[Federal Register Volume 62, Number 249 (Tuesday, December 30, 1997)]
[Proposed Rules]
[Pages 67775-67780]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33926]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 94P-0168]


Food Labeling; Serving Sizes; Reference Amount and Serving Size 
Declaration for Hard Candies, Breath Mints

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
the nutrition labeling regulations to change the label serving size for 
the product category ``Hard candies, breath mints'' to one unit. This 
action is in response to a petition to provide a serving size for 
breath mints that more accurately reflects the amount customarily 
consumed per eating occasion. In a related issue, FDA is proposing to 
allow the declaration of caloric amounts of less than 5 calories in the 
nutrition label.

DATES: Submit written comments by March 16, 1998. Submit written 
comments on the information collection provisions by January 29, 1998. 
See Section V of this document for the proposed effective date of a 
final rule based on this document.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.
    Submit written comments on the information collection provisions to 
the Office of Information and Regulatory Affairs, Office of Management 
and Budget (OMB), New Executive Office Bldg., 725 17th St. NW., rm. 
10235, Washington, DC 20503, Attn: Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Ellen M. Anderson, Center for Food 
Safety and Applied Nutrition (HFS-165), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-5662.

SUPPLEMENTARY INFORMATION:

I. Background

    In response to the Nutrition Labeling and Education Act 
(hereinafter referred to as ``the 1990 amendments''), FDA, among other 
actions, issued a proposal on serving sizes (56 FR 60394, November 27, 
1991). FDA proposed a reference amount customarily consumed per eating 
occasion (hereinafter referred to as ``reference amount'') of 15 grams 
(g) for ``Baking candies * * * and hard candies'' but no separate 
reference amount for breath mints (56 FR 60394 at 60419).
    The agency received several comments from hard candy manufacturers 
opposing the uniform 15-g reference amount for hard candies (58 FR 2229 
at 2266, January 6, 1993). The comments stated that the 15-g reference 
amount would result in the serving size of breath mints being the 
entire package, and that, therefore, breath mints should have a 
separate smaller reference amount. Most comments recommended a 
reference amount of one piece. One comment disagreed, however, arguing 
that several pieces may be consumed during one eating occasion. None of 
the comments that requested a reference amount based on pieces included 
any data to support their request.
    One comment submitted data from a home use mail survey that 
supported 2 g as the customarily consumed amount for large breath 
mints. FDA carefully examined the data from this survey and noted that 
it only tested the manufacturer's own brands of candies and breath 
mints. However, in the final rule for serving sizes, because these data 
were the only breath mint data available to FDA, the agency created a 
separate product category for ``Hard candies, breath mints'' with a 
reference amount of ``2 g'' (58 FR 2229 at 2297). The 2 g reflected the 
weight of one breath mint (Ref. 1).

II. The Petition and Other Communications

    FDA received a petition dated April 20, 1994 (Docket No. 94P-0168), 
from Ferrero USA, Inc., requesting that the agency amend the product 
category for ``Sugars and Sweets: Hard candies, breath mints'' to 
create a separate product category with a 0.5-g reference amount for 
small breath mints (weighing 0.5 g or less) that fulfill the same 
breath-freshening function as a larger mint. The manufacturer submitted 
study data not only on small breath mints but also on five large breath 
mint products. The manufacturer asserted that the data establish that 
their small breath mints (0.38 g each) are consumed one mint at a time, 
and that the majority of consumers never eat 2 g of small breath mints, 
equivalent to five mints, during an entire day.
    The company also stated that consumers chose the small breath mints 
for their breath freshening ability and lower caloric content. The 
manufacturer stated that their trademarked slogan has been ``The 1 1/2 
calorie breath mint,'' based on a serving size of ``1 mint,'' and that 
changing this slogan would result in an economic hardship. The 
petitioner concluded that the serving size for small breath mints 
should be ``1 mint'' and requested that FDA create a separate product 
category for small breath mints with a reference amount of 0.5 g.
    The agency received correspondence opposed to, and in support of, 
this petition. The opposing comments (Docket No. 94P-0168, comments 1 
and 2) stated: (1) That the facts presented in the petition did not 
support the 0.5 g (one mint) reference amount because nearly half of 
the users surveyed consumed two or more mints per occasion; (2) that 
the attempt to establish such an extremely narrow reference category to 
accommodate a single product runs counter to one of the principal 
objectives of the 1990 amendments, to provide consistency in labeled 
serving sizes among comparable and interchangeable products; (3) that 
``breath-freshening function'' is not the

