Nutrition Facts Serv size: 1 package, Amount Per Serving: Calories 45, Fat Cal. 10, Total Fat 1g (2% DV), Sat. Fat 1g (5% DV), Cholest. Omg (0% DV), Sodium 50mg (2% DV), Total carb. 8g (3% DV), Fiber 1g (4% DV), Sugars 4g, Protein 1g, Vitamin A (8% DV), Vitamin C (8% DV), Calcium (0% DV), Iron (2 % DV). Percent Daily Values (DV) are based on a 2,000 calorie diet. (B) Using any of the following abbreviations: Serving size-Serv size Servings per container-Servings Calories from saturated fat-Sat fat cal Monounsaturated fat-Monounsat fat Total carbohydrate-Total carb Soluble fiber-Sol fiber Insoluble fiber-Insol fiber Sugar alcohol-Sugar alc (C) Omitting the footnote required in paragraph (d)(9) of this section and placing another asterisk at the bottom of the label followed by the statement "Percent Daily Values are based on a 2,000 calorie diet" and, if the term "Daily Value" is not spelled out in the heading, a statement that "DV" represents "Daily Value." (D) Presenting the required nutrition information on any label panel. (14) Shell eggs packaged in a carton that has a top lid designed to conform to the shape of the eggs are exempt from outer carton label requirements where the required nutrition information is clearly presented immediately beneath the carton lid or in an insert that can be clearly seen when the carton is opened. (15) The unit containers in a multiunit retail food package where: (i) The multiunit retail food package labeling contains all nutrition information in accordance with the requirements of this section; (ii) The unit containers are securely enclosed within and not intended to be separated from the retail package under conditions of retail sale; and (iii) Each unit container is labeled with the statement "This Unit Not Labeled For Retail Sale" in type size not less than 1/16-inch in height, except that this statement shall not be required when the inner unit containers bear no labeling at all. The word "individual" may be used in lieu of or immediately preceding the word "Retail" in the statement. (16) Food products sold from bulk containers: Provided, That nutrition information required by this section be displayed to consumers either on the labeling of the bulk container plainly in view or in accordance with the provisions of paragraph (a)(2) of this section. (17) Foods in packages that have a total surface area available to bear labeling greater than 40 square inches but whose principal display panel and information panel do not provide sufficient space to accommodate all required information may use any alternate panel that can be readily seen by consumers for the nutrition label. The space needed for vignettes, designs, and other nonmandatory label information on the principal display panel may be considered in determining the sufficiency of available space on the principal display panel for the placement of the nutrition label. Nonmandatory label information on the information panel shall not be considered in determining the sufficiency of available space for the placement of the nutrition label. (18) Food products that are low-volume (that is, they meet the requirements for units sold in paragraphs (j)(18)(i) or (j)(18)(ii) of this section); that, except as provided in paragraph (j)(18)(iv) of this section, are the subject of a claim for an exemption that provides the information required under paragraph (j)(18)(iv) of this section, that is filed before the beginning of the time period for which the exemption is claimed, and that is filed by a person, whether it is the manufacturer, packer, or distributor, that qualifies to claim the exemption under the requirements for average full-time equivalent employees in paragraphs (j)(18)(i) or (j)(18)(ii) of this section; and whose labels, labeling, and advertising do not provide nutrition information or make a nutrient content or health claim. (i) For food products first introduced into interstate commerce before May 8, 1994, the product shall be exempt for the period: (A) Between May 8, 1995, and May 7, 1996, if, for the period between May 8, 1994, and May 7, 1995, the person claiming the exemption employed fewer than an average of 300 full-time equivalent employees and fewer than 400,000 units of that product were sold in the United States; and (B) Between May 8, 1996, and May 7, 1997, if for the period between May 8, 1995, and May 7, 1996, the person claiming the exemption employed fewer than an average of 200 full-time equivalent employees and fewer than 200,000 units of that product were sold in the United States. (ii) For all other food products, the product shall be eligible for an exemption for any 12-month period if, for the preceding 12 months, the person claiming the exemption employed fewer than an average of 100 full-time equivalent employees and fewer than 100,000 units of that product were sold in the United States, or in the case of a food product that was not sold in the 12-month period preceding the period for which exemption is claimed, fewer than 100,000 units of such product are reasonably anticipated to be sold in the United States during the period for which exemption is claimed. (iii) If a person claims an exemption under paragraphs (j)(18)(i) or (j)(18)(ii) of this section for a food product and then, during the period of such exemption, the number of full-time equivalent employees of such person exceeds the appropriate number, or the number of food products sold in the United States exceeds the appropriate number, or, if at the end of the period of such exemption, the food product no longer qualifies for an exemption under the provisions of paragraphs (j)(18)(i) or (j)(18)(ii) of this section, such person shall have 18 months from the date that the product was no longer qualified as a low-volume product of a small business to comply with this section. (iv) A notice shall be filed with the Office of Nutritional Products, Labeling and Dietary Supplements (HFS800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740 and contain the following information, except that if the person is not an importer and has fewer than 10 full-time equivalent employees, that person does not have to file a notice for any food product with annual sales of fewer than 10,000 total units: (A) Name and address of person requesting exemption. This should include a telephone number or FAX number that can be used to contact the person along with the name of a specific contact; (B) Names of the food products (including the various brand names) for which exemption is claimed; (C) Name and address of the manufacturer, distributor, or importer of the food product for which an exemption is claimed, if different than the person that is claiming the exemption; (D) The number of full-time equivalent employees. Provide the average number of full-time equivalent individuals employed by the person and its affiliates for the 12 months preceding the period for which a small business exemption is claimed for a product. The average number of full-time equivalent employees is to be determined by dividing the total number of hours of salary or wages paid to employees of the person and its affiliates by the number of hours of work in a year, 2,080 hours (i.e., 40 hours 52 weeks); (E) Approximate total number of units of the food product sold by the person in the United States in the 12month period preceding that for which a small business exemption is claimed. Provide the approximate total number of units sold, or expected to be sold, in a 12-month period for each product for which an exemption is claimed. For products that have been in production for 1 year or more prior to the period for which exemption is claimed, the 12month period is the period immediately preceding the period for which an exemption is claimed. For other products, the 12-month period is the period for which an exemption is claimed; and (F) The notice shall be signed by a responsible individual for the person who can certify the accuracy of the information presented in the notice. The individual shall certify that the information contained in the notice is a complete and accurate statement of the average number of full-time equivalent employees of this person and its affiliates and of the number of units of the product for which an exemption is claimed sold by the person. The individual shall also state that should the average number of full-time equivalent employees or the number of units of food products sold in the United States by the person exceed the applicable numbers for the time period for which exemption is claimed, the person will notify FDA of that fact and the date on which the number of employees or the number of products sold exceeded the standard. (v) FDA may by regulation lower the employee or units of food products requirements of paragraph (j)(18)(ii) of this section for any food product first introduced into interstate commerce after May 8, 2002, if the agency determines that the cost of compliance with such lower requirement will not place an undue burden on persons subject to it. (vi) For the purposes of this paragraph, the following definitions apply: (A) Unit means the packaging or, if there is no packaging, the form in which a food product is offered for sale to consumers. (B) Food product means food in any sized package which is manufactured by a single manufacturer or which bears the same brand name, which bears the same statement of identity, and which has similar preparation methods. (C) Person means all domestic and foreign affiliates, as defined in 13 CFR 121.401, of the corporation, in the case of a corporation, and all affiliates, as defined in 13 CFR 121.401, of a firm or other entity, when referring to a firm or other entity that is not a corporation. (D) Full-time equivalent employee means all individuals employed by the person claiming the exemption. This number shall be determined by dividing the total number of hours of salary or wages paid directly to employees of the person and of all of its affiliates by the number of hours of work in a year, 2,080 hours (i.e., 40 hours 52 weeks). (k) A food labeled under the provisions of this section shall be deemed to be misbranded under sections 201(n) and 403(a) of the act if its label or labeling represents, suggests, or implies: (1) That the food, because of the presence or absence of certain dietary properties, is adequate or effective in the prevention, cure, mitigation, or treatment of any disease or symptom. Information about the relationship of a dietary property to a disease or health-related condition may only be provided in conformance with the requirements of § 101.14 and part 101, subpart E. (2) That the lack of optimum nutritive quality of a food, by reason of the soil on which that food was grown, is or may be responsible for an inadequacy or deficiency in the quality of the daily diet. (3) That the storage, transportation, processing, or cooking of a food is or may be responsible for an inadequacy or deficiency in the quality of the daily diet. (4) That a natural vitamin in a food is superior to an added or synthetic vitamin. [58 FR 2175, Jan. 6, 1993, as amended at 58 FR 2227, 2533, Jan. 6, 1993; 58 FR 17104, Apr. 1, 1993; 58 FR 17328-17331, Apr. 2, 1993; 58 FR 44048, 44076, Aug. 18, 1993; 58 FR 