[Federal Register Volume 83, Number 134 (Thursday, July 12, 2018)]
[Proposed Rules]
[Pages 32221-32227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14906]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2011-F-0171]
RIN 0910-AH83


Food Labeling: Calorie Labeling of Articles of Food Sold From 
Certain Vending Machines; Front of Package Type Size

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) 
proposes to revise the type size labeling requirements for front of 
package (FOP) calorie declarations for packaged food sold from glass 
front vending machines. We are taking this action in response to 
requests from the vending and packaged foods industries to reduce the 
regulatory burden and increase flexibility, while continuing to provide 
calorie declarations for certain articles of food sold from vending 
machines.

DATES: Submit either electronic or written comments on the proposed 
rule by September 25, 2018. Please note that late, untimely filed 
comments will not be considered.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://www.regulations.gov.
    <bullet> 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:
    <bullet> Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, 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-2011-F-0171 for ``Food Labeling: Calorie Labeling of Articles of 
Food Sold From Certain Vending Machines; Front of Package Type Size.'' 
Received comments, those filed in a timely manner (see DATES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday.
    <bullet> 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 https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Marjan Morravej, Center for Food 
Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 240-402-2371, 
<a href="/cdn-cgi/l/email-protection#eda08c9f878c83c3a0829f9f8c9b8887ad8b898cc385859ec38a829b"><span class="__cf_email__" data-cfemail="efa28e9d858e81c1a2809d9d8e998a85af898b8ec187879cc1888099">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of This Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule

[[Page 32222]]

    C. Legal Authority
    D. Costs and Benefits
II. Background
    A. Requirements for Calorie Labeling of Articles of Food in 
Vending Machines and Our Consideration of Front of Package Labeling 
Issues
    B. Challenges of Existing Type Size Requirement, and Proposed 
Change to ``150 Percent of the Size of the Net Quantity of Contents 
Declaration''
    C. Other Approaches
III. Legal Authority
IV. Description of the Proposed Rule (Proposed Sec.  101.8(b)(2))
V. Proposed Effective and Compliance Dates
VI. Economic Analysis of Impacts
    A. Introduction
    B. Summary of Benefits and Costs of the Proposed Rule
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. References

I. Executive Summary

A. Purpose of This Proposed Rule

    We are proposing to amend our vending machine labeling regulations 
in 21 CFR part 101 by revising Sec.  101.8(b)(2) (21 CFR 101.8(b)(2)), 
in order to revise the type size requirement when FOP labeling is used 
to meet the calorie declaration requirements for articles of food sold 
from certain vending machines. When using FOP labeling, our existing 
regulations at Sec.  101.8(b)(2) require that the type size of the 
calorie declaration for articles of food sold from certain vending 
machines be at least 50 percent of the size of the largest printed 
matter on the label. We propose, instead, to require that the type size 
of the calorie declaration on the front of the package be at least 150 
percent (one and one-half times) the size of the net quantity of 
contents (i.e., net weight) declaration on the package of the vended 
food. We are proposing this change to reduce regulatory burdens that 
the vending and packaged foods industries shared with us after the 
final rule implementing the vending machine labeling requirements (79 
FR 71259, December 1, 2014) was issued, while continuing to provide 
calorie declarations for certain articles of food sold from vending 
machines. Electronic comments must be submitted on or before September 
25, 2018. The https://www.regulations.gov electronic filing system will 
accept comments until midnight Eastern Time at the end of September 25, 
2018. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are postmarked or 
the delivery service acceptance receipt is on or before that date.

B. Summary of the Major Provisions of the Proposed Rule

    This proposed rule would revise the type size requirement for 
calories labeled on the front of the package of vended foods in Sec.  
101.8(b)(2). We are proposing that the type size be anchored to the net 
quantity of contents statement, such that the minimum type size is 150 
percent (one and one-half times) the size of the net quantity of 
contents, instead of being based on the largest printed matter on the 
label. The proposed rule would only apply when calories are displayed 
on the front of the package of foods sold in glass front vending 
machines.