[[Page 67776]]

statutory standard for the reference amount category and would 
inappropriately require FDA to apply subjective criteria to determine 
the correct product category for small breath mints; (4) that basing 
the reference amount on breath-freshening function would be a dangerous 
precedent for the agency because, unlike artificial sugar and salt 
substitutes, there is no established methodology for determining 
breath-freshening function; (5) that granting the petition could result 
in the agency being inundated by requests for new or alternate serving 
sizes for products purporting to have a functional property; and (6) 
that the petitioner was making a mockery of FDA's petition process by 
already using an illegal ``1 mint'' serving size.
    In rebuttal (Docket No. 94P-0168, amendment 1 and comment 3), the 
petitioner argued: (1) That the change recommended in the petition 
would make it easier for breath mint consumers to compare the 
nutritional composition of competing breath mint products, regardless 
of size, on a per mint basis; (2) that comparison on a mint-to-mint 
basis is in keeping with the intent of the 1990 amendments because it 
would accurately reflect the customarily consumed amounts of small 
breath mints that are comparable to large mints in terms of breath 
freshening; (3) that the functional utility of breath mints is a 
necessary element of the product category definition because the 
consumption behavior of consumers is directly related to this 
functional utility, analogous to other functional food products such as 
artificial sweeteners and salt substitutes; (4) that the burden of 
determining breath-freshening ability would be on the manufacturer and 
not on FDA; (5) that there is a well-established and accepted 
scientific methodology for testing breath malodor (included in the 
petition); (6) that the underlying concept in reference amount issues 
is the amount customarily consumed; and (7) that the data conclusively 
establish that, for the specific product researched, the majority of 
consumers eat one mint per eating occasion to attain the same breath-
freshening benefit they would attain by consuming one larger breath 
mint.
    In addition, the agency received letters from two other 
manufacturers of breath mint products requesting a ``1 mint'' serving 
size. FDA received one letter and spoke with a manufacturer of breath 
mints that are even smaller (0.13 g each) than those discussed in the 
petition (Refs. 2 and 3). The letter indicated that under current 
regulations, the serving size for the company's product would need to 
be expressed as ``15 pieces (2 g).'' The manufacturer stated that the 
tablets are promoted as breath mints, that they have been specially 
formulated to be extremely potent, and that it is the manufacturer's 
intent that the consumer need only use one tablet per occasion to 
achieve fresh breath. The manufacturer objected to the 2-g reference 
amount because it felt it would be subject to unlimited liability if 
the serving size remains 15 tablets for its ``extremely potent'' breath 
mint product. The company requested that it be permitted to express the 
serving size as one piece. No data were submitted with the request.
    The agency received another letter from a manufacturer of breath 
mints that are larger (0.67 g each) than those discussed in the 
petition (Ref. 4). This letter stated that, in accordance with current 
regulations, the serving size for the company's product is expressed as 
``3 pieces (2 g).'' The manufacturer stated that the mints are 
characterized by strong flavor and are typically consumed one at a 
time. The manufacturer objected to being required to list their serving 
size as three mints if larger and smaller mints would be permitted to 
use a one mint serving size. The manufacturer stated that it would 
support a proposal to establish a one mint serving size for breath 
mints. No data were submitted in this letter.

