Protein can be expressed to the nearest whole gram (i.e., 1 g); or the label can state "less than 1 gram" or "Contains less than 1 gram."
- Any legible type style may be used, not just Helvetica.
- The heading "Nutrition Facts" must be the largest type size in the nutrition label; i.e., it must be larger than 8-point, but does not need to be 13-point.
- There is no specific thickness required for the three bars that separate the central sections of the nutrition label.
Serving size | Serv size |
Servings per container | Servings |
Calories from fat | Fat cal |
Calories from saturated fat | Sat fat cal. |
Saturated fat | Sat fat |
Monounsaturated fat | Monounsat fat |
Polyunsaturated fat | Polyunsat fat |
Cholesterol | Cholest. |
Total carbohydrate | Total carb. |
Dietary fiber | Fiber |
Soluble fiber | Sol. fiber |
*Insoluble fiber | Insol. fiber |
Sugar alcohol | Sugar alc. |
Other carbohydrates | Other carb. |
These abbreviations may be used regardless of the specific, permitted format used.
Calories from Fat: when the food contains less than 5 calories from fat.
Saturated Fat: when the food contains less than 0.5 grams of total fat per serving and if no claims are made about fat or cholesterol content and if no claims are made about calories from fat.
Cholesterol: when the food contains less than 2 milligrams cholesterol per serving and makes no claim about fat, fatty acids or cholesterol.
Dietary Fiber: when a serving contains less than 1 gram of dietary fiber.
Sugars: when a serving contains less than 1 gram of sugar and no claims are made about sweeteners, sugars, or sugar alcohol content.
Vitamins/Minerals: when a serving contains less than 2% of the RDI.
If so, must a column be included that gives the total nutrients for the noodles and the seasoning packet?
Can the nutrient analysis for a product containing a mixture of nuts or different types of dried fruit be based on a composite of the mixture blended together?
SALES IN FOOD | TOTAL SALES (FOOD & NON-FOOD) | STATUS |
$50,000 or less | $500,000 or less | EXEMPT |
$50,000 or less | $500,001 or more | EXEMPT |
$50,001 or more | $500,000 or less | EXEMPT |
$50,001 or more | $500,001 or more | NOT EXEMPT |
Bakeries and delis that sell foods for immediate consumption (e.g., where the deli or bakery has facilities for customers to sit and consume the food on the premises) are considered analogous to restaurants and all foods sold in such establishments are exempt under 21 CFR 101.9(j)(2).
When foods are not for immediate consumption, they may be exempt if they meet all of the criteria listed in 21 CFR 101.9(j)(3). That is, when the food is ready-to-eat and is processed and prepared primarily on the premises of the establishment from which it is sold, it is exempt - regardless of how it is sold (i.e., from behind a counter or in pre-portioned packages from a self-service shelf). However, if the food is not primarily processed and prepared on-site, nutrition labeling is required.
To meet the criteria for being "primarily processed and prepared on-site", the food must be augmented on site in a manner that changes the nutrient profile of the food i.e., filling, icing, enrobing. Washing and garnishing with nuts, onions or seeds would fall under the definition of "primarily processed and prepared" if the added foods change the nutrition profile of the finished product. Custom cakes are exempt.
If pre-formed dough, pre scaled/molded and par baked dough are merely proofed and baked or simply thawed, the product is considered to be "standardized" and nutrition labeling is required.
Foods which are not prepared on premises and that are portioned to consumer specifications on-site are not required to have nutrition labeling (e.g., 1 lb of potato salad; 2 lb cheese, 1 lb assorted cookies, 5 rolls). However, if these items are packaged and offered for sale in another section of the store (e.g., refrigerator case; self service bins), nutrition labeling is mandatory. 21 CFR 101.9(j)(3)(iv)]
The serving size is so small and all nutrient values are zero.
At this point it is important to determine if your product is in a single serving container. Products packaged and sold in small units are required to be labeled as single-serving containers, and the specifications for these products are described in 21 CFR 101.9(b)(6). If your product is a single serving, it must be labeled in accordance with the labeling requirements for single-serving containers contained in 21 CFR 101.9(b)(6).
*(2) Determine the serving size for your multi-serving product using the reference amount for the product (21 CFR 101.9(b)(2),(3), and (4)).
The serving size is expressed as a common household measure followed by the equivalent metric quantity in parenthesis (e.g., "1/2 cup (112 g)"). Acceptable household measures are listed in order of appropriate use in 21 CFR 101.9(b)(5). Rounding rules for metric quantities and a few additional format options are included in 21 CFR 101.9(b)(7).
