Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Rules and Regulations 71259 

this Web site. Registrants must use this 

form to ensure that complete 

information is submitted. 

(i) Information should be submitted 

by email by typing complete 

information into the form (PDF), saving 

it on the registrant’s computer, and 

sending it by email to 

menulawregistration@fda.hhs.gov. 

(ii) If email is not available, the 

registrant can either fill in the form 

(PDF) and print it out (or print out the 

blank PDF and fill in the information by 

hand or typewriter), and either fax the 

completed form to 301–436–2804 or 

mail it to FDA, CFSAN Menu and 

Vending Machine Registration, White 

Oak Building 22, Rm. 0209, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993. 

(5) When to renew the registration. To 

keep the establishment’s registration 

active, the authorized official of the 

restaurant or similar retail food 

establishment must register every other 

year within 60 days prior to the 

expiration of the establishment’s current 

registration with FDA. Registration will 

automatically expire if not renewed. 

(e) Signatures. Signatures obtained 

under paragraph (d) of this section that 

meet the definition of electronic 

signatures in § 11.3(b)(7) of this chapter 

are exempt from the requirements of 

part 11 of this chapter. 

(f) Misbranding. A standard menu 

item offered for sale in a covered 

establishment shall be deemed 

misbranded under sections 201(n), 

403(a), 403(f) and/or 403(q) of the 

Federal Food, Drug, and Cosmetic Act if 

its label or labeling is not in conformity 

with paragraph (b) or (c) of this section. 

Dated: November 19, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–27833 Filed 11–25–14; 8:45 am] 

BILLING CODE 4164–01–P 

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 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: To implement the vending 

machine food labeling provisions of the 

Patient Protection and Affordable Care 

Act of 2010 (ACA), the Food and Drug 

Administration (FDA or we) is 

establishing requirements for providing 

calorie declarations for food sold from 

certain vending machines. This final 

rule 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. 

This 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. 

DATES:

Effective Date: December 1, 2016. 

Compliance Date: Covered vending 

machine operators must comply with 

the rule by December 1, 2016. See 

section III.E for more information on the 

effective and compliance dates. 

Comment Date: Submit comments on 

information collection issues under the 

Paperwork Reduction Act of 1995 by 

December 31, 2014 (see section V, the 

‘‘Paperwork Reduction Act of 1995’’ 

section of this document). 

ADDRESSES: To ensure that comments on 

the information collection are received, 

the Office of Management and Budget 

(OMB) recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910—New and 

title ‘‘Information Collection Provisions 

of the final rule on Food Labeling: 

Calorie Labeling of Articles of Food in 

Vending Machines.’’ Also include the 

FDA docket number found in brackets 

in the heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Y. Reese, Center for Food Safety 

and Applied Nutrition (HFS–820), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

240–402–2371, email: Daniel.Reese@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

Executive Summary 

Purpose and Coverage of the Final Rule 

Summary of the Major Provisions of the Final 

Rule 

Costs and Benefits 

I. Background 

II. Legal Authority 

III. Comments on the Proposed Rule, FDA 

Responses, and Description of the Final 

Rule 

A. Introduction 

B. General Comments 

C. Comments on Specific Provisions and 

Description of the Final Rule 

D. Determination of Calorie Content 

E. Effective Date 

F. Enforcement 

IV. Analysis of Impacts—Final Regulatory 

Impact Analysis 

V. Paperwork Reduction Act of 1995 

VI. Federalism 

VII. Environmental Impact 

VIII. References 

Executive Summary 

Purpose and Coverage of the Final Rule 

To help make calorie information for 

vending machine foods available to 

prospective purchasers in a direct, 

accessible, and consistent manner to 

enable them to make informed and 

healthful dietary choices, section 4205 

of the ACA and the rule require that 

vending machine operators who own or 

operate 20 or more vending machines, 

or who voluntarily elect to be covered, 

must provide calorie declarations for 

those vending machine foods for which 

the Nutrition Facts label cannot be 

examined prior to purchase or for which 

visible nutrition information is not 

otherwise provided at the point of 

purchase. 

Summary of the Major Provisions of the 

Final Rule 

• The final rule requires vending 

machine operators who own or operate 

20 or more vending machines (or who 

voluntarily register with FDA to be 

subject to the final rule) to provide 

calorie declarations for certain articles 

of food sold from vending machines. 

Æ The final rule defines a vending 

machine operator as a person or entity 

that controls or directs the function of 

the vending machine, including 

deciding which articles of food are sold 

from the machine or the placement of 

the articles of food within the vending 

machine, and is compensated for the 

control or direction of the function of 

the vending machine. 

Æ Through biannual registration, 

vending machine operators who are not 

covered by the final rule can voluntarily 

elect to become subject to it. 

• The final rule describes which 

foods are subject to the calorie 


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declaration requirement. 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. 

• For those foods subject to the 

calorie declaration requirement, the 

final rule specifies how the calories 

must be declared. 

Æ 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. 

Æ 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. 

Æ 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 requires vending 

machine operator contact information to 

be displayed for enforcement purposes. 

• The final rule makes conforming 

amendments to FDA’s labeling 

regulations at § 101.9(j) so that a covered 

vending machine food that is otherwise 

exempt from nutrition labeling under 

§ 101.9 would not lose such exemption 

by complying with the calorie 

declaration requirements of the final 

rule. 

Costs and Benefits 

The Affordable Care Act requires 

nutrition labeling for standard menu 

items on menus and menu boards for 

certain restaurants and similar retail 

food establishments and calorie labeling 

for food sold from certain vending 

machines. FDA is issuing two separate 

final rules (one for menu labeling and 

one for vending machine labeling) to 

implement those labeling requirements. 

For this rule on vending machines 

alone, the expected annualized costs are 

$37.9 million (over 20 years discounted 

at 7 percent), while the benefits have 

not been quantified. Taken together, the 

mean estimated benefits of the labeling 

requirements (menu labeling and 

vending machine labeling rules 

combined) exceed costs by $477.9 

million on an annualized basis (over 20 

years discounted at 7 percent; not 

including net benefits from this final 

rule on vending machine labeling, 

which are not quantified). 

SUMMARY OF COSTS AND BENEFITS OF MENU LABELING AND VENDING MACHINE RULES (IN MILLIONS) * 

Rate 

percent) Benefits Costs Net benefits 

Total for Labeling (menu and vending rules) over 20 years ............................ 3 

7 

$9,221.3 ...........

6,752.8 .............

$1,697.9 

1,333.9 

$7,523.4 

5,418.9 

Annualized for Labeling (menu and vending rules) over 20 years .................. 3 

7 

$601.9 ..............

595.5 ................

$110.8 

117.6 

491.1 

477.9 

Total for Vending Machine Labeling over 20 years ......................................... 3 

7 

Not Quantified ..

Not Quantified ..

531.1 

401.1 

........................

........................

Annualized for Vending Machine Labeling over 20 years ................................ 3 

7 

Not Quantified ..

Not Quantified ..

34.7 

35.4 

........................

........................

* Benefits from this vending machine labeling rule are not quantified and therefore not included. 

I. Background 

The Nutrition Labeling and Education 

Act of 1990 (NLEA) amended the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) to require, in part, 

nutrition information for food labeling 

(section 403(q) (21 U.S.C. 343(q)). Under 

the NLEA and its implementing 

regulations (§ 101.9 (21 CFR 101.9)), 

when a food is in package form, the 

required nutrition information generally 

must appear on the label of the food. 

The regulations require nutrition 

information to be provided for a food 

product intended for human 

consumption and offered for sale unless 

an exemption applies (§ 101.9(a)). One 

of these exemptions applied to food 

products served in a vending machine, 

provided that the food bore no nutrition 

claims or other nutrition information in 

any context on the label or in the 

labeling or advertising (§ 101.9(j)(2)). 

On March 23, 2010, the President 

signed the ACA (Public Law 111–148) 

into law. Section 4205 of the ACA 

amended section 403(q) of the FD&C Act 

and section 403A of the FD&C Act (21 

U.S.C. 343–1), which governs Federal 

preemption of State and local food 

labeling requirements. Section 4205 of 

the ACA added section 403(q)(5)(H)(viii) 

to the FD&C Act to require that if an 

article of food is sold from a vending 

machine that (1) ‘‘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;’’ and (2) ‘‘is operated 

by a person who is engaged in the 

business of owning or operating 20 or 

more vending machines,’’ then 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.’’ 

Under section 403(q)(5)(H)(ix) of the 

FD&C Act, vending machine operators 

who are not subject to the new 

requirements of section 

403(q)(5)(H)(viii) of the FD&C Act can 

register voluntarily with FDA to become 

subject to the Federal requirements. In 

the Federal Register of July 23, 2010 (75 

FR 43182), we published a notice 

specifying the terms and conditions for 

implementation of voluntary 

registration, pending issuance of 

regulations. 