III. Basis for the Proposed Action on Serving Size

A. Evaluation of the Appropriateness of the Current Serving Size 
Declaration on the Label of Small Breath Mints

    As discussed in section I of this document, in the final rule for 
serving sizes (58 FR 2229 at 2297), data on large breath mints were 
used to establish the 2-g reference amount for the ``Hard candies, 
breath mints'' product category.
    FDA has carefully reviewed the evidence (e.g., study design, 
results, conclusions) supporting the petitioner's request that FDA 
create a product category for small breath mints with a reference 
amount of 0.5 g (Refs. 5, 6, and 7). The analysis submitted with the 
petition was based on ``the number of pieces put into the mouth at one 
time.'' However, reference amounts are based on ``amounts customarily 
consumed per eating occasion.'' Therefore, FDA reanalyzed the data to 
estimate the number of mints customarily consumed at a single eating 
occasion. The number of pieces put into the mouth at one time may not 
always represent the number of pieces customarily consumed at a single 
eating occasion. For example, a person may eat 10 jelly beans within a 
few minutes but may only put one piece in his or her mouth at a time 
and finish each one before eating another. This situation would still 
represent 10 jelly beans eaten during a single eating occasion.
    Based on the agency's reanalysis of the data, FDA determined that, 
when compared with larger breath mints, people typically eat more small 
breath mints at a single eating occasion. The agency calculated that 
the mean, median, and modal intakes in the petitioner's survey round to 
two mints customarily consumed per eating occasion. This is greater 
than the one mint reported by the petitioner, but much less than the 
serving size declaration of five breath mints currently required on the 
label. Therefore, the data suggest that serving sizes near 2 g are too 
large for small breath mint products.

B. Consideration of a Different Reference Amount for Breath Mints

    Many of the issues raised by the petitioner and in comments 
objecting to the petition (e.g., marketing position, trademarked 
slogan, and established serving size declarations) are irrelevant with 
regard to determining the reference amount customarily consumed per 
eating occasion.
    ``Breath-freshening'' functionality is important in selecting the 
appropriate product category (e.g., ``Hard candies, breath mints'' as 
opposed to ``Hard candies, other''). However, neither the petition nor 
the comments demonstrated that ``breath freshening efficacy'' and 
``breath malodor elimination'' are related to consumption. Therefore, 
the extent of breath freshening of these various products is immaterial 
in terms of establishing an appropriate reference amount for the 
product category ``Hard candies, breath mints.''
    Based on the current reference amount of 2 g for the ``Hard 
candies, breath mints'' product category, the various breath mint 
products discussed with the agency would have the following serving 
sizes:

                Table 1.--Serving Sizes for Breath Mints                
------------------------------------------------------------------------
                                                                        
------------------------------------------------------------------------
Large breath mints....................................     1 mint (2 g) 
Medium breath mints...................................    3 mints (2 g) 
Small breath mints....................................    5 mints (2 g) 
Very small breath mints...............................   15 mints (2 g) 
------------------------------------------------------------------------

    In response to the petition, FDA has considered various options for 
the breath mint product category and the

[[Page 67777]]

