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(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: (i) Serving sizes used in dietary guidance recommendations or recommended 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: Table 1--Reference Amounts Customarily Consumed Per Eating Occasion: Infant and Toddler Foods1,2,3,4 | Product category | Reference amount | Label statement5 |
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| Cereals, dry instant | 15 g | _ cup (_ g) | | Cereals, prepared, ready-to-serve | 110 g | _ cup(s) (_ g) | | Other cereal and grain products, dry ready-to-eat, e.g., ready-to-eat cereals, cookies, teething biscuits, and toasts | 7 g for infants and 20 g for toddlers for ready-to-eat cereals; 7 g for all others | _ cup(s) (_ g) for ready-to-eat cereals; _ piece(s) (_ g) for others | | Dinners, desserts, fruits, vegetables or soups, dry mix | 15 g | _ tbsp(s) (_ g); _ cup(s) (_ g) | | Dinners, desserts, fruits, vegetables or soups, ready-to-serve, junior type | 110 g | _ cup(s) (_ g); _ cup(s) (_ mL) | | Dinners, desserts, fruits, vegetables or soups, ready-to-serve, strained type | 60 g | _ cup(s) (_ g); _ cup(s) (_ mL) | | Dinners, stews or soups for toddlers, ready-to-serve | 170 g | _ cup(s) (_ g); _ cup(s) (_ mL) | | Fruits for toddlers, ready-to-serve | 125 g | _ cup(s) (_ g) | | Vegetables for toddlers, ready-to- serve | 70 g | _ cup(s) (_ g) | | Eggs/egg yolks, ready-to-serve | 55 g | _ cup(s) (_ g) | | Juices, all varieties | 120 mL | 4 fl oz (120 mL) |
Table 2--Reference Amounts Customarily Consumed Per Eating Occasion: General Food Supply1,2,3,4 | Product category | Reference amount | Label statement5 |
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| Bakery products: | | | | Biscuits, croissants, bagels, tortillas, soft bread sticks, soft pretzels, corn bread, hush puppies55 g | _ piece(s) (_ g) | | Breads (excluding sweet quick type), rolls50 g | _ piece(s) (_ g) for sliced bread and distinct pieces (e.g., rolls); 2 oz (56 g/_ inch slice) for unsliced bread | | Bread sticks--see crackers | | | Toaster pastries--see coffee cakes | | | Brownies40 g | _ piece(s) (_ g) for distinct pieces; fractional slice (_ g) for bulk | | Cakes, heavy weight (cheese cake; pineapple upside-down cake; fruit, nut, and vegetable cakes with more than or equal to 35 percent of the finished weight as fruit, nuts, or vegetables or any of these combined)6125 g | _ piece(s) (_ g) for distinct pieces (e.g., sliced or individually packaged products); _ fractional slice (_ g) for large discrete units | | Cakes, medium weight (chemically leavened cake with or without icing or filling except those classified as light weight cake; fruit, nut, and vegetable cake with less than 35 percent of the finished weight as fruit, nuts, or vegetables or any of these combined; light weight cake with icing; Boston cream pie; cupcake; eclair; cream puff)780 g | _ piece(s) (_ g) for distinct pieces (e.g., cupcake); _ fractional slice (_ g) for large discrete units | | Cakes, light weight (angel food, chiffon, or sponge cake without icing or filling)855 g | _ piece(s) (_ g) for distinct pieces (e.g., sliced or individually packaged products); _ fractional slice (_ g) for large discrete units | | Coffee cakes, crumb cakes, doughnuts, Danish, sweet rolls, sweet quick type breads, muffins, toaster pastries55 g | _ piece(s) (_ g) for sliced bread and distinct pieces (e.g., doughnut); 2 oz (56 g/visual unit of measure) for bulk products (e.g., unsliced bread) | | Cookies30 g | _ piece(s) (_ g) | | Crackers that are usually not used as snack, melba toast, hard bread sticks, ice cream cones915 g | _ piece(s) (_ g) | | Crackers that are usually used as snacks30 g | _ piece(s) (_ g) | | Croutons7 g | _ tbsp(s) (_ g); _ cup(s) (_ g); _ piece(s) (_ g) for large pieces | | French toast, pancakes, variety mixes110 g prepared for french toast and pancakes; 40 g dry mix for variety mixes | _ piece(s) (_ g); _ cup(s) (_ g) for dry mix | | Grain-based bars with or without filling or coating, e.g., breakfast bars, granola bars, rice cereal bars40 g | _ piece(s) (_ g) | | Ice cream cones--see crackers | | | Pies, cobblers, fruit crisps, turnovers, other pastries125 g | _ piece(s) (_g) for distinct pieces; _ fractional slice (_ g) for large discrete units | | Pie crust1/6 of 8 inch crust; 1/8 of 9 inch crust | 1/6 of 8 inch crust (_ g); 1/8 of 9 inch crust (_ g) | | Pizza crust55 g | _ fractional slice (_ g) | | Taco shells, hard30 g | _ shell(s) (_ g) | | Waffles85 g | _ piece(s) (_ g) | | Beverages: | | | | Carbonated and noncarbonated beverages, wine coolers, water240 mL | 8 fl oz (240 mL) | | Coffee or tea, flavored and sweetened240 mL prepared | 8 fl oz (240 mL) | | Cereal and Other Grain Products: | | | | Breakfast cereals (hot cereal type), hominy grits1 cup prepared; 40 g plain dry cereal; 55 g flavored, sweetened dry cereal | _ cup(s) (_ g) | | Breakfast cereals, ready-to-eat, weighing less than 20 g per cup, e.g., plain puffed cereal grains15 g | _ cup(s) (_ g) | | Breakfast cereals, ready-to-eat weighing 20 g or more but less than 43 g per cup; high fiber cereals containing 28 g or more of fiber per 100 g30 g | _ cup(s) (_ g) | | Breakfast cereals, ready-to-eat, weighing 43 g or more per cup; biscuit types55 g | _ piece(s) (_ g) for large distinct pieces (e.g., biscuit type);_ cup(s) (_ g) for all others | | Bran or wheat germ15 g | _ tbsp(s) (_ g); _ cup(s) (_ g) | | Flours or cornmeal30 g | _ tbsp(s) (_ g); _ cup(s) (_ g) | | Grains, e.g., rice, barley, plain140 g prepared; 45 g dry | _ cup(s) (_ g) | | Pastas, plain140 g prepared; 55 g dry | _ cup(s) (_ g); _ piece(s) (_ g) for large pieces (e.g., large shells or lasagna noodles) or 2 oz (56 g/visual unit of measure) for dry bulk products (e.g., spaghetti) | | Pastas, dry, ready-to-eat, e.g., fried canned chow mein noodles25 g | _ cup(s) (_ g) | | Starches, e.g., cornstarch, potato starch, tapioca, etc.10 g | _ tbsp (_ g) | | Stuffing100 g | _ cup(s) (_ g) | | Dairy Products and Substitutes: | | | | Cheese, cottage110 g | _ cup (_ g) | | Cheese used primarily as ingredients, e.g., dry cottage cheese, ricotta cheese55 g | _ cup (_ g) | | Cheese, grated hard, e.g., Parmesan, Romano5 g | _ tbsp (_ g) | | Cheese, all others except those listed as separate categories--includes cream cheese and cheese spread30 g | _ piece(s) (_ g) for distinct pieces;_ tbsp(s) (_ g) for cream cheese and cheese spread; 1 oz (28 g/visual unit of measure) for bulk | | Cheese sauce--see sauce category | | | Cream or cream substitutes, fluid15 mL | 1 tbsp (15 mL) | | Cream or cream substitutes, powder2 g | _ tsp (_ g) | | Cream, half & half30 mL | 2 tbsp (30 mL) | | Eggnog120 mL | 1/2 cup (120 mL); 4 fl oz (120 mL) | | Milk, condensed, undiluted30 mL | 2 tbsp (30 mL) | | Milk, evaporated, undiluted30 mL | 2 tbsp (30 mL) | | Milk, milk-based drinks, e.g., instant breakfast, meal replacement, cocoa240 mL | 1 cup (240 mL); 8 fl oz (240 mL) | | Shakes or shake substitutes, e.g., dairy shake mixes, fruit frost mixes240 mL | 1 cup (240 mL); 8 fl oz (240 mL) | | Sour cream30 g | _ tbsp (_ g) | | Yogurt225 g | _ cup (_ g) | | Desserts: | | | | Ice cream, ice milk, frozen yogurt, sherbet: all types, bulk and novelties (e.g., bars, sandwiches, cones)1/2 cup-includes the volume for coatings and wafers for the novelty type varieties | _ piece(s) (_ g) for individually wrapped or packaged products; 1/2 cup (_ g) for others | | Frozen flavored and sweetened ice and pops, frozen fruit juices: all types, bulk and novelties (e.g., bars, cups)85 g | _ piece(s) (_ g) for individually wrapped or packaged products; _ cup(s) (_ g) for others | | Sundae1 cup | 1 cup (_ g) | | Custards, gelatin or pudding1/2 cup | _ piece(s) (_ g) for distinct unit (e.g., individually packaged products); 1/2 cup (_ g) for bulk | | Dessert Toppings and Fillings: | | | | Cake frostings or icings35 g | _ tbsp(s) (_ g) | | Other dessert toppings, e.g., fruits, syrups, spreads, marshmallow cream, nuts, dairy and nondairy whipped toppings2 tbsp | 2 tbsp (_ g); 2 tbsp (30 mL) | | Pie fillings85 g | _ cup(s) (_ g) | | Egg and Egg Sustitutes: | | | | Egg mixtures, e.g., egg foo young, scrambled eggs, omelets110 g | _ piece(s) (_ g) for discrete pieces; _ cup(s) (_ g) | | Eggs (all sizes)950 g | 1 large, medium, etc. (_ g) | | Egg substitutesAn amount to make 1 large (50 g) egg | _ cup(s) (_ g); _ cup(s) (_ mL) | | Fats and Oils: | | | | Butter, margarine, oil, shortening1 tbsp | 1 tbsp (_ g); 1 tbsp (15 mL) | | Butter replacement, powder2 g | _ tsp(s) (_ g) | | Dressings for salads30 g | _ tbsp (_ g); _ tbsp (_ mL) | | Mayonnaise, sandwich spreads, mayonnaise-type dressings15 g | _ tbsp (_ g) | | Spray types0.25 g | About _ seconds spray (_ g) | | Fish, Shellfish, Game Meats10, and Meat or Poultry Substitutes: | | | | Bacon substitutes, canned anchovies,11anchovy pastes, caviar15 g | _ piece(s) (_ g) for discrete pieces; _ tbsp(s) (_ g) for others | | Dried, e.g., jerky30 g | _ piece(s) (_ g) | | Entrees with sauce, e.g., fish with cream sauce, shrimp with lobster sauce140 g cooked | _ cup(s) (_ g); 5 oz (140 g/visual unit of measure) if not measurable by cup | | Entrees without sauce, e.g., plain or fried fish and shellfish, fish and shellfish cake85 g cooked; 110 g uncooked12 | _ piece(s) (_ g) for discrete pieces; _ cup(s) (_ g); _ oz (_ g/visual unit of measure) if not measurable by cup13 | | Fish, shellfish or game meat10, canned1155 g | _ piece(s) (_ g) for discrete pieces; _ cup(s) (_ g); 2 oz (56 g/_ cup) for products that are difficult to measure the g weight of cup measure (e.g., tuna); 2 oz (56 g/_ pieces) for products that naturally vary in size (e.g., sardines) | | Substitute for luncheon meat, meat spreads, Canadian bacon, sausages and frankfurters55 g | _ piece(s) (_ g) for distinct pieces (e.g., slices, links); _ cup(s) (_ g); 2 oz (56 g/visual unit of measure) for nondiscrete bulk product | | Smoked or pickled11fish, shellfish, or game meat10; fish or shellfish spread55 g | _ piece(s) (_ g) for distinct pieces (e.g., slices, links) or _ cup(s) (_ g); 2 oz (56 g/visual unit of measure) for nondiscrete bulk product | | Substitutes for bacon bits--see miscellaneous category | | | Fruits and Fruit Juices: | | | | Candied or pickled1130 g | _ piece(s) (_ g) | | Dehydrated fruits--see snacks category | | | Dried40 g | _ piece(s) (_ g) for large pieces (e.g., dates, figs, prunes); _ cup(s) (_ g) for small pieces (e.g., raisins) | | Fruits for garnish or flavor, e.g., maraschino cherries114 g | 1 cherry (_ g) | | Fruit relishes, e.g., cranberry sauce, cranberry relish70 g | _ cup(s) (_ g) | | Fruits used primarily as ingredients, avocado30 g | See footnote 13 | | Fruits used primarily as ingredients, others (cranberries, lemon, lime)55 g | _ piece(s) (_ g) for large fruits; _ cup(s) (_ g) for small fruits measurable by cup13 | | Watermelon280 g | See footnote 13 | | All other fruits (except those listed as separate categories), fresh, canned, or frozen140 g | _ piece(s) (_ g) for large pieces (e.g., strawberries, prunes, apricots, etc.); _ cup(s) (_ g) for small pieces (e.g., blueberries, raspberries, etc.)13 | | Juices, nectars, fruit drinks240 mL | 8 fl oz (240 mL) | | Juices used as ingredients, e.g., lemon juice, lime juice5 mL | 1 tsp (5 mL) | | Legumes: | | | | Bean cake (tofu)11, tempeh85 g | _ piece(s) (_ g) for discrete pieces; 3 oz (84 g/visual unit of measure) for bulk products | | Beans, plain or in sauce130 g for beans in sauce or canned in liquid and refried beans prepared; 90 g for others prepared; 35 g dry | _ cup (_ g) | | Miscellaneous Category: | | | | Baking powder, baking soda, pectin0.6 g | _ tsp ( _ g) | | Baking decorations, e.g., colored sugars and sprinkles for cookies, cake decorations1 tsp or 4 g if not measurable by teaspoon | _ piece(s) (_ g) for discrete pieces; 1 tsp (_ g) | | Batter mixes, bread crumbs30 g | _ tbsp(s) (_ g);_ cup(s) (_ g) | | Cooking wine30 mL | 2 tbsp (30 mL) | | Dietary supplementsThe maximum amount recommended, as appropriate, on the label for consumption per eating occasion, or, in the absence of recommendations, 1 unit, e.g., tablet, capsule, packet, teaspoonsful, etc. | _ tablet(s), _ capsule(s), _ packet(s), _ tsp(s) (_ g), etc. | | Drink mixers (without alcohol)Amount to make 240 mL drink (without ice) | _ fl oz (_ mL) | | Chewing gum93 g | _ piece(s) (_ g) | | Meat, poultry and fish coating mixes, dry; seasoning mixes, dry, e.g., chili seasoning mixes, pasta salad seasoning mixesAmount to make one reference amount of final dish | _ tsp(s) (_ g); _ tbsp(s) (_ g) | | Salad and potato toppers, e.g., salad crunchies, salad crispins, substitutes for bacon bits7 g | _ tbsp(s) (_ g) | | Salt, salt substitutes, seasoning salts (e.g., garlic salt)1/4 tsp | 1/4 tsp ( _g); _piece(s) ( _g) for discrete pieces (e.g., individually packaged products) | | Spices, herbs (other than dietary supplements)1/4 tsp or 0.5 g if not measurable by teaspoon | 1/4 tsp (_ g); _ piece(s) (_ g) if not measurable by teaspoons (e.g., bay leaf) | | Mixed Dishes: | | | | Measurable with cup, e.g., casseroles, hash, macaroni and cheese, pot pies, spaghetti with sauce, stews, etc.1 cup | 1 cup (_ g) | | Not measurable with cup, e.g., burritos, egg rolls, enchiladas, pizza, pizza rolls, quiche, all types of sandwiches140 g, add 55 g for products with gravy or sauce topping, e.g., enchilada with cheese sauce, crepe with white sauce14 | _ piece(s) (_ g) for discrete pieces; _ fractional slice (_ g) for large discrete units | | Nuts and Seeds: | | | | Nuts, seeds, and mixtures, all types: sliced, chopped, slivered, and whole30 g | _ piece(s) (_ g) for large pieces (e.g., unshelled nuts);_ tbsp(s) (_ g) ;_ cup(s) (_ g) for small pieces (e.g., peanuts, sunflower seeds) | | Nut and seed butters, pastes, or creams2 tbsp | 2 tbsp (_ g) | | Coconut, nut and seed flours15 g | _ tbsp(s) (_ g); _ cup (_ g) | | Potatoes and Sweet Potatoes/Yams: | | | | French fries, hash browns, skins, or pancakes70 g prepared; 85 g for frozen unprepared french fries | _ piece(s) (_ g) for large distinct pieces (e.g., patties, skins); 2.5 oz (70 g/_ pieces) for prepared fries; 3 oz (84 g/_ pieces) for unprepared fries | | Mashed, candied, stuffed, or with sauce140 g | _ piece(s) (_ g) for discrete pieces (e.g., stuffed potato); _ cup(s) (_ g) | | Plain, fresh, canned, or frozen110 g for fresh or frozen; 125 g for vacuum packed; 160 g for canned in liquid | _ piece(s) (_ g) for discrete pieces;_ cup(s) (_ g) for sliced or chopped products | | Salads: | | | | Gelatin salad120 g | _ cup (_ g) | | Pasta or potato salad140 g | _ cup(s) (_ g) | | All other salads, e.g., egg, fish, shellfish, bean, fruit, or vegetable salads100 g | _ cup(s) (_ g) | | Sauces, Dips, Gravies and Condiments: | | | | Barbecue sauce, hollandaise sauce, tartar sauce, other sauces for dipping (e.g., mustard sauce, sweet