C. Legal Authority

    This action is consistent with our authority in section 
403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
(21 U.S.C. 343(q)(5)(H)). The FD&C Act, at section 403(q)(5)(H), 
requires certain vending machine operators to provide calorie 
declarations for certain articles of food sold from vending machines. 
In addition, we are issuing this proposed rule consistent with our 
authority in sections 201(n), 403(a)(1), and 403(f), of the FD&C Act 
(21 U.S.C. 321(n), 343(a)(1), and 343(f)). Further, we are issuing this 
proposed rule under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), 
which gives us the authority to issue regulations for the efficient 
enforcement of the FD&C Act. We discuss our legal authority in greater 
detail in Section III, ``Legal Authority.''

D. Costs and Benefits

    In response to requests from the vending and packaged foods 
industries to reduce the regulatory burden and increase flexibility, 
FDA is proposing to revise the existing type size requirements when 
calories are displayed on the front of the package of foods sold in 
glass front vending machines. Because this rule only proposes minor 
revisions to FOP calorie labeling type size requirements, we estimate 
there are no costs to vending machine operators and potential costs 
savings to vending machine operators and packaged food manufacturers. 
We welcome data that would help us to better estimate these impacts.

II. Background

A. Requirements for Calorie Labeling of Articles of Food in Vending 
Machines and Our Consideration of Front of Package Labeling Issues

    Section 403(q)(5)(H) of the FD&C Act requires certain vending 
machine operators to provide calorie declarations for certain articles 
of food sold from vending machines. Under section 403(q)(5)(H)(viii) of 
the FD&C Act, if an article of food is sold from a vending machine that 
does not permit a prospective purchaser to examine the Nutrition Facts 
label before purchasing the article, or does not otherwise provide 
visible nutrition information at the point of purchase; and is operated 
by a person who is engaged in the business of owning or operating 20 or 
more vending machines, the vending machine operator must ``provide a 
sign in close proximity to each article of food or the selection button 
that includes a clear and conspicuous statement disclosing the number 
of calories contained in the article.''
    In the Federal Register of December 1, 2014 (79 FR 71259), we 
issued a final rule to implement the vending machine labeling 
requirements in section 403(q)(5)(H) of the FD&C Act. The final rule, 
which became effective on December 1, 2016, requires vending machine 
operators that own or operate 20 or more vending machines (or that 
voluntarily register with us to be subject to the final rule) to 
provide calorie declarations for certain articles of food sold from 
vending machines. The final rule describes which foods are subject to 
the calorie declaration requirement. The final rule also establishes 
type size, color, and contrast requirements for calorie declarations 
in, or on, the vending machines and for calorie declarations on signs 
adjacent to the vending machines. The final rule also clarifies that 
vending machine operators do not have to provide calorie information 
for a food if a prospective purchaser can view certain calorie 
information on the front of the package, in the Nutrition Facts label 
on the food, or in a reproduction of the Nutrition Facts label for the 
food, subject to certain requirements. The calorie declaration 
requirements covered in the final rule are codified at Sec.  101.8.
    In the Federal Register of August 1, 2016 (81 FR 50303), we issued 
a final rule that extended the compliance date for final calorie 
declaration requirements for certain food products sold from glass-
front vending machines to July 26, 2018. The extended compliance date 
applies only to those products in glass front vending machines that 
provide FOP calorie disclosures and that comply with all aspects of the 
final vending machine labeling rule except that the disclosure is not 
50 percent of the size of the largest print on the label.
    In the preamble of the proposed rule (published in the Federal 
Register of April 6, 2011 (76 FR 19237 at 19244)), we stated that FOP 
labeling could be a

