the regulations specify that the new line does not require a % DV for trans fatty acids and withdrew the earlier proposal (FDA, 1999a) that the trans fatty acid line have a footnote stating “Intake of trans fat should be as low as possible.” The regulations, effective January 1, 2006, are a result of research and public comments reviewed by FDA that documented the link between consuming diets high in trans fatty acids and increased serum low-density lipoprotein cholesterol, a risk factor for coronary heart disease.

Other FDA-Regulated Label Elements Related to or Dependent on DVs

Other nutrition information, such as ingredient lists, structure/ function claims, nutrient content claims, and health claims, that is found on food labels outside the Nutrition Facts box also is relevant to a discussion of reference nutrient values. Food products that contain more than one ingredient must list these ingredients on the package. FDA has provided manufacturers with regulations about how the ingredient list must appear on the package and which ingredients must be listed (21 C.F.R. 101.4). Ingredient lists are important label elements because they enable consumers to identify sources of the nutrients, and they can be used to compare products for the presence or absence of ingredients. Claims about the structure and function of a nutrient have historically appeared on labels of conventional food and dietary supplements, as well as on drug labels. (For more information on structure/function claims, see ONPLDS, 2003b.)

Nutrient content claims2 are FDA-regulated statements on food packages that characterize the level of a nutrient in a food, such as “free,” “high,” and “low.” These claims are based on the amounts of the nutrient in the food item, and FDA specifies the package wording and allowable synonyms (FDA, 1993b). With few exceptions, a nutrient content claim can be made only if there is a DV identified for that nutrient and if FDA has established, by regulation, the criteria a food must meet to list the claim.

A health claim3 on a food package is a statement of a scientifically demonstrated relationship between a food substance (defined by

2  

NLEA permits the use of label claims that characterize the level of a nutrient in a food made in accordance with FDA’s authorizing regulations.

3  

According to NLEA, it describes “the relationship between a nutrient of the type required in the label or labeling of a food … and a disease or health related condition and the significance of each such nutrient in affecting such disease or health related condition” (21 U.S.C. § 343(r)(3)(B)(ii)).



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