7. Nutrition Labeling; Questions L1 through L153
The document below is available in several foreign language(s). FDA offers these translations as a service to a broad international audience. We hope that you find these translations useful. While the agency has attempted to obtain translations that are as faithful as possible to the English version, we recognize that the translated versions may not be as precise, clear, or complete as the English version. The official version of this document is the English version.
- Label Formats/Graphics Requirements
- Specific Label Formats
- Trans Fat Labeling
- Serving Size
- Serving Size/Reference Amounts Customarily Consumed (RACCs) and Food Categories
- Serving Size/As Packaged/As Prepared
- Serving Size/Separately Packaged Ingredients
- Serving Size/Dual Column Allowances
- Serving Size/Single Serving Containers
- Serving Size/Servings Per Container
- Serving Size/Small Discrete Units
- Serving Size/Large Discrete Units
- Serving Size/Bulk Products
- Serving Sizes/Common Household Measures
- Exemptions/Special Labeling Provisions
L1. How large must the Nutrition Facts label be?
Answer: There are no specific size requirements for the nutrition label. However, the “Nutrition Facts” heading must be in a type size larger than all other print size in the nutrition label and generally set the full width of the nutrition facts label (21 CFR 101.9(d)(2)). Minimum type sizes of 6 point and 8 point are required for the other information in the nutrition label (21 CFR 101.9(d)(1)(iii)), and there are minimum spacing requirements between lines of text (21 CFR 101.9(d)(1)(ii)(C)).
L2. What are the minimum type sizes and other format requirements for the Nutrition Facts label?
Answer: Format requirements are specified in 21 CFR 101.9(d). For example, the nutrition information must be set off in a box by use of hairlines and must be all black or one color type, printed on a white or other neutral contrasting background whenever practical. 21 CFR 101.9(d)(1)(i)
FDA urges that the nutrition information be presented using the graphic specifications set forth in appendix B to part 101 (see below).
Example of Graphic Enhancements used by FDA
Typeface and Size
- 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).
- Key nutrients & their % Daily Value are set in 8 point Helvetica Black (but “%” is set in Helvetica Regular).
- Nutrition Facts is set in either Franklin Gothic Heavy or Helvetica Black to fit the width of the label flush left and flush right.
- Serving Size and Servings per container are set in 8 point Helvetica Regular with 1 point of leading.
- The table labels (for example, “Amount per Serving”) are set in 6 point Helvetica Black.
- Absolute measures of nutrient content (for example, “1g”) and nutrient subgroups are set in 8 point Helvetica Regular with 4 points of leading.
- Vitamins and minerals are set in 8 point Helvetica Regular, with 4 points of leading, separated by 10 point bullets.
- All type that appears under vitamins and minerals is set in 6 point Helvetica Regular with 1 point of leading.
- A 7 point rule separates large groupings as shown in the example. A 3 point rule separates calorie information from the nutrient information.
- A hairline rule or 1/4 point rule separates individual nutrients, as shown in the example. 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.
All labels are enclosed by ½ point box rule within 3 points of text measure.
L3. Must all of the type specifications shown with the nutrition format example of section 7 L2 (above) be followed?
Answer: No. The mandatory type specifications are listed in 21 CFR 101.9(d). Unlike the illustrative example of section 7 L2 (above):
- 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.
L4. Can I use type sizes larger than 8 point and 6 point?
Answer: The requirement for 6 and 8 point type sizes are minimum requirements. Larger type sizes may be used.
L5. Where should the Nutrition Facts appear on the food label?
Answer: Under 21 CFR 101.9(j)(13)(ii)(D) the Nutrition Facts may be presented on any label panel when the total surface available for labeling is 40 or less
square inches. Packages with more than 40 square inches of available space must place the nutrition information on either the PDP or information panel as defined in 21 CFR 101.2 unless there is insufficient space (excluding vignettes, etc.), in which case the Nutrition Facts may be placed on any panel that may
be seen readily by consumers. 21 CFR 101.9(j)(17)
L6. Can print be condensed?
Answer: Yes, however, if condensing results in a label that does not meet minimum type size requirements, FDA would consider the label misleading. 21 CFR
L7. What can be done if the regular Nutrition Facts label (i.e., the vertical format) does not fit the package?
Answer: On packages with more than 40 square inches available to bear labeling, the “side-by-side” format may be used if the regular Nutrition Facts label does not fit. In this format, the bottom part of the Nutrition Facts label (following the vitamin and mineral information) is placed immediately to the right and separated with a line. If additional vitamins and minerals are listed after iron and the space under iron is inadequate, they may also be listed to the right with a line that sets them apart from the footnotes.
Also, if the package has insufficient continuous vertical space (i.e., about 3 inches) to accommodate the above format, the nutrition label may be presented in a tabular (i.e., horizontal) display. 21 CFR 101.9(d)(11)
1Saturated fat content information is required if claims are made about fat, fatty acid, or cholesterol content or if “calories from saturated fat” is declared.
2Trans fat information is required if claims are made about fat, fatty acid or cholesterol content.
3Cholesterol content is required if claims are made about fat, fatty acids or cholesterol content.
4Sugars content information is required if claims are made about sweeteners, sugars or sugar alcohols.
L8. Are cellophane windows on bags or boxes considered as space available to bear labeling?
Answer: If the window is used for any labeling, including promotional stickers, the window is considered to be available labeling space. However, if no labeling is present it is not considered to be available space.
L9. If a straw is placed over the back of a juice carton, must that panel be considered space available to bear labeling?
Answer: Yes, however, required label information must be presented in a manner so that it is not obscured. Firms having difficulties in presenting nutrition information on such packages may wish to request a special allowance pursuant to 21 CFR 101.9(g)(9) by writing to the Office of Nutrition, Labeling, and Dietary Supplements, HFS-800, 5100 Paint Branch Pkwy., College Park MD 20740.
L10. If the nutrients that are required to be included on the Nutrition Facts label are present at 0 grams per serving, when can they be summarized in a sentence? Can more than one nutrient be included in the sentence?
Answer: The nutrients listed below may be omitted from the list of nutrients and included in a single sentence when present at “zero” levels in a food. This is done by putting the label statement (“Not a significant source of _________”) immediately below the listing of vitamins A and C, calcium, and iron. When the statement “Not a significant source of_____________” is used for more than one nutrient, nutrients must be listed in the order in which they would have been listed in the regular format (e.g., “Not a significant source of calories from fat, saturated fat, trans fat, cholesterol, dietary fiber, sugars, vitamin A, vitamin C, calcium and iron”). The footnote can be used, with any format, to list one or more of the following nutrients: (21 CFR 101.9(c))
|Nutrient||Level per serving||Label statement|
|Calories from fat|
21 CFR 101.9(c)(1)(ii)
|Less than 0.5 g fat||"Not a significant source of calories from fat"|
21 CFR 101.9(c)(2)(i)
|Less than 0.5g of total fat1||"Not a significant source of saturated fat"|
21 CFR 101.9(c)(2)(ii)
|Less than 0.5g of total fat2||"Not a significant source of trans fat"|
21 CFR 101.9(c)(3)
|Less than 2 mg3||"Not a significant source of cholesterol"|
21 CFR 101.9(c)(6)(i)
|Less than 1g||"Not a significant source of dietary fiber"|
21 CFR 101.9(c)(6)(ii)
|Less than 0.5g4||"Not a significant source of sugars"|
|Vitamins A and C, calcium, and iron|
21 CFR 101.9(c)(8)(iii)
|Less than 2% of RDI||"Not a significant source of _________" (listing the vitamins or minerals omitted)|
(1) Saturated fat content information is required if claims are made about fat, fatty acid, or cholesterol content or if “calories from saturated fat” is declared.
(2) Trans fat information is required if claims are made about fat, fatty acid or cholesterol content.
(3) Cholesterol content is required if claims are made about fat, fatty acids or cholesterol content.
(4) Sugars content information is required if claims are made about sweeteners, sugars or sugar alcohols.
L11. A package design firm asked about the option of reversing the Nutrition Facts label copy as white type out of a dark colored background on the grounds that reverse copy, with the appropriate size and color contrast, can be as readable as positive type.
Answer: Part 101.9(d)(1)(i) states that the nutrition information “shall be all black or one color type, printed on a white or other neutral contrasting background whenever practical.” This does not prohibit reverse print or use of other colors.
However, if reverse type is used, FDA expects that any impairment in readability resulting from such a technique will be compensated for by use of other graphic techniques to improve readability, such as increased type size. Reverse printing is
not permitted as a form of highlighting under 21 CFR 101.9(d)(1)(iv) because it would interfere with the consistent look of the label.
L12. Is it necessary to include a calorie conversion footnote which states that fat, carbohydrate, and protein furnish 9, 4, and 4 calories per gram, respectively?
Answer: No, the use of that footnote is optional. 21 CFR 101.9(d)(10)
L13. Do the values under % Daily Value need to be aligned under the heading as specified in 21 CFR 101.9(d)(7)(ii) or aligned to the far right side of the column (i.e., right justified) as shown in the format examples?
Answer: The listing of percent of the Daily Values needs to be in a column aligned under the heading and can be either centered or right justified.
L14. We make bean curd (tofu) hot dogs that are packaged in a film that conforms to the shape of the product. Can I place nutrition labeling on the film, or must I use a paper strip label?
Answer: The Nutrition Facts label can be placed on the film package provided that the color contrast of the print and the indentations made by the product do not prevent consumers from being able to read the information at the point of purchase.
L15. Can we use a continuous print label that would result in the Nutrition Facts label being cut off at an odd spot, with the bottom of the label at the top of the package, and the top of the label near the bottom?
Answer: No. However, if a continuous print label includes one uncut Nutrition Facts label it would be acceptable.
L16. Can the Nutrition Facts label be printed on a sticker and affixed to a package?
