[Federal Register Volume 60, Number 65 (Wednesday, April 5, 1995)]
[Rules and Regulations]
[Pages 17202-17208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-8067]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 93N-0283]
RIN 0905-AD89


Food Labeling; Placement of the Nutrition Label on Food Packages

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its food 
labeling regulations to provide increased flexibility in the placement 
of the nutrition label on packaged foods. In situations in which the 
principal display and information panels cannot accommodate all the 
required labeling information, and the package has a total surface area 
available to bear labeling of greater than 40 square inches (sq in), 
the amendment allows the nutrition label to be placed on any panel that 
can be readily seen by the consumer. This action is being taken in 
response to comments received on the final rule of January 6, 1993, 
entitled ``Food Labeling Regulations Implementing the Nutrition 
Labeling and Education Act of 1990; Opportunity for Comments,'' 
(hereinafter ``the implementation final rule''), and on the proposed 
rule of August 18, 1993, entitled ``Food Labeling; Placement of the 
Nutrition Label on Food Packages.''

EFFECTIVE DATE: May 5, 1995.

FOR FURTHER INFORMATION CONTACT: Arletta M. Beloian, Center for Food 
Safety and Applied Nutrition (HFS-165), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-5430.

SUPPLEMENTARY INFORMATION:

I. Background

A. The Principal Display Panel and Information Panel

    Under FDA's regulations (Sec. 101.1 (21 CFR 101.1)), the part of a 
label that is most likely to be displayed, presented, shown, or 
examined by a consumer under customary conditions of display for retail 
sale is called ``the principal display panel.'' This panel must include 
the statement of identity for the product and its net weight. In 
addition, to provide consistency and uniformity in the presentation of 
label information to consumers, FDA has provided for a second display 
panel for information that must be included on the label but that is 
not required to appear on the principal display panel. This alternate 
panel is called ``the information panel'' (Sec. 101.2 (21 CFR 101.2)).
    The information panel is defined in Sec. 101.2(a) as that part of 
the label that is immediately contiguous and to the right of the 
principal display panel. Section 101.2(a)(1) specifies that if the 
first panel to the right of the principal display panel is too small to 
accommodate the necessary information, or is otherwise unusable label 
space, the panel immediately contiguous and to the right of that part 
of the label may be used as the information panel. Accordingly, FDA's 
regulations direct manufacturers to move the information required to 
appear on the information panel as a unit when the first available 
information panel will not accommodate all the required information. 
Pursuant to Sec. 101.2(e), all information appearing on the information 
panel must be presented in one place without other intervening 
material.
    Section 101.2(b) states that the ingredient listing; name and place 
of business of the manufacturer, packer, or distributor; and nutrition 
information must appear either on the principal display panel or on the 
information panel, unless otherwise specified by regulation. Section 
101.2(d)(1) requires that all information required to appear on the 
principal display panel or the information panel appear on the same 
panel unless there is insufficient space, in which case it may be 
divided between the principal display panel and information panel in 
accordance with Secs. 101.1 and 101.2. In determining the sufficiency 
of the available space, under Sec. 101.2(d)(1), any vignettes, designs, 
and other nonmandatory label information are not to be considered.

