Food Labeling; Serving Sizes; Reference Amounts for Candies

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.

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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.

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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

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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

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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

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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