[Code of Federal Regulations] [Title 21, Volume 2] [Revised as of April 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR101.45] [Page 97-99] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 101_FOOD LABELING--Table of Contents Subpart C_Specific Nutrition Labeling Requirements and Guidelines Sec. 101.45 Guidelines for the voluntary nutrition labeling of raw fruits, vegetables, and fish. (a) Nutrition labeling for raw fruits, vegetables, and fish listed in Sec. 101.44 should be presented to the public in the following manner: (1) Nutrition labeling information should be displayed at the point of purchase by an appropriate means such as by a label affixed to the food or through labeling including shelf labels, signs, posters, brochures, notebooks, or [[Page 98]] leaflets that are readily available and in close proximity to the foods. The nutrition labeling information may also be supplemented by a video, live demonstration, or other media. (2) Serving sizes should be determined, and nutrients declared, in accordance with Sec. 101.9 (b) and (c), respectively, except that the nutrition labeling data should be based on the raw edible portion for fruits and vegetables and on the 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). (3) When nutrition labeling information is provided for more than one raw fruit, vegetable, or fish on signs, posters, brochures, notebooks, or leaflets, it may be presented in charts with horizontal or vertical columns or as a compilation of individual nutrition labels. Nutrition labeling that is presented in a linear display (see Sec. 101.9(j)(13)(ii)(A)(2)) will not be considered to be in compliance. The heading ``Nutrition Facts'' must be in a type size larger than all other print in the nutrition label. The required information (i.e., headings, serving sizes, list of nutrients, quantitative amounts by weight (except for vitamins and minerals), and percent of Daily Values (DV's) (except for sugars and protein) must be clearly presented and of sufficient type size and color contrast to be plainly legible, with numeric values for percent of DV highlighted in contrast to the quantitative amounts by weight and hairlines between all nutrients. (i) Declaration of the number of servings per container need not be included in the nutrition labeling of raw fruits, vegetables, and fish. (ii) Except for the statement ``Percent Daily Values are based on a 2,000 calorie diet,'' the footnote required in Sec. 101.9(d)(9) is not required. However, when labeling is provided in brochures, notebooks, leaflets, or similar types of materials, retailers are encouraged to include the footnote. (iii) When the nutrition labeling information for more than one raw fruit or vegetable is provided on signs, posters, brochures, notebooks, or leaflets, the listings for saturated fat and cholesterol may be omitted from the charts or individual nutrition labels so long as the fact that most fruits and vegetables provide negligible amounts of these nutrients, but that avocados contain 1 gram (g) of fat per ounce, is stated in a footnote (e.g., ``Most fruits and vegetables provide negligible amounts of saturated fat and cholesterol; avocados provide 1 g of saturated fat per ounce''). The footnote may also contain information about the polyunsaturated and monounsaturated fat content of avocados. When the nutrition labeling information for raw fish is provided on a chart, the listings for dietary fiber and sugars may be omitted if the following footnote is used, ``Fish provide negligible amounts of dietary fiber and sugars.'' (4) When nutrition labeling is provided for individual raw fruits, vegetables, or fish on packages or on signs, posters, brochures, notebooks, or leaflets, it should be displayed in accordance with Sec. 101.9, except that the declaration of the number of servings per container need not be included. For individual labels provided by retailers on signs and posters, the footnote required in Sec. 101.9(d)(9) may be shortened to ``Percent Daily Values are based on a 2,000 calorie diet.'' (b) Nutrition label values provided by the Food and Drug Administration (FDA) in Appendices C and D to part 101 for the 20 most frequently consumed raw fruits, vegetables, and fish listed in Sec. 101.44 shall be used to ensure uniformity in declared values. FDA will publish proposed updates of the 20 most frequently consumed raw fruits, vegetables, and fish and nutrition label data for these foods (or a notice that the data sets have not changed from the previous publication) at least every 4 years in the Federal Register. (1) The agency encourages the submission of data bases with new or additional nutrient data for any of the most frequently consumed raw fruits, vegetables, and fish to the Office of Nutritional Products, Labeling and Dietary Supplements (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, for review and evaluation. FDA may incorporate these data in the next [[Page 99]] revision of the nutrition labeling information for the top 20 raw fruits, vegetables, and fish. (i) Guidance in the development of data bases may be found in the ``FDA Nutrition Labeling Manual: A Guide for Developing and Using Data Bases,'' available from the FDA Office of Food Labeling. (ii) The submission to FDA should include, but need not be limited to, information on the following: Source of the data (names of investigators, name of organization, place of analyses, dates of analyses), number of samples, sampling design, analytical methods, and statistical treatment of the data. Proposed quantitative label declarations may be included. The proposed values for declaration should be determined in accordance with the ``FDA Nutrition Labeling Manual: A Guide for Developing and Using Data Bases.'' (2) [Reserved] (c) Data bases of nutrient values for raw fruits, vegetables, and fish that are not among the 20 most frequently consumed may be used to develop nutrition labeling values for these foods. This includes data bases of nutrient values for specific varieties, species, or cultivars of raw fruits, vegetables, and fish not specifically identified among the 20 most frequently consumed. (1) The food names and descriptions for the fruits, vegetables, and fish should clearly identify these foods as distinct from foods among the most frequently consumed list for which FDA has provided data. (2) Guidance in the development of data bases may be found in the ``FDA Nutrition Labeling Manual: A Guide for Developing and Using Data Bases.'' (3) Nutrition labeling values computed from data bases are subject to the compliance provisions of Sec. 101.9(g). (i) Compliance with the provisions of Sec. 101.9(g) may be achieved by use of a data base that has been developed following FDA guideline procedures and approved by FDA. (A) The submission to FDA for approval should include but need not be limited to information on the following: Source of the data (names of investigators, name of organization, place of analyses, dates of analyses), number of samples, sampling design, analytical methods, statistical treatment of the data, and proposed quantitative label declarations. The values for declaration should be determined in accordance with the ``FDA Nutrition Labeling Manual: A Guide for Developing and Using Databases.'' (B) FDA approval of a data base and nutrition labeling values shall not be considered granted until the Center for Food Safety and Applied Nutrition has agreed to all aspects of the data base in writing. Approvals will be in effect for a limited time, e.g., 10 years, and will be eligible for renewal in the absence of significant changes in agricultural or industry practices (e.g., a change occurs in a predominant variety produced). FDA will take steps to revoke its approval of the data base and nutrition labeling values if FDA monitoring suggests that the data base or nutrition labeling values are no longer representative of the item sold in this country. Approval requests shall be submitted in accordance with the provision of Sec. 101.30 of this chapter. (ii) [Reserved] [61 FR 42760, Aug. 16, 1996, as amended at 66 FR 56035, Nov. 6, 2001]