QUESTIONS AND ANSWERS

NUTRITION LABELING

Volume I

(For Foods Other Than Dietary Supplements)

Effective Date (NLEA)

N1. Question: When does nutrition labeling become mandatory?

Answer: FDA has modified the date of applicability to require nutrition labeling on all non exempt products labeled on or after May 8, 1994. Products labeled prior to May 8, 1994 may continue to be shipped in interstate commerce.

N2. Question: Is the deadline going to be extended?

Answer: No

N3. Question: How should information be presented between January 6, 1993 and May 8, 1994?

Answer: The nutrition label may be presented in format and content to conform either to the new regulations or to existing regulations. Use of a combination of the two approaches would not represent compliance. Nutrient Declaration

N4. Question: When the caloric value for a serving of a food is less than 5 calories, can the actual caloric value be declared?

Answer: The caloric value of a product containing less than 5 calories may be expressed as zero or to the nearest 5 calorie increment (i.e., zero or 5 depending on the level). Foods with less than 5 calories meet the definition of "calorie free" and any differences are dietarily insignificant.

N5. Question: How are calories from alcohol to be calculated?

Answer: Calories from alcohol may be calculated using specific Atwater factors as provided for in 101.9(c)(1)(i)(A). USDA Handbook No. 74 provides a specific food factor of 7.07 calories per gram of alcohol.

N6. Question: Does total fat, which is defined as total lipid fatty a cids expressed as triglycerides, include cholesterol?

Answer: No.

N7. Question: The fat content for a serving of my product is 0.1 g. How should I declare fat and calories from fat?

Answer: Because it is present at a level below 0.5 g, the level of fat is expressed as 0 g. Calories from fat would also be expressed as zero.

N8. Question: When grams of saturated, monounsaturated, and polyunsaturated fat are calculated for listing on the nutrition panel, how is the glycerol component of fat dealt with in determining amounts of specific fatty acids?

Answer: Values are expressed as free fatty acids and the glycerol portion is not included in the gram amount per serving. If the fatty acids are measured as their esters, the ester weight of a fatty acid is converted to the fatty acid weight using conversion factors based on the molecular weight of the individual esters and corresponding free fatty acids.

N9. Question: Should the sum of saturated, monounsaturated, and polyunsaturated fatty acids equal the total fat content?

Answer: No. The sum of the fatty acids generally will be lower than the weight of total fat, because the weights of components of fat such as trans fatty acids and glycerol are not included.

N10. Question: If I make a "fat free" claim, must I declare polyunsaturated and monounsaturated fat?

Answer: No. Poly- and monounsaturated fat are only required when fatty acid or cholesterol claims are made on foods that do not meet the criteria for "fat free" (i.e., those foods that contain 0.5 g or more of fat).

N11. Question: When less than 0.5 grams of dietary fiber or saturated fat is present in a serving of a product, the amounts would be shown as zero on the label. However, when the % DV is calculated based on an actual unrounded fiber or saturated fat content of 0.2 grams per serving, the calculation yields 1 percent. To avoid consumer confusion can the % DV be expressed as zero in these cases?

Answer: Yes. In the Federal Register document of August 1993,

FDA modified 101.9(d)(7)(ii) to allow the percent Daily Value for all nutrients other than protein to be calculated by dividing the amount of the nutrient declared on the label (i.e., after rounding) by the DRV for that nutrient. As a result of this change, whenever a declared quantitative amount is zero, the declared percent Daily Value will also be zero.

N12. Question: Does total carbohydrates include dietary fiber?

Answer: Yes. Dietary fiber must be listed as a subcomponent under total carbohydrate.

N13. Question: I have 0.8 grams of fiber in a serving of food. Can I round this up to 1 g, or must I use the statement "less than 1 g?" Can I do the same thing for protein?

Answer: Since this serving contains less than 1 gram of dietary fiber per serving, fiber is to be expressed as "Less than 1 gram" or "Contains less than 1 gram," or the manufacturer has the option to not list dietary fiber and include the following statement at the bottom of the table of nutrients: "Not a significant source of dietary fiber." Protein can be expressed to the nearest whole gram (i.e., 1 g); or the label can state "less than 1 gram" or "Contains less than 1 gram."

N14. Question: Under what circumstances is the listing of "sugar alcohol" required?

Answer: When a claim is made on the label or in labeling about sugar alcohol or sugars when sugar alcohols are present in the food [101.9(c)(6)(iii)].

N15. Question: What Daily Reference Values (DRVs) and Reference Daily Intakes (RDIs) are established for protein for the purpose of listing protein as a percent of Daily Value (%DV)?

Answer: The DRV for protein for adults and children 4 or more years of age is 50 grams. The RDIs for protein for children less than 4 years of age, infants, pregnant women, and lactating women are established at 16 grams, 14 grams, 60 grams, and 65 grams respectively (see 101.9(c)(7)(iii)).

N16. Question: Why is the declaration of the DRV for protein not mandatory?

Answer: The percent of the DRV is required if a protein claim is made for the product or if the product is represented or purported to be for use by infants or children under 4 years of age. Based on current scientific evidence that protein intake is not a public health concern for adults and children over 4 years of age, and because of the costs associated with a determination of the Protein Digestibility Corrected Amino Acid Score (PDCAAS), FDA has determined that declaration of the percent of the DRV for protein need not be provided when a claim is not made.

N17. Question: How should the percent Daily Value (DV) for protein be expressed when it is provided on labeling of foods for adults and children over four?

Answer: When protein is listed as a percent of the 50 gram DRV and expressed as % DV, the %DV is calculated by correcting the actual amount of protein in grams per serving by multiplying the amount by its amino acid score corrected for protein digestibility, dividing by 50 grams, and converting to percent.

N18. Question: When % DV's for protein and potassium are included on the nutrition panel on foods for adults and children over 4 years, where in the footnote is the DRV information to be placed?

Answer: Protein should be listed in the footnote under dietary fiber with the DRV inserted on the same line in the numeric columns. The DRV for protein is based on 10 percent of calories as protein, which equates to 50 grams for a 2,000 calorie diet and 65 grams (62.5 rounded up to 65) for a 2,500 calorie diet. Similarly, potassium would be listed in the footnote under sodium. The DRV for potassium is 3,500 milligrams for both the 2,000 and 2,500 calorie diets.

N19. Question: How do I determine what values to declare on the nutrition label?

Answer: The nutrient values declared on the label are based on the nutrient profile of the product, as packaged, rounded as required by regulation. Rounding rules are provided in 101.9(c) and summarized in attachment A.

N20. Question: In what order must vitamins and minerals be declared?

Answer: The Federal Register of January 6, 1993 erred in the order in which vitamins and minerals were listed. A corrected list was published in the April 1, 1993 Federal Register which listed the order as follows: Vitamin A, Vitamin C, Calcium, Iron, Vitamin D, Vitamin E, Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Biotin, Pantothenic Acid, Phosphorus, Iodine, Magnesium, Zinc, Copper. [101.9(c)(8)(iv)]

N21. Question: How should vitamins and minerals that are permitted to be listed voluntarily be listed?

Answer: If potassium is listed, it should be listed in bold type directly under sodium. Voluntary vitamins and minerals (i.e., those other than vitamin A, Vitamin C, Calcium, and Iron), should be declared horizontally or vertically following the required vitamins and minerals. [101.9(c)(5) and 101.9(d)(8)]

N22. Question: Is it legal to declare 400% of the Daily Value for a vitamin?

Answer: Yes. The percent Daily Value is based on the amount of the nutrient present in the product.

N23. Question: Can information about nutrients that do not have an RDI/DRV such as boron and omega-3 fatty acids be provided on the food label?

Answer: Yes, provided that the information is truthful and not misleading and is provided outside the nutrition label. Such information is limited to statements of amount and may not characterize the level of the nutrient (e.g., can not state "High in Omega-3").

N24. Question: Will the values for the RDIs for adults and children over 4 years of age, which are the same as the U.S. RDAs established in 1973, be changed in the near future?

Answer: Under the provisions of the Dietary Supplement Act of 1992, FDA may not, until after November 8, 1993, propose regulations that require the use of new values for these RDIs, establish RDIs for new nutrients, and establish RDIs for other specific age/sex groups for which label reference values are not codified now. FDA's activities and time tables for this potential revision will be determined, in part, by progress in the debate within the scientific community about whether and how the Recommended Dietary Allowances (RDAs) should be revised.

N25. Question: Please explain why the word "amount" is used in lieu of "% Daily Value" in the example of the format for baby food and identify the applicable regulation.

Answer: Section 101.9(j)(5)(ii) requires that except for protein, vitamins, and minerals, foods for infants and children under 4 years of age shall not include a listing for Daily Value and shall provide the name of the nutrient and quantitative amount in two columns.

N26. Question: Must the percent Daily Value for vitamins and minerals be listed on foods for infants and children?

Answer: Yes

N27. Question: For a product such as frozen, unbaked bread dough, what is the nutrition information based on: the unbaked dough or the baked product?

Answer: Nutrition information is based on the unbaked (as packaged) product. A manufacturer may voluntarily list the nutritional value of the product as prepared in a second column [101.9(e)]

N28. Question: 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).