[[Page 32223]]

way to provide ``visible nutrition information,'' as long as the 
criteria for color, font, and type size are met, and total calories 
contained in the vended food are included. We also tentatively 
concluded that the visible nutrition information must be in a type size 
reasonably related to the most prominent printed matter on the 
labeling, among other things, such that a purchaser is able to notice 
and read the information. The preamble to the proposed rule (76 FR 
19237 at 19244) explained that we considered ``reasonably related'' to 
mean a type size at least 50 percent of the size of the largest print 
on the label. This type size as specified in the preamble to the 
proposed rule is consistent with interpretations we have used in food 
labeling guidance when determining the type size of the statement of 
identity on packaged foods (Ref. 1).
    In the preamble to the final rule (79 FR 71259 at 71269), we noted 
that many comments supported the idea that FOP labeling could provide 
visible nutrition information; these comments said that FOP labeling is 
the most efficient way to satisfy section 403(q)(5)(H)(viii) of the 
FD&C Act. Other comments stated that vending machine operators are 
likely to prefer food products with FOP labeling because operators 
selling such food products in their vending machines would not have to 
provide calorie declarations in compliance with section 
403(q)(5)(H)(viii)(I)(bb) of the FD&C Act.
    We also discussed several comments that said that interpreting 
``reasonably related'' to mean a type size that is at least 50 percent 
of the size of the largest print on the label would require a type size 
that is too large. One comment suggested revising the rule to specify a 
ratio for the size of the FOP calorie disclosure relative to other 
printed material on the label. The comment stated that ``reasonably 
related'' would be hard to enforce, and we should require the FOP 
calorie disclosure to be at least two-thirds the size of the largest 
type size of any other writing on the package, with a minimum size of 
one-half square inch. Other comments stated we should omit type size or 
prominence requirements for the FOP calorie disclosure.
    In response to comments to the proposed rule, we revised the rule 
by removing the words ``reasonably related'' at Sec.  101.8(b)(2) and 
instead required the calorie labeling print to be ``at least 50 percent 
of the size of the largest printed matter on the label.'' We also noted 
that vending machine operators had other options for satisfying section 
403(q)(5)(H)(viii) of the FD&C Act, including using a vending machine 
that provides electronic reproductions of Nutrition Facts labels, as 
provided in Sec.  101.8(b)(1), or posting signs with calorie 
declarations, as provided in Sec.  101.8(c).

B. Challenges of Existing Type Size Requirement, and Proposed Change to 
``150 Percent of the Size of the Net Quantity of Contents Declaration''

    Since the publication of the final rule, several industry 
representatives indicated that the 50 percent type size requirement for 
FOP calorie labeling presents significant technical challenges to the 
packaged foods industry (Refs. 2 and 3). They said it would make the 
calorie declaration very large on some products and would make label 
redesign difficult or not practical. They explained that, for glass 
front vending machines without electronic displays, FOP labeling 
assures that consumers will get accurate calorie information for vended 
foods. The industry representatives also said that many packaged food 
manufacturers who wish to help vending machine operators comply with 
the regulations by providing packaged foods with FOP labeling will have 
to redesign their labels at great expense. They noted the existence of 
several voluntary FOP labeling programs where calorie information is 
presented in a FOP type size that ranges from 100 to 150 percent of the 
size of the net quantity of contents statement on the principal display 
panel. They acknowledged these labeling programs do not meet our type 
size requirements, and said that complying with the type size 
requirement for calorie labeling would significantly disrupt their FOP 
nutrition labeling programs because there would no longer be enough 
room on the label to accommodate both the voluntary FOP information and 
our calorie labeling requirement. Thus, they said that the nutrition 
information beyond calorie labeling that is presently provided under 
industry FOP programs may no longer be included. Additionally, they 
said that, while the existing FOP labeling may not be at least 50 
percent of the size of the largest printed matter on the label, as 
required by our rule, the calorie information is nonetheless visible to 
consumers. Finally, they stated that, in most cases, industry would be 
able to comply with a rule that linked the FOP type size for calorie 
labeling if it were no larger than 150 percent of the type size of the 
net quantity of contents statement. Other industry representatives also 
have expressed support for using the 150 percent standard for purposes 
of the FOP type size requirement (Refs. 4-7).
    Consequently, the proposed rule would remove the requirement 
specifying the FOP labeling be at least 50 percent of the size of the 
largest printed matter on the label and instead link the type size to 
the size of the net quantity of contents statement. Specifically, the 
proposed rule would revise Sec.  101.8(b)(2) pertaining to ``articles 
of food not covered'' to state that the visible nutrition information 
must be in a type size at least 150 percent of the size of the net 
quantity of contents declaration on the front of the package.
    This revision, if finalized, would allow for greater flexibility 
for the use of FOP calorie labeling in glass front vending machines, 
while still ensuring that a FOP calorie declaration would be visible 
for the consumer, regardless of the size of the package. It also would 
minimize the need for label changes for foods that currently have 
voluntary FOP calorie declarations that are 150 percent of the size of 
the net quantity of content statement provided the calorie declarations 
meet the other criteria in the final rule. It is our understanding that 
many packaged food products sold in glass front vending machines that 
currently bear FOP calorie labeling would meet the 150 percent 
requirement that we are proposing. However, to more fully understand 
the current marketplace, we specifically invite comment and data on the 
percentage of food products commonly sold in glass front vending 
machines bearing voluntary FOP calorie labeling, and for those products 
that currently bear voluntary FOP calorie labeling, the type size of 
the FOP calorie labeling used on the products.

