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APPENDIX B TO PART 101-GRAPHIC ENHANCEMENTS USED BY THE FDA (eff. 5-8-94)

Appendix B to Part 101

Examples of Graphic Enhancements used by the FDA

A.Overall

1. Nutrition Facts Label is boxed with all black or one color type printed on a white or neutral ground.

B. Typeface and size

1. The "Nutrition Facts" label uses 6 point or larger Helvetica Black and/or Helvetica Regular type. In order to fit some formats the typography may be kerned as much as -4, (tighter kerning reduces legibility).

2. Key nutrients & their % Daily Value are set in 8 point Helvetica Black (but "%" is set in Helvetica Regular).

3. "Nutrition Facts" is set in either Franklin Gothic Heavy or Helvetica Black to fit the width of the label flush left and flush right.

4. "Serving Size" and "Servings per container" are set in 8 point Helvetica Regular with 1 point of leading.

5. The table labels (for example; "Amount per Serving") are set 6 point Helvetica Black.

6. Absolute measures of nutrient content (for example; "1g") and nutrient subgroups are set in 8 point Helvetica Regular with 4 points of leading.

7. Vitamins and minerals are set in 8 point Helvetica Regular, with 4 points of leading, separated by 10 point bullets.

8. All type that appears under vitamins and minerals is set in 6 point Helvetica regular with 1 point of leading.

C. Rules

1. A 7 point rule separates large groupings as shown in example. A 3 point rule separates calorie information from the nutrient information.

2. A hairline rule or 1/4 point rule separates individual nutrients, as shown in the example. Descenders do not touch rule. The top half of the label (nutrient information) has 2 points of leading between the type and the rules, the bottom half of the label (footnotes) has 1 point of leading between the type and the rules. D. Box

1. All labels are enclosed by 1/2 point box rule within 3 points of text measure.

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Subpart B-Requirements for Specific
Nonstandardized Foods

102.22 Protein hydrolysates (eff. 5-8-94).
102.23 Peanut spreads.

102.26 Frozen "heat and serve" dinners. 102.28 Foods packaged for use in the preparation of "main dishes" or "dinners." 102.30 Noncarbonated beverage products containing no fruit or vegetable juice. 102.32 Diluted orange juice beverages. 102.33 Diluted fruit or vegetable juice beverages other than diluted orange juice beverages.

102.37 Mixtures of edible fat or oil and olive oil.

102.39 Onion rings made from diced onion. 102.41 Potato chips made from dried potatoes.

102.45 Fish sticks or portions made from

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Subpart A-General Provisions

§ 102.5 General principles.

(a) The common or usual name of a food, which may be a coined term, shall accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food or its characterizing properties or ingredients. The name shall be uniform among all identical or similar products and may not be confusingly similar to the name of any other food that is not reasonably encompassed within the same name. Each class or subclass of food shall be given its own common or

usual name that states, in clear terms, what it is in a way that distinguishes it from different foods.

(b) The common or usual name of a food shall include the percentage(s) of any characterizing ingredient(s) or component(s) when the proportion of such ingredient(s) or component(s) in the food has a material bearing on price or consumer acceptance or when the labeling or the appearance of the food may otherwise create an erroneous impression that such ingredient(s) or component(s) is present in an amount greater than is actually the case. The following requirements shall apply unless modified by a specific regulation in subpart B of this part.

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(1) The percentage of a characterizing ingredient or component shall be declared on the basis of its quantity in the finished product (i.e., weight/ weight in the case of solids, or volume/volume in the case of liquids). (2) The percentage of a characterizing ingredient or component shall be declared by the words "containing (or contains) percent (or %) or percent (or %) with the first blank filled in with the percentage expressed as a whole number not greater than the actual percentage of the ingredient or component named and the second blank filled in with the common or usual name of the ingredient or component. The word "containing" (or "contains"), when used, shall appear on a line immediately below the part of the common or usual name of the food required by paragraph (a) of this section. For each characterizing ingredient or component, the words percent or %) shall appear following or directly below the word "containing" (or contains), or directly below the part of the common or usual name of the food required by paragraph (a) of this section when the word "containing" (or contains) is not used, in easily legible boldface print or type in distinct contrast to other printed or graphic matter, and in a height not less than the larger of the following alternatives:

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(i) Not less than one-sixteenth inch in height on packages having a principal display panel with an area of 5 square inches or less and not less than one-eighth inch in height if the area

of the principal display panel is greater than 5 square inches; or

(ii) Not less than one-half the height of the largest type appearing in the part of the common or usual name of the food required by paragraph (a) of this section.

or

(c) The common or usual name of a food shall include a statement of the presence or absence of any characterizing ingredient(s) or component(s) and/or the need for the user to add any characterizing ingredient(s) or component(s) when the presence or absence of such ingredient(s) component(s) in the food has a material bearing on price or consumer acceptance or when the labeling or the appearance of the food may otherwise create an erroneous impression that such ingredient(s) or component(s) is present when it is not, and consumers may otherwise be misled about the presence or absence of the ingredient(s) or component(s) in the food. The following requirements shall apply unless modified by a specific regulation in subpart B of this part.