Format

N29. Question: How large must the nutrition label be?

Answer: There are no specific size requirements for the nutrition facts panel. However, minimum type sizes of 6 points and 8 points are required for various copy, and there are minimum spacing requirements between lines of copy.

N30. Question: Is it necessary to use a nutrition display with a box shape on a round package?

Answer: Yes. Even when using the tabular display, the nutrition information must be set off in a box.

N31. Question: Can the product name be placed within the nutrition panel?

Answer: No. The name may be placed above the box that encloses the nutrition information.

N32. Question: Must all of the type specifications shown with the nutrition format example of Appendix B be followed?

Answer: No. The mandatory type specifications are listed in 101.9(d). Unlike the illustrative example of appendix B:

1. Any legible type style may be used, not just Helvetica.
2. 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.
3. There is no specific thickness required for the three bars that separate the central sections of the nutrition label.

N33. Question: 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.

N34. Question: Can print be condensed?

Answer: Yes, however, if condensing results in a label that is difficult to read or illegible, FDA would consider the label misleading.

N35. Question: Is it acceptable to "downsize" the graphic elements of the Nutrition Facts panel because of space constraints on a label.

Answer: Several of the graphic elements listed in Appendix B to Part 101 on page 2189 of the January 6, 1993 Federal Register are not required. Thus, 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 101.9(d). For example, all information within the nutrition label must be in an easy-to-read type style as required in 101.9(d)(1)(ii), and at least 8-point or 6-point type sizes are required for specified nutrients in 101.9(d)(1)(iii).

N36. Question: A package design firm asked about the option of reversing the nutrition 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 101.9(d)(1)(iv) because it would interfere with the "consistent" look of the label.

N37. Question: Can the "Nutrition Facts" panel be oriented perpendicularly as opposed to parallel, to the base of the package.

Answer: Yes. There is no requirement that any information, other than the net quantity of contents and statement of identity, be printed parallel to the base of the package. However, FDA urges manufacturers to strive for consistency of presentation of nutrition information in the market and to place the nutrition label so that it is readily observable and legible to the consumer at the point of purchase.

N38. Question: Is a break in the vertical alignment allowed with the standard format?

Answer: Yes. The vertical format may be broken in either of the following ways: (1) placement of the footnote to the right of the panel as shown in 101.9, Appendix D "Footnote to Side" or (2) all vitamins and minerals that are listed voluntarily (i.e., after iron) may be moved to the top right of the panel along with the footnote.

N39. Question: What abbreviations for nutrients are permitted and when can they be used?

Answer: Section 101.9(j)(13)(ii)(B) ( as revised in the August 1993 Federal Register document) includes the following list of acceptable abbreviations that can be used only on packages that have 40 or less square inches of available space:

Serving size Serv size

Servings per container Servings

Calories from fat Fat cal

Calories from saturated fat Sat fat cal.

Saturated fat Sat fat

Monounsaturated fat Monounsat fat

Polyunsaturated fat Polyunsat fat

Cholesterol Cholest.

Total carbohydrate Total carb.

Dietary fiber Fiber

Soluble fiber Sol. fiber

Insoluble fiber Insol. fiber

Sugar alcohol Sugar alc.

Other carbohydrates Other carb.

These abbreviations may be used regardless of the specific, permitted format used.

N40. Question: Is the entire footnote used with the standard format, which lists Daily Values 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 Values 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").

N41. Question: The footnote, which states that fat, carbohydrate, and protein furnish 9, 4, and 4 calories per gram, respectively, can confuse consumers because the regulations permit four other methods to be used in calculating calorie content. When any of the other methods are used, consumers will be confused if they apply the 9, 4, and 4 general factors. How is FDA dealing with this problem?

Answer: In the August 1993 Federal Register document, FDA revised 101.9(d)(10) to make the use of this footnote voluntary.

N42. Question: Do the values under "% Daily Value" need to be aligned under the heading as specified in 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 style used by the agency to layout the nutrition facts information is discussed in Appendix B to part 101 (58 FR 2189, Jan. 6, 1993). Right-justifying the values under the "% Daily Value" column is one of the graphic enhancements chosen for the layout and is not required by section 101.9(d)(7)(ii). 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.

N43. Question: Can the heading for "% Daily Value" be abbreviated?

Answer: "Daily Value" may be abbreviated as "DV". When "Daily Value" is not spelled out in the heading, a statement indicating the meaning of "DV" must be used (i.e., "Percent Daily Values (DV) are based on a 2,000 calorie diet").

N44. Question: 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 101.1(c) and 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.

N45. Question: 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".

N46. Question: 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.

N47. Question: 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.

N48. Question: 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.

N49. Question: Are cellophane windows on bags or boxes considered "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.

N50. Question: When may tabular and linear (string) displays be used?

Answer: The tabular display may be used on any package with 40 or less square inches of available label space and on larger packages that do not have sufficient continuous vertical space (approximately 3 inches) to accommodate the vertical format up to and including the declaration of iron. Use of the linear display is limited to packages with 40 or less square inches of available label space and may only be used if the tabular display does not fit on the label.

N51. Question: Under what circumstances can the simplified format be used?

Answer: The simplified format may be used when a food contains insignificant amounts of seven or more of the following: Calories, total fat, saturated fat, cholesterol, sodium, total carbohydrates, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, and iron; except that for foods intended for children less than 2 years of age to which 101.9(j)(5)(i) applies, the simplified format may be used when a food contains insignificant amounts of six or more of the following: Calories, total fat, sodium, total carbohydrates, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, and iron.

N52. Question: What are insignificant amounts of nutrients?

Answer: These are the amounts that are permitted to be shown as zero on the nutrition panel (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 label. (See attachment A for Rounding Rule Table)

N53. Question: 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.

N54. Question: 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.

N55. Question: 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, 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, cholesterol, dietary fiber, sugars, vitamin A, vitamin C, calcium or iron) are voluntarily listed as zero, the footnote required by 101.9(f)(4) is not required.

N56. Question: 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.

N57. Question: 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.

N58. Question: 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 101.9(f) and calories from fat that are present in insignificant amounts) shall be included at the bottom of the nutrition label. [101.9(f)(4)]

N59. Question: What nutrients can be listed using the statement "Not a significant source of_____________" and, when this statement can be used for more than one nutrient, how should they be listed?

Answer: 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, 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:

Calories from Fat: when the food contains less than 5 calories from fat.

Saturated Fat: when the food contains less than 0.5 grams of total fat per serving and if no claims are made about fat or cholesterol content and if no claims are made about calories from fat. Cholesterol: when the food contains less than 2 milligrams cholesterol per serving and makes no claim about fat, fatty acids or cholesterol.

Dietary Fiber: when a serving contains less than 1 gram of dietary fiber.

Sugars: when a serving contains less than 1 gram of sugar and no claims are made about sweeteners, sugars, or sugar alcohol content.

Vitamins/Minerals: when a serving contains less than 2% of the RDI.

N60. Question: Can a tabular format be used for the simplified nutrition label?

Answer: Yes, on packages with 40 or less square inches of available label space. An example of this format is included in the August 1993 Federal Register document.

N61. Question: 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.

N62. Question: What is the correct type size for the "Not a significant source of_____________" footnote.

Answer: 6 point

N63. Question: 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 amount for the product.

N64. Question: I have a recipe on my package which calls for 250% of the reference amount 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 reference amount by 200% or greater, dual declaration would be required. FDA considers recipes on the label as "promoting" a use of the food. The regulations (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.

N65. Question: We want to use dual declaration for cereals. Do we have to include the 240 mL reference amount, 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. An example of this format is given in Appendix E of 101.9 (58 FR 2200; Jan. 6, 1993).

N66. Question: We have a condensed "cream of ___ soup". Should we do dual declaration?

Answer: Dual declaration is optional.

N67. Question: Would a dry mix product such as flavored rice be required to provide nutrition information for both the product as packaged and as prepared?

Answer: Only the nutritional properties of the product as packaged is required. However, nutritional information may be voluntarily presented "as prepared" as provided for in 101.9(h)(4).

N68. Question: 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 reference amount 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 reference amount, such information could be voluntarily listed. However, nutrition information for a specific recipe may be presented outside of the "Nutrition Facts" panel.

N69. Question: 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 panel 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.

N70. Question: 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 panel it would be acceptable.

N71. Question: Can the nutrition facts panel 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.

N72. Question: Must inserts for gift packages follow the standard format? May other displays such as the tabular display be used on the insert?

Answer: The full format must be used because the space available is not limited by the size of the label.

Compliance

N73. Question: Can I use "average" values derived from data bases to determine the nutrient content of my product?

Answer: FDA has not stated how a company should determine the nutrient content of their product for labeling purposes. Therefore, there is no prohibition from using "average" values for its product derived from data bases if a manufacturer is confident that the values obtained meet FDA's compliance criteria. Regardless of its source, a company is responsible for the accuracy and the compliance of the information presented on the label. Use of a data base that has been accepted by FDA affords a firm some measure of security in that the agency has stated that it will work with industry to resolve any compliance problems that might arise for food labeled on the basis of a data base that the agency has accepted. A manual entitled "FDA Nutrition Labeling Manual: A Guide for Developing and Using Databases" is available from Office of Food Labeling (HFS-150), Food and Drug Administration, 200 C St. SW., Washington, DC 20204.

