[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)]
[Proposed Rules]
[Pages 76323-76325]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26407]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2016-N-2938]


Reference Amount Customarily Consumed for Flavored Nut Butter 
Spreads and Products That Can Be Used To Fill Cupcakes and Other 
Desserts, in the Labeling of Human Food Products; Request for 
Information and Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of request for comments.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
establishment of a docket to receive comments, particularly data and 
other information, on the appropriate reference amount customarily 
consumed (RACC) and product category for flavored nut butter spreads 
(e.g., cocoa, cookie, and coffee flavored), and products that can be 
used to fill cupcakes and other desserts, such as cakes and pastries. 
We are taking this action in part because we have recently issued a 
final rule updating certain RACCs, and we have also received a citizen 
petition asking that we either issue a guidance recognizing that ``nut 
cocoa-based spreads'' fall within the ``Honey, jams, jellies, fruit 
butter, molasses'' category for purposes of RACC determination; or 
amend the regulation to establish a new RACC category for ``nut cocoa-
based spreads'' with an RACC of 1 tablespoon (tbsp.). We also are 
taking this action in response to a request to amend our serving size 
regulations to establish an RACC and product category for cupcake 
filling.

DATES: Comments must be received on or before January 3, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified as 
confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-2938 for ``Reference Amount Customarily Consumed for 
Flavored Nut Butter Spreads (e.g., cocoa, cookie, and coffee flavored), 
and Products That Can Be Used To Fill Cupcakes and Other Desserts, in 
the Labeling of Human Food Products; Request for Information and 
Comments.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at http://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on http://www.regulations.gov. Submit both

[[Page 76324]]

copies to the Division of Dockets Management. If you do not wish your 
name and contact information to be made publicly available, you can 
provide this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Cherisa Henderson, Center for Food 
Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 240-402-1450.

SUPPLEMENTARY INFORMATION: 