C. Other Approaches

    Data and information currently available to FDA indicate that the 
proposed rule is consistent with some existing voluntary FOP calorie 
declarations currently used on food product labels and it is feasible 
for other foods that may be sold in vending machines. We also evaluated 
two other approaches for providing visible nutrition information that 
would meet the criteria in section 403(q)(5)(H)(viii) of the FD&C Act, 
such that the food would not be subject to the vending machine calorie 
labeling requirements. We invite comment on these two alternative 
approaches, described more fully below.

[[Page 32224]]

1. Alternative Approach A--At Least 100 Percent of the Size of the Net 
Quantity of Contents Declaration
    The first alternative approach would be to require the visible 
nutrition information to be in a type size that is at least 100 percent 
of the size of the net quantity of contents declaration. Our existing 
food labeling regulations for packaged foods, at 21 CFR 101.7(i), 
require that the declaration of net quantity be in letters and numerals 
in a type size that is established in relation to the area of the 
principal display panel of the package and that the declaration be 
uniform for all packages of substantially the same size. The regulation 
prescribes the following size specifications for net quantity 
declarations:
    <bullet> Not less than one-sixteenth inch in height on packages the 
principal display panel of which has an area of 5 square inches or 
less;
    <bullet> Not less than one-eighth inch in height on packages the 
principal display panel of which has an area of more than 5 but not 
more than 25 square inches;
    <bullet> Not less than three-sixteenths inch in height on packages 
the principal display panel of which has an area of more than 25 but 
not more than 100 square inches; and
    <bullet> Not less than one-fourth inch in height on packages the 
principal display panel of which has an area of more than 100 square 
inches, except not less than \1/2\ inch in height if the area is more 
than 400 square inches.
    If the declaration is blown, embossed, or molded on a glass or 
plastic surface rather than by printing, typing, or coloring, then the 
lettering sizes are to be increased by one-sixteenth of an inch.
    We considered requiring the visible nutrition information to be in 
a type size that is at least 100 percent of the size of the net 
quantity of contents declaration on the front of the package; in other 
words, the visible nutrition information would, at a minimum, be the 
same size as the net quantity of contents declaration. We invite 
comment on the impact of meeting the visible nutrition information 
criteria, required under section 403(q)(5)(H)(viii) of the FD&C Act, 
especially on food in smaller packages, such as small candy bars or 
single serve bags of nuts, that are sold in glass front vending 
machines under this alternative approach where the FOP calorie 
declaration is at least the same size as the net quantity of contents 
declaration.
    FDA invites comment on the advantages and disadvantages of this 
alternative.
2. Alternative Approach B--Not Specifying Any Size
    The second alternative approach would be to not specify any size 
for the visible nutrition information. This option would give the 
packaged food industry considerable flexibility in deciding how large--
or how small--voluntary FOP calorie labeling could be, and may reduce 
the need for packaging changes for some manufacturers. We note that in 
developing the final vending machine labeling rule, we considered, but 
disagreed with comments asking that we omit requirements for prominence 
or type size of FOP calorie disclosures. As we discussed in the 
preamble to that final rule, ``When a vending machine food is in a 
vending machine, a prospective purchaser cannot handle the product to 
make it easier for the purchaser to read the nutrition information. 
Therefore, `visible nutrition information' on the front of package must 
be large enough, and prominent enough, for prospective purchasers to 
see and use the information'' (79 FR 71259 at 71269).
    We invite comment on the advantages and disadvantages of this 
alternative.