N74. Question: How many samples of each product should we analyze for nutrition labeling?

Answer: FDA has not defined the number of samples that must be analyzed. It is the responsibility of the manufacturer/packer/distributor to determine the variability of their product(s) and the number of samples needed to provide accurate nutrient data. The "FDA Nutrition Labeling Manual: A Guide for Developing and Using Databases," available from FDA, may be of assistance in this area. FDA will use a composite of 12 units when performing enforcement analyses.

N75. Question: May I copy my competitor's label?

Answer: Firms are responsible for the accuracy of the nutrition label and there is no assurance that the data from a competitor's product is valid for another product. Products of a similar nature are not necessarily equivalent in ingredients and nutrient value. If FDA found a product to be out of compliance because a firm merely copied its competitor's label, the firm would be hard pressed to prove that they labeled the product "in good faith".

N76. Question: Will FDA analyze my products and send me a report to use for my nutrition label.

Answer: No. FDA does not have the resources to analyze products upon request. However, FDA will collect surveillance samples to monitor the accuracy of nutrition information. The manufacturer, packer or distributor would be advised of any analytical results that are not in compliance. Additionally,depending on circumstances, FDA may initiate regulatory action.

N77. Question: Does FDA produce/provide data base information to industry.

Answer: No. FDA will review and accept industry data bases which remain the property of the organization that developed and submitted the data.

N78. Question: Can FDA recommend an analytical laboratory and must a laboratory be approved to perform nutrient analysis?

Answer: FDA does not approve, and is not in a position to endorse or recommend, specific laboratories. Assistance may be available through the following sources: trade and professional associations, trade publications, colleges and universities, and by looking in local phone books under testing or analytical laboratories. For compliance purposes FDA uses appropriate methods published by the Association of Analytical Chemists (AOAC) in Official Methods of Analysis of the AOAC International, 15th edition (1990) or other methods as needed. You may wish to ascertain if the laboratory is familiar with these methodologies when selecting a laboratory.

Products with Separately Packaged Ingredients and Assortments- 101.9(h)

N79. Question: Can the nutrition label on these products (e.g., a box containing dry noodles and a seasoning packet) list the nutrients in the noodles separately from the seasoning packet? If so, must a column be included that gives the total nutrients for the noodles and the seasoning packet?

Answer: Section 101.9(h)(1) provides the option of listing nutrition information per serving for each component or as a composite value.

The decision is up to the manufacturer. A column of total values is not required.

N80. Question: What are the labeling options for products packed in an assortment that are intended to be eaten at the same time? Can the nutrient analysis for a product containing a mixture of nuts or different types of dried fruit be based on a composite of the mixture blended together?

Answer: Section 101.9(h)(1) of the final regulations pertaining to nutrition labeling of foods allows the nutrition information for assortments of the same type of food (e.g., mixed nuts or mixed fruits) that are intended to be consumed at the same time to be specified for each component or as a composite value. Therefore, if it is reasonable to assume that a consumer would eat an assortment of the nuts or fruits offered, a single composite analysis may be used to determine the nutrient composition. However, if the manufacturer wishes to list each component, the August 1993 Federal Register document includes an example of an aggregate label which can be used to list each component of an assortment individually.

Exemptions - 101.9(j)

N81. Question: 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 section 101.9(j), all applicable labeling regulations must be followed.

N82. Question: 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.

N83. Question: 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.

N84. Question: Is the small business exemption going to be expanded?

Answer: FDA does not have the authority to revise the definition of small business mandated by NLEA. However, Congress is currently considering introducing legislation that would modify the exemption.

N85. Question: If a company produces $ 51,000 worth of food, but had a total gross sales for all products, food and non-food, of $490,000, do they have to 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 [101.9(j)(1)(i)]. The following chart illustrates the exemption:

SALES IN FOOD TOTAL SALES

(FOOD & NON-FOOD) STATUS

$50,000 or less $500,000 or less EXEMPT

$50,000 or less $500,001 or more EXEMPT

$50,001 or more $500,000 or less EXEMPT

$50,001 or more $500,001 or more NOT EXEMPT

N86. Question: Company "X" is a multimillion dollar firm which 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.

N87. Question: 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.

N88. Question: Is FDA's small business exemption different from USDA's exemption and how is the exemption determined if both agencies have jurisdiction in a plant?

Answer: Yes, USDA's exemption is based on the number of employees and volume of product. Firms subject to both USDA and FDA regulations should calculate the dollar volume of retail sales, including meat and poultry, to determine if they meet the criteria for FDA exemption .

N89. Question: Is nutrition labeling required for imported products?

Answer: All imported products labeled after May 8, 1994 are required to have nutrition labeling unless the manufacturer/packer/ distributor qualifies for an exemption. For foreign firms that ship foods into the United States, the business activities to be included for consideration under this small business exemption shall be the total amount of food sales, as well as other sales to consumers, by the firm in the United States. When importing exempt products, including food labeled before May 8, 1994, FDA encourages importers to attach an addendum to the 701 entry form, certifying that the product was either labeled before May 8, 1994 or that the firm that the manufacturer/packer/distributor or product, if not readily apparent, qualifies for exemption.

N90. Question: 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. [101.9(j)(2)(iii) and (j)(2)(iv)(B)]

N91. Question: 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). The August 1993 Federal Register document clarifies the requirements for labeling single service restaurant packets.

N92. Question: 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.

N93. Question: 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.

Ready-To-Eat Foods Not for Immediate Consumption - 101.9(j)(3)

N94. Question: 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 101.9(j)(2). When foods are not for immediate consumption, they may be exempt if they meet all of the criteria listed in 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. [101.9(j)(3)(iv)]

N95. Question: Can a state require that foods made to be eaten at point of purchase include nutrition labeling?

Answer: NLEA provided for preemption of state and local requirements as they apply to foods in interstate commerce. However, 100.1 provides for a process for states to file a petition requesting exemption from preemption. A state requirement for nutrition labeling of foods made to be eaten on site would be pre-empted until it has submitted and received a favorable response to such a petition.

N96. Question: 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.

Foods of No Nutritional Significance - 101.9(j)(4)

N97. Question: 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 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.

N98. Question: 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.

N99. Question: 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.

N100. Question: 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.

Small and Intermediate-Sized Packages - 101.9(j)(13)

N101. Question: If a straw is placed over the back of a juice carton, must that panel be considered "space available to bear labeling"?

Answer: Yes, 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 101.9(g)(9) by writing to the Office of Food Labeling (HFS-150), Food and Drug Administration, 200 C St. SW., Washington, D.C. 20204.

N102. Question: Where should the "nutrition facts" appear on the label?

Answer: Under 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 principal display panel or information panel as defined in 101.2. The agency intends to publish a proposed rule to allow for nutrition labeling to appear on other panels if there is insufficient space available on the principal display panel and the information panel.

Foods Sold from Bulk Containers - 101.9(j)(16)

N103. Question: When nutrition information is provided on the outside of bulk containers in grocery stores, must the information be presented in the format specified in 101.9(d)?

Answer: Yes.

N104. Question: 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 used to protect the contents of the drum.

Voluntary Program

N105. Question: Will nutrition labeling for raw fruit, vegetables, and fish remain voluntary?

Answer: This program will remain voluntary because the survey conducted by the agency in November and December 1992 found substantial compliance. The agency will re-evaluate this program for substantial compliance every two years. If a reevaluation reveals that substantial compliance no longer exists, FDA will propose rules to make nutrition labeling for raw fruits, vegetables and fish mandatory.

N106. Question: When cello pack labeling of fresh fruits or vegetables includes a claim, must nutrition information be provided on the label?

Answer: Claims subject the food to nutrition labeling in accordance with 101.45, which means that nutrition information will have to be available at point of purchase although not necessarily on the package.

N107. Question: Does FDA plan on changing the nutrients and the manner in which they are listed under the voluntary nutrition labeling for raw fruit, vegetables, and fish?

Answer: Yes. FDA will be proposing regulations to update 101.45 to be more consistent with the requirements for packaged foods.

Miscellaneous

N108. Question: 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 or for errors resulting from changes in the regulations published on January 6, 1993. However, such errors should be corrected during the next printing of labels.

N109. Question: When are point-of-purchase materials considered labeling?

Answer: Always.

N110. Question: Do the various published summaries and abstracts of the mandatory nutrition labeling regulation contain the information needed to design and execute a nutrition label for a food package.

Answer: Often these summaries do not contain sufficient detail to enable manufacturers to comply with the nutrition labeling requirements, particularly for small and intermediates size packages and when health or nutrient content claims are made. Manufacturers and package designers are strongly encouraged to obtain and be guided by the full regulation which was published in the Federal Register of January 6, 1993, corrected in the Federal Registers of April 1, 1993 and April 2, 1993 and modified by technical corrections published in the Federal Register of August 1993.

N111. Question: How can I get a copies of the regulations?