B. Mandatory Nutrition Labeling

    In the Federal Register of January 6, 1993, FDA issued a final rule 
entitled ``Food Labeling: Mandatory Status of Nutrition Labeling and 
Nutrient Content Revision, Format for Nutrition Label'' (58 FR 2079) 
(hereinafter referred to as ``the mandatory nutrition labeling final 
rule''), which included provisions to require nutrition labeling on 
most foods that are regulated by FDA and to specify a new format for 
declaring nutrition labeling. FDA took this action, in part, to 
implement the Nutrition Labeling and [[Page 17203]] Education Act of 
1990 (Pub. L. 101-535), which amended the Federal Food, Drug, and 
Cosmetic Act. Section 101.9(i) (21 CFR 101.9(i)), which FDA added to 
its regulations as part of the mandatory nutrition labeling final rule, 
states that, except as provided in Sec. 101.9(j)(13), the location of 
the nutrition label must be in accordance with Sec. 101.2.
    In recognizing the demands for label space made by nutrition 
labeling, the agency included a provision in the mandatory nutrition 
labeling final rule that allows nutrition information to be presented 
on any label panel on packages that have a total surface area available 
to bear labeling of 40 sq in or less (see Sec. 101.9(j)(13)(ii)(D)). 
The flexibility provided by this provision reflects the agency's 
recognition that it is more important that the nutrition information be 
presented on the immediate package than that it be presented in any 
particular place (58 FR 2079 at 2156). FDA stated that given the 
consistent appearance of the nutrition information that will be 
produced by the format elements that it adopted, and the educational 
efforts of government, industry, and consumer organizations, consumers 
will know to look for, and be able to recognize, nutrition information, 
even if it is not presented to the right of the principal display 
panel. Section 101.9(j)(13)(ii)(D) does not provide an exception, 
however, for the placement of nutrition information on packages of more 
than 40 sq in when the principal display and information panels of 
those packages cannot accommodate all of the required information.
    On January 6, 1993, the agency published, along with the mandatory 
nutrition labeling final rule and various other final rules, the 
implementation final rule (58 FR 2066). This document gave interested 
persons 30 days to comment on any technical issues that had not been 
raised in earlier comments. In response to this document, FDA received 
a number of comments that requested greater flexibility in the 
placement of the nutrition label because of the increased amount of 
space needed to meet the type size and spacing requirements of the new 
nutrition label. These comments included product labels that 
illustrated the difficulties presented in trying to place the required 
label information on the information panel.
    In the Federal Register of August 18, 1993 (58 FR 44091), FDA 
published a proposed rule, entitled ``Food Labeling; Placement of the 
Nutrition Label on Food Packages,'' to amend its regulations on the 
placement of nutrition information on packages having a total surface 
area for labeling of greater than 40 sq in. For such situations, the 
agency proposed to add Sec. 101.9(j)(17). Under this provision, when 
the package cannot accommodate all information required by regulation 
on its principal display panel and information panel, the nutrition 
label may be moved to any alternate panel that can be readily seen by 
the consumer. Furthermore, under proposed Sec. 101.9(j)(17), the space 
needed for vignettes, designs, and other nonmandatory label information 
may be considered when determining the sufficiency of available space 
on the principal display panel. FDA also proposed to revise: (1) 
Sec. 101.9(i) to make reference to the exemption from Sec. 101.2 for 
products covered by proposed Sec. 101.9(j)(17), and (2) 
Sec. 101.2(d)(1) to exclude from its coverage products that are exempt 
under Sec. 101.9(j)(17). FDA also proposed to make a number of 
ancillary modifications to all of the regulations that pertain to 
relative nutrient content claims, specifically to those sections that 
require that the statement that compares the amount of the subject 
nutrient in the product per labeled serving with that in the reference 
food appear either adjacent to the most prominent claim or on the 
information panel. Under the proposed modification, the comparative 
quantitative information may be placed either adjacent to the most 
prominent claim or to the nutrition label, without regard to the panel 
on which the nutrition label appears. The agency proposed to make this 
modification to each regulation in part 101 (21 CFR part 101) that 
pertains to relative nutrient content claims (e.g., ``more,'' 
``light'').
    In addition, in response to other comments that FDA received on the 
implementation final rule, the agency proposed to amend 
Sec. 101.61(c)(2)(iii) to require that the statement ``not a sodium 
free food'' on foods that are not sodium free and yet whose label bears 
a claim of ``unsalted'' be placed adjacent to the nutrition label 
rather than on the information panel.
    Interested persons were given until October 18, 1993, to comment on 
the proposal.

II. Comments and the Agency's Response

    FDA received 19 letters, each containing 1 or more comments, in 
response to the proposal from trade associations, food manufacturers, a 
state government, and a foreign government. The comments unanimously 
supported the proposal. However, a few comments contained suggestions 
for clarifying the regulations and for modifying additional related 
sections that were not covered in the proposal. FDA is responding to 
these comments in this document. In addition, the agency received a few 
comments that addressed issues such as type size and leading (i.e., 
format) requirements and specific problems pertaining to the placement 
of the ingredient list on multi-packs of ready-to-eat cereals. These 
issues are outside the scope of the proposal, and therefore FDA will 
not address them in this document.

