[Federal Register Volume 81, Number 147 (Monday, August 1, 2016)]
[Rules and Regulations]
[Pages 50303-50306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18140]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 11 and 101

[Docket No. FDA-2011-F-0171]
RIN 0910-AG56


Food Labeling; Calorie Labeling of Articles of Food in Vending 
Machines; Extension of Compliance Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; extension of compliance date.

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SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
compliance date for certain requirements in the final rule requiring 
disclosure of calorie declarations for food sold from certain vending 
machines. The final rule appeared in the Federal Register of December 
1, 2014. We are taking this action in response to requests for an 
extension and for reconsideration of the rule's requirements pertaining 
to the size of calorie disclosures on front-of-package labeling.

DATES: Effective date: This final rule is effective December 1, 2016.
    Compliance date: The compliance date for type size front-of-pack 
labeling requirements (Sec.  101.8(b)(2) (21 CFR 101.8(b)(2))) and 
calorie disclosure requirements (Sec.  101.8(c)(2)) for certain gums, 
mints, and roll candy products in glass-front machines in the final 
rule published December 1, 2014 (79 FR 71259) is extended to July 26, 
2018. The compliance date for all other requirements in the final rule 
(79 FR 71259) remains December 1, 2016.

FOR FURTHER INFORMATION CONTACT: April Kates, Center for Food Safety 
and Applied Nutrition (HFS-820), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-2371, email: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 1, 2014 (79 FR 71259), we 
published a final rule establishing requirements for providing calorie 
declarations for food sold from certain vending machines. The final 
rule, which is codified primarily at Sec.  101.8, will ensure that 
calorie information is available for certain food sold from a vending 
machine that does not permit a prospective purchaser to examine the 
Nutrition Facts Panel before purchasing the article, or does not 
otherwise provide visible nutrition information at the point of 
purchase. The declaration of accurate and clear calorie information for 
food sold from vending machines will make calorie information available 
to consumers in a direct and accessible manner to enable consumers to 
make informed and healthful dietary choices. The final rule applies to 
certain food from vending machines operated by a person engaged in the 
business of owning or operating 20 or more vending machines. Vending 
machine operators not subject to the rules may elect to be subject to 
the Federal requirements by registering with FDA.
    The final rule also specifies how calories must be declared. In 
brief,
     Vending machine operators do not have to declare 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 on 
the food subject to certain requirements, or if the vending machine 
operator does not own or operate 20 or more vending machines.
     Calorie declarations must be clear and conspicuous and 
placed prominently, and may be placed on a sign in, on, or adjacent to 
the vending machine, so long as the sign is in close proximity to the 
article of food or selection button.
     The final rule 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 establishes requirements for calorie 
declarations on electronic vending machines, those vending machines 
with only pictures or names of the food items, and those vending 
machines with few choices (e.g., popcorn machines).
    The final rule also requires vending machine operator contact 
information to be displayed for enforcement purposes.
    The final rule implements provisions of section 403(q)(5)(H) of the 
Federal

[[Page 50304]]

Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(q)(5)(H)).
    In the preamble to the final rule (79 FR 71259 at 71282 through 
71283), we stated that all covered vending machine operators must come 
into compliance with the rule's requirements no later than December 1, 
2016.

II. Extending the Compliance Date

A. Introduction

    Since we published the final rule in the Federal Register, several 
trade associations have contacted us to state that the type size 
requirement for calorie information on the package, often referred to 
as ``front-of-pack'' or FOP labeling, presents significant technical 
challenges to the packaged food industry. The trade associations asked 
us to amend the type size requirement for FOP labeling and to provide 
additional flexibility for providing calorie information for gums, 
mints, and roll candy (see Refs. 1 and 2).

B. Type Size Requirement for ``Articles of Food Not Covered'' (Sec.  
101.8(b)(2))

    With respect to FOP labeling, Sec.  101.8(b)(2), states that 
articles of food sold from a vending machine are not ``covered vending 
machine food'' if 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. The 
visible nutrition information must appear on the food label itself, be 
clear and conspicuous and able to be easily read on the article of food 
while in the vending machine, and be in a type size at least 50 percent 
of the size of the largest printed matter on the label and with 
sufficient color and contrasting background to other print on the label 
to permit the perspective purchaser to clearly distinguish the 
information.
    In the preamble to the final rule (79 FR 71259 at 71269 (see 
comment 16 and our response)), we discussed how FOP labeling could be a 
way to provide visible nutrition information for articles of food that 
are sold from a vending machine that are not ``covered vending machine 
food'' as interpreted by Sec.  101.8(c). We also noted how some 
comments felt that the rule's type size requirement was too large, 
whereas others stated that the type size would be too small (79 FR 
71259 at 71269). We explained that specifying the minimum type size for 
calorie information on vending machine food labels will provide greater 
clarity for both compliance and enforcement (id.).
    Since the publication of the final rule, several trade associations 
indicated that the type size requirement would make the calorie 
declaration very large on some products and would make label redesign 
difficult and/or not practical. They noted the existence of voluntary 
FOP labeling programs whereby 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 
also asked us to align the compliance date with that for the Nutrition 
Facts labeling rule (81 FR 33742, May 27, 2016) so that food companies 
can ``make all changes to their food labels, including adding FOP 
calorie information, at the same time'' (see Ref. 2). The compliance 
date for the Nutrition Facts label rule is July 26, 2018, for 
manufacturers with $10 million or more in annual food sales.
    Consequently, with respect to Sec.  101.8(b)(2), we have decided to 
extend the compliance date for certain food products sold from a glass-
front vending machine that allow prospective purchasers to view 
packaged foods offered for sale. Specifically, if the food is:
     Sold from a glass-front vending machine that allows 
prospective purchasers to view packaged foods offered for sale;
     not a covered vending machine food within Sec.  
101.8(b)(2); and
     the label for such packaged foods provides front-of-
package calorie disclosures that 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,