II. Legal Authority 

Section 4205 of the ACA amended 

section 403(q)(5) of the FD&C Act, in 

part, by adding a new paragraph (H) to 

require certain vending machine 

operators to 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 nonmisleading. 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 


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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. 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 (21 U.S.C. 

321(n)), 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 final 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 (21 U.S.C. 371(a)), which 

gives us the authority to issue 

regulations for the efficient enforcement 

of the FD&C Act. 

III. Comments on the Proposed Rule, 

FDA Responses, and Description of the 

Final Rule 

A. Introduction 

In the Federal Register of April 6, 

2011 (76 FR 19238), we published a 

proposed rule that would establish 

requirements for calorie declarations for 

certain articles of food sold from 

vending machines to implement section 

403(q)(5)(H)(viii) and (q)(5)(H)(ix) of the 

FD&C Act. We proposed definitions, 

requirements for calorie labeling for 

certain food sold from vending 

machines, and requirements for 

voluntary registration by a vending 

machine operator that is not subject to 

the requirements of section 

403(q)(5)(H)(viii) of the FD&C Act to 

elect to be subject to such requirements. 

We provided a 90-day comment period 

that ended on July 5, 2011. 

We received approximately 250 

comments on the proposed rule each 

containing one or more issues. We 

received comments from consumers; 

consumer groups; trade organizations; 

the vending machine industry; public 

health organizations; Congress; Federal, 

State, and local government agencies; 

and other organizations. 

We describe and respond to the 

comments in sections III.B, C, D, and E 

of this document. To make it easier to 

identify comments and our responses, 

the word ‘‘Comment,’’ in parentheses, 

will appear before the comment’s 

description, and the word ‘‘Response,’’ 

in parentheses, will appear before our 

response. We have also numbered each 

comment to help distinguish between 

different comments. The number 

assigned to each comment is purely for 

organizational purposes and does not 

signify the comment’s value, 

importance, or the order in which it was 

received. 

B. General Comments 

Many comments made general 

remarks supporting or opposing the rule 

and did not focus on a particular section 

of the rule. Other comments addressed 

FDA’s statutory interpretations and 

general economic issues. We address the 

general comments including general 

comments relating to FDA’s statutory 

interpretations and general economic 

issues here. 

(Comment 1) The majority of 

comments supported the proposed rule. 

Some comments stated that the 

proposed rule strikes the right balance 

between making important nutrition 

information available to consumers and 

avoiding unnecessary financial burdens 

on small businesses. Other comments 

said requiring vending machines to 

display calorie information is an 

integral part of a comprehensive 

approach to addressing obesity by 

providing consumers with more 

information to make healthier choices. 

Some comments supported the 

proposed rule’s flexibility regarding 

how covered operators are to declare 

calories on signs. 

In contrast, other comments opposed 

the proposed rule. Some comments 

stated that people do not need to be told 

what to eat. One comment stated that 

labeling responsibilities should be 

placed on food manufacturers, rather 

than vending machine operators, 

because food manufacturers already 

have the information and can place it on 

the food label. One comment asserted 

that calorie declarations on signs in 

close proximity to articles of food sold 

in vending machines or selections 

buttons are unnecessary because 

packaged foods already have nutrition 

information on the labels for such foods. 

(Response 1) The final rule does not 

attempt to tell consumers what they 

should or should not eat. The final rule 

requires certain vending machine 

operators to provide calorie declarations 

for certain articles of food sold from 

vending machines on signs in close 

proximity to such articles of food or 

selection buttons as required by section 

403(q)(5)(H)(viii) of the FD&C Act. The 

purpose of the final rule is to provide 

accurate and clear calorie information 

for vending machine foods to consumers 

in a direct and accessible manner to 

enable consumers to make informed and 

healthful dietary choices. 

As for the comment stating that food 

manufacturers rather than vending 

machine operators should be 

responsible for providing calorie 

declarations for vending machine foods, 

section 403(q)(5)(H)(viii) of the FD&C 

Act expressly applies to certain vending 

machine operators. Therefore, we 

decline to revise the rule to apply the 

requirements of section 

403(q)(5)(H)(viii) of the FD&C Act to 

food manufacturers. 

We note that some packaged foods 

may already list nutrition information 

(including calories) on their labels. Such 

articles of food may be exempt from the 

requirements of section 

403(q)(5)(H)(viii) of the FD&C Act if 

they satisfy the criteria set forth in 

§ 101.8(b). 

(Comment 2) Some comments 

opposed the proposed rule, stating that 

the costs and work to implement the 

proposed requirements would be better 

spent on other programs. Other 

comments questioned the value of the 

calorie declaration requirements and 

asserted that the proposed rule would 

increase the cost of packaged foods sold 

in vending machines. Another comment 

suggested that the Federal Government 

provide tax incentives to small 

businesses to offset costs of 

implementing the rule. 

Other comments questioned whether 

disclosing calorie information would 

have the intended benefits. The 

comments questioned whether vending 

machine calorie labeling would promote 

healthier choices and the need to 

educate consumers about the calorie 

information. The comments also 

questioned whether consumers would 

ignore the calorie information, and 

whether the calorie information would 

affect consumer behavior. 

(Response 2) With respect to those 

comments suggesting that Federal funds 

and labor would be better spent on other 

matters, section 4205 of the ACA 

requires us to issue regulations to 

implement the vending machine 

labeling requirements, as specified in 

section 403(q)(5)(H)(viii) of the FD&C 

Act. 

The final rule does not require food 

manufacturers to change the labeling of 

packaged foods, nor does it require 

vending machine manufacturers to 

change the design of vending machines. 

Nevertheless, it is possible that some 

costs associated with compliance with 

this rulemaking might pass through to 

consumers. However, any changes to the 

cost of packaged foods sold in vending 

machines are likely to be very small, 

because the estimated costs of 

compliance would be very small relative 

to overall sales from vending machines. 

The final rule is directed at certain 

vending machine operators, and we 

discuss the final rule’s economic impact 

and its impact on small businesses in a 


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full Regulatory Impact Analysis for the 

final rule (Ref. 1) which is available at 

http://www.regulations.gov (enter 

Docket No. FDA–2011–F–0171). 

As for the comments suggesting tax 

incentives for small businesses, we 

recognize that nearly 97 percent of the 

covered vending machine operators are 

small businesses, and have provided 

flexibility in the final rule to reduce the 

burden on small businesses. 

Specifically, we have changed the final 

rule’s effective date from 1 year to 2 

years, and are allowing covered vending 

machine operators to choose the method 

for determining calorie content of the 

food and the materials through which 

the calories are declared, including less 

expensive means such as stickers or 

signs. We believe this additional 

flexibility will help minimize burdens 

on and costs for small businesses in 

complying with the requirements of 

section 403(q)(5)(H)(viii) of the FD&C 

Act. 

With respect to the comments 

questioning the rule’s potential benefits, 

we note that section 4205 of the ACA 

requires FDA to implement the calorie 

labeling requirements for vending 

machines in section 403(q)(5)(H)(viii) of 

the FD&C Act. Further, 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. 

(Comment 3) The vending machine 

labeling requirements in section 

403(q)(5)(H)(viii) of the FD&C Act apply 

to all covered food sold from vending 

machines operated by a person who is 

engaged in the business of owning or 

operating 20 or more vending machines. 

The preamble to the proposed rule 

indicates that, as with other vending 

machine operators, vending machine 

operators who are blind and operate 

vending machines through the Vending 

Facility Program of the RandolphSheppard Act of 1936, 20 U.S.C. 107 et 

seq., would be covered by the 

requirements of section 

403(q)(5)(H)(viii) of the FD&C Act only 

if they operate 20 or more vending 

machines that dispense food or if they 

voluntarily register to be covered (76 FR 

19238 at 19240–19241). 

Several comments asked that we 

retain the explanation from the 

preamble to the proposed rule that 

section 403(q)(5)(H)(viii) of the FD&C 

Act does not apply to vending machine 

operators who are blind and operate 

vending machines through the Vending 

Facility Program of the RandolphSheppard Act if they operate fewer than 

20 machines. The comments expressed 

concern that, because State licensing 

agencies responsible for administering 

the Randolph-Sheppard Act often own 

the vending machines, vending machine 

operators would be subject to the calorie 

declaration requirements even if they 

operate fewer than 20 machines. 

(Response 3) Section 403(q)(5)(H)(viii) 

of the FD&C Act applies to all covered 

food sold from vending machines 

‘‘operated by a person who is engaged 

in the business of owning or operating 

20 or more vending machines.’’ Thus, if 

a vending machine operator under the 

Vending Facility Program of the 

Randolph-Sheppard Act does not own 

or operate 20 or more vending 

machines, then the food sold from his 

or her vending machines is outside the 

scope of the final rule unless the 

vending machine operator voluntarily 

registers to be covered by the rule under 

§ 101.8(d). 

(Comment 4) One comment asked that 

we clarify that vending machine 

operators, rather than food 

manufacturers, must comply with this 

final rule. 

