather than the rule for the nutrient content descriptor.⁹⁵

      4.7.9 Statements That Are Not Implied Claims

A number of specific uses of terms are not considered implied nutrient content claims when it is clear that they are not made in a nutrient context.⁹⁶

      1 A claim that a specific ingredient or food component is absent for food allergies, food intolerance, religious beliefs, or dietary practices such as vegetarianism or other non‐nutrition‐related reason (e.g., “100 percent milk free”).

      2 A claim about a substance that is non‐nutritive (e.g., “contains no preservatives,” “no artificial colors”).

      3 A claim about the presence of an ingredient that is perceived to add value to the product (e.g., “made with real butter,” “made with whole fruit,” or “contains honey”).

      4 A statement of identity for a food in which an ingredient constitutes essentially 100 percent of a food (e.g., “corn oil,” “oat bran,” “dietary supplement of vitamin C 60 mg tablet”).

      5 A statement of identity (e.g., “corn oil margarine,” “oat bran muffins,” or “whole wheat bagels”), unless such claim is made in a context that suggests that a nutrient is absent or present in a certain amount.

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