A. Flexibility in Placement

    1. All the relevant comments supported FDA's proposal in 
Sec. 101.9(j)(17) to allow consideration of the space needed for 
vignettes, designs, and other nonmandatory label information on the 
principal display panel in deciding whether the space on that panel and 
the information panel is adequate for presentation of the nutrition 
label. One comment, however, objected to the agency's failure to 
provide for consideration of nonmandatory information on the 
information panel as part of the determination as to whether there is 
sufficient space available for the nutrition label. The comment stated 
that the agency's position that the nutrition facts box will be so 
recognizable that consumers will not have difficulty locating it 
regardless of where it appears on the label seems to support giving 
consideration to space needs for vignettes, designs, and other 
nonmandatory information on the information panel as well as on the 
principal display panel. The comment asked that the agency clarify its 
intent and permit nonmandatory label information on the information 
panel to be taken into account when deciding whether there is 
sufficient space on that panel for the nutrition facts box.
    The agency's intent in this rulemaking was not to remove all 
constraints on the placement of the nutrition label but rather to 
provide added flexibility when needed by industry to facilitate placing 
the new nutrition label on food packages. In attempting to accomplish 
this purpose, the proposal did not address the issue of nonmandatory 
information on the information panel. The agency did not see a need to 
alter the current requirement in Sec. 101.2(d)(1) that all required 
information (including the nutrition label; the ingredient list; the 
name and place of business of the manufacturer, packer, or distributor; 
and the percent juice declaration) be placed on the information panel, 
if not on the principal display panel, when there is sufficient space 
to do so.
    In support of the proposal, FDA noted that the appearance of many 
packages [[Page 17204]] could be significantly affected if regulations 
did not allow vignettes, designs, and other nonmandatory information on 
the principal display panel to be considered in calculating the amount 
of available label space. The agency also noted that current industry 
practice almost never places the nutrition label on the principal 
display panel unless there is no alternative panel on the package. 
These two factors, which were the impetus for the subject proposal, do 
not apply to vignettes, designs, and other nonmandatory information on 
the information panel. Thus, the interests of consumers will be served 
best by continuing to have this information appear together wherever 
possible. Moreover, having the nutrition label, the ingredient list, 
and the name and place of business of the manufacturer, packer, or 
distributor appear on the same panel simplifies the consumers' search 
for this information. The comment did not advance any arguments that 
suggested a countervailing benefit to the public from allowing 
nonmandatory label information to replace nutrition labeling on the 
information panel. Accordingly, the agency is not making the requested 
change.
    2. One comment stated that the second sentence of proposed 
Sec. 101.9(j)(17) needed to be clarified because there was confusion in 
trade publications about the significance of nonmandatory information 
on the information panel.
    FDA agrees that it is necessary to clarify the differences in the 
agency's treatment of nonmandatory information on the principal display 
panel as opposed to on the information panel. Accordingly, the agency 
is revising Sec. 101.9(j)(17) to add a sentence at the end of the 
subparagraph that reads: ``Nonmandatory label information on the 
information panel shall not be considered in determining the 
sufficiency of available space for the placement of the nutrition 
label.''

B. Statements of Ingredients, and Name and Place of Business

    FDA did not propose to modify the requirement that manufacturers 
list ingredient information and the name and place of business of the 
manufacturer, packer, or distributor on the principal display panel or 
the information panel. Under Sec. 101.9(j)(13) and proposed 
Sec. 101.9(j)(17), only the nutrition label could be placed on another 
panel.
    3. Three comments urged that the agency allow the ingredient 
statement (Sec. 101.4) and the name and place of business of the 
manufacturer, packer, or distributor (Sec. 101.5) to be presented 
adjacent to the nutrition label on any other label panel that can be 
readily seen by consumers when the information panel is too small to 
accommodate all the required information. They argued that, although 
consumers may now look for the ingredient list and the name and place 
of business statement on the principal display panel or information 
panel, it was likely that these statements would be seen if listed on 
the same panel as the nutrition information, which must be readily 
observable. Furthermore, the comments argued, consumers are accustomed 
to seeing all of this information on one panel, and manufacturers often 
incorporate the ingredient list, the name and place of business 
statement, and the nutrition label into one design.
    Among these comments, one recommended revised wording in 
Sec. 101.4(a)(1) to implement the change, i.e., to state that 
ingredients are to be listed on either the principal display panel, the 
information panel, or the label panel on which the mandatory nutrition 
information appears. The comment stated that because Sec. 101.5(a) 
requires that the label of a food in package form specify conspicuously 
the name and address of the manufacturer, packer, or distributor, that 
regulation need not be amended because it allows manufacturers the 
option of placing such information in a place where the consumer will 
see it.
    The agency has considered these comments and is not making the 
requested change because a change of the magnitude of that suggested 
was not foreshadowed by the proposal. The ingredient statement and the 
name and place of business statements have appeared on either the 
principal display or the information panels for nearly 20 years. 
Allowing the ingredient list and the name and place of business of the 
manufacturer, packer, or distributor to move off the information panel 
whenever there is insufficient space for them to appear with the 
nutrition label would represent a significant redefinition of what 
constitutes the information panel. While the portion of the food supply 
that would be affected is unknown, it could be substantial. Companies 
interested in pursuing this suggestion should submit a citizen petition 
under Sec. 10.30 (21 CFR 10.30) that would address the possible 
ramifications of such a change on food packages and on consumers' use 
of the required label information.
    It should be noted, however, that under Sec. 101.2(a)(1), when 
there is insufficient space on the panel immediately contiguous and to 
the right of the principal display panel for all required components, 
the ingredient list; the name and place of business of the 
manufacturer, packer, or distributor; and the nutrition label may be 
moved as a unit to the next panel immediately contiguous and to the 
right of that panel.