Answer: Reprints of the Federal Register documents containing the new regulations published on January 6, 1993, and April 1 and 2, 1993 can be obtained by calling the National Technical Information Service at (703) 487-4650 and ask for #PB-93- 139905. The cost is $91.00. Information on the cost and availability of the August 1993 technical corrections will be made available soon. The regulations, including the corrections of April, will be compiled in the April 1, 1993 edition of the Code of Federal Regulations, available from the Government Printing Office.

N112. Question: 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 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 Food Labeling (HFS150), Food and Drug Administration, 200 C St. SW., Washington, D.C. 20204. The letter should: (1) specify that you are requesting an exemption or special provision under 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).

N113. Question: We have a bilingual label and know that we have to include all required information in both languages. Can we provide nutrition information in one bilingual "Nutrition Facts" panel?

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 do not have to be repeated. An example of such a format is included in the August 1993 Federal Register document .

N114. Question: I call my product Frijoles Pintos. Is bilingual labeling required? What about salsa?

Answer: When the only 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.

SERVING SIZE

General Approach

S1. Question: 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:

(1) Locate the appropriate food category and reference amount for your product in the two tables in Section 101.12(b) of the food labeling regulations. FDA established reference amounts customarily consumer" (reference amounts) for 139 food product categories, and these values represent the amount of food customarily consumed at one eating occasion. Most of the reference amounts are for foods in a ready-to-eat form, i.e. "as prepared". If your product in the form in which it is sold, i.e. "as packaged," does not have a reference amount in the tables, then you must generate an appropriate reference amount for your product using 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. At this point it is important to determine if your product is in a single serving container. Products packaged and sold in small units are required to be labeled as single-serving containers, and the specifications for these products are described in 101.9(b)(6). If your product is a single serving, it must be labeled in accordance with the labeling requirements for single-serving containers contained in 101.9(b)(6).

(2) Determine the serving size for your multi-serving product using the reference amount for the product (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 101.9(b)(5). Rounding rules for metric quantities and a few additional format options are included in 101.9(b)(7).

(3) Use the information in 101.9(b)(8) to determine the number of servings and the appropriate rounding rules for numbers of servings.

S2. Question: The table for reference amounts 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 reference amount 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.

S3. Question: If the number of units closest to the reference amount 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 (101.9(b)(5)(ix)). For example, the reference amount 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 candies would weigh exactly 30 g, and the serving size would be rounded to the next incremental value:

"3 cookies (36 g)."

Serving Sizes for Products in Small Discrete Units (101.9(b)(2)(i))

S4. Question: 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 101.9(b)(2)(i). The serving size options depend on the reference amount for the product and the weight of a single discrete unit. If a single unit weighs 50% or less of the reference amount, the serving size will be the number of whole units closest to the reference amount. For example, the reference amount for hard candy is 15 g, therefore 50% of the reference amount 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 reference amount, there are two options for declaring serving size, either 1 or 2 units. For example, the reference amount for snack crackers is 30 g, thus 50% of the reference amount is 15 g and 67% of the reference amount 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 reference amount, then the serving size must be declared as 1 unit. For example, the reference amount for bread is 50 g, therefore 67% of the reference amount is 33.5 g and 200% of the reference amount is 100 g. One slice of bread would be used as the serving size for heavy-weight breads, "1 slice (45 g)." However, if the reference amount is 100 g, or 100 mL for liquids, or larger, and the product weighs more than 150%, but less than 200%, of the reference amount, 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 reference amount, there are two options. The serving size can either be declared as one unit if the entire units can reasonably be eaten on one occasion or can be declared as a portion of the unit. For example, the reference amount for candy bars is 40 g, and 200% of the reference amount is 80 g. For a 90 g candy bar, the serving size could be either

"1 candy bar (90 g) or "1/2 candy bar (45 g)."

FDA also provided additional specific provisions for (1) products (such as pickles) that naturally vary in size; (2) products made up of two or more foods, packaged and intended to be consumed together; and (3) products containing several, fully labeled, single serving units.

S5. Question: The reference amount 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 reference amounts 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 reference amount 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.

S6. Question: The reference amount 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 reference amount for heavy weight cakes (50% of 125 g = 62.5 g), therefore the serving size will be the number of units closest to the reference amount. Two pieces weigh 110 g and 3 pieces weigh 165 g, therefore, the serving size would be "2 pieces (110 g)".

Single-serving Containers (101.9(b)(6))

S7. Question: How do I know if my product is a single-serving container?

Answer: Single-serving containers are discussed in 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 reference amount for the product category. Above 200% of the reference amount, it is the manufacturer's option to label the product as a multiserving container or as a single-serving container if it can reasonably be consumed at a single eating occasion. For example, the reference amount 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.

S8. Question: What about single-serving containers for products that have larger reference amounts, such as soup?

Answer: If a product has a reference amount 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 reference amount. However, packages for such products containing between 150% and 200% of the reference amount may be labeled as one or two servings at the manufacturers option. For example, the reference amount for potato salad is 140 g. Containers of potato salad that are packaged and sold individually and that weigh 210 g or less must be labeled as a single serving. Containers weighing between 210 g and 280 g may be labeled as 1 or 2 servings. However, the serving size for a product labeled as two servings is based on the household measure and not on the weight of 1/2 package.

S9. Question: 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 (101.9(b)(5)(i)-(iii), whereas single-serving containers are required to use a description of the individual container or package (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."

S10. Question: 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 reference amount 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)."

S11. Question: The reference amount 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 reference amount for muffins. Products that weigh more than 200% of the reference amount 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)."

Serving Sizes for Products in Large Discrete Units Usually Divided for Consumption (101.9(b)(2)(ii))

S12. Question: 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 101.9(b)(2)(ii). The serving size depends on the reference amount 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 reference amount. For example, the reference amount for pizza is 140 g. A 16 oz (454 g) pizza can be divided in half (one piece = 227 g), thirds (one piece = 151 g), fourths (one piece = 113 g), etc. The closest fraction is 1/3, therefore the serving size would be "1/3 pizza (151 g)." Allowable fractions include 1/2, 1/3, 1/4, 1/5, 1/6, or smaller fractions that can be generated by further division by 2 or 3. An additional example would be: 1/8 (i.e., 1/4 divided by 2). Thus, fractions such as 1/7, 1/11, 1/13, and 1/14 are not allowed.

Serving Sizes for Bulk Products (101.9(b)(2)(iii))

S13. Question: 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 nondiscrete bulk products (e.g., breakfast cereal, flour, sugar, dry mixes, concentrates, pancake mixes, macaroni and cheese kits) are discussed in 101.9(b)(2)(iii). The serving size depends on the reference amount for the product and on the household measure. The serving size is expressed using the allowed household measure that is closest to the reference amount. For example, the reference amount for snacks is 30 g. If a bag contains a mixture of nuts and caramel popcorn that weighs 23 g per cup, then 1 1/4 cup weighs 28.75 g and 1 1/3 cup weighs 30.7 g. The closest household measure is 1 1/3 cup, therefore the serving size would be "1 1/3 cup (31 g)." Allowable household measures include (a) cups as 1/4, 1/3, 1/2, 2/3, 3/4, 1, 1 1/4, 1 1/3, etc, (b) tablespoons as 1, 1 1/3, 1 1/2, 1 2/3, 2, and 3, and (c) teaspoons as 1/4, 1/2, 3/4, 1, and 2. In addition, piece, slice, tray, jar, fraction, and ounce may be used in accordance with the provisions of 101.9(b)(5).

S14. Question: 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 (101.9(b)(5)(vii)). For example, the reference amount 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)."

S15. Question: 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 "reference amount for the unprepared product." The "reference amount 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 reference amount of the prepared product. For example, a prepared medium-weight cake has a reference amount 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 reference amount for medium weight cakes. Therefore, the reference amount 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)."

Serving Sizes in Common Household Measures (101.9(b)(5))

S16. Question: How do I choose appropriate household measures for declaring the serving sizes for products?

Answer: Common household measures are discussed in 101.9(b)(5). Manufacturers should first try to express serving sizes for their products using cups, tablespoons, or teaspoons (101.9(b)(5)(i)). Second, if cups, tablespoons, and teaspoons are not appropriate, then whole units and fractions of large whole units should be used, such as pieces, slices, tray, or jar (101.9(b)(5)(ii)). Finally, if other options fail (usually because the product size naturally varies to a considerable degree), manufacturers should use ounces with an appropriate visual unit of measure (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."

S17. Question: 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) (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 (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)."

S18. Question: Are there special provisions for individually packaged products?

Answer: Single serving containers and individually packaged products within multiserving containers must use a description of the individual container or package (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 (101.9(b)(5)(iv)): "2 candies (22 g)" or "1 slice (45 g)."

S19. Question: 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 (101.9(b)(5)(i)-(iii)): "2 pancakes with syrup (160 g)" or alternatively "2 pancakes (110 g)" and either "syrup for 2 pancakes (50 g)" or "__ tbsp syrup (50 g)" if 50 g of syrup makes __ tbsp. In addition, these products may also use ounces (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)."

S20. Question: How do we state the serving size for peanuts with shells?

Answer: The reference amount 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 )."

S21. Question: 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.

Declaration on "As Packaged" Basis

S22. Question: My dehydrated mixed dish product has a reference amount 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 reference amount 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.

S23. Question: 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 reference amount of the prepared product. A second column of nutrition information based on the as prepared basis may also be presented.