*(3) Use the information in 21 CFR 101.9(b)(8) to determine the number of servings and the appropriate rounding rules for numbers of servings.
For example, the reference amount for potato salad is 140 g. Containers of potato salad that are packaged and sold individually and that weigh 210 g or less must be labeled as a single serving. Containers weighing between 210 g and 280 g may be labeled as 1 or 2 servings. However, the serving size for a product labeled as two servings is based on the household measure and not on the weight of 1/2 package.
For example, the reference amount for pizza is 140 g. A 16 oz (454 g) pizza can be divided in half (one piece = 227 g), thirds (one piece = 151 g), fourths (one piece = 113 g), etc. The closest fraction is 1/3, therefore the serving size would be "1/3 pizza (151 g)."
Allowable fractions include 1/2, 1/3, 1/4, 1/5, 1/6, or smaller fractions that can be generated by further division by 2 or 3. An additional example would be: 1/8 (i.e.,1/4 divided by 2). Thus, fractions such as 1/7, 1/11, 1/13, and 1/14 are not allowed.
For example, the reference amount for snacks is 30 g. If a bag contains a mixture of nuts and caramel popcorn that weighs 23 g per cup, then 1 1/4 cup weighs 28.75 g and 1 1/3 cup weighs 30.7 g. The closest household measure is 1 1/3 cup, therefore the serving size would be "1 1/3 cup (31 g)."
Allowable household measures include (a) cups as 1/4, 1/3, 1/2, 2/3, 3/4, 1, 1 1/4, 1 1/3, etc, (b) tablespoons as 1, 1 1/3, 1 1/2, 1 2/3, 2, and 3, and (c) teaspoons as 1/4, 1/2, 3/4, 1, and 2. In addition, piece, slice, tray, jar, fraction, and ounce may be used in accordance with the provisions of 21 CFR 101.9(b)(5).
For example, small pastas, such as macaroni, can be measured by cup: "__ cup (__ g)." Larger discrete pastas, such as lasagna, can be measured by the piece: "__ lasagna noodles (__ g)". A few pastas, such as spaghetti, may need to use ounces: "__ oz (__ g/visual unit of measure). Visual units of measure could include descriptive phrases such as "1/8 box " or "about 1 1/4-inch circle of spaghetti."
However, a fraction of the package may be used as part of the visual unit of measure when ounces is used as the primary household measure (21 CFR 101.9(b)(5)(iii)). For example, the serving size listed on a 1 lb (16 oz) box of spaghetti could be:
"2 oz (56 g/ 1/8 box)."
Table 2 only gives reference amounts for prepared and dry pasta.
While the agency will provide a "suggested reference amount" so as to allow the manufacturer to nutrition label its products at this time, FDA believes that it will be necessary at a later date to undertake notice and comment rulemaking to formally establish a reference amount. Alternatively, the manufacturer or any other interested party may petition FDA at any time to establish a reference amount as specified in 21 CFR 101.12(h).
Powdered, flavored candy - 15 g
Colored, flavored syrup-filled wax candy - 15 mL
Ice - 4 ounces
Dried tomatoes (halved, sliced, minced, bits) - 5 g
Dried tomatoes in oil (halved, sliced, minced, bits) - 10 g
fat | 13.0 grams |
saturated fat | 4.0 grams |
cholesterol | 60 milligrams |
sodium | 480 milligrams |
per reference amount customarily consumed, per labeled serving or, for foods with small serving sizes, per 50 grams. There are different levels for meal-type products.
Can I make a "light" version using the regular product a s the reference food?
Examples include vegetable oil spreads that substitu te for margarine or butter and mayonnaise spreads that substitute for mayonnaise.
Would those products still be considered appropriate reference foods for "light" products?
If so, how is the percentage determined?
I f s what percentage is to be declared?
Some juice beverages will have very complex common or usual names, like "cranberry-raspberry flavored juice drink in a blend of three other juices from concentrate."
Does any fruit that is pres ent at a level of less than 2 percent by volume have to be depicted in the vignette?
Also, what if one of the citrus j uices is an expressed juice and is present only in a minor amount, must it be identified by name?
In the second case, the citrus juice that is not from concentrate should be listed as in the example given above in order of predominance, i.e., a blend of 2 citrus juices from concentrate with _____, ______, and ______juices, with the third citrus juice listed in one of the blanks, along with the other expressed juices.
Alternatively, a name such as "citrus punch" or "citrus flavored punch" may be used as the statement of identity without further identification of the component juices.
Consumers know that products labeled with terms such as "punch" and "cocktail" are made from concentrate.
Hypertext updated by j3b/rwk/ear/kwg/cjm 2001-JUN-22