I. Background

A. Flavored Nut Butter Spreads (e.g., cocoa, cookie, and coffee 
flavored)

    Under section 403(q)(1)(A)(i) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 343(q)(1)(A)(i)), food that is 
intended for human consumption and offered for sale must bear nutrition 
information that provides a serving size that reflects the amount of 
food customarily consumed (i.e., the RACC) and is expressed in a common 
household measure that is appropriate to the food (unless an exception 
applies). We established RACCs for specific product categories in a 
final rule that appeared in the Federal Register on January 6, 1993, 
entitled ``Food Labeling; Serving Sizes'' (58 FR 2229, ``1993 final 
rule''). In the 1993 final rule, FDA provided nine general principles 
and factors for establishing RACCs in 21 CFR 101.12(a) to ensure that 
foods that have similar dietary usage, product characteristics, and 
customarily consumed amounts have a uniform reference amount.
    The 1993 final rule included a reference (Ref. 1) to a memorandum 
to the file entitled ``List of products for each product category,'' 
which listed ``Nutella'' as an example of a product in the product 
category ``Other dessert toppings, e.g., fruits, syrups, spreads, 
marshmallow cream, nuts, dairy and non-dairy whipped toppings'' (see 58 
FR 2229 at 2268). The conclusion that ``Nutella'' belongs in the 
``Other dessert toppings, e.g., fruits, syrups, spreads, marshmallow 
cream, nuts, dairy and non-dairy whipped toppings'' category with an 
RACC of two tbsp. was based on a consumer survey conducted in 1991 that 
showed a significant number of respondents used ``Nutella'' as a 
dessert topping, particularly for ice cream.
    In the Federal Register of March 3, 2014, we published a proposed 
rule entitled, ``Food Labeling: Serving Sizes of Foods That Can 
Reasonably Be Consumed at One-Eating Occasion; Dual-Column Labeling; 
Updating, Modifying, and Establishing Certain Reference Amounts 
Customarily Consumed; Serving Size for Breath Mints; and Technical 
Amendments'' (79 FR 11990, ``2014 proposed rule''). The 2014 proposed 
rule proposed to update and modify certain RACCs for previously 
established product categories and establish RACCs for new products and 
product categories. The 2014 proposed rule provided no specific 
discussion with respect to ``Nutella.'' After publication of the 
proposed rule, on March 4, 2014, we received a citizen petition that 
requested we either: (1) Issue guidance recognizing that ``nut cocoa-
based spreads'' fall within the ``Honey, jams, jellies, fruit butter, 
molasses'' category for purposes of RACC determination or (2) amend 
Sec.  101.12 to establish a new product category for ``nut cocoa-based 
spreads'' with an RACC of one tbsp. (Docket No. FDA-2014-P-0263.) Based 
on the information provided, which included data pertaining 
specifically to ``Nutella,'' we understand that the petition intended 
``Nutella'' to be incorporated into a category described as ``nut 
cocoa-based spreads.'' The petitioner submitted results of a consumer 
usage survey that the petitioner had commissioned through a marketing 
research firm. The survey included 722 mothers who purchased 
``Nutella'' in the past 3 months. The survey found that, on average, 74 
percent of ``Nutella'' use was associated with spreading the product on 
bread, including toast and in making sandwiches, and that two percent 
of use was as a topping for ice cream. The petition also included the 
results of an analysis of the National Health and Nutrition Examination 
Survey (NHANES) 2003-2010 consumption data for individuals aged 4 years 
or older (n = 43). The reported mean, median, and mode consumption 
amounts from this analysis for ``Nutella,'' including similar products 
used as chocolate-flavored hazelnut spreads, were 22.6 grams (g) (about 
1 tbsp.), 18 g (1 tbsp.), and 18 g (1 tbsp.), respectively.
    On March 10, 2016, we received a comment in response to the 2014 
proposed rule in which a report prepared by a scientific consulting 
firm analyzed the NHANES data from 2003 through 2012 among participants 
aged 1 year and older for ``Nutella'' and other similar products used 
as chocolate-flavored hazelnut spreads (n = 92) (Ref. 2). The comment 
stated that the results showed that the mean, median, and mode 
consumption amounts were 28.6 g, 18 g (about 1 tbsp.), and 12 g, 
respectively. The comment included a report of an online survey 
designed to estimate the amount of ``Nutella'' typically consumed in an 
eating occasion. The comment asserted that the survey was administered 
to a representative sample of the U.S. population aged 18 to 80 years, 
with an average age of 27.3 years. Four hundred and thirty respondents 
consumed ``Nutella'' in the year before the survey was administered, 
and these respondents reported 824 eating occasions. Based on the 
categorical consumption amount selections weighted by the frequency of 
such amount consumed, the comment concluded that median consumption per 
eating occasion was 18.5 g (about 1 tbsp.), that the mean consumption 
per eating occasion was 32.6 g, and that almost half of the eating 
occasions (46.9 percent) involved using the product as a spread with 
bread or toast, as compared to use with crackers or cookies (17.2 
percent), use by itself (13.9 percent), use as a spread for fruit (10.8 
percent), use as a spread over pancakes or waffles (8.2 percent), and 
other uses (3 percent). The report concluded that the median 
consumption amount from both analyses was one tbsp., consistent with 
the RACC of one tbsp. that we had established for sweet spreads for 
bread such as honey, jams, and jellies.
    Following the receipt of the citizen petition and comment, in the 
Federal Register of May 27, 2016, we published a final rule entitled, 
``Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed 
At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and 
Establishing Certain Reference Amounts Customarily Consumed; Serving 
Size for Breath Mints; and Technical Amendments'' (81 FR 34000) (``2016 
final rule''). The 2016 final rule updated and modified certain

[[Page 76325]]