(Response 4) Section 403(q)(5)(H)(viii) 

of the FD&C Act makes it clear that the 

requirements apply to vending machine 

operators rather than food 

manufacturers. 

Nevertheless, a food manufacturer 

may provide the number of calories for 

a vending machine food to a vending 

machine operator to help the vending 

machine operator meet the calorie 

declaration requirements of this rule. In 

addition, the label for a vending 

machine food may already include 

calorie information, which the vending 

machine operator may use in providing 

the calorie declarations required by this 

rule. Further, as food packaging and 

vending machine technology continue 

to evolve, food manufacturers, vending 

machine manufacturers, and vending 

machine operators may work together to 

help vending machine operators comply 

with this rule. 

(Comment 5) One comment asked 

whether dietary supplements and overthe-counter drugs (e.g., cough drops), 

which are sometimes sold in vending 

machines, would be covered by the 

requirements of section 

403(q)(5)(H)(viii) of the FD&C Act. The 

comment noted that, in some cases, 

these products bear calorie information, 

but the information is within the 

context of the Drug or Supplement 

Facts, and not on the front of package 

(FOP). The comment stated that dietary 

supplements and over-the-counter drugs 

should not be considered articles of 

food and that we should not apply the 

calorie labeling requirements to these 

types of items. 

(Response 5) Section 201(f) of the 

FD&C Act defines ‘‘food’’ as: ‘‘(1) 

Articles used for food or drink for man 

or other animals, (2) chewing gum, and 

(3) articles used for components of any 

such article.’’ Further, section 201(ff) of 

the FD&C Act explains that dietary 

supplements are deemed to be foods 

within the meaning of the FD&C Act 

except for the purposes of sections 

201(g) (definition of ‘‘drug’’) and 417 (21 

U.S.C. 350f) (reportable food registry) of 

the FD&C Act. The requirements of 

section 403(q)(5)(H)(viii) of the FD&C 

Act apply ‘‘[i]n the case of an article of 

food sold from a vending machine’’ and, 

therefore, apply to dietary supplements, 

but do not apply to drugs, including 

over-the-counter drugs. 

(Comment 6) Some comments 

requested that foods in small packages 

whose total surface area available to 

bear labeling is less than 12 square 

inches, e.g., gum and mints, be 

exempted from the rule; these 

comments said such an exemption 

would be consistent with the existing 

exemption from nutrition labeling for 

foods in small packages (§ 101.9(j)(13)). 

One comment further reasoned that an 

exemption for foods sold in small 

packages would be appropriate because 

such packaged foods lack sufficient 

label space to provide FOP calorie 

information that would be easily 

readable by the consumer through the 

vending machine window. The 

comment also speculated that vending 

machine operators may no longer 

choose to sell gums and mints in most 

vending machines. Some comments also 

noted that these foods in small packages 

provide an insignificant calorie 

contribution to the daily diet and 

requested that such foods be exempted 

from this rule. These comments argued 

that the burden of providing calorie 

information is not justified for such 

foods. 

Some comments stated that foods 

exempt from nutrition labeling under 

§ 101.9(j) would lose this exemption if 

they must bear calorie information on 

the front of the package. Similarly, other 

comments asked us to exempt bottled 

water from this rule because bottled 

water contains insignificant amounts of 

nutrients and is generally exempt from 

the nutrition labeling requirements of 

§ 101.9 under the exemption for 

packaged foods in § 101.9(j)(4). One 

comment expressed concern that, if 

bottled water products must comply 

with this rule, the bottled water would 

be required to have a Nutrition Facts 

Panel even though it may be otherwise 

exempt from the nutrition labeling 

requirements. The comment expressed 

concern that vending machine operators 


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may stock less bottled water because 

they would stock products only with 

nutrition information on the label or 

FOP labeling so that they would not 

have to post calorie declarations 

themselves. 

(Response 6) The comments referring 

to the exemptions are describing 

§ 101.9(j)(4) and (j)(13)(i), which FDA 

issued to implement section 403(q)(5)(B) 

and (C) of the FD&C Act before the 

enactment of the ACA. Section 

101.9(j)(13)(i) provides that foods in 

small packages that have a total surface 

area available to bear labeling of less 

than 12 square inches are exempt from 

the nutrition labeling requirements of 

§ 101.9 provided that the labels for these 

foods bear no nutrition claims or other 

nutrition information in any context on 

the label or in labeling or advertising. In 

addition, § 101.9(j)(4) provides in 

relevant part that foods containing 

insignificant amounts of all of the 

nutrients and food components required 

to be included in the declaration of 

nutrition information under § 101.9(c) 

are exempt from the nutrition labeling 

requirements of § 101.9 provided that 

these foods bear no nutrition claims or 

other nutrition information in any 

context on the label or in labeling or 

advertising. However, these exemptions 

only apply to the requirements of 

section 403(q)(1) and (2) of the FD&C 

Act, and not the vending machine 

labeling requirements of section 

403(q)(5)(H)(viii) of the FD&C Act. 

Also, section 403(q)(5)(H)(viii) of the 

FD&C Act does not include an 

exemption for vending machine foods 

based on the package size, amount of 

nutrients, or caloric content of such 

foods. Instead, it provides that calorie 

declarations are not required for food 

sold from a vending machine: (1) That 

permits a prospective purchaser to 

examine the Nutrition Facts Panel 

before purchasing the food; or (2) that 

otherwise provides visible nutrition 

information at the point of purchase. If 

a vending machine food does not fall 

into either of these two categories, a 

covered vending machine operator must 

provide calorie information for the food. 

We note that this final rule requires a 

covered vending machine operator to 

post calorie information on a sign in 

close proximity to a vending machine 

food or its selection button; it does not 

require that such calorie information be 

included on the label of a vending 

machine food. Further, the final rule 

provides a number of options for 

covered vending machine operators to 

post the required calorie information, 

including posting such information on a 

sign adjacent to a vending machine 

(§ 101.8(c)(2)). As a result, the practical 

limitations that may apply to including 

nutrition information on the labels of 

foods in small packages do not apply to 

posting calorie information on signs for 

vending machine food. For these 

reasons, we are not exempting vending 

machine foods that come in small 

packages (e.g., gum, mints) or vending 

machine foods that contain insignificant 

nutrient or caloric content (e.g., bottled 

water) from the requirements of section 

403(q)(5)(H)(viii) of the FD&C Act. 

We are also making changes to clarify 

that a covered vending machine food 

that is exempt from nutrition labeling 

under an exemption provided in 

§ 101.9(j) would not lose such 

exemption by complying with the final 

rule’s calorie labeling requirements. As 

noted previously, § 101.9(j) provides 

exemptions from the requirements of 

§ 101.9, including exemptions that 

apply to vending machine foods. 

Section 101.9(j)(2)(ii) provides, in 

relevant part, that food products which 

are served in establishments other than 

restaurants in which food is served for 

immediate human consumption, 

including vending machines, are 

exempt from the nutrition labeling 

requirements of § 101.9 provided that 

these foods bear no nutrition claims or 

other nutrition information in any 

context on the label or in labeling or 

advertising. Similarly, § 101.9(j)(4) and 

(j)(13)(i) provide exemptions from the 

requirements of § 101.9 provided that 

the food bears no nutrition claims or 

other nutrition information in any 

context on the label or in labeling or 

advertising. Because of these provisions, 

a vending machine food that complies 

with the final rule’s calorie labeling 

requirements would not qualify for the 

exemptions from nutrition labeling in 

§ 101.9(j)(2)(ii), (j)(4), and (j)(13)(i) 

because the labeling for such food 

would bear nutrition information. 

To prevent this outcome, we have 

amended § 101.9(j) so that a covered 

vending machine food that is otherwise 

exempt from nutrition labeling under 

§ 101.9(j) would not lose such 

exemption by complying with the final 

rule’s calorie labeling requirements. We 

have amended § 101.9(j)(2)(ii), (j)(4), and 

(j)(13)(i) to clarify that complying with 

the vending machine food labeling 

requirements of § 101.8(c) will not cause 

a food product meeting the exemption 

to lose the exemption. 

However, we note that providing 

visible nutrition information on the 

label of a vending machine food through 

FOP labeling would constitute a 

nutrient content claim under section 

403(r) of the FD&C Act. Section 101.13 

(21 CFR 101.13), which provides general 

principles for nutrient content claims, 

states, in relevant part, that information 

that is required or permitted by § 101.9 

or § 101.36 (21 CFR 101.36), as 

applicable, to be declared in nutrition 

labeling, and that appears as part of the 

nutrition label, is not considered to be 

a nutrient content claim and is not 

subject to the requirements of this 

section, unless such information is 

declared elsewhere on the label or in 

labeling for the food (§ 101.13(c)). If 

nutrition information that is required or 

permitted by § 101.9 or § 101.36, 

including calorie information, appears 

some place other than the nutrition 

label for a food, such as on the front of 

the food’s package, it is a nutrient 

content claim and is subject to the 

requirements for nutrient content claims 

(§ 101.13(c); 136 Cong. Rec. 20369, at 

20419 (1990) (‘‘Section 403(r)(1) has 

been amended to make it clear that the 

information on the nutrition label is not 

a claim under that provision and 

therefore is not subject to the disclosure 

requirements in section 403(r)(2) . . . 

but the identical information will be 

subject to section 403(r)(2) if it is 

included in a statement in another 

portion of the label.’’)). Accordingly, 

visible nutrition information provided 

through FOP labeling would be 

considered a nutrient content claim 

because it is nutrition information that 

is ‘‘declared elsewhere on the label’’ for 

a food. As such, a covered vending 

machine food that provides visible 

nutrition information at the point of 

purchase through FOP labeling would 

not qualify for the exemptions from 

nutrition labeling in § 101.9(j)(2)(ii), 

(j)(4), and (j)(13)(i), and therefore would 

be subject to the nutrition labeling 

requirements in § 101.9. 

