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).

The Initiation of Rulemaking for Nutritional Claims

In August 1987, FDA published a proposed rule to change its policy by permitting health claims on food labeling if certain criteria were met.13 The proposal generated a large number of thoughtful and often conflicting comments and was followed by a series of meetings between the agency and the food industry, consumer groups, academia, and health professionals (Shank, 1989). A congressional hearing was also held in December 1987. Subsequently, in February 1990, FDA withdrew its original proposal and published a new proposal that defined appropriate health claims more narrowly and set new criteria to be met before allowing a claim.14 During the late 1970s and throughout the 1980s FDA also was acting to increase the availability of nutrition information and to provide for more truthful nutritional claims on all foods. In an effort to respond to consumers and the food industry, FDA initiated rulemaking to provide more flexibility in making claims on foods that could be useful in reducing or maintaining body weight or calorie intake,15 to establish policies concerning the fortification of foods,16 to include sodium content in nutrition labeling and provide for claims about sodium17 and cholesterol content,18 and to allow for food labeling experiments, such as experiments on supermarket shelf labeling.19

The surge in consumer interest in nutrition that was fueling the food industry’s desire to highlight the positive nutritional attributes of food products was due, in part, to the publication in the late 1980s of two landmark consensus reports on nutrition and health.20 The Surgeon General’s Report on Nutrition and Health (HHS, 1988) and the National Research Council’s (NRC’s) report Diet and Health: Implications for Reducing Chronic Disease Risk (NRC, 1989a) emphasized the relationship between diet and the leading causes of death among Americans (e.g., heart disease, cancers, strokes, and diabetes). They suggested that changes in current dietary patterns—in particular, reduced consumption of fat, saturated fatty acids, cholesterol, and sodium and increased amounts of complex carbohydrates and fiber—could lead to a reduced incidence of many chronic diseases. The Surgeon General’s report also called on the food industry to reform products to reduce total fat and to carry nutrition labels on all foods. These reports made useful suggestions for planning healthy diets. However, without specific nutrition information on food labels, consumers were unable to determine how certain individual foods fit into dietary regimens that followed the recommendations of these reports. Major changes in nutrition labeling were necessary if food labels were to be useful to consumers interested in adhering to these recommendations.


In the summer of 1989, concerned that food labeling did not allow Americans to take advantage of the latest advances in nutrition, Dr. Louis W. Sullivan, then Secretary of the U.S. Department of Health and Human Services (HHS), directed FDA to undertake a comprehensive initiative to revise the food label (FDA, 1990).21 He later stated that, “As consumers shop for healthier food, they encounter confusion and frustration. The grocery store has become a Tower of Babel and consumers need to be linguists, scientists, and mind readers to understand the many labels they see” (HHS, 1990). This new food labeling initiative began with the publication of an advance notice of proposed rulemaking in August 1989 asking for public comment22 and a notice of public hearings to


13 52 FR 28843.

14 55 FR 5176.

15 43 FR 43248 and 43261.

16 45 FR 6314.

17 47 FR 26580 and 49 FR 15510.

18 51 FR 42584.

19 69 FR 15236.

20 54 FR 32610.

21 55 FR29487.

22 54 FR 32610.

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