which shall follow the protein declaration, shall include vitamin A, vitamin C, thiamine, riboflavin, niacin, calcium, and iron, in that order, and shall include any of the other vitamins and minerals listed in paragraph (c)(7)(iv) of this section when they are added and may list any of the other vitamins and minerals listed in paragraph (c)(7)(iv) of this section when they are naturally occurring in the order listed therein.

(iv) The following U.S. Recommended Daily Allowances (U.S. RDA) and nomenclature are established for these vitamins and minerals, essential in human nutrition:

Vitamin A, 5,000 International Units.
Vitamin C, 60 milligrams. 3
Thiamine, 1.5 milligrams. 3
Riboflavin, 1.7 milligrams.3
Niacin, 20 milligrams.
Calcium, 1.0 gram.
Iron, 18 milligrams.

Vitamin D, 400 International Units.
Vitamin E, 30 International Units.
Vitamin B., 2.0 milligrams.

Folic acid, 0.4 milligrams.
Vitamin B12, 6 micrograms.
Phosphorus, 1.0 gram.

Iodine, 150 micrograms.

Magnesium, 400 milligrams.

Zinc, 15 milligrams.

Copper, 2 milligrams.

Biotin, 0.3 milligram.

Pantothenic acid, 10 milligrams.

These nutrients and levels have been derived by the Food and Drug Administration from the "Recommended Dietary Allowances," published by the Food and Nutrition Board, National Academy of Sciences-National Research Council, and are subject to amendment from time to time as more information on human nutrition becomes available.

(v) No claim may be made that a food is a significant source of a nutrient unless that nutrient is present in the food at a level equal to or in excess of 10 percent of the U.S. RDA in a serving (portion). No claim may be made that a food is nutritionally supe

rior to another food unless it contains at least 10 percent more of the U.S. RDA of the claimed nutrient per serving (portion).

(d) Products with separately packaged ingredients or to which other ingredients are added by the user may be labeled as follows:

(1) If a product is comprised of two or more separately packaged ingredients enclosed in an outer container, nutrition labeling of the total product shall be located on the outer container to provide information for the consumer at the point of purchase. However, when two or more food products are simply combined together in such a manner that no outer container is used, or no outer label is available, each product shall have its own nutrition information, e.g., two boxes taped together or two cans combined in a clear plastic overwrap.

(2) If a food is commonly combined with another ingredient(s) before eating and directions for such combination are provided, another column of figures may be used to provide a list of the nutrient contents for the final combination in the same format required in paragraph (c) of this section for the food alone (e.g., a dry ready-toeat cereal may be described with one set of percentage U.S. RDA values for the cereal as sold (per ounce), and another set for the cereal and milk as suggested in the label (per ounce of cereal and one-half cup of vitamin D fortified whole milk); and a cake mix may be labeled with one set of percentage U.S. RDA values for the dry mix (per serving), and another set for a serving of the final cake when prepared). The type and quantity of the other ingredient(s) to be added by the user to the product shall be specified. (e) Compliance with this section shall be determined as follows:

(1) A collection of primary containers or units of the same size, type, and style produced under conditions as nearly uniform as possible, designated by a common container code or marking, or in the absence of any common container code or marking a day's production, constitutes a "lot."

(2) The sample for nutrient analysis shall consist of a composite of 12 subsamples (consumer units), taken one

from each of 12 different randomly chosen shipping cases, to be representative of a lot. Composites shall be analyzed by Association of Official Analytical Chemists (AOAC) methods where available or, if no AOAC method is available, by reliable and appropriate analytical procedures. Alternative methods of analysis may be submitted to the Food and Drug Administration to determine their acceptability.

(3) Two classes of nutrients are defined for purposes of compliance:

Class I. Added nutrients in fortified or fabricated foods.

Class II. Naturally occurring (indigenous) nutrients.

If any ingredient which contains a naturally occurring (indigenous) nutrient is added to a food, the total amount of such nutrient in the final food product is subject to Class II requirements unless the same nutrient is also added.

(4) A food with a label declaration of a vitamin, mineral, or protein shall be deemed to be misbranded under section 403(a) of the act unless it meets the following requirements:

(i) Class I vitamin, mineral, or protein. The nutrient content of the composite is at least equal to the value for that nutrient declared on the label.

(ii) Class II vitamin, mineral, or protein. The nutrient content of the composite is at least equal to 80 percent of the value for that nutrient declared on the label.

Provided, That no regulatory action will be based on a determination of a nutrient value which falls below this level by a factor less than the variability generally recognized for the analytical method used in that food at the level involved.

(5) A food with a label declaration of calories, carbohydrates, or fat shall be deemed to be misbranded under section 403(a) of the act unless the nutrient content of the composite is no greater than 20 percent in excess of the value for that nutrient declared on the label.