Answer: Yes, as long as the sticker adheres to the product under the intended storage conditions. Some companies use generic cartons or bags and affix product specific labeling.
L17. On labels that have two languages, may nutrition information be provided in one bilingual Nutrition Facts label?
Answer: When nutrition labeling must be presented in a second language, the nutrition information may be presented in separate nutrition labels for each language or in one label with the second language, translating all required information, following that in English. Numeric characters that are identical in both
languages need not be repeated.
L18. I call my product Frijoles Pintos. Is bilingual labeling required? What about salsa?
Answer: When an accepted common or usual name for a food is in a language other than English (e.g., salsa, chili con carne, croissants, rigatoni), use of this common or usual name does not necessitate dual language declaration. However, if the name of the food is intended to bring the article to the attention of a person who does not speak English (e.g., Frijoles Pintos), all required information must be presented in the foreign language. 21 CFR 101.15(c)
L19. How should variety packs (e.g., breakfast cereals) display the nutrition information?
Answer: When a package contains two or more packaged foods that are intended to be eaten individually, such as a variety pack of breakfast cereals or when packages may be used interchangeably for the same type of food, such as round ice cream containers, the manufacturer may choose to include separate Nutrition Facts labels for each food product, or may use an aggregate Nutrition Facts label.
L20. We produce a cookie assortment containing various percentages of 6 different cookies. What nutrition format should be used?
Answer: The manufacturer may choose to use: (1) a separate Nutrition Facts label for each variety of cookie in the package, (2) an aggregate label (i.e., a single Nutrition Facts label including nutrient content information and % DVs in separate columns for each variety), or, (3) if it is likely that one person would eat an assortment of the cookies at the same time, a composite label that provides one set of nutrition information based on a weighted average of all of the cookies in the assortment. 21 CFR 101.9(h), 21 CFR 101.9(d)(13)
L21. I use a single box to package a variety of different products (e.g., cherry pie, apple pie or cheese cake, etc.). The box is partially prelabeled (i.e., it bears nutrition labeling in the aggregate format for all possible products). When the product is packaged, I print the identity statement for the food on the PDP. Must the Nutrition Facts label be marked or highlighted at the time of packaging to indicate which product is in the package?
Answer: No, the statement of identity on the PDP along with the statement of identity above each column of nutrient values in the aggregate Nutrition Facts label will provide adequate information for the consumer to determine which nutritional values in the aggregate label apply to the contents of the package. 21 CFR 101.9(d)(13)(i)
L22. What are the definitions of “as packaged” and “as prepared”?
Answer: “As packaged” refers to the state of the product as it is marketed for purchase. “As prepared” refers to the product after it has been made ready for consumption (e.g., ingredients added per instructions and cooked such as a cake mix that has been prepared and baked or a condensed or dry soup that has been reconstituted).
L23. If a manufacturer chooses to do so, how may a food be labeled if the labeled food is commonly combined with another food before eating?
Answer: The Nutrition Facts label must state the nutrients in the food “as packaged” (i.e., before consumer preparation). However, manufacturers are encouraged to add a second column of nutrition information showing calories, calories from fat and the % DV for the combination of foods eaten. Quantitative amounts (i.e., g/mg) need only be given for the packaged food. However, as shown in this example, a footnote can be added to indicate the amount of nutrients in the added food. Alternatively, the quantitative amounts of the prepared food may be included immediately adjacent to those for the packaged food (e.g., “Sodium 200 mg, 265 mg”). 21 CFR 101.9(e)
L24. When a second column of nutrient information is provided, is it necessary to repeat the “serving size” and “servings per container”?
Answer: The dual listing of serving size and servings per container is not required when providing a second column of nutrient information. The only requirement is to list the serving size and servings per container that are based on the Reference Amounts Customarily Consumed (RACC) for the product. 21 CFR 101.9(b)(9) and 21 CFR 101.9(e)
L25. I have a recipe on my package which calls for 250% of the RACC of my product for each serving of the food created using the recipe. Must I use dual declaration for the nutrition label?
Answer: Yes. Section 101.9(b)(11) states that if the product is promoted on the label or labeling for a use that differs in quantity from the RACC by 200% or greater, dual declaration would be required. FDA considers recipes on the label as “promoting” a use of the food. The regulations (21 CFR 101.9(b)(11)) specifically exempt bulk products used primarily as ingredients (e.g., flour, sugar, oils) or traditionally used for multi-purposes (e.g., eggs, butter) from dual declaration requirements.
L26. We want to use dual declaration for cereals. Do we have to include the 240 mL RACC, a one cup serving, for the added milk, or can we use 1/2 or 1/4 cup?
Answer: Such a label would have two columns with a heading “Cereal” and “Cereal with 1/2 cup (or 1/4 cup) _____ milk” where the blank is filled in with the type of milk. 21 CFR 101.9(e) (See figure beside L20-L23)
L27. We have a condensed “cream of ___ soup”. Should we do dual declaration?
Answer: Dual declaration is optional. 21 CFR 101.9(e)
L28. If a recipe is placed on the label of a product, does the nutrient profile of the recipe have to be included on the label?
Answer: Only if the recipe calls for 200% or more of the RACC of the product for each serving of the food created by the recipe. When the recipe calls for an amount less than 200% of the RACC, such information could be voluntarily listed. However, nutrition information for a specific recipe may be presented outside of the Nutrition Facts label. 21 CFR 101.9(b)(11)
L29. If a manufacturer chooses to do so, what is an example of the Nutrition Facts label for a food requiring further preparation by the consumer?
Answer: See example to right. However, when the nutrient values in the column for the product prepared according to package directions would be identical to the column for the product as packaged (e.g., the only ingredients added during preparation are ingredients such as water), manufacturers may omit the second column and include the amount made as part of the serving size declaration. For example, a dry beverage mix could declare: “Serving Size: 1 tsp dry powder (4 g (makes cup prepared).” 21 CFR 101.9(b)(7)(v), 21 CFR 101.9(e)(5)
L30. Is there a Nutrition Facts format for a food in which most nutrients are present in insignificant amounts?
Answer: A simplified Nutrition Facts label may be used if at least eight of the following nutrients are present in insignificant amounts: Calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium and iron (slightly different rules for labeling foods intended for children less than 2 years). The five core nutrients, shown in bold in the adjoining example, must always appear on all Nutrition Facts labels regardless of amounts present in the food. In addition, any of the nutrients required on the full Nutrition Facts label that are naturally present or are added to the food must be declared on the simplified Nutrition Facts label. 21 CFR 101.9(f) - List of nutrients; 101.9(f)(1) – “Insignificant” defined; 101.9(c) – “Insignificant” levels listed for nutrients
L31. What are insignificant amounts of nutrients?
Answer: These are the amounts that are permitted to be shown as zero on the Nutrition Facts label (e.g., less than 5 calories may be expressed as 0 calories) except that for total carbohydrate, dietary fiber, and protein, it is the amount that can be declared as “less than 1 g” on the Nutrition Facts label. 21 CFR 101.9(c)
L32. When I use the simplified format, when is the statement “Not a significant source of_____________” required?
Answer: This statement, which must list all nutrients required by the full format that are present at insignificant amounts, must be included when: (1) nutrition claims are made; or (2) vitamins and minerals are added; or (3) naturally occurring nutrients that are not required on the full format (e.g., potassium) are voluntarily declared. 21 CFR 101.9(f)(4)
L33. If a product qualifies for the simplified format, but the company wants to make a claim about a required or voluntary nutrient, can it still use the simplified format?
Answer: Yes. However, as noted in the previous question and answer, when a claim is made, the statement “Not a significant source of _____________” (with the blank filled in with the name(s) of any nutrient(s) identified in 21 CFR 101.9(f) and calories from fat that are present in insignificant amounts) must be included at the bottom of the nutrition label. 21 CFR 101.9(f)(4)
L34. When should a statement be used on simplified format labels to list nutrients present at insignificant amounts?
Answer: A “simplified format label” must include a statement listing “zero” level nutrients when nutrients are added to the food or voluntarily declared on the Nutrition Facts label, and when claims are made on the label. In this example, the manufacturer voluntarily lists polyunsaturated and monounsaturated fat, and therefore must add the statement “Not a significant source of _________” with the blank filled in by the names of nutrients present at insignificant levels. 21 CFR 101.9(f)(4)
L35. When the simplified format is used, can nutrients that are not required to be listed and that are present at insignificant amounts be listed voluntarily (e.g., calories from fat, saturated fat, trans fat, cholesterol, dietary fiber, sugars, vitamin A, vitamin C, calcium and iron)?
Answer: The intent of the simplified format was to minimize the amount of information required to be on the label. While the agency discourages the listing of optional nutrients, present at insignificant amounts, in the simplified format, the regulations do not prohibit such listing. When non required nutrients (e.g., calories from fat, saturated fat, trans fat, cholesterol, dietary fiber, sugars, vitamin A, vitamin C, calcium or iron) are voluntarily listed as zero, the footnote required by 21 CFR 101.9(f)(4) is not required.
L36. If a product qualifies to use the simplified format but the manufacturer elects to use the full format and list the insignificant level of nutrient(s) as zero, can the footnote still be shortened?
Answer: No, since use of the simplified format is optional all required information must be presented when the full format is
used. 21 CFR 101.9(d)(9)
L37. How do I use the “Not a significant source of ____________” in the tabular format?
Answer: When the full format is presented in a tabular display, the statement “Not a significant source of ____________” should be placed beneath the vitamins and minerals and be separated by a hairline. When the simplified format is presented in a tabular display, the statement should be separated by a bar under the nutrients declared.
L38. What is the correct type size for the “Not a significant source of ____________” statement?
Answer: 6 point
L39. Can the simplified format be used regardless of the amount of available label space?
Answer: Yes. The nutrient content of the food, not available label space, is the determining factor. 21 CFR 101.9(f)
L40. When the simplified format is used, what is the required type size?
