[Federal Register Volume 63, Number 5 (Thursday, January 8, 1998)]
[Proposed Rules]
[Pages 1078-1086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-375]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket Nos. 96P-0023 and 96P-0179]
Food Labeling; Serving Sizes; Reference Amounts for Candies
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 modify the product category
``Sugars and Sweets: Hard candies, others'' by adding ``after-dinner
mints, caramels, fondants (e.g., plain mints, candy corn), and liquid
and powdered candies'' as kinds of products included under the
category, and a reference amount customarily consumed per eating
occasion (reference amount) of 15 milliliters (mL) for liquid candies;
create a new product category under ``Sugars and Sweets,'' identified
as ``Chocolate-covered fondants (e.g., chocolate-covered creams,
chocolate-covered mints), taffy, and plain toffee,'' with a reference
amount of 30 grams (g); and clarify what kinds of candies belong to the
``All other candies'' product category by expanding the category name
to include specific examples. This proposal is in response to two
petitions and two letters submitted to the agency. The proposed changes
are based on information provided in the letters and on analyses of the
petitioners' data and of the most recent candy consumption data
available from the U.S. Department of Agriculture's (USDA) 1994 and
1995 Continuing Survey of Food Intakes by Individuals (CSFII).
DATES: Written comments by March 24, 1998. See section V of this
document for the proposed effective date of a final rule based on this
document.
Written comments on the information collection requirements should
be submitted by February 9, 1998.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
[[Page 1079]]
Submit written comments on the information collection requirements
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: Lori A. LeGault, Center for Food
Safety and Applied Nutrition (HFS-165), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5483.
SUPPLEMENTARY INFORMATION:
I. Background
A. Regulatory History
In the Federal Register of July 19, 1990 (55 FR 29517 at 29530),
FDA proposed standard serving sizes for 159 product categories based on
the amount of food commonly consumed per eating occasion by infants,
toddlers (children under 4 years of age), and the general population
(persons 4 years of age or older). The agency proposed a standard
serving size of 1/2 ounce (oz) for ``Baking candies, chips, etc.'' and
1 1/2 oz for ``Candies'' (55 FR 29517 at 29532).
On November 8, 1990, before FDA issued a final rule on serving
sizes, the President signed into law the Nutrition Labeling and
Education Act of 1990 (hereinafter called the 1990 amendments). This
statute amended section 403(q)(1)(A)(i) of the Federal Food, Drug, and
Cosmetic Act (the act) to require that virtually all foods under FDA's
jurisdiction bear nutrition information that is based on a serving size
that reflects the amount of food that is customarily consumed per
eating occasion and that is expressed in a common household measure
that is appropriate to the food (21 U.S.C. 343(q)(1)(A)(i), added to
the act by section 2(a) of the 1990 amendments). The 1990 amendments
also directed FDA to adopt regulations that establish standards for
defining serving sizes (section 2(b)(1)(B) of the 1990 amendments).
In response to the 1990 amendments, FDA, among other actions,
issued a reproposal on serving sizes (56 FR 60394, November 27, 1991).
In this document, FDA proposed standards for deriving a serving size
from the reference amount of a food customarily consumed per eating
occasion (hereinafter referred to as reference amount). FDA also
proposed reference amounts for 131 food product categories.
Specifically, it proposed a reference amount of 15 g for ``Baking
candies (e.g., chips) and hard candies'' and a reference amount of 40 g
for ``All other candies'' (56 FR 60394 at 60419). FDA analyzed USDA
food consumption data from the 1977-1978 Nationwide Food Consumption
Survey (NFCS) (Refs. 1 through 4) and the 1987-1988 NFCS (Ref. 5) and
used these data as the primary basis for determining reference amounts
(Ref. 6).
1. Hard Candies
The agency received several comments from the hard candy industry
opposing the uniform 15-g reference amount for all hard candies
(comment 124, 58 FR 2229 at 2266). The comments stated that the 15-g
reference amount would result in the serving size being the entire
package for breath mints or roll candies. The comments contended that
breath mints and hard roll candies are consumed in much smaller
quantities than other hard candies and should have separate smaller
reference amounts.
After studying all comments and the data submitted, the agency was
persuaded that breath mints, roll-type candies, and mini-size candies
in dispenser-type packages should have separate reference amounts.
Accordingly, in the final rule on serving sizes (58 FR 2229 at 2297,
January 3, 1993) (hereinafter referred to as the serving size final
rule), FDA divided hard candies into the following three product
categories, each with its own reference amount: (1) Hard candies,
breath mints - 2 g; (2) hard candies, roll-type and mini-size in
dispenser-type packages - 5 g; and (3) hard candies, others - 15 g.
2. All Other Candies
FDA also received several comments on the proposal that opposed the
40-g reference amount for all other candies. Some of these comments
recommended a uniform 1-oz reference amount to allow for fast and
accurate nutrition comparisons of different candies (comment 125, 58 FR
2229 at 2267). One comment requested that FDA create a separate product
category for specialty fine chocolates/pralines, with a reference
amount of one piece, and others stated that the proposed reference
amount was too large for ``after dinner mints'' and for fine bonbons
(comment 126, 58 FR 2229 at 2268).
In the serving size final rule, FDA advised that the serving size
on the product label is, by statute, an amount customarily consumed.