III. Legal Authority

    We are proposing to revise the labeling requirements for providing 
calorie declarations for food sold from certain vending machines, as 
set forth in this proposed rule, consistent with our authority in 
section 403(q)(5)(H) of the FD&C Act. Under section 403(q)(5)(H), 
certain vending machine operators must provide calorie declarations for 
certain articles of food sold from vending machines. Under section 
403(a)(1) of the FD&C Act, such information must be truthful and non-
misleading. Under section 403(f) of the FD&C Act, any word, statement, 
or other information required by or under the FD&C Act to appear on the 
label or labeling of an article of food must be prominently placed 
thereon with such conspicuousness (as compared with other words, 
statements, designs, or devices, in the labeling) and in such terms as 
to render it likely to be read and understood by the ordinary 
individual under customary conditions of purchase and use. Under 
section 403(a), (f), or (q) of the FD&C Act, food to which these 
requirements apply is deemed misbranded if these requirements are not 
met. In addition, under section 201(n) of the FD&C Act, the labeling of 
food is misleading if it fails to reveal facts that are material in 
light of representations made in the labeling or with respect to 
consequences that may result from use. Thus, we are issuing this 
proposed rule under sections 201(n), 403(a)(1), 403(f), and 
403(q)(5)(H) of the FD&C Act, as well as under section 701(a) of the 
FD&C Act, which gives us the authority to issue regulations for the 
efficient enforcement of the FD&C Act.

IV. Description of the Proposed Rule (Proposed Sec.  101.8(b)(2))

    The proposed rule would make a change to the existing rule for 
calorie labeling of food sold from vending machines, in order to reduce 
the regulatory burden and increase flexibility while continuing to 
provide calorie declarations for certain articles of food sold from 
vending machines. We propose to revise Sec.  101.8(b)(2) to remove the 
requirement that the type size of the visible calorie declaration for 
articles of food be at least 50 percent of the size of the largest 
printed matter on the label and, instead, to require the type size to 
be at least 150 percent (one and one-half times) the size of the net 
quantity of contents (i.e., net weight) declaration on the package of 
the vended food. We also would make a minor editorial correction to the 
same sentence in Sec.  101.8(b)(2), substituting the word 
``prospective'' in place of ``perspective.''
    We also would revise the first sentence of Sec.  101.8(b)(2) by 
inserting a comma after the word ``minimum.'' This change corrects a 
punctuation error.