C. Clarification

    4. One comment requested that FDA allow for the placement of 
nutrition information on either side of a center-seamed back panel, 
such as on flexible film bags used for snack foods that do not have 
information printed on the sides, top, or bottom of the package. The 
comment argued that the bag is easily rotated from front to back, and 
that the full center-seamed back panel is in plain view.
    Section 101.2(a) states that the ``information panel'' is that part 
of the label immediately contiguous and to the right of the principal 
display panel when observed facing the principal display panel. If the 
part of the label immediately contiguous and to the right of the 
principal display panel is too small to accommodate the necessary 
information, the next panel immediately contiguous and to the right of 
the fold may be used (see Sec. 101.2(a)(1)). In the case of flexible 
film bags of snack foods with folded or pleated side panels that do not 
provide any additional usable label space, the back panel of the bag is 
the information panel. FDA interprets the back panel to be the full 
back panel of the flexible bag, regardless of the presence or absence 
of a seam. Therefore, the nutrition label may be located on any part of 
the back panel. Wherever it is placed, however, Sec. 101.2(e) requires 
that there be no intervening material between it and the other pieces 
of required information.

III. Other Provisions

    5. All comments addressing the aspect of the proposal on relative 
nutrient content claims supported the proposed requirement that the 
comparative quantitative information be positioned adjacent to the most 
prominent claim or to the nutrition label. However, in light of 
Sec. 101.2(e), which states that all required information on the 
information panel appear in one place without other intervening 
material, the agency is concerned that the proposed codified language 
pertaining to relative claims in Secs. 101.54, 101.56, 101.60, 101.61, 
and 101.62 that would require quantitative information to be ``declared 
adjacent to the most prominent claim or to the nutrition label * * *'' 
might be interpreted to mean that when the [[Page 17205]] nutrition 
label remains on the information panel, the quantitative information 
has to be immediately adjacent to the nutrition label rather than being 
allowed to be placed elsewhere on the information panel in proximity 
with other required information, as is in fact the case. Such a literal 
interpretation of the words ``adjacent to the nutrition label'' could 
have the unintended effect of requiring current labels containing 
relative claims to be redesigned for the sole purpose of relocating the 
quantitative information. The same concern exists for 
Sec. 101.61(c)(2)(iii), which addresses the placement of the statement 
``not a sodium free food'' on foods that are not sodium free and yet 
whose label bears a claim of ``unsalted.''
    To prevent such a misunderstanding, FDA is modifying the codified 
language pertaining to relative claims (i.e., ``more'' claims: 
Sec. 101.54(e)(1)(iii)(B) and (e)(2)(iii)(B); ``light'' claims: 
Sec. 101.56(b)(3)(ii), (c)(1)(ii)(B), (c)(2)(ii)(B), and (g); calorie 
claims: Sec. 101.60(b)(5)(ii)(B), (b)(6)(ii)(B), (c)(4)(ii)(B), and 
(c)(5)(ii)(B); sodium claims: Sec. 101.61(b)(6)(ii)(B) and 
(b)(7)(ii)(B); and fat, fatty acid, and cholesterol claims: 
Sec. 101.62(b)(4)(ii)(B), (b)(5)(ii)(B), (c)(4)(ii)(B), (c)(5)(ii)(B), 
(d)(1)(ii)(F)(2), (d)(2)(iii)(E)(2), (d)(2)(iv)(E)(2), (d)(4)(i)(C)(2), 
(d)(4)(ii)(D)(2), (d)(5)(i)(C)(2), and (d)(5)(ii)(D)(2)) and the 
general principles governing nutrient content claims in 
Sec. 101.13(j)(2)(iv)(B) (21 CFR 101.13(j)(2)(iv)(B)) to state that the 
quantitative information ``shall appear adjacent to the most prominent 
claim or to the nutrition label, except that if the nutrition label is 
on the information panel, the quantitative information may be located 
elsewhere on the information panel in accordance with Sec. 101.2.'' 
(For clarity, FDA is making a small change in the placement of the 
illustrative example in these regulations and, for consistency, is 
adding an example to Sec. 101.62(d)(4)(i)(C)(2).) Likewise, the agency 
is modifying Sec. 101.61(c)(2)(iii), which pertains to the placement of 
the statement ``not a low sodium food,'' to state that the statement 
shall appear ``adjacent to the nutrition label of the food bearing the 
claim, or, if the nutrition label is on the information panel, it may 
appear elsewhere on the information panel in accordance with Sec. 101.2 
of this chapter.''