Answer: The type size and layout requirements are the same as that required for the full format. 21 CFR 101.9(f)(5)
L41. Is the entire footnote used with the standard format, which lists DVs for 2,000 and 2,500 calorie diets, required to be used on the simplified format for intermediate sized packages with 40 or less square inches of available space?
Answer: No. The simplified format only requires the statement “Percent Daily Vues are based on a 2,000 calorie diet” regardless of the size of the package. If the term “Daily Value” is abbreviated in the heading as “DV,” the statement must indicate that “DV” means “Daily Value” (e.g., “Percent Daily Values (DV) are based on a 2,000 calorie diet”). 21 CFR 101.9(f)(5)
L42. Why is FDA requiring that trans fatty acids be listed in nutrition labeling?
Answer: FDA is requiring that trans fatty acids be listed in nutrition labeling in response to a petition from the Center for Science in the Public Interest and to published human studies that show that intake of trans fatty acids, similar to the intake of saturated fatty acids, increases low density lipoprotein-cholesterol (LDLC) (“bad cholesterol”) in the blood. An elevated LDL-C increases the risk of developing coronary heart disease. Reports published by the Institute of Medicine of the National Academy of Sciences (IOM/NAS) and the Federal government have recommended that Americans limit their intake of trans fat and other cholesterol-raising fats while consuming a nutritionally adequate diet. For Americans to follow these recommendations, they must know the amount of trans fatty acids in the individual foods that they eat. Therefore, FDA is requiring that this information be provided in nutrition labeling to assist consumers in maintaining healthy dietary practices. (68 FR 41434, July 11, 2003)
L43. How is trans fat defined for labeling purposes?
Answer: The Agency's regulatory chemical definition of trans fatty acids is “all unsaturated fatty acids that contain one or more isolated double bonds (i.e. non conjugated) in a trans configuration.” Trans vaccenic acid, a trans fatty acid with a single double bond, and other trans fatty acids of ruminant origin with either a single double bond or nonconjugated double bonds are included in this definition. Trans fatty acids with conjugated bonds are not included because they do not meet the Agency's definition. Thus, trans fatty acids, regardless of origin, that meet the above definition are to be included in the label declaration of trans fat. Further, using FDA's regulatory chemical definition, the categories “trans fatty acids” and “conjugated fatty acids” are mutually exclusive. The definition of trans fatty acids, excluding fatty acids with conjugated double bonds, is consistent with the way that cis isomers of polyunsaturated fatty acids are defined. (68 FR 41434 at 41461, July 11, 2003.)
L44. Do trans fatty acids need to be listed when mono- and polyunsaturated fatty acids are not listed?
Answer: Yes. The listing of trans fatty acids is mandatory even when mono- and polyunsaturated fatty acids are not listed. 21 CFR 101.9(c), (c)(2)(ii), (c)(2)(iii), and (c)(2)(iv).
L45. How should trans fatty acids be listed?
Answer: Trans fatty acids should be listed as “Trans fat” or “Trans” on a separate line under the listing of saturated fat in the Nutrition Facts label (see figure). The word “trans” may be italicized to indicate its Latin origin. Trans fat content must be expressed as grams per serving to the nearest 0.5-gram increment below 5 grams and to the nearest gram above 5 grams. If a serving contains less than 0.5 gram, the content, when declared, must be expressed as “0 g.” (21 CFR 101.9(c)(2)(ii)).
L46. If a serving contains less than 0.5 gram of trans fat, when would “0 g” of trans fat not have to be declared?
Answer: For conventional food products (those food products other than dietary supplements), declaration of “0 g” of trans fat is not required for such products that contain less than 0.5 g of total fat in a serving and no claims are made about fat, fatty acid or cholesterol content. If trans fat is not listed, the statement “Not a significant source of trans fat” may be placed at the bottom of the table of nutrient values in lieu of declaring “0 g” of trans fat. If these claims are present, then the statement “Not a significant source of trans fat” is not an option and the declaration of “0 g” of trans fat is required. 21 CFR 101.9(c)(2)(ii)
L47. Why is there no % DV for trans fat?
Answer: Although the updated Nutrition Facts label will now list the amount of trans fat in a product, there is no % DV for trans fat. While scientific reports have confirmed the relationship between trans fat and an increased risk of CHD,
none has recommended an amount of trans fat that FDA could use to establish a DV. Without a DV, a % DV cannot be calculated. As a result, trans fat will be listed with only a gram amount. 21 CFR 101.9(d)(7)(ii)
L48. Is it possible for a food product to list the amount of trans fat as 0 g on the Nutrition Facts label if the ingredient list indicates that it contains “partially hydrogenated vegetable oil?”
Answer: Yes. Food manufacturers are allowed to list amounts of trans fat with less than 0.5 gram (½ g) as 0 (zero) on the Nutrition Facts label. As a result, consumers may see a few products that list 0 gram trans fat on the label, while the ingredient list will have “shortening” or “partially hydrogenated vegetable oil” on it. This means the food contains very small amounts (less than 0.5 g) of trans fat per serving.
L49. What about nutrient content claims for trans fat?
Answer: Nutrient content claims are statements that are made on the food label package that indicate that the product contains a range from free to high of the amount of a specific nutrient. Examples: “Low Fat” and “High in Fiber.” At this time, FDA has insufficient scientific information to establish NCCs for trans fat. Such claims are permitted, however, for saturated fat and cholesterol.
L50. What other regulations about nutrition labeling of trans fatty acids is FDA considering?
Answer: The Food and Drug Administration (FDA) issued an advance notice of proposed rulemaking (ANPRM) in the Federal Register (Food Labeling: Trans Fatty acids in Nutrition Labeling; Consumer Research to Consider Nutrient Content and Health Claims and Possible Footnote or Disclosure Statements; 68 FR 41507; July 11, 2003) to solicit information and data that potentially could be used to establish new NCCs about trans fat, to establish qualifying criteria for trans fat in current NCCs for saturated fat and cholesterol, lean and extra lean claims, and health claims that contain a message about cholesterol raising fats, and, in addition, as disclosure and disqualifying criteria to help consumers make heart-healthy food choices. The agency also requested comments on whether to consider statements about trans fat, either alone or in combination with saturated fat and cholesterol, as a footnote in the Nutrition Facts label or as a disclosure statement in conjunction with claims to enhance consumers' understanding about such cholesterol-raising lipids and how to use the information to make healthy food choices. Information and data obtained from comments and from consumer studies conducted by FDA may be used to help draft a proposed rule that would establish criteria for certain nutrient content or health claims or require the use of a footnote, or other labeling approach, about one or more cholesterol-raising lipids in the Nutrition Facts label to assist consumers in maintaining healthy dietary practices.
L51. If we nutrition label in good faith, will FDA take legal action involving small mistakes?
Answer: FDA is unlikely to take regulatory action for minor errors. However, such errors should be corrected during the next printing of labels.
L52. When are point-of-purchase materials considered labeling?
L53. I have tried all the available format options, but without some modification I can not make them work on my label, what can I do?
Answer: Under 21 CFR 101.9(g)(9), FDA may permit alternative means of compliance or additional exemptions to deal with special situations. Firms in need of special allowances should make their request in writing to the Office of Nutrition, Labeling, and Dietary Supplements, HFS-800, 5100 Paint Branch Pkwy., College Park, MD 20740. The letter should: (1) specify that you are requesting an exemption or special provision under 21 CFR 101.9(g)(9), (2) identify the particular product(s) that are the subject of the request, (3) state the reason(s) why it is technologically infeasible or impracticable to adhere to the regulations for such products, and (4) identify the proposed alternative procedure. If possible, include an example of the proposed label(s).
L54. Are mail order sales covered by the food labeling laws?
Answer: The same labeling laws apply to all categories of retail sale, including mail orders. Foods sold by mail order must be fully labeled.
L55. Is it permissible to use stickers to make changes in labeling?
Answer: Correcting label mistakes in any manner is acceptable if the final label is correct and complies with all regulations at the time of retail sale. The stickers should not cover other mandatory labeling, and should adhere tightly.
L56. Does FDA approve labels before printing?
Answer: No, it is the responsibility of the manufacturer or importer of a food to comply with current food labeling regulations.
L57. I am trying to determine the appropriate serving size and number of servings to list on the label of my food product. How do I start, and what steps should I follow?
Answer: Manufacturers must use the information provided in the regulation to determine a specific serving size for their products. The process consists of three steps:
Locate the appropriate food category and Reference Amount Customarily Consumed (RACC) for your product in the two tables in Section 101.12(b) of the food labeling regulations. Table 1 is for infant and toddler foods. Table 2 is foods for the general population. FDA established RACCs for 139 food product categories, and these values represent the amount of food customarily consumed at one eating occasion. Most of the RACCs are for foods in a ready-to-eat form. If your product in the form in which it is sold (i.e., “as packaged”), does not have a RACC in the tables, then you must generate an appropriate RACC for your product using 21 CFR 101.12(c) for products that require further preparation, (d) for imitation foods, (e) for aerated foods, and (f) for products that represent two or more foods packaged and presented to be consumed together.
The first important step in establishing an appropriate serving size is 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; 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 in 21 CFR 101.9(b)(6).
Determine the serving size for your multi-serving product using the RACC 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).
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.
L58. The RACC for a food product is 50 grams, but a single serving of the product weighs 54 grams. Is the nutrition information based on the 50 gram RACC or the actual metric unit?
Answer: The nutrition information on the label is based on the household unit closest to the RACC. In this case it would be based on 54 grams, which would be declared as the weight of the label serving size. The RACC is used as the starting point to determine the serving size for the foods in each product category and to govern claims.
L59. What is the RACC for partially cooked, packaged pasta products? Table 2 only gives RACCs for prepared and dry pasta.