None of the comments submitted food consumption data to show that the
amounts customarily consumed of these candies differ from the proposed
reference amount. Therefore, FDA rejected these requests and adopted
the 40-g reference amount for ``All other candies'' (58 FR 2229 at
2268).
B. Food Consumption Data Bases
The proposed and final rules on serving sizes (56 FR 60394 at 60403
and 58 FR 2229 at 2235) discussed FDA's use of food consumption data as
the primary basis for establishing reference amounts. As stated in
section I.A of this document, the agency based its values on data from
national food consumption data bases, specifically the USDA 1977-1978
NFCS (Refs. 1 through 4) and the 1987-1988 NFCS (Ref. 5), that
contained food intake data for individuals. These data were
representative of the food consumption practices of the three age
groups of interest (i.e., infants, toddlers, and the general population
4 years of age and older). The agency also used the 1985-1986 CSFII
(Refs. 7 and 8) to confirm that apparent trends observed between the
1977-1978 NFCS data and the 1987-1988 NFCS data were not artifacts of
the low response rate to the 1987-1988 survey. In the proposed rule on
serving sizes (56 FR 60394 at 60403), the agency discussed its
selection of these data bases and the advantages and disadvantages of
the various sources of data. In the serving size final rule (58 FR 2229
at 2236), FDA responded to comments supporting and objecting to the
data bases selected.
Since publication of the serving size final rule in 1993, USDA has
made available data from the 1989-1991 CSFII and data for 1994 and 1995
from the 1994-1996 CSFII. The first 2 years of the 1994-1996 CSFII
contain the most recent nationwide food consumption data available and
have a large sample size and high response rate. The 1994 CSFII
contains data on 5,589 individuals with 1-day records (80.1 percent
response rate) and on 5,311 individuals with 2-day records (76.2
percent response rate) (Ref. 9). The 1995 CSFII contains data on 5,326
individuals with 1-day records (79.9 percent response rate) and on
5,072 individuals with 2-day records (76.1 percent response rate) (Ref.
10). Some differences in the CSFII 1994-1996, compared with earlier
surveys, include: (1) A target population of noninstitutional
individuals in all 50 States rather than the 48 contiguous States; (2)
the collection of 2-nonconsecutive days of food intake through face-to-
face interviews rather than 3-consecutive days of food intake using a
1-day recall and a 2-day record; (3) subsampling within households
rather than the collection of information from all members of a
household; and (4) tighter management control to minimize nonresponse.
[[Page 1080]]
FDA will use the most recent applicable data to resolve issues
involving reference amounts that are raised in petitions or letters or
that are identified by the agency.
C. The Petitions
1. Mint Candies
The Nutrition Research Group and representatives of Andes Candies,
Inc., (the petitioners) met with FDA on October 27, 1995, to submit a
petition (Docket No. 96P-0023) to the agency. The petition requested
that FDA amend the ``Sugars and Sweets'' product category for ``Hard
candies, others'' to read ``Hard candies, mint wafers, and others,''
and that it change the reference amount for Andes mint wafers and
similar products from 40 g to 15 g. The petition presented study data
from an ``in-home'' consumption survey in support of a reference amount
of 15 g for Andes mint wafer candies. In the survey, each of the 48
participating households received 2 pounds of test product (i.e., Andes
Creme De Menthe Thins). Household members were asked to record each
eating occasion for up to 2 weeks. The survey results consisted of
1,505 eating occasions, where the exact number of pieces eaten was
recorded in a diary during the time of eating. The gram amounts were
determined by multiplying the number of pieces eaten by the piece
weight of 4.8 g. The study reported the mean (i.e., average) as 16.94
g, median (i.e., 50th percentile value) as 14.4 g, and mode (i.e., most
frequently consumed amount) as 10 g for the amount consumed per eating
occasion.
The petitioners also provided data from the 1989-1991 CSFII and the
1987-1988 NFCS on the reported eating occasions for food code 917-0540,
``Chocolate, white (include summer coating, Andes Mint Wafers).'' For
the 1989-1991 CSFII, the data contained 23 eating occasions with
consumption values reported as the weighted mean (9.34 g), median (10
g), and mode (10 g). For the 1987-1988 NFCS, the data contained 18
eating occasions with consumption values reported as the weighted mean
(30.01 g), median (15 g), and mode (10 g). The petitioners stated that
the product (i.e., Andes mint wafers) could not be identified in the
1977-1978 NFCS data.
At the October 27, 1995, meeting, FDA asked the petitioners whether
candies other than ``mint wafers'' would fit into the requested product
category and suggested that the petitioners provide examples of these
candies. The agency also questioned the methodology by which the survey
data were analyzed because: (1) The total amount of candy provided to
each household was fixed. Consequently, the reported amounts consumed
for any ``large eaters'' who exhausted their fixed supply of candy were
counted less, because their number of eating occasions was fewer, than
smaller eaters whose candy supply lasted for more eating occasions.
This fact suggests a bias toward smaller consumption values. (2) The
reference amounts are based on the amount customarily consumed per
eating occasion. Therefore, measuring each participant's intake for the
same length of time is important so that each eating occasion is given
the appropriate weight.
The petitioners agreed to reanalyze the data based only on the
first 3 days of consumption to more closely conform with the design of
the USDA food consumption surveys.