(Comment 7) One comment requested 

that we require vending machine 

operators to provide calorie declarations 

in a special format for visually impaired 

customers. The comment suggested that 

this format could be large font, Braille, 

or audio recordings. 

(Response 7) We acknowledge the 

potential difficulty that visually 

impaired consumers may confront if the 

calorie declaration exists only in visual 

form, and we would not object if 

vending machine operators wish to 

develop means, such as large font, 

Braille, or audio, to help provide calorie 

declarations to visually impaired 

consumers, so long as the vending 

machine operators otherwise satisfy the 

requirements of section 

403(q)(5)(H)(viii) of the FD&C Act. We 

also would not object if vending 

machine and food manufacturers and 

designers decide to consider the needs 

of visually impaired consumers when 

manufacturing and designing their 


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products. However, we are not requiring 

vending machine operators to provide 

calorie declarations in a special format 

for visually impaired consumers at this 

time. 

(Comment 8) A few comments 

supporting the proposed rule noted that 

requiring calorie labeling for vending 

machine foods sold in schools would be 

beneficial. These comments noted that 

vending machines typically are located 

in schools. Some of these comments 

asked that we require covered vending 

machine operators to provide separate 

calorie information for children, or list 

appropriate ‘‘daily calorie ranges or 

percentages’’ for children. 

(Response 8) We agree that calorie 

labeling for vending machine foods, 

including vending machine foods sold 

in schools, would be beneficial. 

Nevertheless, at this time, we decline 

to require covered vending machine 

operators to provide separate calorie 

information for children, or list 

appropriate ‘‘daily calorie ranges or 

percentages’’ for children as requested 

by some of the comments. Section 

403(q)(5)(H)(viii) of the FD&C Act 

requires covered vending machine 

operators to provide a sign ‘‘disclosing 

the number of calories contained in the 

[covered vending machine food].’’ The 

number of calories contained in an 

article of food does not differ based on 

the population targeted or served by a 

vending machine. 

Vending machine operators may 

voluntarily provide additional 

information that puts the calorie 

declaration for a covered vending 

machine food in the context of a total 

daily diet, provided that such 

information is truthful and not 

misleading. However, we decline to 

require such additional information in 

the final rule because we are only 

establishing regulations for the 

requirements of section 

403(q)(5)(H)(viii) of the FD&C Act, and 

certain related provisions of section 403 

of the FD&C Act, as described in section 

II, at this time. 

(Comment 9) Some comments 

addressed issues unrelated to the 

proposed rule’s specific calorie labeling 

requirements for covered vending 

machine food. These comments 

addressed color-coded package labeling, 

labeling genetically engineered foods, 

and labeling or highlighting other 

ingredients or nutrients (such as trans 

fat). 

(Response 9) This rulemaking is 

intended to implement the vending 

machine calorie labeling requirements 

of section 403(q)(5)(H)(viii) of the FD&C 

Act. Thus, the issues raised by the 

comments are beyond the scope of this 

rulemaking. 

(Comment 10) Some comments stated 

that FDA should not require covered 

vending machine operators to provide 

FOP calorie labeling or calorie 

declarations on signs in languages other 

than English, even if the label on the 

article of food is bilingual, but should 

allow the food manufacturer or 

distributor to voluntarily provide FOP 

calorie labeling or calorie declarations 

in a second language. One comment 

asked us to confirm that ‘‘Cal’’ is an 

acceptable abbreviation for ‘‘Calories’’ 

in both French and Spanish. 

(Response 10) We are not requiring 

covered vending machine operators to 

provide calorie declarations for covered 

vending machine food in languages 

other than English, even if the label on 

the article of food is bilingual. FDA 

regulations at § 101.15(c)(1) (21 CFR 

101.15(c)(1)) require that all words, 

statements, and other information 

required by the FD&C Act to appear on 

the label or labeling of food must appear 

in English, except that for foods 

distributed solely in Puerto Rico or 

other territories where the predominant 

language is not English, the 

predominant language may be 

substituted for English. Therefore, the 

calorie declarations provided by the 

covered vending machine operator, 

whether through the Nutrition Facts 

label or other visible nutrition 

information at the point of purchase 

(e.g., FOP labeling) in accordance with 

section 403(q)(5)(H)(viii)(I)(aa) of the 

FD&C Act or through a sign in close 

proximity to each article of food or the 

selection button in accordance with 

section 403(q)(5)(H)(viii) of the FD&C 

Act, must appear in English, unless the 

foods are distributed solely in Puerto 

Rico or other territories where the 

predominant language is not English, as 

provided in § 101.15(c)(1). In that 

context, we would consider ‘‘Cal’’ to be 

an acceptable abbreviation for 

‘‘Calories’’ in French and Spanish. 

C. Comments on Specific Provisions and 

Description of the Final Rule 

Many comments addressed specific 

provisions in the proposed rule or 

related topics. 

1. Section 11.1(h)—Electronic 

Signatures 

Proposed § 11.1(h) would explain that 

part 11 (21 CFR part 11) regarding 

electronic signatures does not apply to 

electronic signatures obtained under the 

voluntary registration provision for 

vending machine operators at proposed 

§ 101.8(d). 

We received no comments on this 

provision and have finalized it without 

change. 

2. Section 101.8(a)—Definitions 

a. Use of statutory definitions. 

Proposed § 101.8(a) would define 

various terms. It also would explain that 

the definitions of terms in section 201 

of the FD&C Act apply to such terms 

when used in proposed § 101.8. We 

received no comments regarding the use 

of statutory definitions in section 201 of 

the FD&C Act for the purposes of 

§ 101.8, and we have finalized the 

sentence referring to the use of statutory 

definitions in § 101.8(a) without change. 

b. ‘‘Authorized Official of a Vending 

Machine Operator’’. Proposed § 101.8(a) 

would define ‘‘authorized official of a 

vending machine operator’’ as the 

owner, operator, or agent in charge or 

any other person authorized by the 

vending machine operator to register the 

vending machine operator, which is not 

otherwise subject to the requirements of 

section 403(q)(5)(H) of the FD&C Act 

with FDA for purposes of proposed 

§ 101.8(d). (Proposed § 101.8(d) would 

provide for voluntary calorie labeling 

for foods sold from vending machines.) 

We received no comments regarding 

the proposed definition. However, on 

our own initiative, we have revised the 

definition to make non-substantive 

grammatical and technical changes 

(such as changing ‘‘the vending machine 

operator’’ to ‘‘a vending machine 

operator’’ and replacing ‘‘FDA’’ with 

‘‘the Food and Drug Administration’’). 

We also have revised the definition to 

eliminate potential confusion as to who 

can be the authorized official of a 

vending machine operator by deleting 

an unnecessary conjunction (‘‘or’’) in 

the list of persons who may constitute 

an authorized official, to specify the 

provision of the FD&C Act covered by 

the final rule, and to move a descriptive 

phrase closer to the noun that it 

modifies. The final rule now defines an 

‘‘authorized official of a vending 

machine operator’’ as an owner, 

operator, agent in charge, or any other 

person authorized by a vending 

machine operator who is not otherwise 

subject to section 403(q)(5)(H)(viii) of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 343(q)(5)(H)(viii)), to 

register the vending machine operator 

with the Food and Drug Administration 

(‘FDA’) for purposes of paragraph (d) of 

the section. 

c. ‘‘Vending Machine’’. Proposed 

§ 101.8(a) would define ‘‘vending 

machine’’ as a self-service device that, 

upon insertion of a coin, paper 

currency, token, card, or key, or by 

optional manual operation, dispenses 


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servings of food in bulk or in packages, 

or prepared by the machine, without the 

necessity of replenishing the device 

between each vending operation. 

(Comment 11) One comment argued 

that ‘‘turret-style’’ (also referred to as 

‘‘turnstile’’) refrigerated vending 

machines do not meet the proposed 

definition of vending machine. 