(1) The presence or absence of a characterizing ingredient or component shall be declared by the words "containing (or contains) "containing (or contains) no

or "no

tain

or

or "does not conwith the blank being filled in with the common or usual name of the ingredient or component.

(2) The need for the user of a food to add any characterizing ingredient(s) or component(s) shall be declared by an appropriate informative statement.

(3) The statement(s) required under paragraph (c)(1) and/or (2) of this section shall appear following or directly below the part of the common or usual name of the food required by paragraphs (a) and (b) of this section, in easily legible boldface print or type in distinct contrast to other printed or graphic matter, and in a height not less than the larger of the alternatives established under paragraphs (b)(2) (i) and (ii) of this section.

(d) A common or usual name of a food may be established by common usage or by establishment of a regulation in subpart B of this part, in part 104 of this chapter, in a standard of

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(a) The Commissioner of Food and Drugs, either on his own initiative or on behalf of any interested person who has submitted a petition, may publish a proposal to issue, amend, or revoke, under this part, a regulation prescribing a common or usual name for a food, pursuant to part 10 of this chapter.

(b) If the principal display panel of a food for which a common or usual name regulation is established is too small to accommodate all mandatory requirements, the Commissioner may establish by regulation an acceptable alternative, e.g., a smaller type size. A petition requesting such a regulation, which would amend the applicable regulation, shall be submitted pursuant to part 10 of this chapter.

[42 FR 14322, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977]

Subpart B-Requirements for Specific Nonstandardized Foods

$ 102.22 Protein hydrolysates.

The common or usual name of a protein hydrolysate shall be specific to the ingredient and shall include the identity of the food source from which the protein was derived.

(a) "Hydrolyzed wheat gluten," "hydrolyzed soy protein," and "autolyzed yeast extract" are examples of acceptable names. "Hydrolyzed casein" is also an example of an acceptable name, whereas "hydrolyzed milk protein" is not an acceptable name for this ingredient because it is not specific to the ingredient (hydrolysates can be prepared from other milk proteins). The names "hydrolyzed vegetable protein" and "hydrolyzed protein" are not acceptable because they do not identify the food source of the protein.

(b) [Reserved]

[58 FR 2876, Jan. 6, 1993]

EFFECTIVE DATE NOTE: At 58 FR 2876, Jan. 6, 1993 § 102.22 was added, effective May 8, 1994.

§ 102.23 Peanut spreads.

(a) The common or usual name of a spreadable peanut product that does not conform to § 164.150 of this chapter, and more than 10 percent of which consists of nonpeanut ingredients, shall consist of the term "peanut spread" and a statement of the percentage by weight of peanuts in the product in the manner set forth in § 102.5(b), except that peanut percentages shall be based on the amount of peanuts used to make the finished food and shall be declared in 5-percent increments expressed as a multiple of 5, not to exceed the actual percentage of peanuts in the products.

(b) A spreadable peanut product that is nutritionally inferior to peanut butter shall be labeled as an imitation of peanut butter under § 101.3(e)(2) of this chapter; a spreadable peanut product shall be considered nutritionally equivalent to peanut butter if it meets all of the following conditions:

(1) Protein. (i) The protein content of the product is at least 24 percent by weight of the finished product, and the overall biological quality of the protein contained in the product is at least 68 percent that of casein; or

(ii) The protein content of the product is at least 16.6 percent by weight of the finished product, and the overall biological quality of the protein contained in the product is equal to or greater than that of casein.

(2) Other nutrients. The product contains the following levels of nutrients per 100 grams of product:

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tein sources

a nitrogen conversion factor of 6.25 may be used.

(1) Protein quantity: "Official Methods of Analysis of the Association of Official Analytical Chemists" (AOAC), 13th Ed. (1980), using the method described in section 27.007, which is incorporated by reference. Copies may be obtained from the Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20001.

(2) Biological quality of protein: AOAC, 13th Ed. (1980), using the method described in sections 43.21243.216, which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (c)(1) of this section.

(3) Niacin: AOAC, 13th Ed. (1980), using the method described in sections 43.044-43.046, which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (c)(1) of this section.

(4) Vitamin B.: AOAC, 13th Ed. (1980), using the method described in sections 43.188-43.193, which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (c)(1) of this section.

(5) Folic acid: Using the method described in U.S. Department of Agriculture Handbook No. 29, modified by use of ascorbate buffer as described by Ford and Scott, Journal of Dairy Research, 35:85-90 (1968), which is incorporated by reference. Copies are available from the Division of Nutrition, Center for Food Safety and Applied Nutrition (HFF-260), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20001.

(6) Iron: AOAC, 13th Ed. (1980), using the method described in sections 43.217-43.219, which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (c)(1) of this section.

(7) Zinc: AOAC, 13th Ed. (1980), using the method described in sections 25.150-25.153, which is incorporated

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