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67243 Proposed Rules Federal Register Vol. 61, No. 246 Friday, December 20, 1996 This section of the FEDERAL REGISTER FOR FURTHER INFORMATION CONTACT: under § 101.9(c)(1)(i)(C), by multiplying contains notices to the public of the proposed Virginia L. Wilkening, Center for Food the general factor of 4 calories per g by issuance of rules and regulations. The Safety and Applied Nutrition (HFS± the amount of total carbohydrate less purpose of these notices is to give interested 165), Food and Drug Administration, the amount of insoluble dietary fiber; persons an opportunity to participate in the 200 C St. SW., Washington, DC 20204, under § 101.9(c)(1)(i)(D), by using data rule making prior to the adoption of the final rules. 202±205±5763. for specific energy factors for particular SUPPLEMENTARY INFORMATION: foods or ingredients approved by FDA through the food additive or generally I. Background DEPARTMENT OF HEALTH AND recognized as safe (GRAS) petition HUMAN SERVICES A. The 1990 Amendments and processes in parts 170 and 171 (21 CFR Implementing Regulations parts 170 and 171) and provided in Food and Drug Administration The Nutrition Labeling and Education parts 172 or 184 (21 CFR parts 172 or 184); or under § 101.9(c)(1)(i)(E), by 21 CFR Part 101 Act of 1990 (the 1990 amendments) and the final regulations that implement the using bomb calorimetry data. [Docket Nos. 96N±0421 and 94P±0453/CP1] 1990 amendments (58 FR 2066, January FDA also defined the basic nutrients 6, 1993, as modified at 58 FR 44020, that are to be declared as part of the Food Labeling: Nutrient Content August 18, 1993) provided for a number nutrition label (58 FR 2079 at 2086). In Claims Pertaining to the Available Fat of fundamental changes in how food is particular, FDA defined ``total fat'' as Content of Food labeled, including requiring that total lipid fatty acids expressed as nutrition labeling appear on most foods triglycerides (§ 101.9(c)(2)) and AGENCY: Food and Drug Administration, and establishing that terms that HHS. ``saturated fat'' as the sum of all fatty characterize the level of a nutrient in a acids containing no double bonds ACTION: Proposed rule. food may not be used in food labeling (§ 101.9(c)(2)(i) (58 FR 2079 at 2089)). unless defined by FDA. SUMMARY: The Food and Drug In addition to adding section 403(q) The 1990 amendments added section Administration (FDA) is proposing to on nutrition labeling to the act, the 1990 403(q) to the Federal Food, Drug, and amend its food labeling regulations to Cosmetic Act (the act) (21 U.S.C. amendments added section 403(r) on provide for the use of nutrient content 343(q)), which requires that most food nutrient-related claims and, in claims on the food label or in labeling bear nutrition labeling. In response to particular, section 403(r)(1)(A) of the based on the reduced availability of fat this provision, in the January 6, 1993, act, which states that a food is to the body from the food because of the final rule on nutrition labeling (entitled misbranded if it bears a claim in its use of a fat substitute ingredient in the ``Food Labeling: Mandatory Status of label or labeling that expressly or food. This proposal responds, in part, to Nutrition Labeling and Nutrient Content implicitly characterizes the level of any a citizen petition on the use of Revision, Format for Nutrition Label,'' nutrient of the type required to be digestibility coefficients in determining (the nutrition labeling final rule (58 FR declared in nutrition labeling unless the the quantity of fat declared on a food 2079)), FDA prescribed how nutrition claim is made in accordance with label. FDA is undertaking this action to labeling is to be provided on the foods section 403(r)(2) of the act. Section encourage innovation on the part of that are regulated by the agency. Among 403(r)(2)(A)(i) of the act states that a food manufacturers and to foster a other things, the agency required that claim may be made only if the situation that will provide increased the nutrition label include information characterization of the level made in the product choices for consumers in on total calories and calories from fat claim uses terms that are defined in achieving dietary goals. and on the quantitative amounts of regulations of the Secretary of the DATES: Submit written comments by specified nutrients (e.g., total fat, Department of Health and Human April 21, 1997. Submit written saturated fat, total carbohydrate, and Services. comments on the information collection dietary fiber) per serving. In the Federal Register of January 6, requirements by January 21, 1997. The In the nutrition labeling final rule (58 1993 (58 FR 2302), FDA published a agency is proposing that any final rule FR 2079 at 2110), FDA recognized that final rule (entitled ``Food Labeling: that may issue based upon this many food ingredients have caloric Nutrient Content Claims, General proposed rule become effective 30 days values