V. Proposed Effective and Compliance Dates

    We are proposing that any final rule resulting from this rulemaking 
have an effective date of 30 days after the date of its publication in 
the Federal Register. We also are proposing that covered vending 
machine operators comply with any final rule resulting from this 
rulemaking by January 1, 2020. We are proposing this compliance date in 
order to provide sufficient time for the packaged food industry to 
revise their labels, as appropriate, consistent with any new 
requirements.
    As discussed in section II.A., by July 26, 2018, vending machine 
operators with glass front vending machines will have to comply with 
all vending machine requirements of the final rule issued in 2014. 
However, it is unlikely that we will be able to complete the current 
rulemaking to revise the type size labeling requirements for FOP 
calorie declarations before the July 26, 2018 compliance date. 
Therefore, pending completion of this rulemaking, FDA intends to 
exercise enforcement discretion with respect to the July 26, 2018 
compliance date for products sold in glass front vending machines that 
provide a FOP calorie disclosure and

[[Page 32225]]

the product complies with all aspects of the final vending machine 
labeling rule except that the disclosure is not 50 percent of the size 
of the largest print on the label.
    Further, as previously noted, vending machine operators with glass 
front vending machines will have to comply by July 26, 2018, with all 
vending machine requirements, including complying with calorie 
disclosure requirements in 21 CFR 101.8(c)(2). Although these 
requirements cover gums, mints, and roll candy products sold in glass 
front machines, FDA intends to exercise enforcement discretion, at 
least until January 1, 2020, with respect to gums, mints, and roll 
candy products sold in glass front machines in packages that are too 
small to bear FOP labeling. FDA intends to consider this issue further.

VI. Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, Executive Order 13771, the 
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 
13563 direct us to assess all costs and benefits of available 
regulatory alternatives and, when regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). Executive Order 13771 
requires that the costs associated with significant new regulations 
``shall, to the extent permitted by law, be offset by the elimination 
of existing costs associated with at least two prior regulations.'' 
This proposed rule has been designated as a significant regulatory 
action as defined by Executive Order 12866. This proposed rule is 
expected to be an Executive Order 13771 deregulatory action. Additional 
details can be found in the proposed rule's preliminary economic 
analysis.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. The vending machine final rule does not impose 
burdens to the suppliers of vending machine foods. While suppliers are 
not obliged to engage in FOP calorie labeling, this proposed rule, if 
finalized, would allow for greater flexibility for the use of FOP 
calorie labeling in glass front vending machines than the existing 
regulations, potentially reducing the burden on covered vending machine 
operators of providing additional calorie labeling. Thus, we propose to 
certify that the proposed rule will not have a significant economic 
impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $150 million, using the most current (2017) Implicit 
Price Deflator for the Gross Domestic Product. This proposed rule would 
not result in an expenditure in any year that meets or exceeds this 
amount.

B. Summary of Benefits and Costs of the Proposed Rule

    FDA proposes to revise the type size labeling requirements for 
providing FOP calorie declarations for packaged food sold from certain 
vending machines. We are taking this action in response to requests 
from the vending and packaged foods industries to reduce the regulatory 
burden and increase flexibility. The proposed rule would revise the 
type size requirements for FOP calorie labeling on packaged foods 
displayed for sale in glass front vending machines.
    There are currently several voluntary FOP labeling programs where 
calorie information is presented. If finalized, this proposal may 
provide an increased incentive for packaged food manufacturers to add 
new or amend current FOP calorie labeling to foods in order to comply 
with the updated standard. If so, glass front vending machine operators 
carrying exclusively those products will not have to provide signs with 
calorie information for the food, providing an opportunity to reduce 
operator costs. To the extent this occurs, some costs may shift from 
the vending machine operator to the manufacturer. Packaged food 
manufacturing firms may choose to incur additional costs associated 
with amending the FOP label in order to retain revenue streams from 
current customers, including vending machine operators. If total 
revenue is greater than total cost, this proposed rule will provide 
cost savings for packaged food manufacturing firms. We expect the 
potential cost savings to both vending machine operators and packaged 
food manufacturers to outweigh the costs to packaged food manufacturers 
and thus the net effect to be positive, but lack the data to quantify 
this effect. We welcome data that would help us to better estimate 
these impacts.
    We have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the proposed rule. The full analysis of 
economic impacts is available in the docket for this proposed rule 
(Ref. 8) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(k) 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.