then the compliance date for Sec.  101.8(b)(2) is extended to July 26, 
2018. This extension of the compliance date will give us time to 
consider whether a revision to Sec.  101.8(b)(2) is necessary and also 
give packaged food manufacturers more time to consider label redesign 
issues or, in the case of products without FOP calorie labeling, to 
consider whether to add such labeling. We emphasize that this extension 
is limited to vending machine operators whose glass-front vending 
machines are subject to Sec.  101.8(b)(2) and where the packaged food 
has FOP calorie disclosures that 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. Thus, a vending 
machine operator whose vending machines dispense packaged food without 
FOP labeling or use electronic displays is not affected by the 
extension. Similarly, a vending machine operator whose vending machines 
sell unpackaged food (such as fruit) is not affected by the extension.

C. Signage for Gums, Mints, and Roll Candy

    With respect to providing calorie information for gums, mints, and 
roll candy, our regulations, at Sec.  101.8(c), establishes 
requirements for calorie labeling for certain food sold from vending 
machines. Under Sec.  101.8(c)(2)(i)(C), the calorie declaration for 
covered vending machine food must include the total calories present in 
the packaged food, regardless of whether the packaged food contains a 
single serving or multiple servings. Under Sec.  101.8(c)(2)(ii)(A), 
the calorie declarations for covered vending machine food must be clear 
and conspicuous and placed prominently on a sign in close proximity to 
the article of food or selection button so long as the calorie 
declaration is visible at the same time as the food, its name, price, 
selection button, or selection number is visible.
    Several trade associations have disagreed with Sec.  101.8(c)(2) 
insofar as it would apply to gums, mints, and roll candy. The trade 
associations contend that gums, mints, and roll candy suitable for 
vending machines are not typically amenable to FOP labeling due to the 
limited size of the principal display panel, and as a result, there are 
few options for compliance for these products. They also describe that 
in glass-front vending machines, these items are often placed together 
at the bottom of the machine with limited space for signage. In 
addition, the trade associations have asserted that providing calories 
declarations ``per serving'' for these items is preferable to providing 
calories ``per container'', because consumers typically do not consume 
the entire packaged product at one time, and providing calorie 
declarations on a ``per serving'' basis would be consistent with our 
serving size requirements at 21 CFR 101.9. The trade associations also 
explained that these items typically contain insignificant amounts of 
all nutrients and are otherwise exempt from packaged food nutrition 
labeling, and that providing a sign with a range of 0 to 25 calories 
``per serving'' for these items is sufficient for consumers to make 
informed choices (Ref. 1). Based on these distinct challenges, the 
trade associations also suggested that we amend Sec.  101.8(c)(2) by 
adding a new paragraph that would, in effect, provide an exception for 
gums, mints, and roll candies that would allow the use of a range of 
calories (such as ``25 calories or

[[Page 50305]]

less/serving'') and the covered vending machine food:
     Contains at least three servings per package;
     has a ``reference amount customarily consumed'' (the 
portion size based on the amount the average person is likely to eat at 
one time) of 5 grams or less; and
     contains 25 calories or less per serving.