Answer: The RACC for a partially cooked pasta product is the amount of partially cooked pasta that makes one RACC of cooked pasta (140 grams). 21 CFR 101.12(c)
L60. To what category do pickled vegetables belong?
Answer: Pickled vegetables are categorized with “pickles, all types” with a RACC of 30 grams. 21 CFR 101.12(b)
L61. What if my product does not have an appropriate food category listing or RACC?
Answer: The agency realizes that the categories in Table 2 “Reference Amounts Customarily Consumed” may not include all foods marketed in the U.S. Therefore, in order to allow manufacturers to provide nutrition information on currently marketed product labels, the manufacturer should write the agency and send in information regarding the primary usage, amount customarily consumed, and any other information as requested for a petition as discussed in section 21 CFR 101.12(h). FDA will provide a “suggested RACC” for the product that may be used to meet the manufacturer's immediate needs to nutrition label its products. While the agency will provide a “suggested RACC” 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 RACC. Alternatively, the manufacturer or any other interested party may petition FDA at any time to establish a RACC as specified in 21 CFR 101.12(h).
L62. What “suggested RACCs” have been provided to date?
Answer: The “suggested RACCs” to date are shown below. The labeled serving size for these products would be expressed in a household unit followed by the metric equivalent in parentheses.
|Powdered, flavored candy||15 g|
|Colored, flavored syrup-filled wax candy||15 mL|
|Dried tomatoes (halved, sliced, minced, bits)||5 g|
|Dried tomatoes in oil (halved, sliced, minced, bits)||10 g|
|Wrappers for eggrolls, dumplings, wontons or potstickers||60 g|
|Egg whites (fresh, frozen, dried)||about 1 large egg|
|Sugared eggs, sugared egg yolks||about 1 large egg|
|Flavoring oils||1 t|
|Fruit chutney||1 T|
|Dried yeast||0.5 g|
|Baking cocoa, carob powder||2 T|
|Coconut milk||1/3 cup|
|Dried, e.g., sun-dried tomatoes, dried mushrooms, dried seaweed||10 g|
|Dried seaweed sheets||3 g|
|Vegetable spreads (eggplant caponata, olive spread)||2 T|
|Hors d’oeuvres, mini eggrolls, mini pizza rolls and bagel pizzas||85 g|
L63. What terms must be used for the serving size?
Answer: The serving size declaration is made up of two parts: a “household measure term” followed by its metric equivalent in grams (g). For beverages, the household measures may be declared as either fluid ounces, cups, or fractions of a cup with the metric equivalent in milliliters (mL). The examples below show permitted declarations.
|Cookies||"1 cookie (28 g)" or "1 cookie (28 g/1 oz)"|
|Milk, juices, soft drinks||"8 fl oz (240 mL)," or "1 cup (240 mL)" for multiserving containers, or the container (e.g., "1 can") for single serving containers|
|Grated cheese||"1 tablespoon (5 g)" or "1 tablespoon (5 g/0.2 oz)|
L64. Is a RACC different from a serving size?
Answer: Yes, the RACC is used to derive a serving size for a particular product. The following example shows how to use the RACC to determine the serving size for a 16 oz (454g) pizza:
1. 1st step: From the RACCs table (21 CFR 101.12(b)), you determine that
the RACC for pizza is 140g.
2. 2nd step: Calculate the fraction of the pizza that is closest to the RACC of
140g (calculations shown for a pie of net weight 16oz/454g pizza):
1/3 X 454g = 151g
1/4 X 454g = 113g
Note that 151g is closer than 113g to the RACC for pizza (140g)
3. 3rd step: The serving size is the fraction closest to the RACC together with
the actual gram weight for that fraction of the pizza:
Example: “Serving Size 1/3 pie (151g)”
Therefore, the serving size is “ 1/3 pizza (151g)” for this example, whereas the RACC is 140g for all pizzas. Note: Sections 101.9(b)(2)(i) (discrete units), 21 CFR 101.9.(b)(2)(ii) (large discrete units), and 21 CFR 101.9(b)(2)(iii) (bulk products) describe how to use the RACC to derive a serving size. 21 CFR 101.12(b)
L65. The table for RACCs in the regulation contains a column of label statements. What are these and must I use them in declaring a serving size for my food product?
Answer: FDA added a label statement column to the RACC tables to provide manufacturers with examples of how serving sizes could appear on product labels. Exact values were initially provided as part of these statements, but have since been removed because some manufacturers incorrectly believed that the exact label statements were required even if the values were inaccurate for their specific products. Manufacturers should realize that the label statement column is not all inclusive and merely provides a few examples of possible label statements. Manufacturers should use an appropriate household measure and the corresponding metric weight or volume actually measured for their specific product. 21 CFR 101.12(b)
L66. If the number of units closest to the RACC is midway between two numbers, which should be chosen?
Answer: For serving sizes halfway between two numbers of units, the serving size should be rounded up to the higher value (21 CFR 101.9(b)(5)(ix)). For example, the RACC for cookies is 30 g. If the product is a bag of 12 g cookies, then 2 units weigh 24 g, and 3 units weigh 36 g. Thus, 2.5 cookies would weigh exactly 30 g, and the serving size would be rounded to the next incremental value: “3 cookies (36 g).”
L67. How is the serving size calculated for the Nutrition Facts label on a biscuit mix product?
Answer: The following example shows how to calculate the serving size for a biscuit mix product and similar products that require further preparation:
1. 1st step: From the RACC table (21 CFR 101.12(b)), determine that the RACC for biscuits is 55g.
2. 2nd step: Determine amount of mix needed to make a 55g biscuit.
3. 3rd step: Determine closest permitted fraction of tablespoon or cup that
contains the amount of mix closest to the amount determined in step 2.
4. 4th step: The serving size is the fraction of a tablespoon or cup of biscuit
mix determined in step 3 together with the actual gram weight of that measure
of biscuit mix as the serving size.
Use the form “Serving Size __ cup (__ g),” the blanks filled in with
correct values for the product. 21 CFR 101.12(b)&(c)
L68. Is it necessary to reformulate the size of a product such as cookies so that the serving size weighs exactly the RACC (i.e., 30g)?
Answer: It is not necessary to adjust the size of your cookies to fit the RACC. For example, if four cookies weigh 28 grams (and five cookies weigh 35 grams), declare the number of cookies nearest the RACC and label with the exact weight of that number of cookies for the serving size: “Serving size 4 cookies (28g)” or “4 cookies (28g/1 oz).” 21 CFR 101.12(b)
L69. What fractions must be used to express serving sizes in common household measures?
Answer: For cups, these fractions of a cup are allowed household measures: 1/4 cup, 1/3 cup, 1/2 cup, 2/3 cup, 3/4 cup, 1 cup, 1 1/4 cup, etc. If serving sizes are declared in fluid ounces, declare the serving size in whole numbers (such as 4 fl oz, 5 fl oz, 6 fl oz, etc). For tablespoons, the following fractions of a tablespoon are allowed: 1, 1 1/3, 1 1/2, 1 2/3, 2, and 3 tablespoons. For teaspoons, the fractions of a teaspoon shall be expressed as 1/8, 1/4, 1/2, 3/4, 1, or 2 teaspoons. 21 CFR 101.9(b)(5)(i)
L70. For foods that are usually cut into pieces before serving, what fractions must be used in the serving size declaration?
Answer: These fractions must be used in serving sizes for foods such as cakes or pies: “1/2”, “ 1/3”, “1/4”, “1/5”, “1/6”, “1/8”, “1/9”, “1/10”, “1/12” and smaller fractions that can be arrived at by further division by 2 or 3. 21 CFR 101.9(b)(2)(ii)
L71. For a multi-serving package, what is the serving size for a product that is sliced thinner or thicker than the RACC?
Answer: The slices are treated as “discrete units.” One slice is a single serving if it weighs from 67% to less than 200% of the RACC. Larger slices (weighing more than 200% of RACC) may be declared as a serving if the whole slice can reasonably be eaten at a single-eating occasion. For slices weighing between 50%-67% of the RACC, the serving size may be declared as either one or two slices. For slices weighing less than 50% of the RACC, the serving size is the number of slices closest to the RACC. 21 CFR 101.9(b)(2)(i) and 21 CFR 101.12
L72. Should a label show “2 1/2 servings”?
Answer: For packages containing from two to five servings, round the number of servings to the nearest 0.5 serving. Examples: “2 servings,” “2.5 servings,” “3 servings,” “3.5 servings,” “4 servings,” “4.5 servings,” and “5 servings.” For packages containing five or more servings, round the number of servings to the nearest whole serving. Examples: “5 servings,” “6 servings,” “7 servings.” Rounding should be indicated by the term “about” (e.g., “about 6 servings”). 21 CFR 101.9(b)(8)
L73. My dehydrated mixed dish product has a RACC of 1 cup. Do I declare the serving size as 1 cup or the amount of my product to make 1 cup?
Answer: Although the RACC for mixed dish products is one cup, this amount is for the prepared product. The serving size, however, must represent the product as packaged. This will be the amount of the product, expressed in a household measure, that will make one cup when prepared according to package directions. For example, the serving size for a dry seasoned rice mix will be less than one cup since rice expands during cooking. The gram weight in the parenthetical expression will be the weight of the household measure of dry mix. 21 CFR 101.9(b)(9)
L74. Should the serving size and number of servings per container for unpopped popcorn be based on the prepared product?
Answer: The serving size and servings per container for unpopped popcorn is based on the amount of the product as packaged or purchased needed to make the RACC of the prepared product. A second column of nutrition information based on the as prepared basis may also be presented. 21 CFR 101.9(b)(10)(iii)
L75. What about the use of fractions of a package to declare serving sizes, such as a 1/8 package of dry mix?
