to differentiate in any way between vitamins naturally present from those added. (Information Collection requirements were approved by the Office of Management and Budget under OMB control number 0910-0198) [42 FR 14308, Mar. 15, 1977, as amended at 42 FR 27226, May 27, 1977; 44 FR 16006, Mar, 16, 1979; 45 FR 37422, June 3, 1980; 47 FR 11820, Mar. 19, 1982; 49 FR 5609, Feb. 14, 1984; 49 FR 15533, Apr. 18, 1984; 49 FR 26572, June 28, 1984; 52 FR 28691, Aug. 3, 1987; 54 FR 24891, June 12, 1989] EFFECTIVE DATE NOTE: At 59 FR 371, Jan. 4, 1994 in § 101.9, paragraphs (d)(3)(ii), (h)(2), and (j)(6) were revised, effective July 5, 1995. For the convenience of the reader, the revised text is set forth below. § 101.9 Nutrition labeling of food. (d) * (3)*** (ii) "Servings Per Container": The number of servings per container, except that this statement is not required on single serving containers as defined in paragraph (b)(6) of this section or on other food containers when this information is stated in the net quantity of contents declaration. (h) *** (2) If a product consists of two or more separately packaged foods that are intended to be eaten individually and that are enclosed in an outer container (e.g., variety packs of cereals or snack foods), the nutrition information shall: (1) Be specified per serving for each food in a location that is clearly visible to the consumer at the point of purchase; and (ii) Be presented in separate nutrition labels or in one aggregate nutrition label with separate columns for the quantitative amount by weight and the percent Daily Value for each food. (j) * * * (6) Dietary supplements of vitamins or minerals that have an RDI as established in paragraph (c)(8)(iv) of this section or a DRV as established in paragraph (c)(9) of this section shall be labeled in compliance with § 101.36, except that dietary supplements of vitamins or minerals in food in conventional form (e.g., breakfast cereals), of herbs, and of other similar nutritional substances shall conform to the labeling of this section. § 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 on menus). 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. [58 FR 2410, Jan. 6, 1993; 58 FR 17341, Apr. 2, 1993] EFFECTIVE DATE NOTE: At 58 FR 2410, Jan. 6, 1993, and corrected at 58 FR 17341, Apr. 2, 1993, § 101.10 was revised effective May 8, 1994, except concerning restaurant firms of 10 or less individual restaurant establishments for whom this section will become effective on May 8, 1995. For the convenience of the reader, the superseded text is set forth below. § 101.10 Nutrition labeling of restaurant foods. A nutrition claim or nutrition information concerning a combination of restaurant foods, e.g., the total nutritional value of a meal consisting of a hamburger, french fries, and milk shake, may be included in advertising and/or in labeling (other than labels), without causing nutrition information to be required on the label(s) of each article of food: Provided, That complete nutrition information for the combination of foods (the combination as an entity without the nutritional value of each article being specified) in the format established by $101.9(c) is effectively displayed to the customer both when he orders the food and when he consumes the food. This statement of policy does not apply to food dispensed in automatic vending machines. § 101.11 Saccharin and its salts; retail establishment notice. Each retail establishment (except restaurants) that sells food that con tains saccharin shall display the following notice in the locations set forth in paragraph (b) of this section: SACCHARIN This store sells food including diet beverages and dietetic USE OF THIS PRODUCT MAY BE HAZARDOUS THIS STORE IS REQUIRED BY LAW TO DISPLAY THIS NOTICE PROMINENTLY Each notice shall be displayed prominently, in a manner highly visible to consumers (e.g., not shielded by other store signs or merchandise displays) and set up to reduce the likelihood that a notice will be torn, defaced, or removed. (a) The notice shall be printed in a combination of red and black ink on white card stock and be at least 11 by 14 inches. The background of the bold heading, "Saccharin Notice," and the boxed warning statement shall be bright red and the lettering, white. The remaining background shall be white with black ink. All lettering shall be in gothic typeface. (b) Except as provided in paragraph (c) of this section, each retail estab lishment that sells food that contains saccharin shall display a notice in each of the following three locations: (1) Near the entrance to the retail establishment and arranged so that consumers are likely to see the notice upon entering. (2) Centrally located in the area of the retail establishment in which soft drinks containing saccharin are displayed. If there is more than one such place, then in the area where the greatest quantity of diet soft drinks are displayed. (3) In the area in the establishment in which the largest quantity of saccharin-containing foods (including saccharin sold in package form as a sugar substitute) are displayed, other than the area where diet soft drinks are displayed. (c) The following are exceptions to the requirements set forth in paragraph (b) of this section: (1) A retail establishment with 3,200 square feet or less of floor space shall display at least one notice. The notice shall be located near the entrance