Servings Per Container (101.9(b)(5))

S24. Question: 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 reference amount for egg rolls is 140 g. Since the reference amount is greater than 100 g, a package of egg rolls containing more than 150% but less than 200% of the reference amount 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."

Dual Column Allowances

S25. Question: 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 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.

S26. Question: 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 providing 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.

S27. Question: Although sauerkraut and pickled beets are categorized under "pickles, all types" with a reference amount of 30 grams, can they also be labeled as a vegetable side dish with a reference amount 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 panel would show the serving size, servings per container, and nutrition information based on a 30 gram reference amount for the pickled vegetable and the second column could show nutrition information based on the reference amount for the product use as a vegetable side dish.

Reference Amounts and Food Categories

S28. Question: The reference amount 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 reference amount or the actual metric unit?

Answer: The nutrition information on the label is based on the household unit closest to the reference amount. In this case,it would be based on 54 grams, which would be declared as the weight of the label serving size. The reference amount is used as the starting point to determine the serving size for the foods in each product category and to govern claims.

S29. Question: What is the reference amount for partially cooked, packaged pasta products? Table 2 only gives reference amounts for prepared and dry pasta.

Answer: The reference amount for a partially cooked pasta product is the amount of partially cooked pasta that makes one reference amount of cooked pasta (140 grams). (101.12(c))

S30. Question: To what category do pickled vegetables belong?

Answer: Pickled vegetables are categorized with "pickles, all types" with a reference amount of 30 grams.

S31. Question: What if my product does not have an appropriate food category listing or reference amount?

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 101.12(h). FDA will provide a "suggested reference amount" 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 reference amount" so as to allow the manufacturer to nutrition label its products at this time, FDA believes that it will be necessary at a later date to undertake notice and comment rulemaking to formally establish a reference amount. Alternatively, the manufacturer or any other interested party may petition FDA at any time to establish a reference amount as specified in 101.12(h).

S32. Question: What "suggested reference amounts" have been provided to date?

Answer: The "suggested reference amounts" 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

Ice - 4 ounces

Dried tomatoes (halved, sliced, minced, bits) - 5 g

Dried tomatoes in oil (halved, sliced, minced, bits) - 10 g

NUTRIENT CONTENT CLAIMS

C1. Question: What is a nutrient content claim?

Answer: It is a claim on a food product that directly or by implication characterizes the level of a nutrient in the food (e.g., "low fat" or "high in oat bran."). Nutrient content claims are also known as descriptors. (101.13(b))

C2. Question: If a nutrient content claim is not included in FDA's regulations can it be used on a label?

Answer: No. Only those claims, or their synonyms, that are specifically defined in the regulations may be used. All other claims are prohibited. (101.13(b))

C3. Question: Must a statement about a nutrient be defined in 101.13 or subpart D of part 101 to be a permitted claim?

Answer: Generally, the answer is yes. However, statements about nutrients that are defined by regulations other than those in part 101 may not be nutrient content claims and therefore would not be subject to the requirements for nutrient content claims. Such claims include claims of special dietary usefulness (see 101.65(b)(6) and comment 225 of the final rule).

C4. Question: Are there any requirements for nutrient content claims regarding the size or style of type?

Answer: Yes. A nutrient content claim may be no more than twice as prominent as the statement of identity (the name of the food). Specifically, the type size of the claim may be no more than two times the type size of the statement of identity. If the style of the type makes the claim unduly prominent compared to the statement of identity, it will be in violation of the regulations (even if the size of the type is appropriate). (See 101.13(f) and comment (2) of the August 1993 Federal Register document.)

C5. Question: Is there any additional information that is required when a claim is made?

Answer: Yes. A variety of information is required depending on the claim and what information is needed to prevent the claim from being misleading. However, a referral statement and nutrition labeling are required for virtually all claims.

C6. Question: What is a referral statement?

Answer: A referral statement is a required statement that tells a consumer where to look for nutrition information. e.g., "See side panel for nutrition information." (101.13(g))

C7. Question: How must the referral statement be presented on the label?

Answer: It must be in legible boldface type, in distinct contrast to other printed or graphic matter and generally in a type size at least as large as the net quantity of contents declaration. In must also be placed immediately adjacent to the claim.

C8. Question: What is meant by immediately adjacent to?

Answer: "Immediately adjacent to" means just that, right next to the claim. There may be no intervening material such as vignette or other art work or graphics. However, other required information such as the statement of identity (when the claim is part of the statement of identity such as "low fat cheddar cheese"), and special disclosure statements (those required by section 403(r)(2)(A)(iii),(iv) and (v), see for example 101.54(d)) are permitted between the claim and the referral statement.

C9. Question: Could a statement of identity ever be considered intervening material?

Answer: Yes, if the claim and the statement of identity were separate pieces of information on the label. If the statement of identity and the claim were printed in noticeably different type styles, sizes, colors or locations, for example, if the phrase "low fat" were in a star-burst, the claim and the statement of identity would be considered separate pieces of information. In such cases the referral statement would have to be adjacent to the claim, not separated from it by the statement of identity.

C10. Question: How can I determine what type size is required for the referral statement?

Answer: The type size for the referral statement is the same as that required for the net quantity of contents statement in 101.105(i); for example, for packages with a principal display panel (PDP) of 5 square inches or less, the referral statement must be at least 1/16 inch in height; for packages with a PDP of 5-25 square inches, not less than 1/8 inch; for PDP's 25-100 square inches, not less than 3/16 inch, and for packages with a PDP greater than 100 square inches, not less than 1/4 inch.

C11. Question: Are there any exceptions to this?

Answer: Yes. If a claim is less than two times the required size of the net quantity of contents statement, the referral statement may be half the size of the claim but not less than 1/16 inch.

C12. Question: What about extremely small packages?

Answer: If a package has less than 3 square inches of available label space and is an individual serving-size package served with meals in restaurants, the referral statement may be 1/32 inch in height. (See 101.13(g)(1) and comment (4) of the August 1993 Federal Register document for nutrient content claims.)

C13. Question: Are there any situations when a referral statement is not required?

Answer: Yes. If a claim is made on the same panel as that bearing the nutrition information, no referral statement is required (See 101.13(g) and comment (3) in the August 1993 Federal Register document.)

C14. Question: I make several claims on one panel. Is a referral statement required each time I make a claim?

Answer: No. Only one referral statement per panel is required if multiple claims are made on a panel. (101.13(g)(3))

C15. Question: In that situation, is there a requirement for where the referral statement is located?

Answer: It must be adjacent to the claim printed in the largest type on that panel. (101.13(g)(3))

C16. Question: What if two claims on one panel are both in the same size print?

Answer: The referral statement may be next to either claim.

C17. Question: What is a disclosure statement?

Answer: It is a statement that calls the consumer's attention to one or more nutrients in the food, for example, "See back panel for information about sodium and other nutrients." It replaces the referral statement. The disclosure statement is similar to the referral statement but identifies the nutrient that is present in the food in excess of the prescribed levels.

C18. Question: When is a disclosure statements required?

Answer: It is required when a nutrient content claim is made and the food contains one or more of the following nutrients in excess of these levels:

fat 13.0 grams

saturated fat 4.0 grams

cholesterol 60 milligrams

sodium 480 milligrams

per reference amount customarily consumed, per labeled serving or, for foods with small serving sizes, per 50 grams. There are different levels for meal-type products.

C19. Question: What is a food with a small serving size?

Answer: It is a food with a reference amount of 30 g or less or 2 tablespoons or less.

C20. Question: When are disclosure statements required on meal-type products?

Answer: If a meal (see 101.13(l) for the definition of a meal) contains more than 26 g of fat, 8 g of saturated fat, 120 mg of cholesterol, or 960 mg of sodium per labeled serving it must contain a disclosure statement. Likewise, if a main dish (see 101.13(m) for the definition of a main dish) contains more than 19.5 g of fat, 6.0 g of saturated fat, 90 mg of cholesterol or 720 mg of sodium a disclosure statement is required.

C21. Question: What are the requirements for size and placement of the disclosure statement?

Answer: Because the disclosure statement is used in place of the referral statement, all such requirements are the same as for the referral statement.

C22. Question: "High" and "good source" claims are based on a percentage of the daily value. Can a "high" or a "good source" claim be made for a nutrient that does not have an established daily value?

Answer: No. "High" and "good source" claims are defined as a percentage of the Reference Daily Intake (RDI) or Daily Reference Value (DRV) (both declared on the label as the Daily Value (DV)). Therefore, nutrients that do not have an established daily value are not covered by the definition and may not make "high" or "good source" claims.

C23. Question: Some nutrients without DV's such as Omega-3 fatty acids, are also not permitted in nutrition labeling. Is there any way that a manufacturer can let consumers know that a product contains these nutrients?

Answer: A manufacturer may make a statement about a nutrient for which there is no established daily value so long as the claim specifies only the amount of the nutrient per serving and does not imply that there is a lot or a little of that nutrient in the product. Such a claim might be "x grams of omega-3 fatty acids." Such claims must be outside the "Nutrition Facts" box. (101.13(i)(3))

C24. Question: May a label state, "Contains x g of omega-3 fatty acids" or is it limited to statements like "x g of omega-3 fatty acids"?