Answer: Generally, serving sizes cannot be declared on the basis of fractions of a package. The exception is for unprepared products where the entire contents of the package mix is used to prepare one large discrete unit that is usually divided for consumption (e.g., cake mix, pizza kit) (21 CFR 101.9(b)(5)(v)). For example, a mix for a sheet cake may declare: “1/12 package (40 g/about 1/3 cup mix).” This option is not allowed for other dry mixes or other products. 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).”
L76. Are there special provisions for individually packaged products?
Answer: Single serving containers and individually packaged products within multi-serving containers must use a description of the individual container or package (21 CFR 101.9(b)(5)(iv)): “1 can (360 mL)” or “2 boxes (38 g),” and products in discrete units must use a description of the individual unit (21 CFR 101.9(b)(5)(iv)): “2 candies (22 g)” or “1 slice (45 g).”
L77. What are the options for products consisting of several inner packaged components and intended to be mixed together?
Answer: Products consisting of two or more distinct ingredients or components packaged and presented to be consumed together (e.g., dry macaroni and cheese mix, cake and muffin mixes with separate ingredient packages, pancakes and syrup) may declare serving size and nutrition information either: (a) for each component or (b) as a composite. For products where one of the components is represented as the main ingredient, there are provisions for representing the amount of the main ingredient and proportioned minor ingredients (21 CFR 101.9(b) (5)(i)-(iii), CFR 21 101.9(b)(2)(i)(H)): “2 pancakes with syrup (160 g)” or alternatively “2 pancakes (110 g)” and either “syrup for 2 pancakes (50 g)” or “2 tbsp syrup (50 g)” if 50 g of syrup makes 2 tbsp. In addition, these products may also use ounces (21 CFR 101.9(b)(5)(vii)): “4 oz (112 g/about 2/3 cup macaroni and 2 tbsp dry cheese mix)” or alternatively “3 oz dry macaroni (84 g/about 2/3 cup)” and “1 oz dry cheese mix (28 g/about 2 tbsp).”
L78. How do we state the serving size for peanuts with shells?
Answer: The RACC for nuts is 30 grams edible portion. The serving size for peanuts with shells would be the household measure closest to 30 grams of nuts without shells. In order to reduce consumer confusion regarding the serving size, a clarifying statement can be used. For example, the serving size statement for your product might read: “1/2 cup nuts without shells (30 g/ about 1 cup nuts with shells ).”
L79. Is the serving size for all pickled vegetables based on a drained weight basis? Is it the same for canned vegetables?
Answer: The serving size for pickled vegetables is based on the drained weight of the product because the liquid is not usually consumed with these type products. For canned vegetables, the liquid is included in the determination of serving size. 21 CFR 101.9(b)(8)(ii), 21 CFR 101.9(b)(9)
L80. If a product is sold both in the U.S. and exported, can the nutrition information also be declared “per 100 grams” or “per 100 mL” in order to meet certain international requirements?
Answer: Yes. Section 21 CFR 101.9(b)(10) permits the voluntary listing of nutrition information per 100 grams or 100 mL of the food as packaged or purchased. A column may also be presented with nutrition information “per 1 oz” or “per 1 fl oz” as packaged or prepared.
L81. Products such as mini egg rolls, pizza rolls, and stuffed pastry are categorized as mixed dishes. However, on the label of these products, they are promoted as appetizers, as well as side dishes. How can the products be labeled to show their use as appetizers with a smaller serving size than as a side dish?
Answer: The regulations allow a second column of nutrition information to be declared for a food provided that it is not misleading to consumers. The serving size and first column of nutrition information for these products would be based on their use as a mixed dish, but the second column could be based on their use as an appetizer. 21 CFR 101.9(b)(11), 21 CFR 101.9(e)
L82. Although sauerkraut and pickled beets are categorized under “pickles, all types” with a RACC of 30 grams, can they also be labeled as a vegetable side dish with a RACC of 130 grams?
Answer: Yes, manufacturers may use a second column to declare information based on a different serving size. The first column under the Nutrition Facts label would show the serving size, servings per container, and nutrition information based on a 30 gram RACC for the pickled vegetable and the second column could show nutrition information based on the RACC for the product used as a vegetable side dish. 21 CFR 101.9(b)(11) and 21 CFR 101.9(e)
Serving Size/Single Serving Containers
L83. What are the exemptions for single-serving containers?
Answer: Single serving containers may omit the “servings per container” declaration. In addition, most single serving containers may omit the metric equivalent portion of the serving size declaration. However, if it is voluntarily included, it must be consistent with the net quantity of contents value. The serving size for single-serving containers must be a description of the container such as: “Serving Size: 1 package” for food in bags, “Serving Size: 1 container” for foods in plastic containers, or “Serving Size: 1 can” as appropriate. Only those few foods that are required to declare drained weights must include the metric equivalent as part of the serving size declaration (e.g., “Serving size: 1 can drained (__g)”). 21 CFR 101.9(b)(5)(iv), 21 CFR 101.9(b)(7)(i) and 21 CFR 101.9(d)(3)(ii)
L84. How do I know if my product is a single-serving container?
Answer: Single-serving containers are discussed in 21 CFR 101.9(b)(6). Products that are packaged and sold individually are considered to be single servings if they contain less than 200% of the RACC for the product category. Above 200% of the RACC, it is the manufacturer's option to label the product as a multi-serving container or as a single-serving container if it can reasonably be consumed at a single eating occasion. For example, the RACC for brownies is 40 g. All brownies that are packaged and sold individually and that weigh less than 80 g must be labeled as a single serving. If the manufacturer believes it is reasonable for an individually packaged brownie that weighs more than 80 g to be consumed at one time, such a brownie may also be labeled as one serving.
L85 What about single-serving containers for products that have larger RACCs, such as soup?
Answer: If a product has a RACC of 100 g or 100 mL or larger and is packaged and sold individually, it must be labeled as a single-serving if it contains 150% or less of the RACC. However, packages for such products containing between 150% and 200% of the RACC may be labeled as one or two servings at the manufacturer's option. For example, the RACC 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. 21 CFR 101.9(b)(6)
L86. What are the differences between labeling for single-serving containers and multi-serving containers?
Answer: The serving size statement for multi-serving containers must use the hierarchy of common household measures (21 CFR 101.9(b)(5)(i)-(iii)), whereas single-serving containers are required to use a description of the individual container or package (21 CFR 101.9(b)(5)(iv)). Multi-serving packages must list the metric equivalent to the household measure and the number of servings in the container; however this is optional information on single-serving containers. If the metric equivalent is listed on single-serving containers, it must match the net contents declaration for the product. An example of a single-serving container would be a 360 mL can of soda that is packaged and sold individually. The serving size for this product would be “1 can” or “1 can (360 mL),” and the number of servings would be “1” or not listed at all. By contrast, the serving size for a one liter soda bottle (1000 mL) would be “8 fl oz (240 mL) or “1 cup (240 mL),” and the number of servings would be listed as “about 4.”
L87. Won't the serving sizes vary for products, such as soft drinks, that are packaged in different size single-serving containers and in larger bulk containers?
Answer: Yes. The serving size for beverages in single-serving containers is the total contents of the container. Thus, the serving size would be listed as “1 bottle,” but the contents could vary greatly (e.g., 8 fl oz, 12 fl oz, 16 fl oz, etc.). Since the RACC for beverages is 240 mL, the serving size for multi-serving beverage containers such as the commonly available one-liter bottle would be either “1 cup (240 mL)” or “8 fl oz (240 mL).”
L88. The RACC for muffins is 55 grams. If a single, large muffin weighs 130 grams, can it be labeled as one serving?
Answer: A 130 gram muffin weighs 236% of the RACC for muffins. Products that weigh more than 200% of the RACC may be labeled as one serving if the entire contents of the package can reasonably be consumed at a single eating occasion. Therefore, there are two options for the serving size declaration for this large muffin: “1 muffin (130 g)” or “1/2 muffin (65 g).” 21 CFR 101.9(b)(6)
L89. Are there limits on the size of a package that may be labeled as a “single serving”?
Answer: Products that are packaged and sold individually are considered to be single servings if they contain less than 200% of the RACC shown in 21 CFR 101.12. For packages that contain 200% or more of the RACC, it is the manufacturer's option to label the product as a single serving if the entire contents can reasonably be eaten at one time. 21 CFR 101.9(b)(6)
L90. What is the smallest amount of food that may be labeled as two servings?
Answer: The answer depends on the size of the RACC. For foods with RACC less than 100g (solid foods) or 100mL (liquids), packages must contain at least 200% of the RACC to be labeled as 2 servings. For foods with RACCs of 100g or 100mL or more, you may choose to label packages containing more than 150% but less than 200% of the RACC as either one or two servings. 21 CFR 101.9(b)(6) and 21 CFR 101.12(b)
L91. Can the number of servings be listed as “1.5” or “about 1.5”?
Answer: No. Rounding to the nearest 0.5 servings is allowed between 2 and 5 servings. Below 2 servings, the number of servings must be listed as “1” or “about 2.” For example, the RACC for egg rolls is 140 g. Since the RACC is greater than 100 g, a package of egg rolls containing more than 150% but less than 200% of the RACC can be labeled as 1 or 2 servings. For example, a package of egg rolls weighs 225 g and contains 3 egg rolls (75 g each). The manufacturer may choose to label the product as 1 serving (3 egg rolls (225 g)). Alternatively, if the manufacturer chooses to label the product as more than 1 serving, the serving size would be “2 egg rolls (150 g).” The number of servings, determined as the total contents divided by the serving size, would be 1.5 and would be rounded to “about 2.” 21 CFR 101.9(b)(8)
L92. What are the key considerations when determining a serving size for a product that consists of small discrete units?
Answer: Serving sizes for products in discrete units (e.g., muffins, sliced bread, and individually-packaged products in multi-serving packages) are discussed in 21 CFR 101.9(b)(2)(i). The serving size options depend on the RACC for the product and the weight of a single discrete unit.