and sour sauce), all dips (e.g., bean dips, dairy-based dips, salsa)2 tbsp | 2 tbsp (_ g); 2 tbsp (30 mL) | | Major main entree sauces, e.g., spaghetti sauce125 g | _ cup (_ g); _ cup (_ mL) | | Minor main entree sauces (e.g., pizza sauce, pesto sauce), other sauces used as toppings (e.g., gravy, white sauce, cheese sauce), cocktail sauce1/4 cup | 1/4 cup (_ g); 1/4 cup (60 mL) | | Major condiments, e.g., catsup, steak sauce, soy sauce, vinegar, teriyaki sauce, marinades1 tbsp | 1 tbsp (_ g); 1 tbsp (15 mL) | | Minor condiments, e.g., horseradish, hot sauces, mustards, worcestershire sauce1 tsp | 1 tsp (_ g); 1 tsp (5 mL) | | Snacks: | | | | All varieties, chips, pretzels, popcorns, extruded snacks, fruit- based snacks (e.g., fruit chips,) grain-based snack mixes30 g | _ cup(s) (_ g) for small pieces (e.g., popcorn) _ piece(s) (_ g) for large pieces (e.g., large pretzels; pressed dried fruit sheet); 1 oz (28 g/visual unit of measure) for bulk products (e.g., potato chips) | | Soups: | | | | All varieties245 g | _ cup (_ g); _ cup (_ mL) | | Sugars and Sweets: | | | | Baking candies (e.g., chips)15 g | _ piece(s) (_ g) for large pieces; _ tbsp(s) (_ g) for small pieces; 1/2 oz (14 g/visual unit of measure) for bulk products | | Hard candies, breath mints2 g | _ piece(s) (_ g) | | Hard candies, roll-type, mini-size in dispenser packages5 g | _ piece(s) (_ g) | | Hard candies, others15 g | _ piece(s) (_ g) for large pieces;_ tbsp(s) (_ g) for "mini-size" candies measurable by tablespoon; 1/2 oz (14 g/visual unit of measure) for bulk products | | All other candies40 g | _ piece(s) (_ g); 1 1/2 oz (42 g/visual unit of measure) for bulk products | | Confectioner's sugar30 g | _ cup (_ g) | | Honey, jams, jellies, fruit butter, molasses1 tbsp | 1 tbsp (_ g); 1 tbsp (15 mL) | | Marshmallows30 g | _ cup(s) (_ g) for small pieces; _ piece(s) (_ g) for large pieces | | Sugar4 g | _ tsp (_ g) ; _ piece(s) (_ g) for discrete pieces (e.g., sugar cubes, individually packaged products) | | Sugar substitutesAn amount equivalent to one reference amount for sugar in sweetness | _ tsp(s) (_ g) for solids; _ drop(s) (_ g) for liquid; _ piece(s) (_ g) (e.g., individually packaged products) | | Syrups30 mL for syrups used primarily as an ingredient (e.g., light or dark corn syrup); 60 mL for all others | 2 tbsp (30 mL) for syrups used primarily as an ingredient; 1/4 cup (60 mL) for all others | | Vegetables: | | | | Vegetables primarily used for garnish or flavor, e.g., pimento, parsley4 g | _ piece(s) (_ g); _ tbsp(s) (_ g) for chopped products | | Chili pepper, green onion30 g | _ piece(s) (_ g)13; _ tbsp(s) (_ g); _ cup(s) (_ g) for sliced or chopped products | | All other vegetables without sauce: fresh, canned, or frozen85 g for fresh or frozen; 95 g for vacuum packed; 130 g for canned in liquid, cream-style corn, canned or stewed tomatoes, pumpkin, or winter squash | _ piece(s) (_ g) for large pieces (e.g., brussel sprouts); _ cup(s) (_ g) for small pieces (e.g., cut corn, green peas); 3 oz (84 g/visual unit of measure) if not measurable by cup13 | | All other vegetables with sauce: fresh, canned, or frozen110 g | _ piece(s) (_ g) for large pieces (e.g., brussel sprouts); _ cup(s) (_ g) for small pieces (e.g., cut corn, green peas); 4 oz (112 g/visual unit of measure) if not measurable by cup | | Vegetable juice240 mL | 8 fl oz (240 mL) | | Olives1115 g | _ piece(s) (_ g); _ tbsp(s) (_ g) for sliced products | | Pickles, all types1130 g | 1 oz (28 g/visual unit of measure) | | Pickle relishes15 g | _ tbsp (_ g) | | Vegetable pastes, e.g., tomato paste30 g | _ tbsp (_ g) | | Vegetable sauces or purees, e.g, tomato sauce, tomato puree60 g | _ cup (_ g); _ cup (_ mL) |