Answer: The statements "Contains x grams of omega-3 fatty acids per serving" or "Provides 'x g' of omega-3 fatty acids" are permitted. However "Contains omega-3 fatty acids" or "provides omega 3 fatty acids" would not be permitted. Such claims would be synonyms for a "good source" claim which is not permitted for nutrients that do not have established daily values. To use the words "contains" or "provides" for nutrients without DV's, the specific amount of the nutrient must be stated.

C25. Question: Are such statements considered nutrient content claims and must they bear a referral statement?

Answer: Yes. Such statements are considered expressed nutrient content claims (101.13(b)(1)). Therefore, the labels must bear the required referral statement and any other required information such as a disclosure statement.

C26. Question: Statements that describe the percentage of the RDI of a vitamin or mineral in a food outside the nutrition panel are permitted. Is a referral statement required with such statements?

Answer: Yes. While these claims are exempt from certain labeling requirements, they are not exempt from bearing a referral statement or a disclosure statement.

C27. Question: Can a food that is normally low in or free of a nutrient bear a "low" or "free" claim if it has an appropriate disclaimer, e.g., "fat free -- broccoli, a fat free food"?

Answer: No. Only foods that have been specially processed, altered, formulated or reformulated so as to lower the amount of nutrient in the food, remove the nutrient from the food, or not include the nutrient in the food may bear such a claim (e.g., "low sodium potato chips") (101.13(e)(1)). Other foods may only make a statement that refers of all foods of that type (e.g., "corn oil, a sodium free food" or "broccoli, a fat free food").

C28. Question: When is a formulated food considered to be specially processed and permitted to bear a "low" or "free" claim?

Answer: If a similar food would normally be expected to contain a nutrient, such as sodium in canned peas, and the labeled food is made in such a manner that it has little or none of the nutrient, then the food is considered specially processed and may bear a "free" or a "low" claim.

C29. Question: If I make a product that does not have a regular version such as a spice mix, and I do not include salt in it, could I label the product "sodium free"?

Answer: Yes. FDA would consider that the food was formulated so as not to include the nutrient in the food and therefore it would be eligible to bear a "sodium free" claim if it otherwise meets the criteria for the term "sodium free."

C30. Question: I make a cooking oil spray. It has a very small serving size and therefore has less than 0.5 grams of fat. Can I make a "fat free" claim even though the product is essentially all fat?

Answer: Although the food technically qualifies to make a "fat free" claim, the agency considers that such a claim on a product that is essentially all fat would be misleading. Under section 403(a) and 201(n) of the act, the label would have to disclose that the product is 100% fat. However, the terms "fat free" and "100% fat" or "all fat" are contradictory and would likely confuse consumers. FDA believes a claim such as "for fat free cooking" is more appropriate, so long as it was not made in a misleading manner and the words "fat free" were not highlighted, printed in a more prominent type, or otherwise set off from the rest of the statement.

C31. Question: What is meant by "product category" when the regulation say that for "less," "fewer" and "more" claims, the reference food may be a dissimilar food within a product category that can generally be substituted for one another in the diet. Are these product category the same as the 139 product categories used to describe the reference amounts for serving sizes?

Answer: These are not the same as the product categories established for serving sizes. The agency intentionally did not define "product category" in the final rule in order to allow for the use of a flexible standard. It intended that comparisons be made for foods that are interchangeable in the diet, recognizing that sometimes these foods would be dissimilar, for example "apples have less fat than potato chips").

C32. Question: When would such a claim be considered misleading?

Answer: A claim would be misleading if it compared two foods that are not reasonably likely to be used as alternative food choices for a specified eating occasion, for example, "apples have less fat than sour cream."

C33. Question: Can I use a "less" or "fewer" claim to compare ready-to-eat breakfast cereals to other breakfast options such as sausages or danish pastries?

Answer: The agency would not object to such a claim if it were properly framed in the context of an eating occasion such as "Try a change for breakfast. A serving of this cereal has __ % less fat than a serving of Danish pastry."

C34. Question: Will I have to similarly frame, in the context of an eating occasion, comparisons between foods that are normally considered to be alternatives for one another such as pretzels for potato chips or one cookie for another cookie?

Answer: No. Such substitutions would be generally understood by the consumer and would not have to be specified.

C35. Question: What is an appropriate reference food for a food bearing a "light" claim?

Answer: The reference food must be a food or group of foods that are representative of the same type as the food bearing the claim. For example a chocolate ice cream would use as its reference food, other chocolate ice creams. The nutrient value for fat or calories in a reference food that is used as a basis for a "light" claim may be determined in several ways. It may be a value in a representative valid data base, an average value determined from the top three national (or regional) brands of the food, a market basket norm, or where its nutrient value is representative of the food type, an individual food like a market leader (101.13(j)(ii)(A)). The nutrient value used as a basis for a "light" claim should be similar to that calculated by averaging the nutrient values of many of the foods of the type. It should not be the value of a single food or group of foods at the high end of the range of nutrient values for the food. When compared to an appropriate reference food, a "light" food should be a food that the consumer would generally recognize as a food that is improved in its nutrient value compared to other average products of its type.

C36. Question: What do you consider to be an average nutrient value?

Answer: It might be a value in a data base that is appropriate for the food, or an average of nutrient levels in several of the leading brands of that type of food. It might also be a market basket norm. In determining an average nutrient value for a particular type of food, a manufacturer should take into account the nutrient variability of the product. Some types of products are fairly uniform, others, such as chocolate chip cookies, are not. Obviously, in products in which there is wide variability between different versions of the same food type, more products should be considered in arriving at an accurate nutrient level.

C37. Question: How will any one know what the reference food is and how it was derived?

Answer: The type of food used as a reference food must be identified on the label as part of the accompanying information (101.13(j)(2)(i)). In addition, the regulation requires that manufacturers using calculated nutrient values (averages, norms, etc.) as a basis for a claim be able to provide specific information on how the nutrient values were derived. This information must be available on request to consumers and to appropriate regulatory officials (101.13(j)(1)(ii)(A)).

C38. Question: How would you state the identity of a reference food when the nutrient value used as a reference for the claim was from a data base or was an average of several foods?

Answer: The label might state "50% less fat than regular Italian Salad Dressing" on light Italian dressing or "half the fat of the average Creamy Italian Salad Dressing" on a light creamy Italian salad dressing. The label is not required to state that the reference nutrient value came from a data base.

C39. Question: Can a reference food for a "light" product be an average of regional brands?

Answer: Yes, so long as the regional brands are available in the same area in which the "light" product is sold.

C40. Question: Are there any circumstances in which the reference food for a "light" claim may be a single food?

Answer: Yes. The agency has stated that if the nutrient levels in a food, such as the leading national or regional brand, were accurately reflective of the average of foods of that type, that food might be an appropriate reference food for a "light" product.

C41. Question: Is a market leader always an appropriate reference food?

Answer: No. For example, if there are two market leaders with widely different nutrient profiles, selecting the one with the slightly higher market share for the reference food could be misleading. In that case the nutrient values for the two market leaders should be averaged together to determine a nutrient value for the basis of the "light" claim.

C42. Question: What if my product is a unique product and the only one of its kind on the market? Can I make a "light" version using the regular product as the reference food?

Answer: Products that are truly unique may make the "light" comparisons to the regular version of the product. However, situations such as this will be fairly rare.

C43. Question: In discussing reference foods for "light" claims in the final rule (comment 203) the agency stated that "... all improved foods, including those that bear "light" claims, should be considered together with regular foods when deriving appropriate reference nutrient values on which to base ["light"] claims." If foods bearing "light" claims are included in the calculation of average nutrient levels, and the improved foods gain a substantial portion of the market share, the average nutrient levelwould change, the entire food type could be precluded from bearing the term "light," and the incentive to create such products would be greatly reduced. Does the agency still hold the view articulated in the final rule?

Answer: No. While the agency recognized that there would be a general downward trend in the overall level of nutrients in different types of foods when "light" versions of the food were made, and felt that to not include these foods in determining the average for that type of food would be misleading, the agency clearly did not intend to discourage product innovation or provide a disincentive for the development of foods that are "light" in calories or fat. The agency further recognizes that without certain claims, the ability of consumers to quickly identify improved products would be greatly diminished. Therefore, the agency has changed its view and would not expect average nutrient values for reference foods for "light" claims to include other "light" versions of the food.

C44. Question: What is the appropriate reference food for a nutrient content claim on a product that substitutes for a food and bears a name that is significantly different from that food? Examples include vegetable oil spreads that substitute for margarine or butter and mayonnaise spreads that substitute for mayonnaise.

Answer: To bear a claim, the labeled food, for example vegetable oil spread, must be "not nutritionally inferior" to the food that it resembles and for which it substitutes, e.g., margarine. The reference food on which the claim is based should be the food that it resembles and for which it substitutes, i.e., margarine.

C45. Question: What happens if the "light" version or other improved versions of the product become so popular that the regular version is no longer marketed?

Answer: The agency believes, as it discussed in the final rule in response to a question on "reduced" products (comment 206), that it would misleading for comparisons to be made to products that are no longer marketed. Therefore, especially for products that are nontraditional or unique, the agency would find claims which are based on products that have been discontinued for more than 6 months to be misleading.