According to the comment, once a food 

item in a turnstile vending machine is 

sold, the space that was occupied by the 

food becomes empty and needs to be 

restocked. The comment stated that a 

turnstile refrigerated vending machine, 

therefore, does not meet the part of the 

vending machine definition that reads: 

‘‘. . . without the necessity of 

replenishing the device between each 

vending operation.’’ The comment also 

stated that the legislative intent of 

Congress may have been to exclude 

turnstile refrigerated vending machines, 

which are normally stocked with 

sandwiches, milk, burritos, or 

refrigerated foods because they are not 

the same as snack vending machines 

that primarily sell ‘‘junk food.’’ 

(Response 11) We disagree with the 

comment’s assertion that ‘‘turret-style’’ 

or turnstile vending machines are 

outside the definition of ‘‘vending 

machine.’’ The definition uses the word 

‘‘replenished’’ in relation to the 

‘‘device’’ rather than the precise space 

the food once occupied. Contrary to the 

comment’s interpretation, the final 

rule’s definition of ‘‘vending machine’’ 

considers whether the machine, as a 

whole, needs to be restocked after each 

vending operation and not whether 

individual space(s) for food are 

‘‘replenished.’’ 

If we were to accept the comment’s 

interpretation and focus on the need to 

restock a specific space for a food after 

a vending operation, then one could 

argue that every vending machine 

would be outside the definition because 

operators do not necessarily restock 

each space after every purchase. It is 

true that, in turnstile vending machines, 

an empty space is created when a 

consumer buys an item from a particular 

space. However, the turnstile vending 

machine has multiple spaces within a 

level or tray, and the next consumer can 

rotate the turret to make another 

selection. Thus, the vending machine 

operator does not have to replenish the 

machine after each vending operation. 

Furthermore, the type or nutritional 

quality of a food carried by the vending 

machine—whether it is a ‘‘meal’’ or a 

‘‘snack’’—makes no difference under 

section 403(q)(5)(H)(viii) of the FD&C 

Act, nor did the proposed rule make 

such a distinction. 

For these reasons, turret-style or 

turnstile vending machines are 

‘‘vending machines’’ as defined by 

§ 101.8(a). We note that the proposed 

definition used both the words ‘‘device’’ 

and ‘‘machine’’ interchangeably; for 

consistency, we have revised the 

definition of ‘‘vending machine’’ by 

replacing the term ‘‘device’’ with 

‘‘machine.’’ 

d. ‘‘Vending Machine Operator’’. 

Proposed § 101.8(a) would define a 

‘‘vending machine operator’’ as a 

person(s) or entity that controls or 

directs the function of the vending 

machine, including deciding which 

articles of food are sold from the 

machine or the placement of the articles 

of food within the vending machine, 

and is compensated for the control or 

direction of the function of the vending 

machine. 

We received no comments on the 

proposed definition and have finalized 

it without change. 

3. Section 101.8(b)—Articles of Food 

Not Covered 

a. Ability to examine the nutrition 

facts label. Proposed § 101.8(b) would 

describe the circumstances under which 

articles of food dispensed from a 

vending machine are not ‘‘covered 

vending machine food’’ such that the 

requirements of section 

403(q)(5)(H)(viii) of the FD&C Act do 

not apply. Proposed § 101.8(b)(1) would 

provide that an article of food dispensed 

from a vending machine is not ‘‘covered 

vending machine food’’ if the 

prospective purchaser ‘‘can view the 

entire Nutrition Facts Panel on the label 

of the vended food without an 

obstruction,’’ and the Nutrition Facts are 

the information, and are in the format, 

required in § 101.9(c) and (d), and in a 

size that ‘‘permits the prospective 

purchaser to be able to easily read the 

nutrition information contained in the 

Nutrition Facts Panel on the label of the 

article of food in the vending machine.’’ 

Proposed § 101.8(b)(1) also would 

provide that we would not consider the 

smaller formats allowed for Nutrition 

Facts for certain food labeling under 

§ 101.9 to be a size that a prospective 

purchaser is able to easily read. 

(Comment 12) Most comments 

supported proposed § 101.8(b)(1). One 

comment suggested that we give 

additional details as to how the food 

would need to be positioned in the 

vending machine in order to ensure the 

visibility of the Nutrition Facts Panel. 

One comment objected to the 

proposed requirement that a prospective 

purchaser be able to view the entire 

Nutrition Facts Panel without an 

obstruction and said that would be too 

restrictive. The comment conceded that 

the dispensing coils in a vending 

machine might partially obscure the 

Nutrition Facts Panel, but said that each 

coil is only one-eighth of an inch wide, 

and virtually the entire Nutrition Facts 

Panel can be visible and readable in the 

vending machine making additional 

calorie disclosure unnecessary. 

Another comment stated that we 

should not stipulate that modified or 

smaller formats of the Nutrition Facts 

Panel would not satisfy the 

requirements of section 

403(q)(5)(H)(viii)(I)(aa) of the FD&C Act. 

The comment said that it is possible that 

a product manufacturer or vending 

machine operator could design a clearly 

visible, readable, and conspicuous 

Nutrition Facts Panel in a modified or 

smaller format. 

(Response 12) We are revising the rule 

as suggested by one comment. Section 

101.8(b) of the final rule provides, in 

relevant part, that an article of food sold 

from a vending machine is not covered 

if the prospective purchaser can view 

the calories, serving size, and servings 

per container listed in the Nutrition 

Facts label (rather than ‘‘the entire’’ 

Nutrition Facts label) without any 

obstruction. 

Under section 403(q)(5)(H)(viii)(I)(aa) 

of the FD&C Act, if the Nutrition Facts 

label on a vending machine food can be 

examined by a prospective purchaser 

before purchasing the article, a vending 

machine operator is not required to 

provide the calorie information required 

by section 403(q)(5)(H)(viii) of the FD&C 

Act for such food. (Although section 

403(q)(5)(H)(viii) of the FD&C Act uses 

the term ‘‘Nutrition Facts Panel’’ and we 

used the same term in the proposed 

rule, for the purposes of this final rule, 

we use the term ‘‘Nutrition Facts label’’ 

instead of ‘‘Nutrition Facts Panel’’ to be 

consistent with how we generally refer 

to the nutrition information listed under 

the heading ‘‘Nutrition Facts’’ on the 

food label.) 

In order for a consumer to examine 

the Nutrition Facts label to determine 

the amount of calories contained in the 

article of food, the consumer must be 

able to see the calories, serving size, and 

servings per container listed in the 

Nutrition Facts label. These pieces of 

information advance the overarching 

goal of the rule, which is to provide 

consumers with the necessary calorie 

information in a direct and accessible 

manner to enable consumers to make 

informed and healthful dietary choices. 

To conclude that the prospective 

purchaser must be able to see additional 

nutrition information on the Nutrition 

Facts label, beyond the number of 

calories contained in the article of food, 


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would mean that even if a prospective 

purchaser could see the relevant calorie 

information on the Nutrition Facts label, 

the vending machine operator would 

still be required to post a calorie 

declaration for the food under section 

403(q)(5)(H)(viii) of the FD&C Act. Such 

a conclusion seems to provide a 

redundant or otherwise unnecessary 

outcome. 

Therefore, we have revised 

§ 101.8(b)(1) to indicate that the 

prospective purchaser must be able to 

view ‘‘the calories, serving size, and 

servings per container listed in the 

Nutrition Facts label’’ rather than ‘‘the 

entire Nutrition Facts label’’ itself. 

These three pieces of information must 

be visible ‘‘without any obstruction.’’ 

Regarding the comment suggesting that 

dispensing coils that are one-eighth of 

an inch thick should not be considered 

an obstruction, we disagree. Because 

there are different types of vending 

machines, different types of food 

products dispensed from vending 

machines, as well as different ways in 

which the Nutrition Facts label may be 

presented on a food package, any 

thickness of a coil could potentially 

obstruct one of the three required pieces 

of information. 

Regarding the use of smaller formats 

of the Nutrition Facts label, as we noted 

in the preamble to the proposed rule (76 

FR 19238 at 19243), it is unlikely that 

a prospective purchaser would be able 

to easily read the nutrition information 

prior to purchase, as required by section 

403(q)(5)(H)(viii)(I)(aa) of the FD&C Act. 

We note that certain small format 

Nutrition Facts labels can display 

calories in as small as 6 point type size 

(see § 101.9(j)(13)(i)), and that the 

information in such formats is 

compressed (e.g., linear or ‘‘string’’ 

format; see § 101.9(j)(13)(ii)(A)(2)). 

Because such formats are more difficult 

to read on vending machine foods prior 

to purchase, we, therefore, decline to 

consider a modified or smaller format 

size of the Nutrition Facts to be a size 

that a prospective purchaser could 

easily read prior to purchase. The 

comment did not provide any data or 

information (e.g., label design) that 

would suggest that such a format would 

be readable. 