substantially different from the Principles, Petitions, Definitions of after its date of publication in the general factors of 4, 4, and 9 calories per Terms; Definitions of Nutrient Content Federal Register. gram (g) for protein, carbohydrate, and Claims for the Fat, Fatty Acid, and ADDRESSES: Submit written comments fat, respectively. Therefore, the agency Cholesterol Content of Food,'' to the Dockets Management Branch provided a number of options for hereinafter referred to as ``the nutrient (HFA±305), Food and Drug calculating the energy value of foods. content claims final rule'') that Administration, 12420 Parklawn Dr., For example, FDA stated that calories implemented the nutrient content rm. 1±23, Rockville, MD 20857. Submit may be calculated, under claims provisions of the act by written comments on the information § 101.9(c)(1)(i)(A) (21 CFR establishing general rules for how such collection requirements to the Office of 101.9(c)(1)(i)(A)), by using specific claims are to be made and defining Information and Regulatory Affairs, Atwater factors given in Table 13 various terms (e.g., ``high,'' ``low,'' OMB, New Executive Office Bldg., 725 ``Energy Value of Foods-Basis and ``free,'' and ``reduced'') that could be 17th St. NW., Washington, DC 20503, Derivation,'' U.S. Department of used to characterize the level of various ATTN: Desk Officer for FDA. Agriculture (USDA) Handbook No. 74; nutrients in the food. 67244 Federal Register / Vol. 61, No. 246 / Friday, December 20, 1996 / Proposed Rules FDA noted that its approach to or 184 of this chapter, or by other means as Additionally, the petitioner requested developing a system of nutrient content appropriate. that FDA amend § 101.9(c)(2) to provide claims emphasized three objectives: (1) The requested change would allow the that a food factor be used to calculate Consistency among definitions, (2) amount of total fat present per serving the quantity of all fatty acids (i.e., claims that are consistent with public to be multiplied by a specific factor saturated fat, polyunsaturated fat, and health goals, and (3) claims that will approved by FDA, to yield the quantity monounsaturated fat) declared on the help consumers to maintain healthy of fat that is to be declared in nutrition nutrition label. dietary practices (58 FR 2302 at 2319). labeling, even though the declared value II. Agency Response The agency stated that it is important for may be less than the actual amount of effective consumer education to fat in the food. The approach suggested A. Definition of Terms establish consistent definitions for by the petitioner, that the factor used to descriptive terms whenever possible to calculate available fat content be To understand the issues raised by the limit the possibility of consumer approved by FDA, is similar to the petition, and the agency's response to confusion (58 FR 2302 at 2319). approach taken by FDA in those issues, it is important to § 101.9(c)(1)(i)(D), which provides that distinguish among three terms, B. Citizen Petition specific food factors may be used to ``bioavailability'' or ``availability,'' ``food Nabisco Group (Nabisco) (hereinafter calculate total caloric content declared factor,'' and ``digestibility coefficient.'' ``the petitioner'') submitted a citizen in nutrition labeling if they have been These terms are often used petition (filed December 21, 1994, approved by FDA and provided for in interchangeably but have substantially Docket No. 94P±0453/CP1) requesting part 172, part 184, or by other means as different meanings. The agency's that FDA amend its food labeling appropriate. The petitioner also approach to how energy and nutrient regulations to permit the use of a suggested that the agency could permit values are declared in nutrition labeling ``digestibility coefficient'' or ``food self-determination of a food factor for is determined by the differences among factor'' in determining the quantity of calculating nutrient availability by a these terms. fat to be declared on the nutrition label manufacturer, pending agency review of FDA notes that bioavailability is the and to permit nutrient content claims to a GRAS petition for the ingredient to result of a series of complex events, i.e., be based on the quantity of fat declared. which the factor applies. digestion, absorption, and metabolism According to the petitioner, this action The petitioner noted, for example, (Ref. 1). Digestion refers to the chemical would permit claims on a class of that it had filed a GRAS petition for and physical breakdown of food and its products that contain significantly less salatrim (GRASP 4G0404) that proposed macromolecular components in the available fat compared to an appropriate a food factor of 5/9 for this ingredient.1 gastrointestinal tract (e.g., the reference food but that may not qualify The petitioner maintained that the breakdown of triglycerides (fats) into to bear a calorie claim or a fat claim amount of available (i.e., absorbed/ fatty acids and glycerol).