to the retail establishment and arranged so that consumers are likely to see the notice upon entering. (2) A retail establishment with more than 3,200 but less than 10,000 square feet of floor space shall display at least two notices. The first notice shall be located near the entrance to the retail establishment and arranged so that consumers are likely to see the notice upon entering. The second notice shall be centrally located in the area of the retail establishment in which soft drinks containing saccharin are displayed. If there is more than one such place, then in the area where the greatest quantity of diet soft drinks are displayed. If diet soft drinks are not sold, then in the area of the establishment in which the largest quantity of saccharin-containing foods (including saccharin sold in package form as a sugar substitute) are displayed. (3) A large retail establishment, e.g., department store, whose primary business consists of selling nonfood items (i.e., the proportion of food sold is extremely small compared to other items) shall display at least one notice. The notice shall be located in the area of the establishment in which foods containing saccharin are displayed. If there is more than one such area, then a notice shall be displayed in each area. (d) Each manufacturer of saccharincontaining food who customarily delivers his products directly to retail establishments shall make available at least three notices to each retail establishment in which his products are sold. Each manufacturer shall also arrange to supply additional notices to a retail establishment that asks for them. (e) Manufacturers who do not customarily deliver their saccharin-containing food products directly to retail establishments may fulfill their obligation to provide notices either in the manner set forth in paragraph (d) of this section or by participating in, and performing the actions required by, a trade association coordinated program that meets the following requirements: (1) The coordinating association shall have filed notice of the program with the Food and Drug Administration, including the association's name, mailing address, telephone number, and contact person. (2) Each manufacturer participating in the program shall file notice of its participation with the coordinating association, including its name, mailing address, telephone number, and contact person. (3) The association shall ensure that retail establishment notices, in the form specified in this section, are readily available to participating manufacturers. (4) The association shall take affirmative steps to coordinate with retail establishments, their trade associations, and the trade press to disseminate information about the applicable requirements of the Saccharin Study and Labeling Act and these regulations, the existence of the association coordinated program, and the availability of notices through the program. (5) Each manufacturer shall, in consultation with the association, communicate with its contacts in the distributional chain to inform them of the applicable requirements of the Saccharin Study and Labeling Act and these regulations, and the continued availability of notices. (6) Each manufacturer shall ensure that notices are promptly provided on request to any retail establishment carrying its products. (7) The association shall consult with participating manufacturers concerning the implementation and progress of the program and shall disseminate information to facilitate the conduct of the program based on such consultations or consultation with the Food and Drug Administration. (8) The association shall, on request, permit the Food and Drug Administration to have access to the participation notices filed by manufacturers, samples showing the form of retail establishment notices made available, and typical communication materials used by the association in the course of the program. [43 FR 8795, Mar. 3, 1978] § 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. sion, 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: rec (i) Serving sizes used in dietary guidance recommendations or ommended by other authoritative systems or organizations; (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: (4) To determine the amount of food customarily consumed per eating occaTABLE 1.-REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION: INFANT AND TODDLER FOODS 1,2,3,4 Cereals, dry instant Cereals, prepared, ready-to-serve ready-to-eat, e.g., ready-to-eat cereals, cookies, teething biscuits, and toasts. Dinners, desserts, fruits, vegetables or soups, dry mix. Dinners, desserts, fruits, vegetables or soups, ready-to-serve, junior type. Dinners, desserts, fruits, vegetables or soups, ready-to-serve, strained type. Dinners, stews or soups for toddlers, ready-to-serve. 15 g 110 g 7 g for infants and 20 g for toddlers for 15 g 110 g 60 9 170 g TABLE 1.-REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION: INFANT AND TODDLER FOODS 1.2.3.4—Continued These 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). Copies of the list of products for each product category are available from the Office of Food Labeling (HFS-150), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC 20204. 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 Cakes, heavy weight (cheese cake; Cakes, medium weight (chemically 80 g 55 g g) for distinct g) for g) for distinct |