[Title 21 CFR 101.45] [Code of Federal Regulations (annual edition) - April 1, 1996 Edition] [Title 21 - FOOD AND DRUGS] [Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--CONTINUED] [Subchapter B - FOOD FOR HUMAN CONSUMPTION] [Part 101 - FOOD LABELING] [Subpart C - Specific Nutrition Labeling Requirements and Guidelines] [Sec. 101.45 - Guidelines for the voluntary nutrition labeling of raw fruit, vegetables, and fish.] [From the U.S. Government Publishing Office]21 FOOD AND DRUGS 2 1996-04-01 1996-04-01 false Guidelines for the voluntary nutrition labeling of raw fruit, vegetables, and fish. 101.45 Sec. 101.45 FOOD AND DRUGS FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--CONTINUED FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Nutrition Labeling Requirements and Guidelines Sec. 101.45 Guidelines for the voluntary nutrition labeling of raw fruit, vegetables, and fish. Nutrition labeling for raw fruit, vegetables, and fish listed in Sec. 101.44 should be presented to the public in the following manner: (a) Nutrition labeling information should be displayed at the point of purchase by an appropriate means, including by affixing it to the food, by posting a sign, or by making the information readily available in brochure, notebook, or leaflet form in close proximity to the foods. The nutrition labeling information may also be supplemented by a video, live demonstration, or other media. (b) Nutrition information should be provided on the label or in labeling in accordance with Sec. 101.9, as modified by the following guidelines: (1) The percent U.S. RDA for protein, thiamin, riboflavin, and niacin may be declared in the nutrition labeling. Declaration of complex carbohydrates, sugars, dietary fiber, saturated fat, and cholesterol is also voluntary. (2) Nutrition labeling information may be presented on individual labels or in charts in vertical columns or in lines. When lines are used, any subcomponents declared should be listed parenthetically after principal components (e.g., saturated fat should be parenthetically listed after fat). (3) Declaration of the number of servings per container need not be included in nutrition labeling of raw fruit, vegetables, and fish. (4) The nutrition label data should be based on raw edible portion for fruit and vegetables and on a cooked edible portion for fish. The methods used to cook fish should be those that do not add fat, breading, or seasoning (e.g., salt or spices). (c) Nutrient data and proposed nutrient values for nutrition labeling for raw fruit, vegetables, and fish may be submitted to the Center for Food Safety and Applied Nutrition (HFS-150), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, for review and evaluation. The data and nutrient values for nutrition labeling are appropriate for use if they are accepted by the Food and Drug Administration (FDA). The submission to FDA should include information on the source of the data (names of investigators, name of organization, place of analysis, dates of analyses), number of samples, sampling scheme, analytical methods, statistical treatment of the data, and proposed quantitative label declarations. The nutrient values for the nutrition labeling should be determined in accordance with FDA guidance. (d) Composite data that reflect representative nutrient levels for various varieties, species, cultivars; seasons; and geographic regions may be used to label raw fruit, vegetables, and fish. Alternatively, data that reflect a specific variety, species, cultivar; season; or geographic region may be used to label raw fruit, vegetables, and fish; the nutrition labeling information for such [[Page 90]] variety, etc., should provide food names and descriptions for the fruit, vegetables, and fish that appropriately reflect the samples analyzed for nutrient values. (e) The FDA manual ``Compliance Procedures for Nutrition Labeling'' (or subsequent revisions of this manual) should be used to develop nutrition label values from data base values. The manual is available from the Division of Nutrition. (f) If the agency's Center for Food Safety and Applied Nutrition agrees to all aspects of a submitted data base, FDA will notify a submitter in writing of its acceptance of the nutrient data and nutrient values for nutrition labeling. FDA's acceptance will be for a period of 10 years or until other data for the same food are submitted to FDA and found to be superior. Those obtaining data base and nutrient value acceptance from FDA are responsible for continued maintenance of the data base. FDA will renew its acceptance of a data base upon request after 10 years unless the data have been superseded by other data on the same food or there have been demonstrated changes in agricultural or industry practices. When agricultural or industry practices change (e.g., a change occurs in a predominant variety produced), or when FDA monitoring suggests that the data base or nutrient values are no longer representative of the item sold in this country, FDA will take steps to revoke its acceptance of the data base and nutrient values. A revised data base and proposed nutrient values may be submitted to FDA for acceptance. (g) If the nutrition information is in accordance with an FDA- accepted data base, the nutrient values have been computed following FDA guidelines, and the food has been handled in accordance with current good manufacturing practices to prevent nutrient loss, a nutrition label will not be subject to the agency compliance review under Sec. 101.9(e). (h) Organizations may use data bases that they believe validly reflect the nutrient content of raw fruit, vegetables, and fish; however, labeling computed from data bases not reviewed, evaluated, and accepted by the agency is subject to the compliance procedures of Sec. 101.9(e). (i) FDA will publish, and provide an opportunity for comment on, updates of the nutrition labeling data for the 20 most frequently consumed raw fruit, vegetables, and fish (or a notice that the data sets have not changed from the previous publication) at least every 2 years in the Federal Register. FDA accepted data for other raw fruit, vegetables, and fish, or for other nutrients, are available from the Center for Food Safety and Applied Nutrition (HFS-150), 200 C St. SW., Washington, DC 20204. [55 FR 60890, Nov. 27, 1991, as amended at 61 FR 14479, Apr. 2, 1996]