When Congress passed the Nutrition Labeling and Education Act of 1990 (NLEA) one of the principal differences of that act compared to the FDA's 1990 proposal was the inclusion of "complex carbohydrates" as one of the components that was mandatory on the nutrition label (Section 403(q)(1)(D)) (11). In November 1991 the FDA published a revised proposal for mandatory nutrition labeling to conform agency regulations to the NLEA requirements. (12) Following the
Scarbrough lead of Congress the agency proposed that complex carbohydrates be made mandatory on nutrition labels in that document. The definition (starches and dextrins with 10 or more saccharide units) remained as had been proposed in July 1990. However, the November 1991 re-proposal recognized that the NLEA gave the FDA some latitude in determining which nutrients should be listed on the nutrition label. Section 403(q)(2)(B) of the act allows the Secretary (and, by delegation, the FDA) to determine whether information relating to nutrients specified in section (q)(1)(D) inter alia is necessary to assist consumers in maintaining healthy dietary practices and, if not, to delete such nutrients from the required list of nutrients in nutrition labeling. The agency raised the four concerns cited above and requested specific comment.
Many comments on the revised proposal expressed opposition to the FDA's proposed definition of complex carbohydrate. The comments raised concerns about the feasibility of compliance and the economic burden of developing databases and analytical methods. Many comments recommended that the definition of "complex carbohydrate" be changed to be the difference between total carbohydrate and sugars because this difference could be readily calculated. Comments also noted that carbohydrates with saccharide units of 5 through 9 would not be accounted for in any of the labeled sub-components of carbohydrate, leading to possible consumer confusion. The cut-off of 10 saccharide units was criticized as being arbitrary because there are no known nutritional or physiological differences to justify a distinction between polysaccharides at this dividing line. Several comments suggested that the commonly accepted usage of "complex carbohydrate" includes all carbohydrates larger than disaccharides. Other comments suggested that complex carbohydrate should be defined as all digestible polysaccharides (e.g., dextrins, starch, and glycogen) rather than on the basis of the number of saccharide units, but no information was provided on reliable methods for determining carbohydrate digestibility or for distinguishing energy derived from intestinal digestion from that derived from colonic fermentation. Comments emphasized that while there was not a consensus on a precise definition for "complex "S carbohydrate," the agency's proposed definition was not commonly recognized, g nor was it consistent with the use of the term in the IOM report. (8) One comment j from a state government recommended that to avert undue emphasis on complex carbohydrate substances added to foods and to avoid the potential for misleading claims about complex carbohydrates, the term "other carbohydrate" should be used rather than "complex carbohydrate."
In the final regulations implementing the NLEA, published in the Federal Register on January 6, 1993, the FDA concluded that the comments indicated that there was not sufficient consensus on the meaning of the term "complex carbohydrate" to justify adopting a definition and requiring mandatory inclusion in the nutrition label. (13) Further, because there was no apparent consensus on the health benefits or physiological effects of "complex carbohydrates" per se,
the agency determined that the term "other carbohydrates" should be used voluntarily on the label. "Other carbohydrate" is calculated as the amount of carbohydrate remaining after subtraction of dietary fiber, sugars, and sugar alcohols from total carbohydrate. The agency recognized that this new definition will include many substances added to processed foods for technical purposes, such as for texture modification or as bulking agents. The FDA stated the belief that to declare these substances as complex carbohydrates would be misleading. The intent of dietary recommendations to increase the consumption of complex carbohydrates and dietary fiber is to select diets with plenty of fruits, vegetables, and grain products, not foods that have complex carbohydrates as added texturizers or bulking agents.
Because "other carbohydrate" is calculated as that amount of carbohydrate remaining after subtraction of the amount of dietary fiber, sugars, and sugar alcohols (when declared) from total carbohydrate, it was logical to rearrange the subcomponents of total carbohydrate to place "other carbohydrate" at the bottom of the list. This reordering was intended help to reduce any potential confusion over the meaning of the term "other carbohydrate."
When "other carbohydrate" is omitted from the label, the declared subcomponents of total carbohydrate (i.e., dietary fiber and sugars) will not add up to the value for total carbohydrate in most foods. The agency recommended that consumer education programs should inform interested persons that other forms of carbohydrate beyond those declared on the label are in the food product. This situation is analogous to the fat category where the sum of saturated, polyunsatu-rated, and monounsaturated fatty acids often do not add up to 100 percent of the value for total fat because trans fatty acids are not included in the definition of the fatty acids but are included in the value for total fat.
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