On January 18, 1996, the petitioners submitted an addendum
containing the following information: (1) A list of 41 examples of mint
candies (including hard candy mints) that they thought would fit in the
requested product category. The examples included piece sizes and
serving size label statements based on a 15-g reference amount. (2) A
revision to rename the suggested product category as ``Hard candies and
mints, other'' with a reference amount of 15 g. (3) Study data
reanalyzed using only the first 3 days of each household's consumption.
The 3-day data results showed 476 eating occasions and showed the mean
(17.7 g), median (14.4 g), and mode (10 g).
The petitioners submitted a second addendum on October 10, 1996,
containing data on candy consumption that were generated from the 1994
CSFII. The data analysis included both hard and soft individually-
wrapped, small mint candies weighing 15 g or less per piece and
``Mints, not further specified (NFS).'' Hard candy mints that have
reference amounts of 2 g (breath mints) and 5 g (roll-type and mini-
size in dispensers) were excluded. Also excluded, however, were mints
that weigh more than 15 g and mints that are usually not individually
wrapped. The estimates were calculated for 39 eating occasions, and the
weighted data showed the mean (13.91 g), median (15 g), and mode (15
g). The petitioners suggested that a possible description for this
product category would be ``Other hard candies and individually-wrapped
small mints (15 g or less per piece).''
2. Candies Weighing 20 Grams or Less Per Piece
The Chocolate Manufacturers Association (CMA) and the National
Confectioners Association (NCA) jointly submitted a petition (Docket
No. 96P-0179) to FDA on May 30, 1996, requesting that the agency amend
the ``Sugars and Sweets'' product category by establishing a new 25-g
reference amount for candies (other than hard candies or baking
candies) weighing 20 g or less per piece. CMA and NCA presented
combined data derived from two in-home consumption surveys (one for
chocolate candies and one for nonchocolate candies). The surveys
involved 12 types of small-piece (20 g or less) candy products that are
sold either as individually-wrapped pieces (Hershey's Kisses (4.9 g);
Andes Creme De Menthe Thins (4.8 g); Snickers Fun-Size Bars (20 g);
Brach's Milk Maid Caramels (9.65 g); Starburst Fruit Chews (5 g); and
Tootsie Roll Midgees (6.67 g)) or as unwrapped components of larger,
bulk packages (Pangburn's Assorted Chocolates (17 g); Fannie May
Kitchen Fresh Candies (16 g); Perugina Classic Collection Finest
Assorted Chocolates (11.6 g); Farley's Candy Corn (1.47 g); Dae Julie
Gummi Bears (2.22 g); and Farley's Jelly Beans (2.35 g)). The surveys
did not consider hard candies or baking candies, which are already
subject to product-specific reference amounts separate from the ``All
other candies'' product category (Sec. 101.12(b) (21 CFR 101.12(b)),
Table 2). It should be noted that the survey data provided for Andes
Creme De Menthe Thins are the identical data submitted in support of
the petition described in section I.C.1 of this document.
Each of the 652 households that participated in the surveys
received 2 pounds of test product (i.e., one type of candy). Household
members were asked to record each eating occasion and the exact number
of pieces eaten for up to 2 weeks. The gram amounts were determined by
multiplying the number of pieces eaten by the piece weight of the
specific candy. The data consisted of 13,884 eating occasions with the
mean (28.3 g), median (23.2 g), and mode (15 g). Based on FDA's request
of Andes Candies, Inc., CMA and NCA also provided the data for the
first 3 days of each household's consumption. These 3-day data showed
6,124 eating occasions with the mean (29.9 g), median (23.2 g), and
mode (15 g).
CMA and NCA asserted that the subject products are typically
consumed at a level significantly below 40 g, and that the data are
strongly skewed toward lower levels of consumption. CMA and NCA also
stated that the median value (i.e., 23.2 g) is the most appropriate
measure of central tendency for consumption of candies weighing 20 g or
less per piece, and that a way to
[[Page 1081]]
compensate for strongly skewed data is to remove extreme ``outliers''
and to include only data within 2 or 3 standard deviations from the
mean. On this basis, for all eating occasions, CMA and NCA reported
that the mean is reduced from 28.3 g to 26.1 g (data within 3 standard
deviations from the mean) or to 24.1 g (data within 2 standard
deviations from the mean); the median remains at 23.2 g.
CMA and NCA provided a supplement on July 22, 1996, noting that a
small number of individuals in the previously mentioned surveys
consumed very large amounts of the candy (up to 415 g) during a single
eating occasion. These large consumption values raised the mean but did
not otherwise affect the amounts of candy that most consumers ate per
eating occasion, i.e., the large consumption values did not affect the
median or mode. As mentioned in this petition and explained previously,
if the relatively few extreme-upper-end consumers (i.e., outliers more
than 3 standard deviations above the mean) are removed from the
calculation, the mean value of candy consumed drops by several grams,
and the median (as well as the mode) remains the same. CMA and NCA also
emphasized that, while they provided calculations based not only on all
data but also on data with outliers removed from the data set, they
included all data in the petition (i.e., outliers had not been
removed).
CMA and NCA submitted a second supplement on October 1, 1996, in
response to a request from FDA for further explanation of the methods
and rationale for eliminating outliers in evaluating the data contained
in the petition. In addition to addressing the agency's request, the
CMA and NCA cited further statistical support for recommending that,
because the data were strongly skewed, the median value (23.2 g) was
the best measure of central tendency.