On our own initiative, we have 

further revised § 101.8(b) to make 

certain non-substantive and editorial 

changes. We have replaced the term 

‘‘dispensed’’ with ‘‘sold’’ in the first 

sentence in § 101.8(b) to better reflect 

the language of section 403(q)(5)(H)(viii) 

of the FD&C Act. We have moved the 

words ‘‘the prospective purchaser’’ in 

the first sentence of § 101.8(b)(1) to 

precede the colon that introduces 

§ 101.8(b)(1) and (b)(2), inserted the 

words ‘‘all the information in,’’ in the 

first sentence of § 101.8(b)(1), deleted 

the words ‘‘the information’’ in the 

second sentence of § 101.8(b)(1), and 

replaced ‘‘Nutrition Facts Panel’’ with 

‘‘Nutrition Facts label’’ in § 101.8(b)(1). 

We have also capitalized one instance of 

‘‘nutrition facts’’ where it was not 

capitalized in the proposal and added 

the word ‘‘or’’ between § 101.8(b)(1) and 

(b)(2). 

(Comment 13) Several comments 

asserted that any display (e.g., a sign or 

electronic display) of the Nutrition Facts 

Panel should exempt the vending 

machine operator from the calorie 

declaration requirements. The 

comments added that a display would 

not have to be on the package of the 

vending machine food itself, but could 

be a reproduction of the Nutrition Facts 

Panel. Another comment stated that 

some electronic displays allow the 

consumer to view the full Nutrition 

Facts Panel and rotate a virtual image of 

the product, and that FDA should 

consider such displays sufficient in 

satisfying section 403(q)(5)(H)(viii)(I)(aa) 

of the FD&C Act. 

(Response 13) We agree with the 

comments that certain reproductions of 

a Nutrition Facts label would be 

sufficient to satisfy section 

403(q)(5)(H)(viii)(I)(aa) of the FD&C Act. 

Specifically, we conclude that a 

reproduction of a Nutrition Facts label 

that allows the prospective purchaser to 

view the calories, serving size, and 

servings per container would be 

sufficient to satisfy section 

403(q)(5)(H)(viii)(I)(aa) of the FD&C Act 

if the reproduction is a reproduction of 

an actual Nutrition Facts label that 

complies with § 101.9 for a vending 

machine food, is presented in a size that 

permits the prospective purchaser to be 

able to easily read the nutrition 

information, and the calories, serving 

size, and servings per container are 

displayed by the vending machine 

before the prospective purchaser makes 

his or her purchase. Such reproductions 

could include electronic reproductions 

of the Nutrition Facts label displayed by 

a vending machine. Therefore, we have 

revised final § 101.8(b)(1) to allow for 

such reproductions of Nutrition Facts 

labels. 

b. Visible nutrition information at the 

point of purchase. Proposed 

§ 101.8(b)(2) would provide that an 

article of food dispensed from a vending 

machine is not covered vending 

machine food if the article provides 

‘‘visible nutrition information at the 

point of purchase,’’ including the total 

number of calories for the article of food 

as dispensed. 

Proposed § 101.8(b)(2) also would 

require that the visible nutrition 

information appear on the food label 

itself, and that it be ‘‘clear and 

conspicuous and easily read on the 

article of food while in the vending 

machine, in a type size reasonably 

related to the largest printed matter on 

the label and with sufficient color and 

contrasting background to other print on 

the label to permit the prospective 

purchaser to clearly distinguish the 

information.’’ 

(Comment 14) Because section 

403(q)(5)(H)(viii)(I)(aa) of the FD&C Act 

and proposed § 101.8(b)(2) did not 

define the term ‘‘visible nutrition 

information,’’ the preamble to the 

proposed rule provided two possible 

interpretations for the term ‘‘visible 

nutrition information’’ (76 FR 19238 at 

19244). We noted that one approach 

would be to conclude that ‘‘nutrition 

information’’ means ‘‘total calories in 

the article of food.’’ We noted that an 

alternative approach would be that 

‘‘nutrition information’’ means 

‘‘something more than total calories’’ 

and ‘‘could include, in addition to total 

calories in the food, information such as 

serving size information or information 

on the nutrients that are required to be 

disclosed in the Nutrition Facts . . . .’’ 

(Id.). The preamble to the proposed rule 

invited comment on ‘‘what other 

nutrition information, if any, should be 

required if this alternative interpretation 

were adopted’’ (Id.). 

Many comments agreed that, in the 

context of the rule, the term ‘‘nutrition 

information’’ should mean total calories 

in the article of food. One comment 

pointed out that ‘‘total calories’’ is the 

information that section 

403(q)(5)(H)(viii) of the FD&C Act 

otherwise requires covered vending 

machine operators to provide on a sign 

for foods sold in vending machines. 

Another comment would revise 

proposed § 101.8(b)(2) to read ‘‘The 

visible nutrition information at the 

point of purchase may include only the 

total number of calories in the article of 

food, as dispensed, at the point of 

purchase’’ (emphasis added). 

Other comments supported the 

alternative approach, which interprets 

‘‘nutrition information’’ as something 

more than total calories. These 

comments suggested that, for a vending 

machine food to be exempt from the 

requirements of section 

403(q)(5)(H)(viii) of the FD&C Act, 

‘‘nutrition information’’ should mean 

total calories as well as other 

information such as serving size 

information, the amount of other 

nutrients (e.g., sodium, fat), and the 

presence of allergens. Another comment 


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stated that ‘‘Congress did not depart 

from its previous definition of ‘nutrition 

information’ and as such it is logical to 

conclude that Congress intended the 

definition in [section] 343(q)(1) [of the 

FD&C Act] to apply to [section] 

343(q)(5)(H)(viii)(I)(aa) [of the FD&C 

Act]—i.e., the entire Nutrition Facts 

Panel or its equivalent be visible.’’ 

(Response 14) As described 

previously, we noted in the proposed 

rule that there are two possible ways to 

interpret ‘‘nutrition information’’ within 

the meaning of section 403(q)(5)(H)(viii) 

of the FD&C Act. We noted that 

‘‘nutrition information’’ could mean 

‘‘total calories in the article of food’’ or 

‘‘something more than total calories’’ 

(76 FR 19238 at 19244). As to any 

comments suggesting that our proposed 

interpretation that ‘‘nutrition 

information’’ means ‘‘total calories’’ is 

not a permissible interpretation, we 

conclude, as described in more detail to 

follow, that this interpretation is 

permissible in light of the language of 

section 403(q)(5)(H)(viii) of the FD&C 

Act and other sections of the FD&C Act. 

The comments seem to be raising the 

question of what Congress intended 

‘‘nutrition information’’ to mean within 

the context of section 403(q)(5)(H)(viii) 

of the FD&C Act. In construing section 

403(q)(5)(H)(viii)(I)(aa) of the FD&C Act, 

FDA is confronted with two questions. 

First, has Congress directly spoken to 

the precise question presented 

(‘‘Chevron step one’’)? Chevron, U.S.A., 

Inc. v. NRDC, Inc., 467 U.S. 837, 842 

(1984). If the ‘‘intent of Congress is 

clear,’’ an Agency ‘‘must give effect to 

the unambiguously expressed intent of 

Congress.’’ (Id. at 843.) However, if 

‘‘Congress has not directly addressed 

the precise question at issue,’’ and the 

statute is ‘‘silent or ambiguous with 

respect to the specific issue,’’ then our 

interpretation of the term ‘‘nutrition 

information’’ will be upheld as long as 

it is based on a ‘‘permissible 

construction’’ of the statute (‘‘Chevron 

step two’’). Chevron, 467 U.S. at 842–43; 

FDA v. Brown & Williamson Tobacco 

Corp, 529 U.S. 120, 132 (2000). To find 

no ambiguity, Congress must have 

clearly manifested its intention with 

respect to the particular issue. See e.g., 

Young v. Community Nutrition Institute, 

476 U.S. 974, 980 (1986). 

We have determined that, in enacting 

section 403(q)(5)(H)(viii)(I)(aa) of the 

FD&C Act, Congress did not speak 

directly and precisely to the meaning of 

‘‘nutrition information.’’ In conducting 

the Chevron step one analysis, all the 

traditional tools of statutory 

construction are available, e.g., the 

statute’s text, structure, and legislative 

history. Pharmaceutical Research & 

Manufacturers of America v. Thompson, 

251 F.3d 219, 224 (D.C. Cir. 2001). Since 

the term is not defined in section 

403(q)(5)(H)(viii) or elsewhere in the 

FD&C Act, we have examined the 

language and design of the FD&C Act as 

a whole to determine that the meaning 

of ‘‘nutrition information’’ in section 

403(q)(5)(H)(viii) of the FD&C Act is 

ambiguous. See e.g., Davis v. Michigan 

Department of Treasury, 489 U.S. 803, 

809 (1989) (‘‘It is a fundamental canon 

of statutory construction that the words 

of a statute must be read in their context 

and with a view to their place in the 

overall statutory scheme.’’); Martini v. 