- If a single unit weighs 50% or less of the RACC, the serving size will be the number of whole units closest to the RACC. For example, the RACC for hard candy is 15 g; therefore, 50% of the RACC is 7.5 g. For a bag of candy where the individual candies weigh 4 g (less than 7.5 g), the serving size would be “4 candies (16 g).”
- If a single unit weighs more than 50% but less than 67% of the RACC, there are two options for declaring serving size, either 1 or 2 units. For example, the RACC for snack crackers is 30 g; thus 50% of the RACC is 15 g, and 67% of the RACC is 20.1 g. For a box of crackers where the individual crackers weigh 17 g, (15 g < 17 g < 20.1 g), the serving size would be either “1 cracker (17 g)” or “2 crackers (34 g).”
- If a single unit weighs 67% or more but less than 200% of the RACC, then the serving size must be declared as 1 unit. For example, the RACC for bread is 50 g; therefore 67% of the RACC is 33.5 g, and 200% of the RACC is 100 g. One slice of bread would be used as the serving size for breads: “1 slice (45 g).” However, if the RACC is 100 g, or 100 mL for liquids, or larger, and the product weighs more than 150% but less than 200% of the RACC, the manufacturer may decide whether the individual unit is 1 or 2 servings (also, see questions for single-serving containers).
- If the single unit weighs 200% or more of the RACC, there are two options. The serving size can either be declared as one unit if the entire unit can reasonably be eaten on one occasion or can be declared as a portion of the unit. For example, the RACC for candy bars is 40 g, and 200% of the RACC is 80 g. For a 90 g candy bar, the serving size could be either “1 candy bar (90 g)” or “½ candy bar (45 g).” FDA also provides additional specific provisions for (1) products (such as pickles) that naturally vary in size 21 CFR 101.9(b)(8)(ii); (2) products made up of two or more foods, ackaged and intended to be consumed together 21 CFR 101.9(b)(5)(vii); and (3) products containing several, fully labeled, single serving units. 21 FR 101.9(b)(5)(iv)
L93. The RACC for beverages is 240 mL (8 fl oz). If a product is packaged as a group of 6 fl oz bottles (discrete units), should the serving size for this product be declared as “8 fl oz (240 mL)”?
Answer: For products with RACCs of 100 mL or larger, the serving size for discrete units that contain 67% or more but less than or equal to 150% of the RACC is 1 unit. For beverages, this range is 160.8 mL to 360 mL. Thus, “1 bottle” would be the serving size for beverages packaged in 6 fl oz (180 mL) bottles.
L94. The RACC for “cakes, heavy weight” is 125 grams. If the individual portions of a pre-sliced cake weigh 55 grams, what would be the serving size declaration?
Answer: The pre-portioned slices are treated like all other discrete units. The 55 g piece of cake is less than 50% of the RACC for heavy weight cakes (50% of 125 g = 62.5 g); therefore the serving size will be the number of units closest to the RACC. Two pieces weigh 110 g, and 3 pieces weigh 165 g; therefore, the serving size would be “2 pieces (110 g)”. 21 CFR 101.9(b)(2)(i)(A)
L95. What are the steps for determining a serving size for a product that is a large discrete unit?
Answer: Serving sizes for products in large discrete units usually divided for consumption (e.g., cake, pie, pizza, melon, cabbage) are discussed in 21 CFR 101.9(b)(2)(ii). The serving size depends on the RACC for the product and on the fraction of the large discrete unit. The serving size is expressed using the allowed fraction (“friendly fraction”) that is closest to the RACC. For example, the RACC 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.
L96. I have several products that are bulk products and I want to know the appropriate serving size to list on the label. How do I start, and what steps should I follow?
Answer: Serving sizes for non-discrete bulk products (e.g., breakfast cereal, flour, sugar, dry mixes, concentrates, pancake mixes, macaroni and cheese kits) are discussed in 21 CFR 101.9(b)(2)(iii). The serving size depends on the RACC for the product and on the household measure. The serving size is expressed using the allowed household measure that is closest to the RACC. For example, the RACC 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 1/8, 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).
L97. What if the dehydrated mixed dish product contains several inner packages of ingredients intended to be mixed together to prepare a bulk product, such as macaroni and cheese?
Answer: In these cases, manufacturers may use an ounce declaration (21 CFR 101.9(b)(5)(vii)). For example, the RACC for prepared macaroni and cheese is 1 cup. If a 12 oz package (9 oz dry macaroni and 3 oz dry cheese mix) makes 3 cups of prepared macaroni and cheese, then the serving size for the composite product could be expressed as “4 oz (112 g/about 2/3 cup macaroni and 2 tbsp dry cheese mix).” Alternatively, the manufacturer may provide nutrition information separately for each component. Thus, the serving size could also be expressed as “3 oz dry macaroni (84 g/about 2/3 cup)” and “1 oz dry cheese mix (28 g/about 2 tbsp).”
L98. What is the serving size for products such as a cake mix?
Answer: For products that require further preparation, where the entire contents of the package are used to prepare a large discrete unit usually divided for consumption, the serving size is the amount of the unprepared product used to make one “RACC for the prepared product.” The “RACC for the unprepared product” is the amount of the unprepared product that is required to make the fraction of the prepared product closest to the RACC of the prepared product. For example, a prepared medium-weight cake has a RACC of 80 grams. If 480 grams of cake mix makes 900 grams of prepared cake, then 1/12 of the prepared cake (75 g) is the closest fraction to the 80 gram RACC for medium weight cakes. Therefore, the RACC for the unprepared cake is 1/12 of 480 g, or 40 g. The serving size could be listed as “1/12 package (40 g/about 1/3 cup mix).”
L99. How do I choose appropriate household measures for declaring the serving sizes for products?
Answer: Common household measures are discussed in 21 CFR 101.9(b)(5). Manufacturers must first try to express serving sizes for their products using cups, tablespoons, or teaspoons (21 CFR 101.9(b)(5)(i)). Second, if cups, tablespoons, and teaspoons are not appropriate, then whole units and fractions of large whole units must be used (if appropriate), such as pieces, slices, tray, or jar (21 CFR 101.9(b)(5)(ii)). Finally, if other options fail (usually because the product size naturally varies to a considerable degree), manufacturers must use ounces with an appropriate visual unit of measure (21 CFR 101.9(b)(5)(iii)).
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.”
L100. If a manufacturer chooses to nutrition label voluntarily a food that is otherwise exempt, must the manufacturer follow the labeling regulations?
Answer: Yes, if a manufacturer, packer, distributor or retailer chooses to nutrition label a product that is exempt under 21 CFR 101.9(j), all applicable labeling regulations must be followed.
L101. If a nutrient content claim is made for only one size package, are packages that do not include the claim, and that are otherwise exempt, required to also bear nutrition labeling?
Answer: No, only the package that bears the claim is required to provide nutrition labeling.
L102. If a product is produced and sold in the same state (i.e., not shipped in interstate commerce), is it exempt from these regulations?
Answer: Generally speaking, a food that involves no interstate commerce (i.e., it is not manufactured from ingredients that have moved in interstate commerce or itself is not distributed in interstate commerce) would not be subject to FDA regulation. However, FDA notes that interstate commerce is interpreted very broadly and, additionally, many states model their requirements after FDA's.
L103. Is nutrition labeling required for imported products?
Answer: All imported products are required to have nutrition labeling unless the product qualifies for an exemption. 21 CFR 101.9(j)
L104. Would foods that are exempt from nutrition labeling under 21 CFR 101.9(j) also be exempt from other labeling requirements?
Answer: The exemptions in 21 CFR 101.9(j) apply only to nutrition labeling requirements when the food bears no claim or other nutrition information.
L105. If a retail establishment produces $51,000 worth of food, but had a total gross sales for all products, food and non-food, of $490,000, do they need a nutrition label?
Answer: No. The firm is exempt provided that no claims are made. A firm whose total gross sales for all products, food and non-food, is $501,000, with only $49,000 of this figure representing sales of food, is also exempt. Under the NLEA, firms who have an annual gross sales made or business done in sales to consumers that is not more than $500,000 or have annual gross sales made or business done in sales of food to consumers of not more than $50,000 are exempt under 21 CFR 101.9(j)(1)(i). The following chart illustrates the exemption:
|Sales in Food to Consumers||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|
L106. Company “X” is a multimillion dollar firm that produces only private label products for other companies using the other companies trade name and logo. Are products produced by company “X” required to bear nutrition labeling?
Answer: Products manufactured for a company that is not exempt must bear nutrition labeling. The company whose name appears on the label is responsible for providing nutrition information. Company “X” is not required by law to provide the nutrition information to the private labeler. However, company “X” may wish to develop nutrition information for their product line and provide it to their customers for use on the label.
L107. What type of records need to be kept to substantiate a small business exemption, and will FDA be maintaining copies of any records for this exemption?
Answer: It is up to each company to maintain records, such as tax returns, to support such an exemption. FDA will not maintain such records.
L108. When determining whether or not there is a small business exemption, is it required that “brokered sales” of foods be included in determining gross sales for the business?
Answer: The agency defines “brokered sales” as the sale of foods shipped in bulk form that are not for distribution to consumers but are for use solely in the manufacture of other foods or that are to be processed, labeled, or repackaged at a site other than where originally processed or packed. Accordingly, any brokered sale would not need to be considered in determining eligibility for the small business exemption.
L109. A manufacturer who qualifies for a small business exemption sells his product to a large retailer who then repacks it in the deli and places it on self-service shelves. Is the product exempt from nutrition labeling if the retailer puts the small manufacturer's name on the product?
Answer: Yes. As long as the retailer is simply repacking the food into smaller containers and placing the small business's name and address on the packaged food (i.e., the package label bears no name or logo that would tie the product to the larger retailer), the food would retain any exemption it was eligible for under 21 CFR 101.9(j)(1) or (18).
