U.S. Food and Drug Administration
Center for Food Safety & Applied Nutrition
Booklet: August 1994
Food Labeling
QUESTIONS AND ANSWERS
NUTRITION LABELING
(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 re-
evaluation 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 (HFS-
150), 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 multi-
serving 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 multi-
serving 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
level
would 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.
01/18/97
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