59363, Nov. 9, 1993; 58 FR 60109, Nov. 15, 1993; 59 FR 371, Jan. 4, 1994; 59 FR 62317, Dec. 5, 1994; 60 FR 17205, Apr. 5, 1995; 60 FR 30788, June 12, 1995; 60 FR 67174, Dec. 28, 1995; 61 FR 8779, Mar. 5, 1996; 61 FR 14479, Apr. 2, 1996; 61 FR 40978, Aug. 7, 1996; 62 FR 15342, Mar. 31, 1997; 62 FR 49848, Sept. 23, 1997; 63 FR 14035, Mar. 24, 1998; 64 FR 12889, Mar. 16, 1999; 65 FR 56479, Sept. 19, 2000; 66 FR 56035, Nov. 6, 2001] § 101.10 Nutrition labeling of restaurant foods. Nutrition labeling in accordance with § 101.9 shall be provided upon request for any restaurant food or meal for which a nutrient content claim (as defined in § 101.13 or in subpart D of this part) or a health claim (as defined in § 101.14 and permitted by a regulation in subpart E of this part) is made, except that information on the nutrient amounts that are the basis for the claim (e.g., "low fat, this meal provides less than 10 grams of fat") may serve as the functional equivalent of complete nutrition information as described in § 101.9. Nutrient levels may be determined by nutrient data bases, cookbooks, or analyses or by other reasonable bases that provide assurance that the food or meal meets the nutrient requirements for the claim. Presentation of nutrition labeling may be in various forms, including those provided in § 101.45 and other reasonable means. [61 FR 40332, Aug. 2, 1996] § 101.12 Reference amounts customarily consumed per eating occasion. (a) The general principles and factors that the Food and Drug Administration (FDA) considered in arriving at the reference amounts customarily consumed per eating occasion (reference amounts) which are set forth in paragraph (b) of this section, are that: (1) FDA calculated the reference amounts for persons 4 years of age or older to reflect the amount of food customarily consumed per eating occasion by persons in this population group. These reference amounts are based on data set forth in appropriate national food consumption surveys. (2) FDA calculated the reference amounts for an infant or child under 4 years of age to reflect the amount of food customarily consumed per eating occasion by infants up to 12 months of age or by children 1 through 3 years of age, respectively. These reference amounts are based on data set forth in appropriate national food consumption surveys. Such reference amounts are to be used only when the food is specially formulated or processed for use by an infant or by a child under 4 years of age. (3) An appropriate national food consumption survey includes a large sample size representative of the demographic and socioeconomic characteristics of the relevant population group and must be based on consumption data under actual conditions of use. (4) To determine the amount of food customarily consumed per eating occasion, FDA considered the mean, median, and mode of the consumed amount per eating occasion. (5) When survey data were insufficient, FDA took various other sources of information on serving sizes of food into consideration. These other sources of information included: (ii) Serving sizes recommended in comments; (iii) Serving sizes used by manufacturers and grocers; and (iv) Serving sizes used by other countries. (6) Because they reflect the amount customarily consumed, the reference amount and, in turn, the serving size declared on the product label are based on only the edible portion of food, and not bone, seed, shell, or other inedible components. (7) The reference amount is based on the major intended use of the food (e.g., milk as a beverage and not as an addition to cereal). (8) The reference amounts for products that are consumed as an ingredient of other foods, but that may also be consumed in the form in which they are purchased (e.g., butter), are based on use in the form purchased. (9) FDA sought to ensure that foods that have similar dietary usage, product characteristics, and customarily consumed amounts have a uniform reference amount. (b) The following reference amounts shall be used as the basis for determining serving sizes for specific products: TABLE 1-REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION: INFANT AND TODDLER FOODS 1,2,3,4 1These values represent the amount of food customarily consumed per eating occasion and were primarily derived from the 1977-1978 and the 1987-1988 Nationwide Food Consumption Surveys conducted by the U.S. Department of Agriculture. 2 Unless otherwise noted in the Reference amount column, the reference amounts are for the ready-to-serve or almost readyto-serve form of the product (i.e., heat and serve, brown and serve). If not listed separately, the reference amount for the unprepared form (e.g., dry cereal) is the amount required to make the reference amount of the prepared form. Prepared means prepared for consumption (e.g., cooked). 3 Manufacturers are required to convert the reference amount to the label serving size in a household measure most appropriate to their specific product using the procedures in 21 CFR 101.9(b). 4Copies of the list of products for each product category are available from 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. 5 The label statements are meant to provide guidance to manufacturers on the presentation of serving size information on the label, but they are not required. The term "piece" is used as a generic description of a discrete unit. Manufacturers should use the description of a unit that is most appropriate for the specific product (e.g., sandwich for sandwiches, cookie for cookies, and bar for frozen novelties). TABLE 2-REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION: GENERAL FOOD |