IV. Environmental Impact

    The agency previously considered the environmental effects of this 
rule as announced in the proposed rule of August 18, 1993 (58 FR 
44091). No new information or comments have been received that would 
affect the agency's previous determination that there is no significant 
impact on the human environment and that an environmental impact 
statement is not required.

V. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this final rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the final 
rule is not a significant regulatory action as defined by the Executive 
Order and so is not subject to review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because this final rule will allow for increased 
flexibility in complying with labeling rules, and therefore results in 
positive net benefits, the agency certifies that the final rule will 
not have a significant economic impact on a substantial number of small 
entities. Therefore, under the Regulatory Flexibility Act, no further 
analysis is required.

List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
101 is amended as follows:

PART 101--FOOD LABELING

    1. The authority citation for 21 CFR part 101 continues to read as 
follows:

    Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act 
(5 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342, 
343, 348, 371).

    2. Section 101.2 is amended by revising paragraph (d)(1) to read as 
follows:


Sec. 101.2  Information panel of package form food.

* * * * *
    (d)(1) Except as provided by Sec. 101.9(j)(13) and (j)(17), all 
information required to appear on the principal display panel or on the 
information panel pursuant to this section shall appear on the same 
panel unless there is insufficient space. In determining the 
sufficiency of the available space, except as provided by 
Sec. 101.9(j)(17), any vignettes, designs, and other nonmandatory label 
information shall not be considered. If there is insufficient space for 
all of this information to appear on a single panel, it may be divided 
between these two panels except that the information required pursuant 
to any given section or part shall all appear on the same panel. A food 
whose label is required to bear the ingredient statement on the 
principal display panel may bear all other information specified in 
paragraph (b) of this section on the information panel.
* * * * *
    3. Section 101.9 is amended by revising paragraph (i) and by adding 
new paragraph (j)(17) to read as follows:


Sec. 101.9  Nutrition labeling of food.

* * * * *
    (i) Except as provided in paragraphs (j)(13) and (j)(17) of this 
section, the location of nutrition information on a label shall be in 
compliance with Sec. 101.2.
    (j) * * *
    (17) Foods in packages that have a total surface area available to 
bear labeling greater than 40 square inches but whose principal display 
panel and information panel do not provide sufficient space to 
accommodate all required information may use any alternate panel that 
can be readily seen by consumers for the nutrition label. The space 
needed for vignettes, designs, and other nonmandatory label information 
on the principal display panel may be considered in determining the 
sufficiency of available space on the principal display panel for the 
nutrition label. Nonmandatory label information on the information 
panel shall not be considered in determining the sufficiency of 
available space for the nutrition label.
* * * * *
    4. Section 101.13 is amended by revising paragraph (j)(2)(iv)(B) to 
read as follows:


Sec. 101.13  Nutrient content claims--general principles.