(6) Reasonable excesses of a vitamin, mineral, or protein over labeled amounts are acceptable within good manufacturing practices. Reasonable

deficiencies of calories or fat under labeled amounts are acceptable within good manufacturing practices.

(f) Nutrition information provided by a manufacturer or distributor directly to professionals (e.g., physicians, dietitians, educators) may vary from the requirements of this section but shall also contain or have attached to it the nutrition information exactly as required by this section.

(g) The location of nutrition information on a label shall be in compliance with § 101.2.

(h) The following foods are exempt from this section or are subject to special labeling requirements:

(1)(i) Except where expressly covered by § 105.65 of this chapter, infant, baby, and junior-type food promoted for infants and children under 4 years of age shall include nutrition information on the label and in labeling in compliance with this section.

(ii) Both the U.S. RDA levels for infants from birth to 12 months of age and the U.S. RDA values for children under 4 years of age may be declared for foods represented or intended for use by both infants and children under 4 years of age. If such dual declaration is used on any label, it shall also be included in all labeling, and equal prominence shall be given to both values in all promotional material.

(iii) For the purposes of labeling these foods with a percent of the U.S. RDA for protein for infants, a value of 18 grams of protein shall be the U.S. RDA value for protein with a protein efficiency ratio (PER) equal to or greater than casein, and 25 grams if the PER of the protein is less than the PER of casein but greater than 40 percent of casein. For purposes of labeling foods for children under 4 years of age with a percent of the U.S. RDA for protein, a value of 20 grams of protein shall be the U.S. RDA value for protein with a PER equal to or greater than casein, and 28 grams if the PER of the protein is less than the PER of casein but greater than 20 percent of casein.

(iv) Total protein with a PER less than 40 percent of the PER of casein may not be stated on the label in terms of percentage U.S. RDA for in

fants, and the statement of protein content in grams per serving under paragraph (c)(4) of this section shall be modified by the statement "not a significant source of protein for infants" immediately adjacent to the protein content statement regardless of the actual amount of protein present.

(2) Dietary supplements are exempted, except that the labeling of a dietary supplement in food form, e.g., a breakfast cereal, shall conform to the labeling established in paragraph (c) of this section, including the order for listing vitamins and minerals established in parragraph (c)(7)(iv) of this section.

(3) Any food represented for use as the sole item of the diet shall be labeled in compliance with Part 105 of this chapter.

(4) Foods represented for use solely under medical supervision to meet nutritional requirements in specific medical conditions shall be labeled in compliance with Part 105 of this chapter.

(5) Iodized salt shall be labeled in compliance with § 100.155 of this chapter and when used in a food does not subject that food to labeling under this section if it is declared in the ingredient statement by its name (iodized salt) and neither iodine nor iodized salt is otherwise referred to on the label or in labeling or advertising.

(6) A nutrient(s) included in food solely for technological purposes may be declared solely in the ingredient statement, without complying with this section, if the nutrient(s) is otherwise not referred to on the label or in labeling or in advertising.

(7) A standardized food containing an added nutrient(s), e.g., enriched flour, and included in another food as a component may be declared in the ingredient statement by its standardized name, without compliance with this section, if neither the nutrient(s) nor the component is otherwise referred to on the label or in labeling or in advertising.

(8) Food products shipped in bulk form for use solely in the manufacture of other foods and not for distribution to consumers in such bulk form or container.

(9) Food products containing an added vitamin, mineral, or protein, or for which a nutritional claim is made on the label or in labeling or in advertising, which are supplied for institutional food service use only: Provided, That the manufacturer or distributor provides the nutrition information required by this section directly to those institutions on a current basis.

(10) Fresh fruits and fresh vegetables, pending promulgation of specific labeling requirements for these products.

(i) 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 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. (2) That a balanced diet of ordinary foods cannot supply adequate amounts of nutrients.

(3) 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.

(4) 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.

(5) That the food has dietary properties when such properties are of no significant value or need in human nutrition. Ingredients or products such as rutin, other bioflavonoids, paraamino-benzoic acid, inositol, and similar substances which have in the past been represented as having nutritional properties but which have not been shown to be essential in human nutrition may not be combined with vitamins and/or minerals, added to food labeled in accordance with this section, or otherwise used or represented in any way which states or implies nutritional benefit. Ingredients or products of this type may be marketed as individual products or mixtures thereof: Provided, That the possibility of nutritional, dietary, or therapeutic value is not stated or implied, e.g.,

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 establishment 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 cne 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 exother tremely small compared to 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 Administra tion, including the association's name, mailing address, telephone number, and contact person.