C46. Question: What if the product is not discontinued but has an extremely small market share? Would those products still be considered appropriate reference foods for "light" products?

Answer: The agency would not consider any food to be an appropriate reference food for any relative claim if it did not have a significant market share. Also,just as it does not want foods to be specially created to be reference foods for relative claims, neither would it expect foods that can no longer be purchased by the consumer to be appropriate reference foods.

C47. Question: Is this always the case?

Answer: There are conceivably some circumstances in which a traditional food (hypothetically, full-fat yogurt) might no longer be marketed and only the nutritionally improved food would be available. The agency would not generally consider comparisons of the nutritionally improved food to the traditional food to be misleading, as long as consumers are likely to have a knowledge of the traditional food and the term "light" signals that the product was improved relative to the traditional food.

C48. Question: Is there any information that must be placed on the label when making a "light" claim?

Answer: When making "light" claims, as with other relative claims such as "reduced," "less," "fewer," "more," or "added," the label must state the percentage or fraction by which the food has been modified, the reference food, and the amount of nutrient that is the subject of the claim that is in the labeled food and the reference food. These statements are called "accompanying information."

C49. Question: Where must the accompanying information be placed?

Answer: The percentage or fraction by which the food is modified and the identity of the reference food must be immediately adjacent to the most prominent claim on the label. (101.13(j)(2)). The actual amount of the nutrient in the labeled food and the reference food may be adjacent to the most prominent claim or on the same panel as the nutrition label.

C50. Question: What is the most prominent claim?

Answer: In order, the most prominent claims are: 1) a claim on the principal display panel as a part of or adjacent to the statement of identity, 2) a claim elsewhere on the principal display panel, 3) a claim on the information panel, 4) a claim elsewhere on the label or in labeling.

C51. Question: How large must the accompanying information be?

Answer: Generally it must be at least 1/16 of an inch.

C52. Question: Is this always the case?

Answer: No. There are certain exemptions from this requirement for packaged foods that meet certain size requirements. Generally, this is 1/32 inch for products with a total surface area available to bear labeling of less than 12 square inches. However, in certain circumstances 3/64 inch in height is required. (See comment 5 of the technical corrections document.) (See also the "format" section of this document for discussion of how "space available to bear labeling" is calculated.)

C53. Question: I currently make a food which I call a "whole wheat bagels." Does this statement of identity imply that my bagel is a good source of fiber and must my bagel contain at least 10 percent of the daily value for fiber (2.5 g per reference amount)?

Answer: Not necessarily. Comments 224 and 230 in the final rule discuss such claims in depth. For example, in comment 224 the agency said "...if the labeling of oat bran muffins includes a discussion of the importance of fiber in the diet, FDA believes that the "oat bran muffins" name is an implied claim that the muffins are high in fiber. If the labeling is devoid of such information, FDA is not likely to consider the name to be an implied nutrient content claim." The agency stated that it will evaluate such claims on a contextual, case-by-case basis to determine whether they are claims or whether they merely describe the nature of the product. On the other hand, even if there is no additional specific nutrient statement, the prominence of the term could create a context in which "whole wheat" would be an implied fiber claim. For example, a prominent star-burst or other highlight giving the term "whole wheat" significantly greater prominence than the rest of the name of the food could draw enough attention to the term to constitute a claim.

C54. Question: Implied nutrient content claims in brand names have to be authorized by the FDA. Does a petition have to be submitted before a claim may be used in any brand name?

Answer: No. Implied claims that are specifically identified either in 101.65 or in the January 6 preamble (e.g., in comment 236) may be used in a brand name without submission of a petition under 101.69(o).

PERCENT JUICE DECLARATIONS

J1. Question: When does a beverage purport to contain a fruit or vegetable juice?

Answer: Under 101.30 (a), a beverage purports to contain fruit or vegetable juice if the product's advertising, label, or labeling, bears the name of, or makes any other direct or indirect representation with respect to any fruit or vegetable juice, or the label or labeling bears any vignette (i.e., depiction of a fruit or vegetable) or another pictorial representation of any fruit or vegetable, or product contains color and flavor that gives the appearance and taste of a fruit or vegetable juice. The beverages may be carbonated or noncarbonated, full strength, diluted, or contain no juice.

J2. Question: Are bar mixes required to bear percent juice declarations under 21 CFR 101.30?

Answer: Bar mixes are subject to the same requirements as other beverage products. Thus, a percent juice declaration would be required on labels of bar mixes that meet the definition set out in 101.30(a).

J3. Question: Is a whiskey sour mix that contains lemon juice from concentrate as the only juice component and a number of juice flavors and other ingredients, and that makes no claim or bears no pictures of fruits/fruit juices on the label required to bear a percent juice declaration?

Answer: No. A percent juice declaration would not be required on the whiskey sour mix if the only reference to the lemon juice is in the ingredient statement and no pictures of fruits/fruit juice appear on the label or in its labeling.

J4. Question: Would a strawberry daiquiri mix have to bear a percent juice declaration?

Answer: A strawberry daiquiri mix would purport to contain strawberries or strawberry juice because the term "strawberry" appears in the identity statement. Also, there is no indication that the strawberry is present only as a flavor or flavoring. If its label or labeling also includes pictures of the juice dripping from strawberries or if the product looks and tastes like it contains strawberry juice or strawberry pulp, the product would have to bear a declaration of the percent of juice or the absence of such juice on the information panel of the label. However, if the product were labeled "Strawberry flavored daiquiri mix" and did not otherwise purport to contain strawberry juice, it would not need a percent juice declaration.

J5. Question: Must bloody mary mix bear a percent juice declaration?

Answer: Bloody mary mix, by appearance and taste, purports to contain tomato juice and thus would be required to bear a statement as to the percentage of juice contained in the product.

J6. Question: Would a beverage that is made by reconstituting a blend of dehydrated fruits or vegetables be required to bear a percent juice declaration? If so, how is the percentage determined?

Answer: The declaration is required if the product purports to contain juice. However, because FDA has not established specific procedures for calculating the percentage of juice when beverages are prepared by rehydrating juice solids, it will evaluate labels of products made by this process on a case by case basis. Brix values, where provided in 101.30(h), may be used as guidelines in calculating the level of total juice solids necessary to prepare full strength juices, provided the beverage does not contain other non-juice ingredients.

J7. Question: Do lemon and lime juices, used for mixed drinks, have to bear a percent juice declaration?

Answer: Yes. The percentage juice declaration would be based on the anhydrous citric acid content of the lemon juice or lime juice, listed in 101.30(h)(1).

J8. Question: Is apple cider required to bear a percent juice declaration?

Answer: Apple cider is juice that is expressed from apples and must bear a declaration of the percent of juice.

J9. Question: Does apple cider vinegar have to bear a percent juice declaration?

Answer: No. Apple cider vinegar does not purport to be a beverage and thus is not required to bear a percent juice declaration. Although the product is made from apple juice, it is not considered to be a juice beverage.

J10. Question: Must concentrated juices bear percent declarations? If so, what percentage is to be declared?

Answer: Concentrated juice products must bear a percentage juice declaration and that declaration may not be greater than 100 percent. The label may explain that when the product is diluted according to label directions, the product yields a "___percent juice from concentrate," with the blank being filled in with the correct percentage based on the Brix values set out in 101.30(h)(1), as applicable.

J11. Question: Is there an exemption from the requirement that the percent juice declaration be on the information panel for multi-unit packages that are packed in a secure shrink wrap and are not for sale by individual unit, and the percentage of juice is declared on the outer shrink wrap?

Answer: No, there is no specific exemption from the requirement that the percent juice declaration be on the information panel of individual juice packages packed in a multi-unit shrink wrap pack.

J12. Question: Can printed material intervene between the percent juice declaration and the other information required to appear on the information panel, e.g., nutrition label, ingredient statement, and name of the packer or distributor?

Answer: Yes. The statement of the percentage of juice, appearing on the information panel of the label, must be located near the top of the panel, with no other printed information appearing above the statement except the brand name, product name, logo, or universal product code (101.30 (e)(1)). The regulations do not specify what appears below the declaration. However, the agency points out that there may not be any intervening printed material among the nutrition label, ingredient statement, and packer/distributor (101.2(e)) when all three are on the information panel.

J13. Question: Must the entire common or usual name of a juice beverage be in one place and in a single type size? Some juice beverages will have very complex common or usual names, like "cranberry-raspberry flavored juice drink in a blend of three other juices from concentrate."

Answer: The entire common or usual name must be in one place. If some or all of the juices listed in the name are from concentrate, the term "from concentrate" must follow the names and may be in a smaller type size, but not less than one half the height of the letters in the other part of the common or usual name.

J14. Question: Regarding vignettes on juice labels, do the pictures have to be proportional to the fruits in the juice? Does any fruit that is present at a level of less than 2 percent by volume have to be depicted in the vignette?