L110. A small retailer purchases a bulk product from a large manufacturer and repacks the product for retail sale using the retailer's name and logo. Is the product exempt from nutrition labeling?
Answer: If the retailer is eligible for the exemption in 21 CFR 101.9(j)(1) (based on gross sales), product purchased from a large manufacturer but repacked by the retailer would be exempt from nutrition labeling, as long as the package label bears no name or logo that would tie the product to the manufacturer. However, to be eligible for the exemption in 21 CFR 101.9(j)(18), the product must meet the definition of low volume products (based on the total number of units of the product sold by the large manufacturer in the United States).
L111. What are the requirements for the exemption from nutrition labeling for a low volume food product?
Answer: The exemption for low volume food products is based on the average number of full time equivalent employees (FTE's) and the number of units of product sold in the United States.
L112. Do all firms need to file with FDA for a small business exemption?
Answer: No. Firms eligible for the exemption based on gross sales and firms with less than 10 FTE's and less than 10,000 units do not have to file with the FDA. However, such firms can choose to do so voluntarily in order to establish a record that they are claiming an exemption. Also, all importers must file. FD&C Act 403(q)(5)(E)(iii), 21 U.S.C. 343(q)(5)(E))iii) and 21 CFR 101.9(j)(1) & (j)(18)
L113. Do the small business exemptions apply to restaurants?
Answer: There is a separate exemption from nutrition labeling for foods sold in restaurants of any size, provided the food does not bear a claim (21 CFR 101.9(j)(2)). These foods do not need the small business exemptions. However, to the extent that a restaurant distributes food products for sale outside the restaurant (e.g., through grocery stores), such products may be eligible for an exemption from nutrition labeling under the small business exemptions.
L114. Is a manufacturer that produces institutional and restaurant foods required to provide nutrition information?
Answer: Foods which are served or sold for use only in restaurants and other establishments in which food is served for immediate consumption are exempt from nutrition labeling. However, if there is a reasonable possibility that the product will be purchased directly by consumers (e.g., club stores), nutrition information is required. 21 CFR 101.9(j)(2)(iii) and 21 CFR 101.9(j)(2)(v)(B)
L115. Must nutrition information be presented on individual packets intended for use in restaurants and institutions (e.g., catsup, mayonnaise, soy sauce) if claims are made?
Answer: Individual serving size packages that are served to consumers and make a claim are required to have nutrition labeling (e.g., light salad dressing).
L116. Would it be useful for labels of products that are exempt to carry a disclaimer such as “not intended for retail sale” or “for further processing”?
Answer: It is up to the manufacturer to determine its own exemption status, and such a statement can not be used to avoid compliance with the regulations.
L117. Would food served or sold in carry-out boxes, doggie bags, or sanitary wrappers be considered “packaged food?”
Answer: Food sold in a restaurant or other retail establishment (e.g., a bakery or delicatessen) that is sold from behind a counter and placed in a wrapper, carryout box, or other non-durable container whose sole purpose is to facilitate handling would not be considered “packaged food” and would not need to bear a net weight statement, ingredient declaration, or the other labeling required of packaged foods. However, if consumers make their selections based on the food in its packaged form (e.g., the food is wrapped or boxed by the retailer and sold from a self-service case in a corner of a restaurant, or across the aisle from an in-store deli), the food must bear all required information.
L118. Could FDA provide additional guidance on what foods sold in delis and bakeries are exempt?
Answer: This exemption is based on 3 primary criteria: 1) when the food is consumed, 2) the location in which the food is processed and prepared, and 3) the extent to which the food is processed and prepared (i.e., must be ready-to-eat and of the type served in restaurants). 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)provided no claims are made. 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)
L119. I manufacture candy for sale on premises and at my two satellite stores. The total dollar volume of my firm is over $500,000. Am I required to nutrition label my products?
Answer: Candy sold at the manufacturing site is not required to have nutrition labeling. Also, individual candies offered from behind a counter for consumer selection (i.e., packaged to consumer specification) are not required to have nutrition labeling. However, consumer packages of candy offered for sale at the satellite stores must have nutrition labeling. The same applies to bakeries that sell product at satellite stores.
L120. Are spices, coffee, and tea required to be nutrition labeled?
Answer: The regulations provide for an exemption for foods that contain insignificant amounts, as defined in 21 CFR 101.9(j)(4), of all of the nutrients and food components required to be included in the nutrition label. Exempted foods include coffee beans (whole or ground), tea leaves, plain instant unsweetened instant coffee and tea, condiment-type dehydrated vegetables, flavor extracts, and food colors. Some spices contain levels of nutrients that would not meet the criteria of “insignificant” and would require nutrition labeling.
L121. Must aerosol oil sprays have nutrition labeling? The serving size is so small and all nutrient values are zero.
Answer: A product would be exempt from nutrition labeling if it contains insignificant amounts of all the nutrients required to be on the label, so long as no nutrient content or health claims are made for the product.
L122. When labeling mineral water, is nutrition labeling required if the label does not reference any specific minerals?
Answer: Under FDA labeling regulations the term Mineral Water is a statement of identity and does not trigger mandatory nutrition labeling if there is no nutrient content claims about a particular mineral and if all required nutrients are present at insignificant levels.
L123. Does FDA require nutrition labeling if minerals are declared on bottled water to meet state regulations?
Answer: If a nutrient for which there is an RDI or DRV is referenced on the label, nutrition information is required. However, if state regulations require declaration of nutrients which are not provided for on the nutrition label (e.g., fluoride, arsenic), nutrition labeling cannot accommodate such nutrients and
nutrition labeling is therefore not required.
L124. What are the special aspects of the Nutrition Facts labels for products intended for infants and small children?
Answer: Nutrition Facts labels for foods specifically for children less than 4 years do not provide % Daily Values for the macronutrients or footnote required in 21 CFR 101.9(d)(9). Also, foods specifically for children less than 2 years of age must not present information on calories from fat and calories from saturated fat and quantitative amounts for saturated fat, polyunsaturated fat, monounsaturated fat and cholesterol. In both cases, % Daily Value is declared only for protein, vitamins, and minerals.
L125. What are the special labeling provisions for small and intermediate-sized packages?
Answer: Food packages with a surface area of 40 sq. in. or less available for labeling may place the Nutrition Facts label on any label panel (not limited to the information panel), may omit the footnote required in 21 CFR 101.9(d)(9) if an asterisk is placed at the bottom of the label with the statement “Percent Daily Values are based on a 2,000 calorie diet,” and, may also use the tabular display label format.
21 CFR 101.9(j)(13)(ii)(A)(1)
L126. Is there another special labeling provision if the tabular display label does not fit on small and intermediate-sized packages?
Answer: A linear (string) format may be used on food packages with 40 sq. in. For less total surface area available for labeling if the package shape or size cannot accommodate the nutrition information placed in columns on any label panel.
21 CFR 101.9(j)(13)(ii)(A)(2)
L127. Are abbreviations permitted in Nutrition Facts labels for small and intermediate-sized packages?
Answer: Food packages with a surface area of 40 sq. in. or less available for labeling may use the following abbreviations in the Nutrition Facts label:
|Label Term||Abbreviation||Label Term||Abbreviation|
|Serving size||Serv size||Cholesterol||Cholest|
|Servings per container||Servings||Total carbohydrate||Total carb|
|Calories from fat||Fat cal||Dietary fiber||Fiber|
|Calories from saturated fat||Sat fat cal||Soluble fiber||Sol fiber|
|Saturated fat||Sat fat||Insoluble fiber||Insol fiber|
|Monounsaturated fat||Monounsat fat||Sugar alcohol||Sugar alc|
|Polyunsaturated fat||Polyunsat fat||Other carbohydrate||Other carb|
21 CFR 101.9(j)(13)(ii)(B)
L128. What is the exemption for small food packages?
Answer: Small packages (less than 12 sq. in. total surface area available to bear labeling) may be printed with a telephone number or an address to obtain nutrition information. This exemption (using a telephone number or address in place of the Nutrition Facts label) is permitted only if there are no nutrient content claims or other nutrition information on the product label or in labeling and advertising. 21 CFR 101.9(j)(13)(i) IMAGE 153397
L129. What is the minimum type size for the Nutrition Facts label on small packages?
Answer: Small packages (less than 12 sq. in. total surface area available to bear labeling) may use type sizes no smaller than 6 point or all uppercase type of not less than 1/16 inch for all required nutrition information. 21 CFR 101.9(j)(13)(i)(B)
L130. Is it acceptable to “downsize” the graphic elements of the Nutrition Facts label because of space constraints on a label?
Answer: If space is limited on the label, there is flexibility to adjust non-required graphic elements to help fit the nutrition label to the available space. The required graphic elements are those that are specified in 21 CFR 101.9(d).
L131. How is “total space available to bear labeling” calculated?
Answer: In determining the total surface area available to bear labeling, flanges and ends (tops and bottoms) of cans, shoulders and necks and caps of bottles and jars, and folded flaps and other unusable area may be excluded; as provided for in 21 CFR 101.1(c) and 21 CFR 101.2(a)(1). However, packages that provide label information on tops, bottoms, or necks should include those areas when calculating available label space. The available label space includes the principal display panel and is not limited to currently labeled areas.
L132. When should the bottoms of packages be included in calculating space available to bear labeling?
Answer: When normal handling by the consumer would result in the bottom of the box being easily seen, such as frozen food boxes. The bottom of boxes stored end up would not be considered “available to bear labeling” since consumers do not look at these areas during normal handling. Likewise, the bottoms of cans and jars are not normally seen and would not be calculated when determining “space available to bear labeling.”
L133. Is the criteria for exemption of “less than 12 square inches” applied to the total labeling area or only to the principal display and information panels?
Answer: Section 101.9(j)(13)(i) states clearly that the area available for labeling is based on the total surface area available to bear a label.