VIII. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no new 
collection of information beyond what was described in the December 
2014 final rule and approved under OMB control number 0910-0782. 
Therefore, clearance by the Office of Management and Budget under the 
Paperwork Reduction Act of 1995 is not required.

IX. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. Section 4(a) of the 
Executive Order requires Agencies to construe a Federal statute to 
preempt State law only where the statute contains an express preemption 
provision or there is some other clear evidence that the Congress 
intended preemption of State law, or where the exercise of State 
authority conflicts with the exercise of Federal authority under the 
Federal statute. Federal law includes an express preemption provision 
that preempts any nutrition labeling requirement of food that is not 
identical to the requirement of section 403(q) of the FD&C Act, except 
that this provision does not apply to food that is offered for sale in 
a restaurant or similar retail food establishment that is not part of a 
chain with 20 or more locations doing business under the same name and 
offering for sale substantially the same menu items unless such 
restaurant or similar retail food establishment elects to comply 
voluntarily with the nutrition information requirements under section 
403(q)(5)(H)(ix) of the FD&C Act. The proposed rule would create 
requirements for nutrition labeling of food under section 403(q) of the 
FD&C

[[Page 32226]]

Act that would preempt certain non-identical State and local nutrition 
labeling requirements.
    Section 4205 of the Patient Protection and Affordable Care Act 
(ACA), which amended the FD&C Act to require certain vending machine 
operators to provide calorie declarations for certain articles of food 
sold from vending machines, also included a Rule of Construction 
providing that nothing in the amendments made by section 4205 of the 
ACA shall be construed: (1) To preempt any provision of State or local 
law, unless such provision establishes or continues into effect 
nutrient content disclosures of the type required under section 
403(q)(5)(H) of the FD&C Act and is expressly preempted under 
subsection (a)(4) of such section; (2) to apply to any State or local 
requirement respecting a statement in the labeling of food that 
provides for a warning concerning the safety of the food or component 
of the food; or (3) except as provided in section 403(q)(5)(H)(ix) of 
the FD&C Act, to apply to any restaurant or similar retail food 
establishment other than a restaurant or similar retail food 
establishment described in section 403(q)(5)(H)(i) of the FD&C Act (see 
Pub. L. 111-148, section 4205(d) of the ACA, 124 Stat. 119, 576 
(2010)).
    We interpret the provisions of section 4205 of the ACA related to 
preemption to mean that States and local governments may not impose 
nutrition labeling requirements for food sold from vending machines 
that must comply with the Federal requirements of section 403(q)(5)(H) 
of the FD&C Act, unless the State or local requirements are identical 
to the Federal requirements. In other words, States and localities 
cannot have additional or different nutrition labeling requirements for 
food sold either: (1) From vending machines that are operated by a 
person engaged in the business of owning or operating 20 or more 
vending machines subject to the requirements of section 
403(q)(5)(H)(viii) of the FD&C Act; or (2) from vending machines 
operated by a person not subject to the requirements of section 
403(q)(5)(H)(viii) of the FD&C Act who voluntarily elects to be subject 
to those requirements by registering biannually under section 
403(q)(5)(H)(ix) of the FD&C Act.
    Otherwise, for food sold from vending machines not subject to the 
nutrition labeling requirements of section 403(q)(5)(H)(viii) of the 
FD&C Act, States and localities may impose nutrition labeling 
requirements. Under our interpretation of section 4205(d)(1) of the 
ACA, nutrition labeling for food sold from these vending machines would 
not be nutrient content disclosures of the type required under section 
403(q)(5)(H)(viii) of the FD&C Act and, therefore, would not be 
preempted. Under this interpretation, States and localities would be 
able to continue to require nutrition labeling for food sold from 
vending machines that are exempt from nutrition labeling under section 
403(q)(5) of the FD&C Act. This interpretation is consistent with the 
fact that Congress included vending machine operators in the voluntary 
registration provision of section 403(q)(5)(H)(ix) of the FD&C Act. 
There would have been no need to include vending machine operators in 
the provision that allows opting into the Federal requirements if 
States and localities could not otherwise require non-identical 
nutrition labeling for food sold from any vending machines.
    In addition, the express preemption provisions of 21 U.S.C. 343-
1(a)(4) do not preempt any State or local requirement respecting a 
statement in the labeling of food that provides for a warning 
concerning the safety of the food or component of the food. This is 
clear from both the literal language of 21 U.S.C. 343-1(a)(4) with 
respect to the scope of preemption and from the Rule of Construction at 
section 4205(d)(2) of the ACA.