advantages and disadvantages of the various approaches. The agency 
searched for a rationale that is applicable to all breath mint products 
and that would not penalize small manufacturers who cannot easily 
obtain supportive data.
    Because consumption is the basis for establishing a reference 
amount, the objection in the opposing comments that nearly half of the 
users surveyed consumed two or more mints per occasion remains a valid 
concern. As stated earlier, FDA's reanalysis of the data on small 
breath mints suggests that the consumption per eating occasion is, in 
fact, closer to two mints than to one mint (Ref. 5).
    However, FDA is not convinced that creating a separate category for 
small breath mints in Table 2 of Sec. 101.12 (b) (21 CFR 101.12(b)), as 
suggested by the petitioner, is the most reasonable option for 
achieving appropriate serving sizes for labeling all of the different 
breath mint products on the market. The agency is reluctant to create a 
0.5 g-reference amount for small breath mints (as requested by the 
petitioner) or a reference amount equivalent to ``2 pieces'' (as 
supported by the data). These options may not be appropriate for other 
breath mint products and could result in a proliferation of requests 
for additional product categories for other breath mints. This action 
could evolve into reference amounts that are brand dependent (e.g., 
separate reference amounts for each size or brand of breath mints) and 
would require each manufacturer to obtain independent data to 
demonstrate how their particular product is used.
    The agency is not convinced by the data presented that there is 
justification for revising the current reference amount of 2 g because 
the majority of breath mint packages sold to consumers contain breath 
mints whose weight is closer to 2 g (the weight of large breath mints) 
than to any other value (Ref. 8). Furthermore, as discussed in section 
III.A of this document, the data available to the agency indicate that 
some people may consume more small breath mints than large breath mints 
at a single eating occasion, resulting in an amount consumed that is 
greater than the weight of an individual small breath mint. 
Accordingly, FDA tentatively concludes that there is not a sufficient 
basis for revising the current reference amount of ``2 g.''
    However, the agency is concerned about the apparent 
inappropriateness of the resulting serving sizes on the labels of small 
and very small breath mints (e.g., 5 small breath mints or 15 very 
small breath mints per serving). The comments that the agency has 
received from manufacturers, as well as the limited consumption data 
available to FDA, all suggest that the products were designed to be 
consumed singly or in small numbers, and that consumers do, in fact, 
limit their consumption to such amounts.
    Therefore, the agency is persuaded that it is worthwhile to 
consider requiring the serving size on the label of all breath mints to 
be declared as one mint to more accurately reflect consumption across 
the broad spectrum of breath mint sizes, rather than declaring the 
serving size in terms of the number of mints closest to the 2-g 
reference amount, an amount reflective of products at only one end of 
the spectrum. A way to accomplish this approach would be to revise 
Footnote 9 to Table 2 in Sec. 101.12 to require the serving size 
declaration on the label of breath mints to be expressed as ``1 piece 
(____ g)'' similar to the current declaration of ice cream cones, eggs, 
and chewing gum but to keep 2 g as the reference amount.
    This action would allow comparison of breath mints on a mint-to-
mint basis and would more accurately reflect consumption of this type 
of product. A serving size declaration of ``1 mint (2 g)'' would 
continue to reflect the consumption data for the large breath mints 
that were the basis for the current reference amount. In addition, for 
the petitioner's small breath mints, a serving size declaration of ``1 
mint (0.4 g)'' is closer to the amount consumed (i.e., 2 mints based on 
FDA's reanalysis) than a declaration of ``5 mints (2 g).''
    Accordingly, while proposing to maintain a fixed value (2 g) as the 
reference amount, FDA is proposing to revise Sec. 101.12, Table 2, 
Footnote 9 to state ``Label serving sizes for ice cream cones, eggs, 
and breath mints of all sizes will be 1 unit.'' Such action will allow 
for efficient enforcement of the act by maintaining one subcategory in 
Table 2 for all breath mints, yet it will prevent consumer confusion 
that could result from inappropriately high numbers of pieces specified 
for a serving on the nutrition label.
    At the same time, by maintaining a fixed value (2 g) as the 
reference amount, this action provides for a consistent basis for 
nutrient content and health claims, although in all likelihood the 
reference amount will have little impact on most claims. For example, 
because the reference amount is small (i.e., 30 g or less or 2 
tablespoons or less), products making ``low'' claims (e.g., ``low 
calorie'') must meet the claim criteria based not only on the amount of 
the nutrient per reference amount but also per 50 g of product. The per 
50-g criterion will be the most difficult for breath mints to meet and 
will, therefore, be the determining factor. For ``free'' claims, 
products must meet the claim criteria based on the amount of the 
nutrient per serving size (one piece) and per reference amount (2 g). 
Thus, a ``calorie free'' claim would only be permitted on products 
containing less than 5 calories per breath mint and per 2 g of breath 
mints (e.g., in the case of small breath mints, the product would have 
to have less than 5 calories per five pieces, so a small breath mint 
with 1 1/2 calories per mint would not be ``calorie free'').