D. Written Requests
1. Powdered Candy
After publication of the serving size final rule, two manufacturers
submitted written requests asking the agency to classify powdered
candies in the ``Hard candies, others'' product category with a
reference amount of 15 g (Refs. 11 and 12). This type of product is
frequently sold in clear or colored straws or small packets. Both
manufacturers stated that they had no consumption data available but
agreed that 15 g is a more reasonable reference amount for this type of
candy than the 40-g reference amount for all other candies.
In written responses to both requests, FDA acknowledged that an
appropriate reference amount for flavored and colored powdered candy
had not been specifically included in the January 6, 1993, regulations.
To enable the manufacturers to nutrition label their products, FDA
stated that, until it adopted a reference amount, it would be unlikely
to object to the use of a 15-g reference amount for powdered candy
based on the information that the manufacturers had provided (Refs. 13
and 14). The agency also provided this suggested reference amount in
its August 1993 publication, ``Food Labeling QUESTIONS AND ANSWERS''
(Ref. 15). However, FDA made clear that it intended to undertake notice
and comment rulemaking to establish a reference amount for this product
(Refs. 13 through 15).
2. Liquid Candy
One of the requests regarding powdered candy asked that the agency
classify liquid candy in the ``Hard candies, others'' product category,
with a reference amount of 15 mL (Ref. 11). This type of product is
frequently sold in wax containers containing syrup or flavored liquid.
Although the requester provided no consumption data, it stated that the
syrup is very sweet, and that the 40-g reference amount for all other
candies is unrealistic for this type of candy. In a written response,
FDA acknowledged that an appropriate reference amount for liquid
candies had not been specifically included in the January 6, 1993,
regulations and stated that, to enable the manufacturer to nutrition
label its product, given the information the manufacturer had provided,
it did not intend to object to the use of a 15-mL reference amount for
syrup-filled wax candies (Ref. 13). The agency also provided this
suggested reference amount in its August 1993 publication, ``Food
Labeling QUESTIONS AND ANSWERS'' (Ref. 15). Again, FDA stated that it
intended to undertake notice and comment rulemaking to establish a
reference amount for this product (Refs. 13 and 15).
II. Evaluation of the Petitioners' Data
FDA assessed the supporting evidence (e.g., study design,
estimates, conclusions) submitted by Andes Candies, Inc., and the
supporting evidence submitted by CMA and NCA (Ref. 16). As stated in
section I.C.2 of this document, the consumption data provided in the
Andes Candies petition are identical to the data provided by CMA and
NCA for consumption of Andes Creme de Menthe Thins. Because the survey
data submitted by Andes Candies, Inc., are a subset of the larger
survey data submitted by CMA and NCA, the following evaluation applies
to both petitions.
First, each of the 12 candies surveyed by CMA and NCA was matched
to a specific population profile based on an ``appropriate age ratio
and gender for users.'' The selection of which type of candy was sent
to a given household was determined by whether the household fit the
appropriate profile. If the households had been randomly assigned to
receive one of the 12 candy products, then extraneous factors that
might affect consumption would likely have been equally distributed
over all households in the sample. However, random assignment was
apparently not used. Thus, given that each of the 12 different candy
products had its own distinct demographic profile of users, the
research appears to be a series of 12 smaller surveys containing
approximately 150 completed diaries each. Therefore, FDA questions
whether the sample size for each of the 12 subsamples is large enough
to be representative of the U.S. population or even of the typical
consumers of the different candy products.
Other potential flaws in the surveys relate to the adequacy of the
candy supply and the household size. To determine the amount
customarily consumed per eating occasion, it is important that each
participant has access to the same amount of candy during an equal
period of time, so that the reported amounts consumed can be weighted
properly. Even if the analysis is restricted to the first 3 days of
consumption to be more comparable to the USDA food consumption surveys,
unless: (1) The 2-pound allotment of candy provided to each
participating household was a sufficient supply for the number of
eaters, and (2) no household exhausted its supply within 3 days, there
is a flaw in the design of the surveys. Upon closer analysis, the data
revealed that five households reported eating more than the allotted 2
pounds (907.17 g) of candy during the first 3 days of the data
collection. In addition, the amount of candy delivered to each
participating household was not proportional to the household size. For
example, in the 3-day data, the number of participants per household
varied from one to eight. Clearly, 2 pounds of candy in a household
with one consumer represents far more product per person than does 2
pounds in a household in which there are eight consumers.
Given the methodology questions stated above, the agency has
concerns
[[Page 1082]]
about the reliability and validity of these data. However, FDA
reanalyzed the first 3 days of the data and determined the mean,
median, and modal values for the amounts consumed for each of the 12
types of candies (Ref. 16). The results of the reanalysis showed that
the consumed amounts were not consistent over all 12 candies. Among the
12 types of candies, the reanalysis showed that the consumption values
clustered around five intake amounts. The consumption values for: Andes
Creme De Menthe Thins clustered around 15 g; Hershey's Kisses, Brach's
Milk Maid Caramels, Starburst Fruit Chews, and Tootsie Roll Midgees
clustered around 20 g; Perugina Classic Collection Finest Assorted
Chocolates, Farley's Candy Corn, Dae Julie Gummi Bears, and Farley's
Jelly Beans clustered around 25 g; Pangburn's Assorted Chocolates and
Fanny May Kitchen Fresh Candies clustered around 35 g; and Snickers
Fun-Size Bars clustered around 40 g.