* * * * *
    (j) * * *
    (2) * * *
    (iv) * * *
    (B) This statement shall appear adjacent to the most prominent 
claim or to the nutrition label, except that if the nutrition label is 
on the information [[Page 17206]] panel, the quantitative information 
may be located elsewhere on the information panel in accordance with 
Sec. 101.2.
* * * * *
    5. Section 101.54 is amended by revising paragraphs (e)(1)(iii)(B) 
and (e)(2)(iii)(B) to read as follows:


Sec. 101.54  Nutrient content claims for ``good source,'' ``high,'' and 
``more.''

* * * * *
    (e) * * *
    (1) * * *
    (iii) * * *
    (B) Quantitative information comparing the level of the nutrient in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``Fiber content of white bread is 1 gram (g) per 
serving; (this product) 3.5 g per serving'') is declared adjacent to 
the most prominent claim or to the nutrition label, except that if the 
nutrition label is on the information panel, the quantitative 
information may be located elsewhere on the information panel in 
accordance with Sec. 101.2.
    (2) * * *
    (iii) * * *
    (B) Quantitative information comparing the level of the nutrient in 
the product per specified weight with that of the reference food that 
it replaces (e.g., ``The fiber content of `X brand of product' is 2 g 
per 3 oz. This product contains 4.5 g per 3 oz.'') is declared adjacent 
to the most prominent claim or to the nutrition label, except that if 
the nutrition label is on the information panel, the quantitative 
information may be located elsewhere on the information panel in 
accordance with Sec. 101.2.
    6. Section 101.56 is amended by revising paragraphs (b)(3)(ii), 
(c)(1)(ii)(B), (c)(2)(ii)(B), and (g) to read as follows:


Sec. 101.56  Nutrient content claims for ``light'' or ``lite.''

* * * * *
    (b) * * *
    (3) * * *
    (ii) Quantitative information comparing the level of calories and 
fat content in the product per labeled serving size with that of the 
reference food that it replaces (e.g., ``lite cheesecake--200 calories, 
4 grams (g) fat per serving; regular cheesecake--300 calories, 8 g fat 
per serving'') is declared adjacent to the most prominent claim or to 
the nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located 
elsewhere on the information panel in accordance with Sec. 101.2; and
* * * * *
    (c) * * *
    (1) * * *
    (ii) * * *
    (B) Quantitative information comparing the level of sodium per 
labeled serving size with that of the reference food that it replaces 
(e.g., ``lite soy sauce 500 milligrams (mg) sodium per serving; regular 
soy sauce 1,000 mg per serving'') is declared adjacent to the most 
prominent claim or to the nutrition label, except that if the nutrition 
label is on the information panel, the quantitative information may be 
located elsewhere on the information panel in accordance with 
Sec. 101.2.
    (2) * * *
    (ii) * * *
    (B) Quantitative information comparing the level of sodium per 
labeled serving size with that of the reference food that it replaces 
(e.g., ``lite canned peas, 175 mg sodium per serving; regular canned 
peas 350 mg per serving'') is declared adjacent to the most prominent 
claim or to the nutrition label, except that if the nutrition label is 
on the information panel, the quantitative information may be located 
elsewhere on the information panel in accordance with Sec. 101.2.
* * * * *
    (g) The term ``lightly salted'' may be used on a product to which 
has been added 50 percent less sodium than is normally added to the 
reference food as described in Sec. 101.13(j)(1)(i)(B) and 
(j)(1)(ii)(B), provided that if the product is not ``low in sodium'' as 
defined in Sec. 101.61(b)(4), the statement ``not a low sodium food,'' 
shall appear adjacent to the nutrition label of the food bearing the 
claim, or, if the nutrition label is on the information panel, it may 
appear elsewhere on the information panel in accordance with Sec. 101.2 
and the information required to accompany a relative claim shall appear 
on the label or labeling as specified in Sec. 101.13(j)(2).
    7. Section 101.60 is amended by revising paragraphs (b)(4)(ii)(B), 
(b)(5)(ii)(B), (c)(4)(ii)(B), and (c)(5)(ii)(B) to read as follows:


Sec. 101.60  Nutrient content claims for the calorie content of foods.