IV. Basis for the Proposed Action on Declaration of Calories

    FDA's regulations permit a claim about the amount of a nutrient in 
a product (e.g., ``1 tablet has 5 calories'') provided that: (1) It is 
a factual statement that is not false or misleading; and (2) it does 
not in any way implicitly characterize the level of the nutrient as 
being high or low (Sec. 101.13(i)(3)). In addition, the amount claimed 
must be accompanied by a referral statement (e.g., ``See back panel for 
nutrition information'') (Sec. 101.13(g)). These claims may be based on 
the amount of the nutrient in a serving or unit of the product. To not 
be misleading, claims based on the amount of nutrient in a unit (e.g., 
one mint) must identify the unit if the serving size declared on the 
label is not one unit.
    Under the agency's nutrition labeling regulations, products 
containing less than 5 calories per serving must either declare the 
calories to the nearest 5-calorie increment, i.e., as ``5 calories,'' 
or as ``0'' (Sec. 101.9(c)(1)). Accordingly, calorie values of 2.49 or 
less per serving would always be declared in the nutrition label as 
``0,'' while values of 2.5 to 4.99 calories could be declared as ``0'' 
or rounded to ``5.'' FDA set the rounding rules because it concluded 
that the caloric contribution of foods could not be determined with 
sufficient accuracy to justify smaller increments (55 FR 29487 at 
29503, July 19, 1990). In addition, FDA concluded that amounts of less 
than 5 calories per serving are trivial and of no physiological 
significance (56 FR at 60421 at 60438, November 27, 1991).
    The agency is aware, however, that amount claims are being made 
under Sec. 101.13(i)(3) on labels of breath mints stating that the 
mints have 1 1/2 calories, a specific amount that is not allowed to be 
declared on the nutrition label.
    While the regulations do not specifically state that the 
quantitative

[[Page 67778]]

amount specified in an amount claim must be consistent with the amount 
declared on the nutrition label, the agency has stated its belief in 
the importance of consistency between nutrient content claims and 
information in the nutrition label to prevent consumer confusion 
(technical amendments published on August 18, 1993 (58 FR 44020 at 
44024)). This expectation of consistency appears to have been shared by 
at least one comment who suggested that ``FDA should permit the use of 
amount and percentage statements to convey information regarding the 
calorie content per serving of food, consistent with the number of 
calories that appear on the nutrition panel'' (58 FR 2302 at 2309).
    FDA still considers the difference between 0 and 5 calories to be 
insignificant. However, the agency does not consider it likely that 
consumers would be misled by a calorie declaration of less than 5 
calories. Results of an FDA nutrition label format study found that 
consumers respond to the absolute size of numbers used to describe 
nutrient amounts. Subjects estimated the significance of all small 
numbers as small (Refs. 9 and 10).
    Therefore, the agency tentatively concludes that consumers will 
interpret any specific calorie declaration of less than 5 calories as 
implying that the food has an insignificant amount of calories. To 
resolve the discrepancy of declaring 0 calories on the nutrition label 
and amounts such as 1, 1.5, or 2 calories in an amount claim elsewhere 
on the label and to allow manufacturers more flexibility in label 
statements, FDA is proposing to modify Sec. 101.9(c)(1) to state that, 
if a manufacturer provides a claim about the amount of calories in a 
food for which a serving of a product contains less than 5 calories per 
serving, e.g., ``1 calorie per mint,'' the number of calories declared 
in the nutrition label shall be consistent with the amount declared in 
the claim. FDA is also proposing to amend Sec. 101.9(c)(1) to allow the 
nutrition label on any product with less than 5 calories per serving to 
optionally declare the exact amount of calories in lieu of zero 
calories. This added flexibility will allow any products with less than 
5 calories per serving to declare the exact amount of calories rather 
than just those products that make amount claims on the label.

V. Effective Date

    The agency periodically establishes by final rule in the Federal 
Register uniform effective dates for compliance with food labeling 
requirements (see, e.g., the Federal Register of December 27, 1996 (61 
FR 68145)). FDA proposes that any final rule that may issue based upon 
this proposal become effective in accordance with a uniform effective 
date for compliance with food labeling requirements, which is 
established by final rule in the Federal Register and which is not 
sooner than 1 year following publication of any final rule based upon 
this proposal. The final rule would apply to affected products 
initially introduced or initially delivered for introduction into 
interstate commerce on or after its effective date. However, FDA notes 
that it generally encourages industry to comply with new labeling 
regulations as quickly as feasible. Thus, when industry members 
voluntarily change their labels, it is appropriate that they respond to 
any new requirements that have been published as final regulations up 
to that time. On the other hand, if any industry members can foresee 
that the proposed effective date will create particular problems, they 
should bring these problems to the agency's attention in comments on 
this proposal.