III. Evaluation of the Appropriateness of the 40-Gram Reference
Amount
As discussed in section I.A of this document and in reference 2 to
the proposed and final rules on serving sizes (Ref. 6), FDA determined
in 1991 and 1993 that the food consumption data for candies other than
hard candies and baking candies supported a 40-g reference amount. The
data analysis encompassed a large variety of candy products,
representative of 70 candy food codes from the 1977-1978 NFCS and 107
candy food codes from the 1987-1988 NFCS. Because data submitted in
both petitions that are the subject of this document suggest that some
types of candies may customarily be consumed in amounts significantly
different than 40 g, FDA analyzed data from the 1994 and 1995 CSFII,
the most recent nationwide candy consumption data available to the
agency, to decide whether a change in the reference amount for some
types of candies is warranted.
First, the agency identified the candy food codes in the 1994 and
1995 CSFII data base that were reflective of the candies specified in
the petitions. FDA combined the candies with like characteristics and
categorized the food codes into the following eight candy groups: (1)
Plain chocolate candies; (2) white chocolate (includes summer coating,
Andes Mint Wafers); (3) caramels; (4) candy bars; (5) taffy/toffee,
plain; (6) fondants, plain; (7) fondants, chocolate-covered; and (8)
gel/jellied candies (Ref. 17).
Next, FDA calculated the consumption amounts for each of the eight
groups. Based on the general principles that FDA considered in
developing the reference amounts and the procedures that FDA used to
apply these principles, described in the 1991 proposed rule on serving
sizes (56 FR 60394 at 60402 through 60406) and in reference 2 to the
proposed and final rules on serving sizes (Ref. 6), the data revealed
that the eight groups resolved into three groupings. The amount
consumed for: (1) White chocolate (includes summer coating, Andes Mint
Wafers), caramels, and plain fondants reflected a reference amount of
15 g (equivalent to 0.5 oz), rather than 40 g; (2) chocolate-covered
fondants, taffy, and plain toffee reflected a reference amount of 30 g
(equivalent to 1 oz), rather than 40 g; and (3) all the remaining candy
types (i.e., plain chocolate candies, candy bars, and gel/jellied
candies) reflected a reference amount of 40 g (equivalent to 1.5 oz),
which is consistent with the current 40-g reference amount for ``All
other candies'' (see Ref. 17 for more detailed description and data).
The agency recognizes that the 1994 and 1995 CSFII contain some
specific candy subcodes and measure codes, making it possible to
identify more candies by their brand name and piece size. However, in
most cases, the ``n'' value (i.e., number of eating occasions) for a
specific subcode is too small to give a reliable estimate of the
customarily consumed amount (Ref. 17). Additionally, the act has
directed the agency to establish uniform serving sizes. Therefore, the
same food should have the same reference amount regardless of its
shape, size, or type of packaging (e.g., individually wrapped).
Accordingly, it is the amount customarily consumed per eating occasion
for the type of candy that determines the reference amount, not the
specific size, shape, or weight of the candy.
IV. Proposed Action
A. Division of ``All Other Candies'' Product Category
Because the consumption data for certain candies (i.e., Andes Mint
Wafers, caramels, fondants) support a 15-g reference amount (Ref. 17),
and because of the agency's desire to simplify the product category
description, the agency is proposing to include ``after-dinner mints,
caramels, and fondants (e.g., plain mints, candy corn)'' in the same
product category as ``Hard candies, others'' in Sec. 101.12(b), Table
2, and to revise the name of the product category to reflect this
change. It should be noted that this proposal would place mint wafers
consisting of chocolate flavored confectionary coating rather than
chocolate that complies with the standard in 21 CFR 163.111, such as
Andes Creme De Menthe Thins, in this ``Hard candies, others'' product
category.
Because the consumption data for certain candies (i.e., chocolate-
covered fondants, taffy, and plain toffee) support a 30-g reference
amount (Ref. 17), the agency is proposing to establish a new product
category of candies in Sec. 101.12(b), Table 2, under ``Sugars and
Sweets,'' identified as ``Chocolate-covered fondants (e.g., chocolate-
covered creams, chocolate-covered mints), taffy, and plain toffee''
with a reference amount of ``30 g.''
In accordance with Sec. 101.12(h)(11), the agency also analyzed
candy consumption from the 1994 and 1995 CSFII using the food codes for
all other candies excluding those that were shown to support a 15-g or
30-g reference amount as stated previously (Ref. 17). The resulting
data were consistent and continue to support the 40-g reference amount
for ``All other candies.'' To clarify the types of candy that are
included in the ``All other candies'' product category, the agency is
proposing, in Sec. 101.12(b), Table 2, to expand the name of the
product category to ``All other candies (e.g., candy bars, chocolate
candies, fudge, licorice, gumdrops, nut or raisin candies)'' and to
retain the reference amount of ``40 g.''