* * * * *
    (b) * * *
    (4) * * *
    (ii) * * *
    (B) Quantitative information comparing the level of the nutrient 
per labeled serving size with that of the reference food that it 
replaces (e.g., ``Calorie content has been reduced from 150 to 100 
calories per serving.'') is declared adjacent to the most prominent 
claim or to the nutrition label, except that if the nutrition label is 
on the information panel, the quantitative information may be located 
elsewhere on the information panel in accordance with Sec. 101.2.
* * * * *
    (5) * * *
    (ii) * * *
    (B) Quantitative information comparing the level of the nutrient in 
the product per specified weight with that of the reference food that 
it replaces (e.g., ``Calorie content has been reduced from 108 calories 
per 3 oz to 83 calories per 3 oz.'') is declared adjacent to the most 
prominent claim or to the nutrition label, except that if the nutrition 
label is on the information panel, the quantitative information may be 
located elsewhere on the information panel in accordance with 
Sec. 101.2.
* * * * *
    (c) * * *
    (4) * * *
    (ii) * * *
    (B) Quantitative information comparing the level of the sugar in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``Sugar content has been lowered from 8 g to 6 g per 
serving.'') is declared adjacent to the most prominent claim or to the 
nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located 
elsewhere on the information panel in accordance with Sec. 101.2.
    (5) * * *
    (ii) * * *
    (B) Quantitative information comparing the level of the nutrient in 
the product per specified weight with that of the reference food that 
it replaces (e.g., ``Sugar content has been reduced from 17 g per 3 oz 
to 13 g per 3 oz.'') is declared adjacent to the most prominent claim 
or to the nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located 
elsewhere on the information panel in accordance with Sec. 101.2.
    8. Section 101.61 is amended by revising paragraphs (b)(6)(ii)(B), 
(b)(7)(ii)(B), and (c)(2)(iii) to read as follows:


Sec. 101.61  Nutrient content claims for the sodium content of foods.

* * * * *
    (b) * * *
    (6) * * *
    (ii) * * *
    (B) Quantitative information comparing the level of the sodium in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``Sodium content has been lowered from 300 to 150 mg 
per serving.'') is declared adjacent to the most prominent claim or to 
the nutrition label, except that if the nutrition label is on the 
information [[Page 17207]] panel, the quantitative information may be 
located elsewhere on the information panel in accordance with 
Sec. 101.2.
* * * * *
    (7) * * *
    (ii) * * *
    (B) Quantitative information comparing the level of sodium in the 
product per specified weight with that of the reference food that it 
replaces (e.g., ``Sodium content has been reduced from 217 mg per 3 oz 
to 150 mg per 3 oz.'') is declared adjacent to the most prominent claim 
or to the nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located 
elsewhere on the information panel in accordance with Sec. 101.2.
* * * * *
    (c) * * *
    (2) * * *
    (iii) If the food is not sodium free, the statement, ``not a sodium 
free food'' or ``not for control of sodium in the diet'' appears 
adjacent to the nutrition label of the food bearing the claim, or, if 
the nutrition label is on the information panel, it may appear 
elsewhere on the information panel in accordance with Sec. 101.2.
* * * * *
    9. Section 101.62 is amended by revising paragraphs (b)(4)(ii)(B), 
(b)(5)(ii)(B), (c)(4)(ii)(B), (c)(5)(ii)(B), (d)(1)(ii)(F)(2), 
(d)(2)(iii)(E)(2), (d)(2)(iv)(E)(2), (d)(4)(i)(C)(2), (d)(4)(ii)(D)(2), 
(d)(5)(i)(C)(2), and (d)(5)(ii)(D)(2) to read as follows:


Sec. 101.62  Nutrient content claims for fat, fatty acid, and 
cholesterol content of foods.