Answer: FDA has not established specific requirements for vignettes on labels of juice beverages. FDA urges manufacturers to use vignettes that accurately depict each fruit or vegetable contained in the multiple juice products. However, a vignette depicting only some of the fruits or vegetables may not be considered misleading, if the name of the food adequately and appropriately describes the contribution of the pictured juice. For example, a 100 percent juice consisting of apple, grape and raspberry juices, in which raspberry juice provides the characterizing flavor, and bears a vignette that only depicts raspberries, would not necessarily be misleading if the identity statement were "raspberry juice blended with apple and grape juices." Alternatively, the statement of identity may be "raspberry flavored fruit juice blend" or "raspberry juice in a blend of two other juices, 3 to 8 percent raspberry juice" (58 FR 2897 at 2921).

J15. Question: Do I make any adjustments to the analytical Brix value in declaring the percentage of juice when tomato juice contains added salt or other dry ingredients (e.g., spices)?

Answer: Yes. The soluble solids content for tomato juice must be determined before addition of any spices. The soluble solids for tomato juice, determined by refractometer, should be corrected for salt content as prescribed in 156.3(b) and (c).

J16. Question: I want to make a PDP statement "100 percent juice," and I have another ingredient (ascorbic acid) that does not dilute the juice solids. It appears that this is a nutrient content claim as well and I will have to meet all the requirements for "more" vitamin C, including the referral and comparison statements, and fortification policy. Have I understood correctly?

Answer: If ascorbic acid is added at levels consistent with fortification of the juice, its declaration in the name of the 100 percent juice would constitute a nutrition claim, triggering compliance with the "more" claim for vitamin C and the referral and comparison statements. However, it is not necessary to specifically list the added ingredient by name in the 100 percent juice statement, i.e., the statement of identity could be "100 percent ___juice with preservative." In this case the ascorbic acid would be added as a chemical preservative and listed by name in the ingredient statement in accordance with 101.22(j).

J17. Question: Do I have to say "fruit punch from concentrate" or "lemonade from concentrate?"

Answer: No. Section 102.33(g) states that if one or more of the juices in a juice beverage is made from concentrate, then the name of the juice must include the term "from concentrate" or "reconstituted." Because the names "fruit punch" and "lemonade" do not include the name a specific juice, these names do not have to contain the term "from concentrate" or reconstituted."

J18. Question: Is the declaration on a lemonade made in terms of the lemon juice only, exclusive of sugar?

Answer: Yes, before adding sugar.

J19. Question: We have a juice product for food service only, and we are exempt from nutrition labeling for this product (we know that is never goes to club stores). Are we also exempt from percent juice declarations?

Answer: No. There are no exemptions from the requirement for label declaration of the percentage of juice on food service containers of juices.

J20. Question: Is the common or usual name regulation in 102.33 applicable to 100 percent juices or only to diluted juices?

Answer: The regulation is applicable to both.

J21. Question: We have very small labels, about 7 square inches. How do you name a citrus punch which contains five juices in which three are from concentrate and two are expressed juices, and the expressed juices are not citrus juices nor do their flavors characterize the beverage? Also, what if one of the citrus juices is an expressed juice and is present only in a minor amount, must it be identified by name?

Answer: There are several alternatives. In the first case, the common or usual name may be "a blend of 3 citrus juices from concentrate with ______ and ____juices", the blanks filled in the with names of the expressed juices. In the second case, the citrus juice that is not from concentrate should be listed as in the example given above in order of predominance, i.e., a blend of 2 citrus juices from concentrate with _____, ______, and ______juices, with the third citrus juice listed in one of the blanks, along with the other expressed juices. Alternatively, a name such as "citrus punch" or "citrus flavored punch" may be used as the statement of identity without further identification of the component juices.

J22. Question: Is it necessary to state that juices are from concentrate when they are contained in a beverage such as punch? Consumers know that products labeled with terms such as "punch" and "cocktail" are made from concentrate.

Answer: Yes, sometimes. If the juices are specifically named in the statement of identity, and the juices are from concentrate, their names must be followed by the term "from concentrate" in accordance with 102.33(g). If no reference is made to specific juices in the name of a punch that is made from concentrated juices, the statement of identity does not have to include the term "from concentrate." However, each of the concentrated juices used in the punch must be declared in order of predominance in the ingredient statement of the label.

J23. Question: Does a punch have to be made from fruit juice?

Answer: No. FDA does not have a specific definition or standard of identity for punch, or any other requirement that a punch contain fruit juice. A punch may be an artificially flavored beverage, with or without natural flavorings, or it may be made from tea and other ingredients, exclusive of fruit juice. Such products must be clearly distinguished from products which are made from fruit juices or fruit concentrates or purees. Products containing artificial or natural flavors must be labeled in accordance with 101.22.

J24. Question: In the case of a vegetable juice cocktail that is 100 percent juice, can the name include the term "cocktail?"

Answer: Yes.

INGREDIENT DECLARATIONS

Standardized Ingredients

D1. Question: When do you declare water as an ingredient in tomato concentrate?

Answer: Water that is added to adjust the Brix level of the standardized food within the permitted range of soluble solids (e.g., water used to adjust a Brix of 28o to 24o in tomato paste, or to adjust a Brix of 16o to 10o in tomato puree) does not have to be declared. However, water added to tomato paste (Brix of 24o) to make a product with a Brix of 16o (tomato puree) would have to be declared.

D2. Question: Can tomato paste, tomato puree, and tomato concentrate be used interchangeably in the ingredient statement?

Answer: Tomato paste and tomato puree are different foods based on the amount of soluble solids present in the product, and thus, the names can not be used interchangeably in the ingredient statement. However, the term "tomato concentrate" may be used in lieu of tomato paste, tomato pulp, or tomato puree when the concentrate complies with the requirements of such foods and the statement "for remanufacturing purposes only" appears on the label of packages equal to or less than 3.1 kilograms or 109 oz. Further, tomato concentrate may be used in lieu of tomato paste, tomato pulp, or tomato puree in the ingredient labeling of catsup.

D3. Question: Do ingredients of standardized foods have to be listed when the standardized food is an ingredient in a non-standardized food?

Answer: Yes. The ingredients of the standardized food may be declared parenthetically following the name of the standardized ingredient or may be declared by dispersing each ingredient in its order of predominance in the ingredient statement without naming the standardized food.

D4. Question: Do you have to parenthetically declare all of the ingredients in flavors that conform to a standard of identity?

Answer: If the flavor is declared by the standardized name, each ingredient must also be declared parenthetically following the standardized name. However, the standardized flavor may simply be declared as flavoring, natural flavoring, artificial flavoring, as appropriate.

Juices

D5. Question: If fruit is canned in juice from concentrate, does the water used to reconstitute the juice have to be declared?

Answer: Yes. The reconstituted juice in which the fruit is canned is prepared from juice concentrate and water, thus both ingredients have to be declared.

D6. Question: Can juice concentrates be grouped in the ingredient statement (e.g., Fruit Juice Concentrates (grape, apple, cherry))?

Answer: No. "Fruit juice concentrates" is not established as a common or usual name, nor is it established as an appropriate collective name for a variety of different concentrated fruit juices.

Lakes

D7. Question: Do certified color additive lakes have to be declared separately from the certified color in the ingredient statement?

Answer: Yes. Certified color additives and their lakes are separate ingredients and, thus, must be declared separately in the ingredient statement.

D8. Question: FDA did not discuss lakes in the ingredient proposal. I have already changed my label and did not declare lakes separately. What do I do?

Answer: The agency recognizes that readers of the June 21, 1991 proposal may not have fully understood that lakes and certified color additives were to be considered as separate ingredients for labeling purposes. Because of this, FDA intends to be lenient in enforcement of this provision. Therefore, as a matter of enforcement discretion, the agency is unlikely to take regulatory action before May 8, 1994, against products that bear the required certified color additive declaration but not the required certified color additive lake declaration.

D9. Question: What are permissible declarations for certified colors?

Answer: Certified colors may be declared by their common or usual name (e.g., FD&C Blue No. 1, FD&C Blue No. 1 Lake) or by the permissible abbreviation (e.g., Blue 1, Blue 1 Lake).

Protein Hydrolysates

D10. Question: How do you declare protein hydrolysates that are made of blends of proteins?

Answer: For proteins that are blended prior to being hydrolyzed an appropriate name for the hydrolyzed protein product must be sufficiently descriptive of the protein product and must include all of the various proteins that were used to make the hydrolyzed protein. For example a hydrolyzed protein made from a blend of corn and soy protein would be "hydrolyzed corn and soy protein." However, if the proteins are hydrolyzed prior to blending, then the common or usual name must be specific to each individual hydrolyzed protein e.g., "hydrolyzed corn protein" and "hydrolyzed soy protein," and the ingredients must be declared in their order of predominance. In addition, any other ingredients that are blended with the hydrolyzed protein products must also be declared by their common or usual names in the ingredient statement in order of predominance.

Type Size Requirements

D11. Question: Are there type size, typeface, case requirements for the ingredient statement?

Answer: Yes. All lettering must appear prominently and conspicuously. The letters and/or numbers in the ingredient statement may be no less than one sixteenth (1/16) inch in height unless an exemption is established based on the total surface area of the package. The letters must be no more than three (3) times as high as they are wide. There is no requirement for case; however, if upper and lower case letters or all lower case letters are used, it is the lower case "o" or its equivalent that must meet the minimum standards.