B. Powdered Candy
As stated in section I.D.1 of this document, a 15-g reference
amount has been used for powdered candy since 1993. Furthermore,
powdered candy products (e.g., Pixy Stix, Space Dust) are included as
hard candies in the NFCS and CSFII data bases (Refs. 5 and 7 through
10), and FDA has established a reference amount of 15 g for ``Hard
candies, others'' (Sec. 101.12(b), Table 2) based on its consideration
of these data bases. The agency is, therefore, proposing to include
``powdered candy'' in the same product category with other hard candies
in Sec. 101.12(b), Table 2, and to revise the name of the product
category to reflect this change.
C. Liquid Candy
As stated in section I.D.2 of this document, a 15-mL reference
amount has been used for liquid candy since 1993. Data from the 1994
and 1995 CSFII showed only one eating occasion for liquid-filled waxed
candy, and the amount consumed was shown as 23 g. One eating occasion
is inadequate to represent the amount customarily
[[Page 1083]]
consumed for the population ages 4 years and above and therefore is
inadequate to use as the primary basis for determining the reference
amount. No data were reported for consumption of liquid candy in the
previous USDA surveys.
The manufacturer who submitted the original request, as discussed
in section I.D.2 of this document, included some samples of the syrup-
filled wax candy with the submission. The package sizes submitted
included the following: (1) 1/2 fluid (fl) oz (14 mL) package
containing five wax containers, about 2.8 mL per container; (2) 1/2 fl
oz (20 mL) package containing five wax bottle containers, about 4 mL
per bottle; (3) a case of 20 wax bottle containers with a net contents
of 2 1/2 fl oz (80 mL), about 4 mL per bottle; and (4) large, single-
wrapped wax figures containing 3/4 fl oz (22.5 mL) or 1/2 fl oz (15 mL)
each. Additionally, the requester stated that because the syrup is so
sweet, it is unlikely that more than four or five of the small
containers or more than one of the largest containers would be consumed
at a single eating occasion.
These five package sizes suggested to the agency a reference amount
of 15 mL to 25 mL. The agency then applied the general principles it
uses to arrive at a reference amount to these values.
FDA described the general principles that it followed in expressing
the reference amounts Sec. 101.12(b) in the proposed and final rules on
serving sizes (56 FR 60394 at 60406; 58 FR 2229 at 2238). FDA expressed
reference amounts for fluids in milliliters. It expressed reference
amounts for other foods, to the extent possible, in grams. As explained
further in comment 21 of the final rule on serving sizes (58 FR 2229 at
2238), ``The act requires that serving sizes be declared in common
household measures, and therefore, those measures must drive the
reference amounts * * *. Thus, it is important to adjust the reference
amounts to be in metric amounts that convert to useful, whole number
household measures rather than rounded metric units.'' Based on these
principles, considering the packaging information that the manufacturer
provided as stated above, and in the interest of minimizing the number
of product categories, FDA has tentatively determined that 15 mL
(equivalent to the whole number household measure of 1 tablespoon
(Sec. 101.9(b)(5)(viii) (21 CFR 101.9(b)(5)(viii)) is the most
reasonable reference amount for liquid candies. FDA requests comments
on this tentative determination.
The agency has become aware, through conversations and informal
investigations in the marketplace, of two other forms of liquid
candies: (1) Clear or colored straws containing syrups and flavored
honeys, and (2) bottles with bubble wands containing liquid candy that
can be blown into bubbles before consuming. Based on the proposed
reference amount of 15 mL, the appropriate serving sizes for these
liquid candies would be ``____ straws (____ mL)'' for syrup or flavored
honey in straws and ``1 tablespoon (15 mL)'' for liquid candy in
bottles. Additional clarifying language could be provided for liquid
candy that is to be blown into bubbles before consuming, e.g., ``1
tablespoon (15 mL) (makes ____ bubbles),'' with the blank to be filled
in with a number (Sec. 101.9(b)(7)(v)). FDA would consider any bottle
of liquid candy that contains less than 30 mL to be a single-serving
container (Sec. 101.9(b)(6)).
Considering all of the information that is available to the agency,
as stated previously, FDA is proposing to include ``liquid candy'' with
a reference amount of ``15 mL'' in the same product category with other
hard candies in Sec. 101.12(b), Table 2, to revise the name of the
product category, and to add the reference amount to reflect this
change.
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 it may issue based on
this proposal become effective in accordance with a uniform effective
date for compliance with food labeling requirements, which is no sooner
than 1 year following publication of the final rule. 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 25.30(k) and 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 some manufacturers to revise the
serving size and corresponding nutrition labeling information on
product labels for after-dinner mints, caramels, fondants, taffy, and
plain toffee. FDA estimates that there are at least 116 firms producing
candy products of the type covered by this proposed rulemaking. These
manufacturers produce 730 labels that may be revised as a result of
this rule. The specific costs of a labeling change are a function of
the type of printing process used, the type of label used, the
complexity of the label change, average label inventory, and length of
the compliance period. On average, the administrative, redesign, and
inventory disposal costs for a labeling change of this type, with a 1-
year compliance period are $500 per product, or a total of $365,000.
The benefit of this proposed regulation is that because
manufacturers will provide information on a serving size that is more
appropriate for particular types of candy, product labels will provide
more accurate information to consumers.
VIII. Small Entity Analysis
FDA has examined the economic implications of this 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
[[Page 1084]]
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 FDA concludes that this proposed rule will have a significant
impact on a substantial number of small entities.