Federal National Mortgage Association, 

178 F.3d 1336, 1345 (D.C. Cir. 1999). 

While the term ‘‘nutrition information’’ 

is used in other provisions of the FD&C 

Act, the term is typically accompanied 

by specific nutrients identified within 

the particular provision. For example, 

section 403(q)(1) of the FD&C Act 

provides that a food is misbranded 

unless its label or labeling bears certain 

nutrition information. Specifically, 

sections 403(q)(1)(C) to (E) of the FD&C 

Act identify particular nutrients 

included within the meaning of 

‘‘nutrition information’’ under section 

403(q)(1) of the FD&C Act (‘‘A food shall 

be deemed misbranded . . . unless its 

label or labeling bears nutrition 

information that provides . . . the total 

number of calories . . . [t]otal fat, 

saturated fat, cholesterol, sodium, total 

carbohydrates, complex carbohydrates, 

sugars, dietary fiber, and total protein 

. . . any vitamin, mineral or other 

nutrient required to be placed on the 

label and labeling of food under this Act 

[under certain conditions].’’). 

Similarly, section 403(q)(5)(H)(ii)(III) 

of the FD&C Act, which was added to 

the FD&C Act by section 4205 of the 

ACA, along with the vending machine 

food labeling requirements of section 

403(q)(5)(H)(viii) of the FD&C Act, 

explicitly requires restaurants and 

similar retail food establishments to 

provide ‘‘the nutrition information 

required under clauses (C) and (D) of 

[section 403(q)(1) of the FD&C Act].’’ 

Section 403(q)(5)(H)(viii) of the FD&C 

Act does not expressly identify 

nutrients other than the number of 

calories contained in a vending machine 

food. Further, as one comment noted, 

the number of calories contained in a 

vending machine food is the nutrition 

information that a vending machine 

operator must provide on a sign under 

section 403(q)(5)(H)(viii) of the FD&C 

Act if the provisions in section 

403(q)(5)(H)(viii)(I)(aa) of the FD&C Act 

are not met. Having concluded that the 

meaning of ‘‘nutrition information’’ in 

section 403(q)(5)(H)(viii) of the FD&C 

Act is ambiguous, FDA has considered 

how to define the term so as to achieve 

a ‘‘permissible construction’’ (Chevron 

step two). Chevron, 467 U.S. at 842–43. 

In conducting the Chevron step two 

analysis, the same tools of statutory 

construction are available as those for 

the step one analysis. Because total 

calories is the nutrition information that 

a covered vending machine operator 

would otherwise have to provide on a 

sign for a covered vending machine 

food, we believe that ‘‘nutrition 

information’’ in the context of section 

403(q)(5)(H)(viii)(I)(aa) of the FD&C Act 

means, at a minimum, the number of 

calories contained in the vending 

machine food. To conclude that 

‘‘nutrition information’’ means more 

than the total number of calories for an 

article of food would mean that even if 

a vending machine operator provided 

such calorie information on the label of 

the food, the operator would still be 

required to post a calorie declaration for 

the food under section 403(q)(5)(H)(viii) 

of the FD&C Act. Such a reading seems 

to provide a redundant or otherwise 

unnecessary outcome. For these reasons, 

we conclude that a vending machine 

that otherwise provides visible nutrition 

information at the point of purchase for 

an article of food must provide, at a 

minimum, the total calories in the 

vending machine food, in order for the 

requirements of section 

403(q)(5)(H)(viii) of the FD&C Act to not 

apply to such food. As a result, we have 

revised § 101.8(b)(2) by inserting ‘‘at a 

minimum’’ before ‘‘the total number of 

calories’’ to specify that the label for a 

vending machine food may provide 

other nutrition information, including 

serving size information, in addition to 

the total number of calories. 

In addition, we decline to amend 

§ 101.8(b)(2) to include the phrase ‘‘may 

include only’’ the total number of 

calories in the vending machine food 

because it is not necessary to limit the 

information to calories. We would not 

object to food manufacturers or vending 

machine operators voluntarily providing 

information in addition to total calories 

to consumers at the point of purchase, 

provided that such information is 

truthful and not misleading and 

otherwise complies with the FD&C Act 

and FDA regulations. 

On our own initiative, we have made 

non-substantive and editorial changes to 

§ 101.8(b)(2) to complement the changes 

we made to § 101.8(b)(1), as described in 

our response to comment 8. We have 

revised the first sentence in § 101.8(b)(2) 

to state that the prospective purchaser 

can otherwise view visible nutrition 

information, including, at a minimum 


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the total number of calories for the 

article of food as sold at the point of 

purchase. We discuss additional 

considerations and changes to 

§ 101.8(b)(2) in our response to 

comments 15 and 16 in the paragraphs 

that follow. 

(Comment 15) Because section 

403(q)(5)(H)(viii)(I)(aa) of the FD&C Act 

does not specify how a vending 

machine can provide ‘‘visible nutrition 

information at the point of purchase’’ 

for an article of food in accordance with 

section 403(q)(5)(H)(viii)(I)(aa) of the 

FD&C Act, the preamble to the proposed 

rule noted that the phrase ‘‘at the point 

of purchase’’ suggests that ‘‘the 

information, like the Nutrition Facts 

Panel, should be on the article of food 

itself’’ (76 FR 19238 at 19244). We 

tentatively concluded that such 

information must be presented on the 

label of the food itself (76 FR 19238 at 

19244). Under proposed § 101.8(b)(2), 

for nutrition information on the label to 

be considered ‘‘visible,’’ it would need, 

in relevant part, to be clear and 

conspicuous and easily read on the 

article of food while in the vending 

machine. Further, under proposed 

§ 101.8(b)(2) a vending machine food 

would not be covered by the 

requirements of section 

403(q)(5)(H)(viii) of the FD&C Act, as 

long as the food provides visible 

nutrition information ‘‘at the point of 

purchase,’’ and that the visible nutrition 

information ‘‘appear[s] on the food label 

itself.’’ 

The preamble to the proposed rule 

also stated that the phrase ‘‘at the point 

of purchase’’ could be read to mean that 

the visible nutrition information could 

be provided in places other than on the 

package of the food in the vending 

machine, such as on the vending 

machine itself (Id.). We invited 

comment on this alternative 

interpretation and specifically requested 

comment on whether, under this 

alternative interpretation, signs 

(including posters) or booklets would be 

sufficient in providing ‘‘otherwise 

visible nutrition information at the 

point of purchase’’ (Id.). We also 

requested comment on ways to 

determine if the nutrition information is 

‘‘visible’’ (Id.). 

Several comments asserted that any 

display (including a brochure, sign, or 

electronic display) of nutrition 

information at the point of purchase 

should exempt the vending machine 

operator from the calorie declaration 

requirements. The comments added that 

a display would not have to be on the 

package of the vending machine food 

itself, but could be nutrition information 

through other means, such as booklets. 

One comment recommended that we 

define ‘‘point of purchase’’ as ‘‘before 

and after the consumer inserts the 

required money, token, card, or key into 

the machine or manually operates it and 

before the consumer makes their final 

item selection.’’ 

(Response 15) We disagree with the 

comments asserting that any display of 

nutrition information beyond the 

package of the food itself ‘‘should 

exempt the vending machine operator 

from the calorie declarations 

requirements.’’ As we noted in the 

proposed rule, in order for nutrition 

information to be ‘‘visible’’ at the point 

of purchase, the information must be 

clear and conspicuous and able to be 

easily read by a prospective purchaser 

(76 FR 19238 at 19244, 19254). 

Nutrition information in brochures or 

booklets would not be visible at the 

point of purchase in the same way that 

such information would be visible if 

presented on the label of a vending 

machine food, such as through FOP 

labeling. Nutrition information in a 

brochure or booklet would not be clear 

and conspicuous such that a prospective 

purchaser would be able to easily read 

the information when making a 

purchase selection as it would if the 

nutrition information were on the label 

of the food. In addition, brochures and 

booklets can be easily detached, lost, or 

otherwise absent, from a vending 

machine. For these reasons, we decline 

to include brochures and booklets 

within § 101.8(b)(2). 

Regarding electronic displays of 

nutrition information, we note that 

proposed § 101.8(c)(2)(ii)(E) would 

provide that electronic vending 

machines (i.e., machines with digital or 

electronic or liquid crystal display 

(LCD) displays) could be used to comply 

with the calorie declaration 

requirements in section 

403(q)(5)(H)(viii) of the FD&C Act. As 

discussed further in section III.C.4.b.x of 

this preamble in connection with 

§ 101.8(c)(2)(ii)(E), we conclude that 

electronic vending machines can be 

used to comply with the calorie 

declaration requirements in section 

403(q)(5)(H)(viii) of the FD&C Act and 

§ 101.8(c). Further, electronic signs 

otherwise placed in, on, or adjacent to 

the vending machine can be used to 

provide calorie declarations under 

§ 101.8(c), provided that such signs are 

located in close proximity to the article 

of food or the selection button, and 

otherwise comply with section 

403(a)(1), (q)(5)(H)(viii), and (f) of the 

FD&C Act and the requirements of 

§ 101.8(c). Because electronic vending 

machines and signs can be used to 

provide calorie declarations in 

accordance with § 101.8(c), it would be 

difficult and perhaps unnecessary for 

FDA to determine whether a vending 

machine operator is using such a 

method to provide ‘‘visible nutrition 

information at the point of purchase’’ in 

accordance with § 101.8(b) or to provide 

calorie declarations in accordance with 

§ 101.8(c). For these reasons, we believe 

that it is unnecessary to include such 

electronic displays within § 101.8(b)(2). 