VI. Environmental Impact

    The agency has determined under 21 CFR 25.32(p) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VII. Executive Order 12866 Analysis

    FDA has examined the economic implications of the proposed rule as 
required by Executive Order 12866. Executive Order 12866 directs 
agencies to assess all costs and benefits of available regulatory 
alternatives and, when regulation is necessary, to select the 
regulatory approach which maximizes net benefits (including potential 
economic, environmental, public health and safety effects; distributive 
impacts; and equity). Executive Order 12866 classifies a rule as 
significant if it meets any one of a number of specified conditions, 
including having an annual effect on the economy of $100 million or 
adversely affecting in a material way a sector of the economy, 
competition, or jobs, or if it raises novel legal or policy issues. FDA 
finds that this proposed rule is not a significant rule as defined by 
Executive Order 12866.
    This proposed rule will cause the labels of small breath mints to 
be revised. FDA estimates that there are 18 brands and 125 labels of 
breath mints of all sizes. Of those breath mints for which FDA has 
information regarding the size of the product, there are 4 firms 
producing 5 brands of small breath mints, or 30 distinct small breath 
mint labels. For breath mint products, the average administrative, 
redesign, and inventory disposal costs for a labeling change of this 
type, with a 1-year compliance period are $500 per label, or a total of 
$15,000.
    The benefit of this proposed regulation is that manufacturers can 
provide a serving size that is more appropriate for small breath mints 
providing more accurate information to consumers.

VIII. Small Entity Analysis

    FDA has examined the economic implications of the proposed rule as 
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a 
rule has a significant impact on a substantial number of small 
entities, the Regulatory Flexibility Act requires agencies to analyze 
options that would minimize the economic impact of that rule on small 
entities. Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), the 
agency certifies that this proposed rule will not have a significant 
impact on a substantial number of small entities.
    According to the Regulatory Flexibility Act, the definition of a 
small entity is a business independently owned and operated and not 
dominant in its field. The Small Business Administration has set size 
standards for most business categories through use of four-digit 
Standard Industrial Classification codes. FDA estimates that three of 
the firms producing small breath mints are small (under 500 employees). 
One of these small entities is the petitioner. FDA has received 
information from the other two small entities stating that they are in 
favor of granting the petition. Because FDA is providing these small 
entities with exactly what they requested, the agency concludes that 
this rule will not result in a significant impact on a substantial 
number of small entities.

IX. The Paperwork Reduction Act of 1995

    This proposed rule contains information collection requirements 
that are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The title, description, and respondent description of the 
information collection requirements are shown below with an estimate of 
the annual reporting burden. Included in the estimate is the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and

[[Page 67779]]

completing and reviewing each collection of information.
    FDA invites comments on: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
    Title: Nutrition Labeling; Declaration of Caloric Amounts and 
Serving Sizes for Breath Mints.
    Description: Section 403(q) of the act requires that the label or 
labeling of a food bear nutrition information, including information on 
the number of calories present in the product and the serving size and 
number of servings per container. FDA has issued regulations in 
Sec. 101.9(c)(1) that require that the nutrition facts panel of the 
food label disclose the number of calories in the food. FDA has issued 
regulations in Sec. 101.9(d)(3) that require that the nutrition facts 
panel disclose the serving size of the food product and the number of 
servings in each package.
    The regulations set forth in this proposed rule would modify the 
rounding rules for calories in Sec. 101.9(c)(1) to allow the voluntary 
declaration of caloric amounts of less than 5 in the nutrition label. 
The regulations would also require that the number of calories declared 
on the nutrition label of a food product be consistent with any claims 
about caloric content that are made in its labeling. As a result of 
this proposed rule, manufacturers and other producers of products that 
make claims that their products contain between 1 and 5 calories would 
be required to change the declaration of the amount of calories on the 
nutrition label. Finally, as a result of the proposed rule, 
manufacturers of small breath mints would be required, under 
Sec. 101.9(b), to change the serving size disclosed on the labels of 
their products and, under Sec. 101.9(c) and (d), the amounts and daily 
values for nutrients listed in the nutrition label for their products.
    Description of Respondents: Persons and businesses, including small 
businesses.