A. Estimate and Description of the 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 (SBA) has set
size standards for most business categories through use of four-digit
Standard Industrial Classification codes. For candies, a business is
considered small if it has fewer than 500 employees.
FDA estimates that 99 of the firms producing after-dinner mints,
caramels, fondants, taffy, and plain toffee are small. The small firms
that FDA has identified produce between 1 and 23 product labels
(average equals 4 labels) that might be relabeled as a result of this
rule.
B. Description of the Impacts
The cost of this rule per small firm will be between $500 ($500
multiplied by 1 product) and $11,500 ($500 multiplied by 23 products)
with the average cost per small firm of $2,000. FDA considers these
costs to be significant to a small entity. Under the Regulatory
Flexibility Act (5 U.S.C. 605), the agency concludes that this proposed
rule will have a significant impact on a substantial number of small
entities.
C. Compliance Requirements and Necessary Skills
The Regulatory Flexibility Act also requires agencies to describe
the projected reporting, recordkeeping, and other compliance
requirements of the rule and the type of professional skills necessary
for preparation of the report or record. Manufacturers of after-dinner
mints, caramels, fondants, taffy, and plain toffee will be required to
amend their labels to reflect the new serving size. Manufacturers must
recalculate the reported levels of nutrients in the foods based on the
new serving size. No further analyses are required, only that the
reported amounts are based on the correct serving size.
D. Alternatives
FDA has examined the following alternatives to the proposed action
that could minimize the significant economic impact on small entities
consistent with stated objectives.
1. Exempt Small Entities
The agency has published an exemption from mandatory nutrition
labeling for low-volume food products of small businesses in
Sec. 101.9(j)(18) (59 FR 11872, March 14, 1994). As of May 1997,
Sec. 101.9(j)(18) applies to manufacturers, packers, distributors, or
retailers of low volume products, defined as fewer than 100,000 units,
produced by firms with fewer than 100 employees. To the extent that
after-dinner mints, caramels, fondants, taffy, and plain toffee are
eligible for this exemption, they will not require relabeling as a
result of this rule. However, if the products are nutritionally labeled
either because the label contains nutrient content claims, or because
the manufacturer has voluntarily labeled the product, then the
nutrition facts panel must be correct and the label must be changed.
FDA is uncertain of how many products, if any, can or will take
advantage of this option.
2. Lengthen the Compliance Period
FDA also considered the option of providing small entities with a
longer compliance period. If finalized, labels must be changed by the
appropriate uniform compliance date. Depending on when the final rule
publishes, firms will have as little as 1 year or as much as 2 years to
complete labeling changes. Longer compliance periods typically result
in lower costs because firms can combine mandated label changes with
planned changes and because firms have more opportunity to use up
existing labels. A 2-year compliance period would reduce costs to $300
per firm.
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 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 the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Title: Food Labeling; Serving Sizes; Reference Amounts for Candies.
Description: Section 403(q)(1)(A) and (q)(1)(B) of the act requires
that the label or labeling of a food bear information that provides the
serving size that is appropriate to the food and the number of servings
per container. FDA has issued regulations in Sec. 101.9(d)(3) that
require that the nutrition facts panel on the label of a food disclose
the serving size of the food and the number of servings per container.
FDA has also issued regulations in Sec. 101.9(b) that provide that the
serving size declared on a food label shall be determined from the
``Reference Amounts Customarily Consumed Per Eating Occasion'' that
appear in Sec. 101.12(b).
The regulations set forth in this proposed rule would revise the
reference amount that is used for determining the serving size for
after-dinner mints, caramels, fondants, taffy, and plain toffee. As a
result, manufacturers and other producers of these products would be
required to change the serving sizes, number of servings per container,
and levels of nutrients per serving disclosed in the nutrition facts
panel of their products.
Description of Respondents: Persons and businesses, including small
businesses.
[[Page 1085]]
Table 1.--Estimated Additional Reporting Burden1
----------------------------------------------------------------------------------------------------------------
No. of Total No. of Hours per Total Operating
21 CFR Section Respondents Responses Response Total Hours Costs
----------------------------------------------------------------------------------------------------------------
101.12(b) 116 730 1 730 $365,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital or maintenance costs associated with this collection of information.
The proposed change in the reference amount for after-dinner mints,
caramels, fondants, taffy, and plain toffee would result in a one-time
burden created by the need for firms to revise the labels for their
products. In addition to changing the serving size, firms would have to
recalculate the number of servings per container and the levels of
nutrients per serving based on the new serving size. As noted in
section VII of this document, in the Executive Order 12866 analysis,
FDA estimates that there are at least 116 firms producing candy
products of the type affected by this proposed rulemaking. FDA
estimates that these firms would require an average of 1 hour per
product to comply with the requirements of a final rule based on this
proposal. Further, as noted in section VII of this document, in the
Executive Order 12866 analysis, the proposed rule would result in a
one-time operating cost of $365,000.
In compliance with section 3507(d) of the PRA (44 U.S.C. 3507(d)),
the agency has submitted the information collection requirements of
this proposed rule to OMB for review. Interested persons are requested
to send comments regarding information collection by February 9, 1998,
to the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, ATTN:
Desk Officer for FDA.