(c) If a product requires further preparation, e.g., cooking or the addition of water or other ingredients, and if paragraph (b) of this section provides a reference amount for the product in the prepared but not the unprepared form, then the reference amount for the unprepared product shall be determined using the following rules: (1) Except as provided for in paragraph (c)(2) of this section, the reference amount for the unprepared product shall be the amount of the unprepared product required to make the reference amount for the prepared product as established in paragraph (b) of this section. (2) For products where the entire contents of the package is used to prepare one large discrete unit usually divided for consumption, the reference amount for the unprepared product shall be the amount of the unprepared product required to make the fraction of the large discrete unit closest to the reference amount for the prepared product as established in paragraph (b) of this section. (d) The reference amount for an imitation or substitute food or altered food, such as a "low calorie" version, shall be the same as for the food for which it is offered as a substitute. (e) If a food is modified by incorporating air (aerated), and thereby the density of the food is lowered by 25 percent or more in weight than that of an appropriate reference regular food as described in 101.13(j)(1)(ii)(A), and the reference amount of the regular food is in grams, the manufacturer may determine the reference amount of the aerated food by adjusting for the difference in density of the aerated food relative to the density of the appropriate reference food provided that the manufacturer will show FDA detailed protocol and records of all data that were used to determine the density-adjusted reference amount for the aerated food. The reference amount for the aerated food shall be rounded to the nearest 5-g increment. Such products shall bear a descriptive term indicating that extra air has been incorporated (e.g., whipped, aerated). The density-adjusted reference amounts described in paragraph (b) of this section may not be used for cakes except for cheese cake. The differences in the densities of different types of cakes having different degrees of air incorporation have already been taken into consideration in determining the reference amounts for cakes in 101.12(b). In determining the difference in density of the aerated and the regular food, the manufacturer shall adhere to the following: (1) The regular and the aerated product must be the same in size, shape, and volume. To compare the densities of products having nonsmooth surfaces (e.g., waffles), manufacturers shall use a device or method that ensures that the volumes of the regular and the aerated products are the same. (2) Sample selections for the density measurements shall be done in accordance with the provisions in 101.9(g). (3) Density measurements of the regular and the aerated products shall be conducted by the same trained operator using the same methodology (e.g., the same equipment, procedures, and techniques) under the same conditions. (4) Density measurements shall be replicated a sufficient number of times to ensure that the average of the measurements is representative of the true differences in the densities of the regular and the "aerated" products. (f) For products that have no reference amount listed in paragraph (b) of this section for the unprepared or the prepared form of the product and that consist of two or more foods packaged and presented to be consumed together (e.g., peanut putter and jelly, cracker and cheese pack, pancakes and syrup, cake and frosting), the reference amount for the combined product shall be determined using the following