                                Table 2.--Estimated Additional Reporting Burden<SUP>1                                
----------------------------------------------------------------------------------------------------------------
                                                                                                       Total    
         21 CFR Section               No. of       Total No. of      Hours per      Total Hours      Operating  
                                    Respondents      Responses       Response                          Costs    
----------------------------------------------------------------------------------------------------------------
101.9(b) and (c)(1)                     4              30               1              30         $15,000       
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital or maintenance costs associated with this collection of information.                   

    The proposed modification of the rules for the declaration of the 
amount of calories and the proposed change of the label serving size on 
the nutrition facts panel would result in a one-time burden created by 
the need for firms to revise their labels. In addition to changing the 
statement of calories and the serving sizes, firms would have to 
recalculate the number of servings per container and any nutrient 
amounts and Daily Values affected by the change in serving size. As 
noted in section VII of this document, Executive Order 12866 Analysis, 
FDA is aware of only four firms that currently market small breath 
mints. These are the only firms that would be affected by this proposed 
rule. FDA estimates that there are approximately 30 labels for products 
marketed by these firms that would require revision because of this 
proposed rule. FDA estimates that these firms would require an average 
of 1 hour per label to comply with the requirements of a final rule 
based on this proposal. Further, as discussed in section VII of this 
document, Executive Order 12866 Analysis, the proposed rule would 
result in a one-time operating cost of $500 per label or a total 
estimated operating cost of $15,000.
    In compliance with section 3507(d) of the PRA (44 U.S.C. 3507(d)), 
the agency has submitted the information collection requirements of the 
proposed rule to OMB for review. Interested persons are requested to 
send comments regarding information collection by January 29, 1998, to 
the Office of Information and Regulatory Affairs, OMB (address above), 
ATTN: Desk Officer for FDA.

X. Comments

    Interested persons may, on or before March 16, 1998, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.

XI. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Memorandum to file, from Lori A. LeGault and Ellen M. 
Anderson, Center for Food Safety and Nutrition (CFSAN), FDA, August 
28, 1997.
    2. Letter to F. Edward Scarbrough, CFSAN, FDA, from Richard J. 
Litner, Nutrinfo Corp., August 24, 1994.
    3. Memorandum of telephone conversation between Ellen M. 
Anderson, CFSAN, FDA, and Richard J. Litner and David Kiernan, 
Nutrinfo Corp., November 4, 1994.
    4. Letter to F. Edward Scarbrough, CFSAN, FDA, from Sheryl A. 
Marcouiller, Kraft Foods, June 28, 1996.
    5. Memorandum from Sara Fein, CFSAN, FDA, to Lynn McFerron, 
CFSAN, FDA, September 9, 1994.
    6. Memorandum from Sara Fein, CFSAN, FDA, to Lori LeGault, 
CFSAN, FDA, February 5, 1996.
    7. Memorandum to file from Lori A. LeGault and Ellen M. 
Anderson, CFSAN, FDA, August 28, 1997.
    8. Memorandum to file from Thomas B. O'Brien, Mary M. Bender, 
and Ellen M. Anderson, CFAN, FDA, August 28, 1997.
    9. Memorandum from Sara B. Fein, CFSAN, FDA, to Virginia 
Wilkening, CFSAN, FDA, May 13, 1997.
    10. Levy, Alan S., Sara B. Fein, and Raymond E. Schucker, 
``Performance Characteristics of Seven Nutrition Label Formats,'' 
Journal of Public Policy and Marketing, 15 (1)(Spring 1996): 1-15.

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, it is 
proposed that 21 CFR part 101 be amended as follows:

[[Page 67780]]

PART 101--FOOD LABELING

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

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 
343, 348, 371.

    2. Section 101.9 is amended by revising paragraph (c)(1) 
introductory text to read as follows:

Sec. 101.9  Nutrition labeling of food.

