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Sugar Claims84
A “sugar free” claim requires less than 0.5 grams of sugars per reference amount customarily consumed (RACC) and per labeled serving. In addition, because consumers may reasonably expect that a food represented as containing no sugars or sweeteners is also a product that is low in calories or significantly reduced in calories, a food may not be labeled as “sugar free” unless it is also labeled “low calorie” or “reduced calorie” or the “sugar free” claim is immediately accompanied by one of the following disclaimers: “not a reduced calorie food,” “not a low calorie food,” or “not for weight control.”
If a food bearing a “sugar free” claim contains an ingredient that is a sugar or that is generally understood by consumers to contain sugars, then the listing of that ingredient in the ingredient statement must be followed by an asterisk that refers to a statement below the list of ingredients, “adds a trivial amount of sugar,” “adds a negligible amount of sugar,” or “adds a dietarily insignificant amount of sugar.”
Synonyms for “sugar free” are “free of sugar,” “no sugar,” “zero sugar,” “without sugar,” “sugarless,” “trivial source of sugar,” “negligible source of sugar,” and “dietarily insignificant source of sugar.”
The terms “no added sugar,” “without added sugar,” or “no sugar added” may be used only if no amount of sugar is added and no ingredient that contains sugars that functionally substitute for added sugars is added. An example of a functional substitute for added sugars would be adding concentrated fruit juice. Ingredients that contain added sugars such as jam or jelly also count as added sugar. In addition, the food cannot have been processed to increase the sugars content, such as by the use of enzymes. Finally, the claim may only be made when the food that it resembles and for which it substitutes normally contains added sugars. If the food does not meet the definition of “low calorie” or “calorie reduced,” then the label must direct consumers’ attention to the nutrition panel for further information on sugar and calorie content.
Inherent Claims85
When a food inherently meets the nutritional requirements of the “free” or “low” claim for a nutrient without special processing or altering, the claim must indicate that the food inherently meets the claim by clearly referring to all foods of that type rather than that particular brand. For example, “Corn oil, a sodium‐free food.”
Nutrient Statements That Are Not Nutrient Content Claims
The FDCA provides strict regulation for a claim that “characterizes the level of any nutrient” on the label or labeling of the food.86 FDA chose the term “nutrient content claim,” but “nutrient level description” might more precisely convey the language in the Act. This distinction is important because nutrient claims that only indicate the factual quantity of a nutrient without characterizing the level are not regulated as nutrient content claims.
Nutrient content claims characterize the level of a nutrient. For instance, “High in antioxidants” characterizes the level as “high.” As an alternative, a quantitative statement of the presence of a component of a food is not a nutrient content claim because it does not characterize the level; for example, “Contains X mg flavonoids per serving.” Of course, 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