L134. Can we use the linear display on a small package that does not have room for the tabular display because of the space required by the UPC code?
Answer: No. When determining what format is required, space occupied by vignettes, design and other non-mandatory label information must be considered as available label space. 21 CFR 101.9(j)(17)
L135. How can nutrition labeling be put on novel packages such as a jar in the shape of an animal?
Answer: If the package has less than 12 square inches of space available to bear labeling because of the irregular container surface and no claims are made, nutrition labeling requirements may be met by providing an address or phone number where consumers could obtain the information. 21 CFR 101.9(13)(i)
L136. How should nutrition labeling be accomplished for foods sold from bulk containers?
Answer: Section 101.9(j)(16) allows foods sold from bulk containers to display the required nutrition information on the outside of the container or on posters, counter cards, tags, or similar measures. The containers these foods are put into when sold to the consumer do not need to bear nutrition labeling as long as the required nutrition information is displayed at point-of-purchase (i.e., plainly in view by the bulk containers).
L137. When nutrition information is provided on the outside of bulk containers in grocery stores, must the information be presented in the format specified in 21 CFR 101.9(d)?
L138. Is the inside of the lid an acceptable location for placing nutrition labeling on bulk containers?
Answer: The regulations require that nutrition information be displayed to consumers on the labeling of the container plainly in view. Therefore, this method of labeling would be acceptable if the underside of the lid were displayed at all times and another means is used to protect the contents of the drum.
L139. If a bulk food is repacked at the retail level and sold in packaged form instead of from the bulk container, do the individual packages have to carry nutrition labeling?
Answer: Yes. When foods are received by a retail store in bulk form and repacked for sale to consumers as a packaged food, the package must meet all mandatory labeling requirements.
L140. When placing nutrition labeling on bulk foods, how should the number of servings per bulk container be declared?
Answer: The number of servings in a bulk container will vary according to the fill of the container, and such a number is of little or no usefulness to consumers. FDA would be unlikely to object to a statement that the “Servings per container” are “varied” on bulk food containers or on random weight portions of foods repackaged by the retailer.
L141. Who is responsible for providing nutrition information for bulk foods?
Answer: The retailer is responsible for displaying the nutrition information in the required format on or adjacent to the bulk container. The information may be obtained/provided by either the supplier or retailer. The decision as to who actually develops the information is up to those parties involved.
L142. If a co-op sells bulk foods directly to consumers or consumer groups, must the bulk container bear nutrition labeling?
Answer: Yes. Subject, of course, to the exemptions for small businesses.
L143. What are the 20 most frequently consumed raw fruits, vegetables, and fish? Are they determined on a regional basis?
Answer: On July 25, 2006 (71 FR 42031), (corrected August 17, 2006 (71 FR 47439), FDA published a final rule to update the names and nutrition values of the top 20 raw fruits, vegetables, and fish. The 20 foods for each group are identified in 21 CFR 101.44. The same list is to be used nationwide. The 20 most frequently consumed raw fruits are: Apple, avocado (California), banana, cantaloupe, grapefruit, grapes, honeydew melon, kiwifruit, lemon, lime, nectarine, orange, peach, pear, pineapple, plums, strawberries, sweet cherries, tangerine, and watermelon. The 20 most frequently consumed raw vegetables are: As para gus, bell pepper, broccoli, carrot, cauliflower, celery, cucumber, green (snap) beans, green cabbage, green onion, iceberg lettuce, leaf lettuce, mushrooms, onion, potato, radishes, summer squash, sweet corn, sweet potato, and tomato. The 20 most frequently consumed raw fish are: Blue crab, catfish, clams, cod, flounder/sole, haddock, halibut, lobster, ocean perch, orange roughy, oysters, pollock, rainbow trout, rockfish, salmon (Atlantic/coho/Chinook/sockeye, chum/pink), scallops, shrimp, swordfish, tilapia, and tuna.
L144. Can retailers provide nutrition labeling for raw fruit, vegetables, and fish that are not among the top 20 items?
Answer: Yes. The names and descriptions of these foods should clearly identify them as distinct from the foods among the most frequently consumed list for which FDA has provided data (21 CFR 101.45(c)(1)). Nutrition labeling values for foods not on FDA's lists are subject to the compliance provisions of 21 CFR 101.9(g).
L145. We package fresh tomatoes and want to put nutrition labeling on the package. Should we follow the guidelines for the voluntary program for raw fruit, vegetables, and fish (21 CFR 101.45) or the nutrition labeling format required by 21 CFR 101.9?
Answer: When providing nutrition information on the package, even when nutrition labeling is otherwise voluntary, the information must be presented in a format that is consistent with the format requirements in 21 CFR 101.9(d).
L146. How does FDA define “raw fruit and vegetables” for the voluntary nutrition labeling program? Are fresh herbs and nuts included under the voluntary nutrition labeling program if they are sold in the produce section of retail stores?
Answer: The NLEA provides for voluntary nutrition labeling of “raw agricultural commodities and raw fish.” The FD&C Act defines “raw agricultural commodities” as any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing. Therefore, fruit and vegetables that receive little or no processing and no heat treatment, regardless of whether the fruit and vegetables are waxed, are subject to the voluntary program. In addition, for ease of administration the agency has chosen to draw a practical line in terms of retail selling practices and program implementation by including raw fruit and vegetables that are sold in the produce section and that are peeled, trimmed, cut and/or packaged with no added ingredients (e.g., carrot sticks, mixed salad greens) in the voluntary program when no claims are made for the product. When claims are made, nutrition labeling is required on the package unless the required nutrition information is provided on a poster or other means as specified in 21 CFR 101.45. Accordingly, fresh herbs and nuts (e.g., walnuts, peanuts) that have no added ingredients, such as salt, and that are sold in the produce section would be exempt from nutrition labeling under the voluntary program. However, when shelled or unshelled nuts or produce are processed in a manner other than mixing with other raw produce items, peeling, trimming , or cutting, (e.g., dried fruit, roasted nuts, frozen melon balls), nutrition labeling is required under 21 CFR 101.9.
L147. Is nutrition labeling still voluntary on packages of raw vegetables or fruits when processed foods, such as salad dressings and croutons, are added to the package?
Answer: When processed foods, such as salad dressings or croutons, are added to packages of raw vegetables or fruits, the product is considered to be a multi-ingredient processed packaged food and is no longer part of the voluntary program. Therefore, nutrition labeling is mandatory for the entire contents of the package. (Subject, of course, to the exemption for ready-to-eat food that is primarily processed or prepared at the retail location and the small business exemptions.)
L148. Would the packaged salad with dressing be considered ready-toeat if consumers have to open the package of dressing and add it to the salad greens themselves?
Answer: Because restaurant salads may be served with the dressing on the side or the croutons in a side package, packages of salads prepared in the retail establishment would be considered ready-to-eat when the only preparation needed by the consumer is adding the dressing or croutons. In contrast, products that require a significant amount of assembly or preparation (e.g., a pizza kit) would generally not be considered ready-to-eat.
L149. I understand that adding salad dressing to a package of greens makes the food a multi-ingredient processed food and nutrition labeling is required for the entire contents of the package. Does the requirement change if the packaged salad contains a packet of salad dressing that already bears nutrition labeling?
Answer: No. Nutrition labeling is still required for both the greens and the salad dressing. However, 21 CFR 101.9(h)(1) allows separately packaged ingredients that are intended to be eaten at the same time to be labeled individually or with a composite value. Therefore, the greens and salad dressing can be labeled individually. If the nutrition label on the packet is visible at the point of purchase, the information on the dressing need not be reprinted on the outer bag.
L150. Is nutrition labeling required for candied or caramel apples sold in the produce department?
Answer: Yes. These products are multi-ingredient processed food products. Therefore, nutrition labeling is mandatory.
L151. Is nutrition labeling required for raw, frozen fish that are packed or repacked by the retailer and sold in the frozen food section of the retail store?
Answer: Raw single-ingredient fish that are packaged by the retailer, whether fresh or frozen, fall under the voluntary nutrition labeling program. However, for the retail store to be in compliance with the voluntary program, the nutrition labeling information must be available at point of purchase (i.e., be displayed in close proximity to the product) of both the fresh and frozen fish. It may be necessary for some retail stores to display signs/brochures with the nutrient data for fish in the frozen food section as well as the fresh fish section of the store. (21 CFR 101.45) In contrast, raw frozen fish that are packaged by a manufacturer (e.g., packaged in a box with a printed label and brand name) come under the mandatory nutrition labeling program.
L152. Is nutrition labeling required for crab meat that is canned and pasteurized, but not shelf-stable?
Answer: Pasteurized crab meat that is not shelf-stable and is sold on ice or refrigerated is included under the voluntary nutrition labeling program, whereas canned crab meat that is shelf-stable must bear nutrition labeling.
L153. Are steamed shrimp exempt from nutrition labeling if they are purchased from a manufacturer and repacked in the retail store for sale from either the fresh fish or deli counters? Would it make a difference if the retailer adds a seasoning mix when steaming the shrimp or if a cocktail sauce is added to the package?
Answer: Plain, thermally processed shelled or unshelled lobster, crab, and shrimp are included in the voluntary nutrition labeling program when sold in either the fresh fish or deli sections of the store. However, consistent with earlier answers for fruit and vegetable products, when a food is composed of more than one ingredient, some of which are not included in the voluntary program (such as a seasoning mix or cocktail sauce), it must bear nutrition labeling. These added ingredients would generally alter the nutrient content of the product so that the nutrient values posted for the voluntary program would no longer accurately represent the finished product. However, if the finished product meets the criteria for a ready-to-eat food, primarily processed and prepared at the location from which it is sold (e.g., steamed, spiced shrimp prepared in-house), it may be exempt from nutrition labeling under 21 CFR101.9(j)(3).
For questions regarding this document, contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-2371.