* * * * *
    (c) * * *
    (1) ``Calories, total,'' ``Total calories,'' or ``Calories'': A 
statement of the caloric content per serving, expressed to the nearest 
5-calorie increment, up to and including 50 calories, and 10-calorie 
increment above 50 calories, except that amounts less than 5 calories 
may be expressed either as zero or as the exact amount. However, if a 
manufacturer provides a claim under Sec. 101.13(i) about the amount of 
calories in a serving of a product containing less than 5 calories 
(e.g., ``1 calorie per mint''), the number of calories declared in the 
nutrition label shall be consistent with that declared in the amount 
claim (e.g., ``1''). Energy content per serving may also be expressed 
in kilojoule units, added in parentheses immediately following the 
statement of the caloric content.
* * * * *
    3. Section 101.12 is amended in paragraph (b), Table 2, under the 
``Sugars and Sweets'' category by revising the entry for ``Hard 
candies, breath mints'' and Footnote 9 to read as follows:


Sec. 101.12  Reference amounts customarily consumed per eating 
occasion.

* * * * *
    (b) * * *

        Table 2.--Reference Amounts Customarily Consumed Per Eating Occasion: General Food Supply <SUP>1 <SUP>2 <SUP>3 <SUP>4       
----------------------------------------------------------------------------------------------------------------
          Product category                      Reference amount                      Label Statement <SUP>5         
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
Sugars and Sweets:                                                                                              
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
  Hard candies, breath mints <SUP>9        2 g                                   ____ piece(s) (____ g)              
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
----------------------------------------------------------------------------------------------------------------
\1\ These values represent the amount (edible portion) of food customarily consumed per eating occasion and were
  primarily derived from the 1977-1978 and the 1987-1988 Nationwide Food Consumption Surveys conducted by the   
  U.S. Department of Agriculture.                                                                               
\2\ Unless otherwise noted in the Reference Amount column, the reference amounts are for the ready-to-serve or  
  almost ready-to-serve form of the product (i.e, heat and serve, brown and serve). If not listed separately,   
  the reference amount for the unprepared form (e.g., dry mixes; concentrates; dough; batter; fresh and frozen  
  pasta) is the amount required to make the reference amount of the prepared form. Prepared means prepared for  
  consumption (e.g., cooked).                                                                                   
\3\ Manufactures are required to convert the reference amount to the label serving size in a household measure  
  most appropriate to their specific product using the procedures in 21 CFR 101.9(b).                           
\4\ Copies of the list of products for each product category are available from the Office of Food Labeling (HFS-
  150), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C St. SW., Washington,  
  DC 20204.                                                                                                     
\5\ The label statements are meant to provide guidance to manufacturers on the presentation of serving size     
  information on the label, but they are not required. The term ``piece'' is used as a generic description of a 
  discrete unit. Manufacturers should use the description of a unit that is most appropriate for the specific   
  product (e.g., sandwich for sandwiches, cookie for cookies, and bar for ice cream bars). The guidance provided
  is for the label statement of products in ready-to-serve or almost ready-to-serve form. The guidance does not 
  apply to the products which require further preparation for consumption (e.g., dry mixes, concentrates) unless
  specifically stated in the product category, reference amount, or label statement column that it is for these 
  forms of the product. For products that require further preparation, manufacturers must determine the label   
  statement following the rules in Sec.  101.9(b) using the reference amount determined according to Sec.       
  101.12(c).                                                                                                    
\6\ Includes cakes that weigh 10 g or more per cubic inch.                                                      
\7\ Includes cakes that weigh 4 g or more per cubic inch but less than 10 g per cubic inch.                     
\8\ Includes cakes that weigh less than 4 g per cubic inch.                                                     
\9\ Label serving size for ice cream cones, eggs, and breath mints of all sizes will be 1 unit. Label serving   
  size of all chewing gums that weigh more than the reference amount that can reasonably be consumed at a single-
  eating occasion will be 1 unit.                                                                               

 * * * * *

    Dated: December 17, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-33926 Filed 12-29-97; 8:45 am]
BILLING CODE 4160-01-F