rules: (1) For bulk products (e.g., peanut butter and jelly), the reference amount for the combined product shall be the reference amount, as established in paragraph (b) of this section, for the ingredient that is represented as the main ingredient plus proportioned amounts of all minor ingredients. (2) For products where the ingredient represented as the main ingredient is one or more discrete units (e.g., cracker and cheese pack, pancakes and syrup, cake and frosting), the reference amount for the combined product shall be either the number of small discrete units or the fraction of the large discrete unit that is represented as the main ingredient that is closest to the reference amount for that ingredient as established in paragraph (b) of this section plus proportioned amounts of all minor ingredients. (3) If the reference amounts are in compatible units, they shall be summed (e.g., the reference amount for equal volumes of peanut butter and jelly for which peanut butter is represented as the main ingredient would be 4 tablespoons (tbsp) (2 tbsp peanut butter plus 2 tbsp jelly). If the reference amounts are in incompatible units, the weights of the appropriate volumes should be used (e.g., 110 grams (g) pancakes plus the gram weight of the proportioned amount of syrup). (g) The reference amounts set forth in paragraphs (b) through (f) of this section shall be used in determining whether a product meets the criteria for nutrient content claims, such as "low calorie," and for health claims. If the serving size declared on the product label differs from the reference amount, and the product meets the criteria for the claim only on the basis of the reference amount, the claim shall be followed by a statement that sets forth the basis on which the claim is made. That statement shall include the reference amount as it appears in paragraph (b) of this section followed, in parenthesis, by the amount in common household measure if the reference amount is expressed in measures other than common household measures (e.g., for a beverage, "Very low sodium, 35 mg or less per 240 mL (8 fl oz)"). (h) The Commissioner of Food and Drugs, either on his or her own initiative or in response to a petition submitted pursuant to part 10 of this chapter, may issue a proposal to establish or amend a reference amount in paragraph (b) of this section. A petition to establish or amend a reference amount shall include: (1) Objective of the petition; (2) A description of the product; (3) A complete sample product label including nutrition label, using the format established by regulation; (4) A description of the form (e.g., dry mix, frozen dough) in which the product will be marketed; (5) The intended dietary uses of the product with the major use identified (e.g., milk as a beverage and chips as a snack); (6) If the intended use is primarily as an ingredient in other foods, list of foods or food categories in which the product will be used as an ingredient with information on the prioritization of the use; (7) The population group for which the product will be offered for use (e.g., infants, children under 4 years of age); (8) The names of the most closely related products (or in the case of foods for special dietary use and imitation or substitute foods, the names of the products for which they are offered as substitutes); (9) The suggested reference amount (the amount of edible portion of food as consumed, excluding bone, seed, shell, or other inedible components) for the population group for which the product is intended with full description of the methodology and procedures that were used to determine the suggested reference amount. In determining the reference amount, general principles