Even before the issuance of the first Dietary Guidelines for Americans in 1980, the FDA and the food industry had realized the problems created by there being no indication on the food label of the "complex carbohydrate" content of a food. At the same time dietary guidance almost universally advised consumers to increase their consumption of "complex carbohydrates". For example, in 1978, the Kellogg Company had submitted a petition to the FDA to voluntarily permit the declaration of (1) "grams per serving of starch and related carbohydrates", (2) "grams per serving of sucrose and other sugars", and (3) "grams per serving of total carbohydrates [the sum of (1) and (2)]". The Agency did not grant the Kellogg petition, but in the years from 1980 to 1993 many cereal companies listed either "complex carbohydrates" or "starches" and "related carbohydrates" on the labels of their products and the FDA took no regulatory actions.
In 1979 the FDA in cooperation with the United States Department of Agriculture (USDA) and the Federal Trade Commission (FTC) undertook a major food label reform initiative. The tentative positions of the three agencies were published in the Federal Register of December 29, 1979. However, the issue of complex carbohydrates did not surface as one of the major issues of the initiative. (5) Because of a number of factors, including a change in political administrations, little came of the 1979 food label reform initiative.
In the late 1980s the FDA again launched a food label reform effort. This effect was primarily based on the recognition that the food label continued to be out of step with the shifts in public health concerns from nutrient deficiencies to the health consequences of over-consumption. This label initiative was announced by Secretary of Health and Human Services, Dr. Louis Sullivan, in March 1989. On August 8, 1989, the FDA published an Advance Notice of Proposed RuleMaking (ANPRM) asking all interested parties to comment on a number of specific labeling issues. (6) The agency specifically asked, "How should the | listing of components of carbohydrates be treated within the context of nutrition labeling (e.g., complex starches, total sugars)?" (6) Throughout the fall of 1989, j the FDA conducted a series of Public Hearings and Consumer Exchange meetings Jj on how the food label could be improved. The inclusion of complex carbohydrate content on the food label was often raised in these discussions.
In July 1990 the agency proposed to modify the nutrition label. (7) In that |
document, the FDA clearly set out the factors that it considered in deciding whether a nutrient or food component should be mandatory or voluntary in nutrition labeling.
The agency has proposed to make the declaration of a nutrient or food component mandatory in nutrition labeling when quantitative intake rec-
Scarbrough ommendations with respect to the nutrient or component are high-lighted in the reports cited above (e.g., "Reduce total fat intake to 30% or less of calories.". . .), and the nutrient or component is of particular public health significance as defined in several recent consensus documents. ... On the other hand, for those nutrients or food components for which quantitative intake recommendations are not highlighted but that do have some public health significance (e.g., ". . . increase intakes of starches . . ."), or for which quantitative recommendations are available but that are not of pressing public health importance (e.g., the Recommended Dietary Allowances for several vitamins and minerals . . .), the agency is proposing to make declaration of the nutrient or component voluntary" (7, p 29493).
Following these principles, the FDA did not propose to require the mandatory declaration of complex carbohydrates in nutrition labeling. It should also be noted that the National Academy of Sciences, in their report, Nutrition Labeling, had recommended that the declaration of complex carbohydrates be voluntary. (8)
In response the FDA in July of 1990 proposed to make the declaration of complex carbohydrates voluntary with the following statement.
The FDA is proposing in 101.9(c)(6)(i) to permit the voluntary declaration of the complex carbohydrate content because recent dietary reports have discussed the need to increase consumption of complex carbohydrates. (9, 10) Because recommendations to increase consumption of complex carbohydrates have not been quantified, however, the agency finds that a basis for requiring declaration of this food component in nutrition labeling has not been established (7, page 29497).
For labeling purposes the FDA defined complex carbohydrates in the proposal as the sum of dextrins and starches, or more specifically those carbohydrate "S components that contain 10 or more saccharide units exclusive of dietary fiber (7, g p. 29497). The agency, however, expressed concern that the inclusion of dextrins j (saccharide units of 10 or more) within the definition of complex carbohydrates t? may inappropriately classify the relatively low molecular weight carbohydrates in some nutritive sweeteners as complex carbohydrates. ^
This definition may result in some foods, such as coffee whiteners and ice cream, that contain large amounts of low conversion (low dextrose equivalent) corn sweeteners, being classified as sources of complex carbohydrates. These low molecular weight carbohydrates may have nutritional or metabolic effects different from those of commonly recognized complex carbohydrates. Thus, it may be misleading to consumers if these foods are labeled as containing complex carbohydrate.
Comments on this proposal indicated consumer interest in having complex carbohydrates as a mandatory part of nutrition labeling, based largely on the dietary guidance recommendations. Industry comments, however, generally supported a voluntary declaration of complex carbohydrates. There were four main reasons cited by comments advocating voluntary listing.
First, the mandatory inclusion of complex carbohydrate on the label may suggest that this food component has greater public health significance than has been established by existing diet and health studies. The identification of a specific health benefit for complex carbohydrates is confounded by the fact that diets high in complex carbohydrates are usually mixed diets that contain significant amounts of cereal grains, fruits, and vegetables which are high in vitamins, minerals, and fiber and low in fat. It is unclear the extent to which complex carbohydrates impart health benefits separate from these factors.
Second, dietary guidance documents have not specified a recommended level of intake for complex carbohydrates and thus the agency would be unable to establish a label reference value, such as a Daily Recommended Value (DRV), for labeling purposes. It was felt that DRVs would be helpful in planning overall diets and the extent to which the absence of a DRV for complex carbohydrates would be problematic or confusing to consumers was unknown.
Third, the term "complex carbohydrate" had not been clearly or consistently defined. For labeling purposes the agency needed a chemical definition that reflected the physiological effects and health benefits. For voluntary labeling purposes the agency had defined "complex carbohydrates" as the sum of dextrins and starches, or those carbohydrate components that contain 10 or more saccharide units, exclusive of dietary fiber. But FDA was concerned about the appropriateness of this rather arbitrary definition.
Fourth, and perhaps most important of all, available analytical methods for carbohydrates in foods were not considered sufficiently specific for regulatory purposes. For example, methods generally measured carbohydrates either as more than 4 saccharide units or as single saccharide units up to 4 units. Suitable analytical procedures were needed if complex carbohydrates were to be defined as those carbohydrates that contain a specified number of saccharide units.
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