The trade associations indicated that the extension would only be for 
vending machine operators who, by December 1, 2016, have ``interim 
calorie signage'' that would consist of a single sign in close 
proximity to the article of food or selection button or inside the 
vending machine, where the sign states that gum, mint, and roll candies 
provide 25 calories or less/serving.
    We addressed a similar issue in the preamble to the final rule (see 
79 FR 71259 at 71276 through 71277 (see comment 24 and our response)) 
and explained why the calorie declaration requirement applies to the 
entire package rather than to a serving in the package. We disagree 
with the trade associations' suggestion that the final vending machine 
rule's serving size requirement should be consistent with that in our 
serving size rule. The vending machine rule applies to certain vending 
machine operators, whereas the serving size rule applies to food 
manufacturers. The statutory authority behind each regulation also 
differs; the vending machine label requirement is found in section 
403(q)(5)(H) of the FD&C Act, which requires, generally, that food sold 
in certain vending machines disclose the number of calories contained 
in food, whereas section 403(q)(1)(A)(i) of the FD&C Act requires, with 
certain exceptions, that food that is intended for human consumption 
and offered for sale bear nutrition information that provides a serving 
size that reflects the amount of food customarily consumed and is 
expressed in a common household measure that is appropriate to the 
food. Section 2(b)(1)(B) of the Nutrition Labeling and Education Act 
further requires the Secretary of Health and Human Services to issue 
regulations to establish standards to define serving size. 
Nevertheless, we note that, in the preamble to the final vending 
machine rule, we said we would allow, in addition to the total calorie 
declaration for the food as vended, the voluntary declaration of 
calories per serving for covered vending machine foods (see 79 FR 71259 
at 71277). The voluntary declaration of calories per serving, in 
addition to declaration of calories per container (required by Sec.  
101.8(c)(2)), should accommodate the trade associations' desire to 
disclose the number of calories per serving.
    However, we also are mindful that the gums, mints, and roll candies 
mentioned by the trade associations tend to be sold in small packages 
that do not lend themselves to FOP labeling and often are located or 
placed in a small space in glass-front vending machines; the small 
space may limit the size of any sign(s) that would disclose calorie 
information for each gum, mint, or roll candy. For example, we are 
aware that some glass-front vending machines may have trays that are 
different sizes; the tray width for bags of potato chips is larger than 
the tray width for a roll of mints or hard candies or for a small 
package of gum. The smaller tray size for gums, mints, and roll candy 
may make it difficult to add information, inside the vending machine, 
beyond the product's price and selection number. Therefore, we are 
extending the compliance date for Sec.  101.8(c)(2) to July 26, 2018, 
so that we may consider this issue further. This extension of the 
compliance date is limited to:
     Gums, mints, and roll candy sold in packages that are too 
small to bear FOP labeling and where the gums, mints, and roll candy 
are located in a small space within a glass-front vending machine that 
allows prospective purchasers to view packaged foods offered for sale;
     the space within the glass-front vending machine holding 
the gum, mints, and roll candy is so small such that it is not 
practicable to provide calorie information under each gum, mint, or 
roll candy; and
     the glass-front vending machine also does not or is not 
capable of providing calorie information electronically.
    This limited change in the compliance date for Sec.  101.8(c)(2) 
will give us time to consider issues relating to signage and vending 
machine design and give vending machine operators some flexibility in 
their disclosure of calorie information for gums, mints, and roll 
candies in small packages. In the interim, so consumers can make 
informed choices, we encourage vending machine operators to provide 
calorie information through a sign in close proximity to the gums, 
mints, and roll candy inside the vending machine that states the gums, 
mints, and roll candies provide ``X'' calories or less/serving, where X 
represents the value of the largest number of calories per serving for 
the gums, mints, and roll candies. We emphasize that this extension 
does not extend to other products in glass-front vending machines or 
glass-front vending machines that are capable of providing information 
electronically, nor does it extend to other types of vending machines. 
We also emphasize that the limited compliance date extension for Sec.  
101.8(c)(2) is intended to give vending machine operators more 
flexibility in providing calorie information for gums, mints, and roll 
candy in glass-front vending machines where those gums, mints, and roll 
candy are located or placed in a small space such that it is not 
practicable to provide calorie information under each gum, mint, or 
roll candy. Our final rule already gives vending machine operators 
other ways to comply with the calorie disclosure requirement; for 
example, vending machine operators can provide calorie declarations on 
a sign adjacent to the vending machine (see Sec.  101.8(c)(2)(ii)(C)).

III. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, 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). We 
have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of this final rule (Ref. 3). We believe that this 
final rule is not a significant regulatory action as defined by 
Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because the final rule changes the compliance date for Sec.  
101.8(b)(2) and (c)(2), under the limited circumstances described in 
this document, from December 1, 2016, to July 26, 2018, we certify that 
the final 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 issuing ``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

[[Page 50306]]

annually for inflation) in any one year.'' The current threshold after 
adjustment for inflation is $146 million, using the most current (2015) 
Implicit Price Deflator for the Gross Domestic Product. This final rule 
would not result in an expenditure in any year that meets or exceeds 
this amount.

IV. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

V. 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.

VI. References

    The following references are on display in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 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. Letter from Karin F. R. Moore, Vice President and General 
Counsel, Grocery Manufacturers Association, to Susan Mayne, Ph.D., 
Director, Center for Food Safety and Applied Nutrition, dated March 
31, 2016.
2. Letter from Karin Moore, Senior Vice President and General 
Counsel, Grocery Manufacturers Association, to Susan Mayne, Ph.D., 
Director, Center for Food Safety and Applied Nutrition, dated June 
26, 2016.
3. Economics Staff, Office of Planning, Office of Policy, Planning, 
Legislation, and Analysis, Office of the Commissioner, Food and Drug 
Administration, ``Food Labeling; Calorie Labeling of Articles of 
Food in Vending Machines; Extension of Compliance Date,'' dated July 
2016.

    Dated: July 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18140 Filed 7-29-16; 8:45 am]
 BILLING CODE 4164-01-P