and factors in paragraph (a) of this section should be followed. (10) The suggested reference amount shall be expressed in metric units. Reference amounts for fluids shall be expressed in milliliters. Reference amounts for other foods shall be expressed in grams except when common household units such as cups, tablespoons, and teaspoons, are more appropriate or are more likely to promote uniformity in serving sizes declared on product labels. For example, common household measures would be more appropriate if products within the same category differ substantially in density, such as frozen desserts. (i) In expressing the reference amounts in milliliters, the following rules shall be followed: (A) For volumes greater than 30 milliliters (mL), the volume shall be expressed in multiples of 30 mL. (B) For volumes less than 30 mL, the volume shall be expressed in milliliters equivalent to a whole number of teaspoons or 1 tbsp, i.e., 5, 10, or 15 mL. (ii) In expressing the reference amounts in grams, the following general rules shall be followed: (A) For quantities greater than 10 g, the quantity shall be expressed in the nearest 5-g increment. (B) For quantities less than 10 g, exact gram weights shall be used. (11) A petition to create a new subcategory of food with its own reference amount shall include the following additional information: (i) Data that demonstrate that the new subcategory of food will be consumed in amounts that differ enough from the reference amount for the parent category to warrant a separate reference amount. Data must include sample size; and the mean, standard deviation, median, and modal consumed amount per eating occasion for the petitioned product and for other products in the category, excluding the petitioned product. All data must be derived from the same survey data. (ii) Documentation supporting the difference in dietary usage and product characteristics that affect the consumption size that distinguishes the petitioned product from the rest of the products in the category. (12) A claim for categorical exclusion under 25.30 or 25.32 of this chapter or an environmental assessment under 25.40 of this chapter, and (13) In conducting research to collect or process food consumption data in support of the petition, the following general guidelines should be followed. (i) Sampled population selected should be representative of the demographic and socioeconomic characteristics of the target population group for which the food is intended. (ii) Sample size (i.e., number of eaters) should be large enough to give reliable estimates for customarily consumed amounts. (iii) The study protocol should identify potential biases and describe how potential biases are controlled for or, if not possible to control, how they affect interpretation of results. (iv) The methodology used to collect or process data should be fully documented and should include: study design, sampling procedures, materials used (e.g., questionnaire, and interviewer's manual), procedures used to collect or process data, methods or procedures used to control for unbiased estimates, and procedures used to correct for nonresponse. (14) A statement concerning the feasibility of convening associations, corporations, consumers, and other interested parties to engage in negotiated rulemaking to develop a proposed rule consistent with the Negotiated Rulemaking Act (5 U.S.C. 561). [58 FR 44051, Aug. 18, 1993; 58 FR 60109, Nov. 15, 1993, as amended at 59 FR 371, Jan. 4, 1994; 59 FR 24039, May 10, 1994; 62 FR 40598, July 29, 1997; 62 FR 49848, Sept. 23, 1997; 63 FR 14818, Mar. 27, 1998; 64 FR 12890, Mar. 16, 1999; 66 FR 56035, Nov. 6, 2001]
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