X. References

    The following references are on display in the Dockets Management 
Staff (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 https://www.regulations.gov. FDA has 
verified the website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.

1. FDA, ``Guidance for Industry: A Food Labeling Guide (4. Name of 
Food)'', last updated January 2013. Retrieved from https://www.fda.gov/downloads/Food/GuidanceRegulation/UCM265446.pdf.
2. Letter from Karin F. R. Moore, Vice President and General 
Counsel, Grocery Manufacturers Association, and cosigned by the 
American Beverage Association, National Automated Merchandising 
Association, National Confectioners Association, and SNAC 
International, to Susan Mayne, Ph.D., Director, Center for Food 
Safety and Applied Nutrition, dated March 31, 2016.
3. Letter from Karin F. R. Moore, Senior Vice President and General 
Counsel, Grocery Manufacturers Association, and cosigned by the 
American Beverage Association, National Automated Merchandising 
Association, National Confectioners Association, and SNAC 
International, to Susan Mayne, Ph.D., Director, Center for Food 
Safety and Applied Nutrition, dated June 28, 2016.
4. Letter from Karin F. R. Moore, Senior Vice President and General 
Counsel, Grocery Manufacturers Association, and cosigned by the 
American Beverage Association, National Automated Merchandising 
Association, National Confectioners Association, and SNAC 
International, to Scott Gottlieb, M.D., Commissioner of Food and 
Drugs, FDA, dated July 19, 2017.
5. Letter from Jason Eberstein, Director, State & Federal Government 
Affairs, National Automatic Merchandising Association, to Scott 
Gottlieb, M.D., Commissioner of Food and Drugs, FDA, dated November 
21, 2017.
6. Letter from Brad G. Figel, Vice President, North America Public 
Affairs, Mars, Inc., to Mick Mulvaney, Director, Office of 
Management and Budget, dated January 30, 2018.
7. Letter from Elizabeth Avery, President and CEO, SNAC 
International, to Dockets Management Staff, FDA, dated February 12, 
2018.
8. FDA, ``Food Labeling: Calorie Labeling of Articles of Food Sold 
From Certain Vending Machines; Front of Package Type Size, 
Preliminary Regulatory Impact Analysis, Initial Regulatory 
Flexibility Analysis, Preliminary Small Entity Analysis,'' dated 
June 2018. Also available at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

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, we propose 
that 21 CFR part 101 be amended as follows:

PART 101--FOOD LABELING

0
1. The authority citation for 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; 42 U.S.C. 243, 264, 271.

0
2. Section 101.8 is amended by revising paragraph (b)(2) to read as 
follows:


Sec.  101.8   Vending machines.

* * * * *
    (b) * * *
    (2) The prospective purchaser can otherwise view visible nutrition 
information, including, at a minimum, the total number of calories for 
the article of food as sold at the point of purchase. This visible 
nutrition information must appear on the food label itself. The visible 
nutrition information must be clear and conspicuous and able to be 
easily read on the article of food while in the

[[Page 32227]]

vending machine, in a type size at least 150 percent of the size of the 
net quantity of contents declaration on the front of the package, and 
with sufficient color and contrasting background to other print on the 
label to permit the prospective purchaser to clearly distinguish the 
information.
* * * * *

    Dated: July 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14906 Filed 7-11-18; 8:45 am]
 BILLING CODE 4164-01-P


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>