that a food was misbranded if it “fails to reveal facts material in the light of such representation.” FDA argued that when a manufacturer added a nutrient to a food or made claims about its nutrient content, nutrition labeling was necessary to present all of the material facts, both positive and negative, about that food (Hutt, 1995).

When finalized in 1973, these regulations specified that when nutrition labeling was present on labels of FDA-regulated foods, it was to include the number of calories; the grams of protein, carbohydrate, and fat; and the percent of the U.S. Recommended Daily Allowance (U.S. RDA) of protein, vitamins A and C, thiamin, riboflavin, niacin, calcium, and iron.6 Sodium, saturated fatty acids, and polyunsaturated fatty acids could also be included at the manufacturer’s discretion. All were to be reported on the basis of an average or usual serving size. The U.S. RDAs were based on the Recommended Dietary Allowance (RDA) set forth by the National Academy of Sciences (NAS) in 1968 (NRC, 1968). Because of the need for a single set of standard nutrient requirements for nutrition labeling purposes, the values selected for the U.S. RDA were generally the highest value for each nutrient given in the RDA table for adult males and non-pregnant, non-lactating females. However, values for calcium and phosphorus were limited to 1 g because of their physical bulk and solubility. The Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) provided for nutrition labeling of meat and poultry products in a similar manner through policy memoranda.7

As can be seen in the annex to this chapter, few changes were made in nutrition labeling regulations over the next decade (Hutt, 1995; Scarbrough, 1995). FDA, USDA, and the Federal Trade Commission held hearings in 1978 to gather information on food labeling issues and suggestions on how to make improvements.8 The vast majority of comments from the hearing favored mandatory nutrition labeling but also suggested making changes to the format to make it more useful.9

The Rise in Use of Undefined Nutrient Content and Health Claims on Labels

After 1973, scientific knowledge about the relationship between diet and health grew rapidly, and, as a result, consumers wanted to have more information on food labels, particularly on the labels of processed and packaged foods. Food manufacturers were eager to respond to the consumer interest and did so in a variety of ways, often through the use of an assortment of new, undefined claims on product labels that attempted to state or imply something about the special value of the food, such as “extremely low in saturated fat,” in order to catch consumers’ attention (Taylor and Wilkening, 2008a). The proliferation of ambiguous claims on labels and in advertising led to charges that the government was tolerating claims that were “at best confusing and at worst deceptive economically and potentially harmful” (IOM, 1990).

In addition to making claims about the nutritional content of foods, some food manufacturers were also interested in making label claims about the health benefits of their food products. FDA’s regulations had prohibited the explicit discussion of disease or health on food labels since passage of the FD&C Act in 1938.10 The implementing regulations for that act stated that a food was deemed to be misbranded if its labeling “represents, suggests, or implies: That the food because of the presence or absence of certain dietary properties is adequate or effective in the prevention, cure, mitigation, or treatment of any disease or symptom.”11 A food making such claims was considered to be misbranded or an illegal drug (Shank, 1989). This policy began when many of the links between diet and disease had yet to be established or substantiated. It helped prevent misleading and potentially harmful claims, but it also prevented useful and truthful claims from being made (Kessler, 1989). The agency’s policy was challenged in 1984 when the Kellogg Company, in cooperation with the National Cancer Institute, began a labeling campaign using the back panel of a high-fiber breakfast cereal to link fiber consumption to a possible reduction in the risk of certain cancers. That campaign changed food labeling and marketing dramatically, as other companies, in the absence of regulatory action, began making similar claims (Geiger, 1998).


38 FR 6493.


56 FR 60302 at 60303.


43 FR 25296.


44 FR 75990.


Federal Food, Drug, and Cosmetic Act, Sec. 403.


38 FR 6950 at 6961, paragraph (i) and (i)(1).

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