* * * * *
    (b) * * *
    (4) * * *
    (ii) * * *
    (B) Quantitative information comparing the level of fat in the 
product per labeled serving with that of the reference food that it 
replaces (e.g., ``Fat content has been reduced from 8 g to 4 g per 
serving.'') is declared adjacent to the most prominent claim or to the 
nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located 
elsewhere on the information panel in accordance with Sec. 101.2.
* * * * *
    (5) * * *
    (ii) * * *
    (B) Quantitative information comparing the level of fat in the 
product per specified weight with that of the reference food that it 
replaces (e.g., ``Fat content has been reduced from 7.5 g per 3 oz to 5 
g per 3 oz.'') is declared adjacent to the most prominent claim, to the 
nutrition label, or, if the nutrition label is located on the 
information panel, it may appear elsewhere on the information panel in 
accordance with Sec. 101.2.
* * * * *
    (c) * * *
    (4) * * *
    (ii) * * *
    (B) Quantitative information comparing the level of saturated fat 
in the product per labeled serving with that of the reference food that 
it replaces (e.g., ``Saturated fat reduced from 3 g to 1.5 g per 
serving'') is declared adjacent to the most prominent claim or to the 
nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located 
elsewhere on the information panel in accordance with Sec. 101.2.
* * * * *
    (5) * * *
    (ii) * * *
    (B) Quantitative information comparing the level of saturated fat 
in the product per specified weight with that of the reference food 
that it replaces (e.g., ``Saturated fat content has been reduced from 
2.5 g per 3 oz to 1.7 g per 3 oz.'') is declared adjacent to the most 
prominent claim or to the nutrition label, except that if the nutrition 
label in on the information panel, the quantitative information may be 
located elsewhere on the information panel in accordance with 
Sec. 101.2.
* * * * *
    (d) * * *
    (1) * * *
    (ii) * * *
    (F) * * *
    (2) Quantitative information comparing the level of cholesterol in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``Contains no cholesterol compared with 30 mg 
cholesterol in one serving of butter. Contains 13 g of fat per 
serving.'') is declared adjacent to the most prominent claim or to the 
nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located 
elsewhere on the information panel in accordance with Sec. 101.2.
    (2) * * *
    (iii) * * *
    (E) * * *
    (2) Quantitative information comparing the level of cholesterol in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``Cholesterol lowered from 30 mg to 5 mg per serving; 
contains 13 g of fat per serving.'') is declared adjacent to the most 
prominent claim or to the nutrition label, except that if the nutrition 
label is on the information panel, the quantitative information may be 
located elsewhere on the information panel in accordance with 
Sec. 101.2.
    (iv) * * *
    (E) * * *
    (2) Quantitative information comparing the level of cholesterol in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``Cholesterol lowered from 30 mg to 5 mg per serving; 
contains 13 g of fat per serving.'') is declared adjacent to the most 
prominent claim or to the nutrition label, except that if the nutrition 
label is on the information panel, the quantitative information may be 
located elsewhere on the information panel in accordance with 
Sec. 101.2.
* * * * *
    (4) * * *
    (i) * * *
    (C) * * *
    (2) Quantitative information comparing the level of cholesterol in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``[labeled product] 50 mg cholesterol per serving; 
[reference product] 30 mg cholesterol per serving'') is declared 
adjacent to the most prominent claim or to the nutrition label, except 
that if the nutrition label is on the information panel, the 
quantitative information may be located elsewhere on the information 
panel in accordance with Sec. 101.2.
    (ii) * * *
    (D) * * *
    (2) Quantitative information comparing the level of cholesterol in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``Cholesterol lowered from 55 mg to 30 mg per serving. 
Contains 13 g of fat per serving.'') is declared adjacent to the most 
prominent claim or to the nutrition label, except that if the nutrition 
label is on the information panel, the quantitative information may be 
located elsewhere on the information panel in accordance with 
Sec. 101.2.
* * * * *
    (5) * * *
    (i) * * *
    (C) * * *
    (2) Quantitative information comparing the level of cholesterol in 
the product per specified weight with that of the reference food that 
it replaces (e.g., ``Cholesterol content has been reduced from 35 mg 
per 3 oz to 25 mg per 3 oz.'') is declared adjacent to the most 
prominent claim or to the nutrition label, except that if the nutrition 
label is on the information panel, the quantitative information may be 
located elsewhere on the information panel in accordance with 
Sec. 101.2. [[Page 17208]] 
    (ii) * * *
    (D) * * *
    (2) Quantitative information comparing the level of cholesterol in 
the product per specified weight with that of the reference food that 
it replaces (e.g., ``Cholesterol lowered from 30 mg to 22 mg per 3 oz 
of product.'') is declared adjacent to the most prominent claim or to 
the nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located 
elsewhere on the information panel in accordance with Sec. 101.2.
* * * * *
    Dated: March 24, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-8067 Filed 3-31-95; 4:32 pm]
BILLING CODE 4160-01-P