X. Comments
Interested persons may, on or before March 24, 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 numbers 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. U.S. Department of Agriculture, Nationwide Food Consumption
Survey/Individual--Spring Quarter 1977-1978, accession no. PB80-
190218INC, National Technical Information Service, Springfield, VA,
1980.
2. U.S. Department of Agriculture, Nationwide Food Consumption
Survey/Individual--Summer Quarter 1977-1978, accession no. PB80-
197429INC, National Technical Information Service, Springfield, VA,
1980.
3. U.S. Department of Agriculture, Nationwide Food Consumption
Survey/Individual--Fall Quarter 1977-1978, accession no. PB80-
200223INC, National Technical Information Service, Springfield, VA,
1980.
4. U.S. Department of Agriculture, Nationwide Food Consumption
Survey/Individual--Winter Quarter 1977-1978, accession no. PB81-
118853INC, National Technical Information Service, Springfield, VA,
1981.
5. U.S. Department of Agriculture, Nationwide Food Consumption
Survey/Individual Intake--1987-1988, accession no. PB90-504044INC,
National Technical Information Service, Springfield, VA, 1990.
6. LeGault, Lori A., Memo to file, ``Background Documentation
for Determining the Reference Amounts Customarily Consumed per
Eating Occasion (Reference Amounts) for Candies,'' CFSAN, FDA,
Washington, DC, August 13, 1997.
7. U.S. Department of Agriculture, Continuing Survey of Food
Intakes by Individuals: Four Days Food Intake for Women and Their
Children 1-5, 1985, accession no. PB88-201249INC, National Technical
Information Service, Springfield, VA, 1988.
8. U.S. Department of Agriculture, Continuing Survey of Food
Intakes by Individuals: Four Days Food Intake for Women 19-50,
Children 1-5, 1986, accession no. PB89-154355INC, National Technical
Information Service, Springfield, VA, 1989.
9. U.S. Department of Agriculture, Continuing Survey of Food
Intakes by Individuals, 1994, accession nos. PB96-500095INC
(Magnetic Tape) and PB96-501010INC (CD-ROM), National Technical
Information Service, Springfield, VA, 1996.
10. U.S. Department of Agriculture, Continuing Survey of Food
Intakes by Individuals, 1995, accession nos. PB97-500771INC
(Magnetic Tape) and PB97-500789INC (CD-ROM), National Technical
Information Service, Springfield, VA, 1997.
11. Knupfer, David, W & F Products Inc., letter to FDA, March
31, 1993.
12. Mercurio, Kenneth C., Nestle USA, Inc., letter to FDA, May
11, 1993.
13. Saltsman, Joyce J., FDA, letter to David Knupfer, W & F
Products, August 26, 1993.
14. Saltsman, Joyce J., FDA, letter to Kenneth C. Mercurio,
Nestle USA, Inc., August 11, 1993.
15. U.S. Department of Health and Human Services, ``Food
Labeling QUESTIONS AND ANSWERS,'' Food and Drug Administration, pp.
32-33, Washington, DC, August 1993.
16. Heaton, Alan W., Comments on Consumer Research Submitted to
FDA in Two Petitions, CFSAN, FDA, March 25, 1997.
17. LeGault, Lori A., Memo to file, ``Documentation Supporting
the Proposed Changes to the Reference Amounts Customarily Consumed
per Eating Occasion (Reference Amounts) for Candies,'' CFSAN, FDA,
Washington, DC, August 14, 1997.
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:
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 101.12 is amended in paragraph (b), Table 2, under the
``Product Category'' column under ``Sugars and Sweets'' by revising the
entry for ``Hard candies, others,'' by adding a new candy subcategory,
and by revising the entry for ``All other candies'' to read as follows:
Sec. 101.12 Reference amounts customarily consumed per eating
occasion.
* * * * *
(b) * * *
[[Page 1086]]
Table 2.--Reference Amounts Customarily Consumed Per Eating Occasion: General Food Supply1, 2, 3, 4
----------------------------------------------------------------------------------------------------------------
Product category Reference amount Label statement5
----------------------------------------------------------------------------------------------------------------
* * * * * *
*
Sugars and Sweets:
* * * * * *
*
Hard candies, others; after-dinner 15 mL for liquid candies; 15 g for ____ piece(s) (____ g) for large
mints, caramels, fondants (e.g., all others pieces; ____ tbsp(s) (____ g) for
plain mints, candy corn), liquid small pieces; ____ straw(s) (____
and powdered candies g) for powdered candies; ____ wax
bottle(s) (____ mL) for liquid
candies; 1/2 oz (14 g/ visual unit
of measure) for bulk products
Chocolate-covered fondants (e.g., 30 g ____ piece(s) (____ g); 1 oz (28 g/
chocolate-covered creams, visual unit of measure) for bulk
chocolate-covered mints), taffy, products
and plain toffee
All other candies (e.g., candy 40 g ____ piece(s) (____ g); 1 1/2 oz (42
bars, chocolate candies, fudge, g/ visual unit of measure) for bulk
licorice, gumdrops, nut or raisin products
candies)
* * * * * *
*
----------------------------------------------------------------------------------------------------------------
\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).
* * * * *
Dated: December 31, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-375 Filed 1-7-98; 8:45 am]
BILLING CODE 4160-01-F