RACCs for previously established product categories and established 
RACCs for new products and product categories. The preamble to the 2016 
final rule explained in the response to the comment on nut cocoa-based 
spreads that the primary usage of hazelnut spread, which was a 
reference to nut cocoa-based spreads such as ``Nutella'' discussed in 
the comment, is as a spread for bread instead of as a dessert topping 
(81 FR 34000 at 34029 to 34030). However, with respect to specific 
assertions raised in the March 10, 2016, comment, we responded that, 
while we recognize a need for an RACC for hazelnut spread outside of 
the dessert product category,'' and agreed that the primary usage of 
hazelnut spread is as a spread for bread instead of as a dessert 
topping because the proposed rule was silent about an RACC for hazelnut 
spread, and because we intended to provide the opportunity for public 
comment on this specific issue, we intended to consider whether to move 
hazelnut spread to a different appropriate product category in a future 
rulemaking'' (81 FR 34000 at 34029). This notification of request for 
comments represents the first step of our evaluation of the appropriate 
RACC and product category for flavored nut butter spreads (e.g., cocoa, 
cookie, and coffee flavored), which we consider to include ``nut cocoa-
based spread'' as described in the citizen petition and comment to the 
2014 proposed rule.

B. Products Used as a Filling for Cupcakes and Other Desserts

    In response to the 2014 proposed rule, one comment requested that 
we establish an RACC for icing intended for use as cupcake filling. In 
the preamble to the 2016 final rule, we said that we recognize a need 
for an RACC for this specific food product as well as for other types 
of cake or pastry fillings,'' but we further explained that, because 
the proposed rule was silent about an RACC for cupcake filling, and 
because we intended to provide the opportunity for public comment on 
this specific issue, we intend to establish an RACC for this product 
category in future rulemaking'' (81 FR 34000 at 34029). This 
notification of request for comments represents the first step of our 
evaluation of the appropriate RACC and product category for products 
used as a filling for cupcakes and other desserts.

II. Other Issues for Consideration

    We invite interested persons to comment on the appropriate RACC and 
product category for flavored nut butter spreads (e.g., cocoa, cookie, 
and coffee flavored), and products used as fillings for cupcakes and 
other desserts, such as cakes and pastries. In responding to the 
specific questions identified in this notice, please provide additional 
data and information that you believe we should consider. Please 
thoroughly explain your reasoning and provide data and other 
information to support your comments and responses to these questions. 
If you submit data, please also provide information regarding the type 
of survey or study conducted, research methodology, sampling frame, 
results of statistical analyses, and any other information needed to 
interpret the data.
    We are particularly interested in responses to the following 
questions:
     What additional data and information are available to 
determine the customary consumption amounts of and appropriate product 
category for flavored nut butter spreads (e.g., cocoa, cookie, and 
coffee flavored)?
     What is the major intended use of flavored nut butter 
spreads (e.g., cocoa, cookie, and coffee flavored)?
     What other products on the market, if any, are similar to 
flavored nut butter spreads (e.g., cocoa, cookie, and coffee flavored)? 
What product characteristics make these products similar? What dietary 
usage makes these products similar? Which product categories do 
flavored nut butter spreads (e.g., cocoa, cookie, and coffee flavored) 
compete with or take market share and volume from? What data and 
information are available regarding the customary consumption amounts 
and product category for these similar products?
     What additional data and information are available 
regarding the customary consumption amounts and product category of 
products used as fillings for cupcakes and other desserts, such as 
cakes and pastries?
     What is the major intended use of fillings for cupcakes 
and other desserts, such as cakes and pastries?
     What other products on the market, if any, are similar to 
cupcake filling, such as cakes and pastries fillings? What product 
characteristics make these products similar? What dietary usage makes 
these products similar? Which product categories do fillings for 
cupcakes and other desserts, such as cakes and pastries, compete with 
or take market share and volume from? What data and information are 
available regarding the customary consumption amounts and product 
category for these similar products?

III. References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at http://www.regulations.gov.

    1. Park, Y., Memorandum to the File, List of Products for Each 
Product Category, October 8, 1992.
    2. Ferrero Inc., Comment to the Food Labeling: Serving Sizes of 
Foods That Can Reasonably Be Consumed at One-Eating Occasion; Dual 
Column Labeling; Updating, Modifying, and Establishing Certain 
Reference Amounts Customarily Consumed; Proposed Rule. August 1, 
2014.

    Dated: October 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26407 Filed 11-1-16; 8:45 am]
 BILLING CODE 4164-01-P