Similarly, regarding non-electronic 

signs providing nutrition information, 

we note that § 101.8(c)(2) allows for the 

use of signs in, on, or adjacent to a 

vending machine to provide calorie 

declarations for covered vending 

machine food. Therefore, to the extent a 

vending machine operator provides 

calorie information for a vending 

machine food on such a sign and 

otherwise meets the requirements of 

section 403(a)(1), (q)(5)(H)(viii), and (f) 

of the FD&C Act and § 101.8(c), the 

operator would be in compliance with 

this rule. Because such signs can be 

used to provide calorie declarations in 

accordance with § 101.8(c), it would be 

difficult and perhaps unnecessary for 

FDA to determine whether a vending 

machine operator is using such a 

method to provide ‘‘visible nutrition 

information at the point of purchase’’ in 

accordance with § 101.8(b) or to provide 

calorie declarations in accordance with 

§ 101.8(c). For these reasons, we believe 

that it is also unnecessary to include 

signs within § 101.8(b)(2). 

As explained in the previous 

paragraphs, brochures, booklets, 

electronic displays, and non-electronic 

signs would not satisfy § 101.8(b)(2). 

Therefore we conclude, as we did in the 

proposal, that ‘‘visible nutrition 

information at the point of purchase’’ 

for an article of food sold from a 

vending machine must be presented on 

the label of the food itself. 

Regarding the comment that would 

interpret ‘‘point of purchase’’ as a 

moment in time, we agree that ‘‘point of 

purchase’’ can be interpreted both with 

regard to a place (where the prospective 

purchaser buys the vending machine 

food item) and a time (when the 

prospective purchaser makes the 

selection). Accordingly, to provide 

visible nutrition information at the 

point of purchase, such information 

must be on the label of a food sold in 

a vending machine before the 

prospective purchaser makes a 

purchase. In order for a prospective 

purchaser to be able to view nutrition 

information on the label of a vending 

machine food at the point of purchase, 

the prospective purchaser must be able 

to read the nutrition information before 

purchasing the food, which typically 


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means that the vending machine would 

have to have a clear front so that the 

prospective purchaser would be able to 

see the information. 

(Comment 16) The preamble to the 

proposed rule stated that FOP labeling 

could be a way to provide ‘‘visible 

nutrition information’’ so long as the 

criteria for color, font, and type size are 

met, and the total calories contained in 

the vending machine food are included 

(76 FR 19238 at 19244). We tentatively 

concluded that the visible nutrition 

information must be in a type size 

reasonably related to the most 

prominent printed matter on the label 

and in a color that sufficiently contrasts 

with the background, such that a 

prospective purchaser is able to notice 

and read the information (Id.). The 

preamble to the proposed rule explained 

that we consider ‘‘reasonably related’’ to 

mean a type size that is ‘‘at least 50 

percent’’ of the size of the largest print 

on the label (Id.). We also noted that if 

a nutrient content claim or health claim 

is included on the front of the package, 

the claim must comply with relevant 

FDA regulations authorizing such 

claims (Id.). 

Many comments supported the idea 

that FOP labeling could provide visible 

nutrition information, stating 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 such labeling would exempt the 

operators from having to provide calorie 

declarations for such foods on signs 

under section 403(q)(5)(H)(viii)(I)(bb) of 

the FD&C Act. These comments added 

that vending machine operators may 

pressure food manufacturers to provide 

FOP labeling in exchange for product 

distribution in their vending machines. 

Several comments argued 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 would revise 

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 for inspectors to 

enforce and, therefore, FDA should 

require the FOP calorie disclosure to be 

at least two-thirds the size of the largest 

font size of any other writing on the 

package, and a minimum size of 1⁄2

square inch. Other comments said that 

the final rule should omit requirements 

for prominence or type size of the FOP 

calorie disclosure. 

(Response 16) We agree that FOP 

labeling can be an efficient way to 

provide visible nutrition information 

within the context of section 

403(q)(5)(H)(viii)(I)(aa) of the FD&C Act, 

provided that the criteria for color and 

type size are met, and the total calories 

contained in the article of food are 

included. (We would not consider FOP 

labeling that provides only the calories 

per serving to count as ‘‘visible nutrition 

information’’ within the context of 

section 403(q)(5)(H)(viii)(I)(aa) of the 

FD&C Act). Some manufacturers have 

already been including calories on their 

FOP labels. With respect to the 

comments concerning possible 

interactions between food 

manufacturers and vending machine 

operators, such interactions will depend 

on, and are best left to, vending machine 

operators and their suppliers. 

In response to the comments 

regarding type size and prominence of 

the visible nutrition information on the 

label of the food, we have revised 

§ 101.8(b)(2)(i) to replace the words 

‘‘reasonably related’’ with ‘‘at least 50 

percent of the size of the largest printed 

matter on the label.’’ Specifying the 

minimum type size for calorie 

information on vending machine food 

labels will provide greater clarity for 

both compliance and enforcement. 

While we recognize that some 

comments asserted that 50 percent of 

the size of the largest print on the label 

would result in type sizes that are too 

large, other comments asserted that the 

resulting type size would be too small, 

and some comments asked FDA to omit 

any requirements for prominence or 

type size. 

Further, we clarify that section 

403(q)(5)(H)(viii)(I)(aa) of the FD&C Act 

describes foods that are not subject to 

the vending machine labeling 

requirements specified in section 

403(q)(5)(H)(viii) of the FD&C Act. 

Therefore, by specifying the type size of 

the visible nutrition information, we are 

not imposing any additional 

requirements on vending machine food. 

Instead, we are explaining when articles 

of food sold from vending machines 

satisfy the language of section 

403(q)(5)(H)(viii)(I)(aa) of the FD&C Act 

such that such foods are not covered by 

the labeling requirements of section 

403(q)(5)(H)(viii) of the FD&C Act. In 

addition, there are other options that 

vending machine operators may choose 

to satisfy 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 § 101.8(b)(1), or posting 

signs with calorie declarations, as 

provided in § 101.8(c). 

We disagree with comments asking 

that we omit requirements for 

prominence or type size of FOP calorie 

disclosures for the purposes of section 

403(q)(5)(H)(viii)(I)(aa) of the FD&C Act. 

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. 

Furthermore, § 101.8(b)(2) requires 

the visible nutrition information to be 

‘‘clear and conspicuous and able to be 

easily read on the article of food while 

in the vending machine.’’ Type size is 

one factor in determining whether the 

nutrition information on a food label is 

‘‘clear and conspicuous and easily 

read,’’ and other considerations, such as 

color and contrasting background 

(which § 101.8(b)(2) also addresses), can 

affect the prospective purchaser’s ability 

to read the nutrition information. For 

example, a prospective purchaser might 

be able to read nutrition information in 

one vending machine, but not in 

another vending machine if the first 

vending machine’s design enabled the 

prospective purchaser to get close to the 

food label. In contrast, if a vending 

machine’s design results in the food 

label being several inches away from the 

prospective purchaser, the nutrition 

information might not be as easy to 

read. The important consideration is to 

ensure that prospective purchasers are 

able to read and use the nutrition 

information for a vending machine food 

before purchasing the food. 

4. Section 101.8(c)—Requirements for 

Calorie Labeling for Certain Food Sold 

From Vending Machines 

Proposed § 101.8(c) would establish 

requirements for calorie declarations for 

foods sold from vending machines, as 

required by section 403(q)(5)(H)(viii) of 

the FD&C Act. In brief, proposed 

§ 101.8(c)(1) would define ‘‘covered 

vending machine food,’’ and proposed 

§ 101.8(c)(2) would establish 

requirements for calorie declarations on 

signs in, on, or adjacent to the vending 

machine. 

a. Covered vending machine food. 

Proposed § 101.8(c)(1) would explain 

the ‘‘applicability’’ of the calorie 

labeling requirements to foods sold from 

vending machines by defining ‘‘covered 

vending machine food’’ as an article of 

food that is: 

• Sold from a vending machine that: 

Æ Does not permit the consumer to 

examine the Nutrition Facts Panel prior 

to purchase as provided in paragraph (b) 

of this section, or otherwise provide 


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visible nutrition information at the 

point of purchase as provided in 

paragraph (b); 

Æ Is operated by a person engaged in 

the business of owning or operating 20 

or more vending machines; and 

Æ Is a vending machine with a 

selection button; or 

• Sold from a vending machine that 

is operated by a vending machine 

operator that has voluntarily elected to 

be subject to the requirements of this 

section by registering with FDA under 

the provisions of paragraph (d) of this 

section. 

(Comment 17) The preamble to the 

proposed rule explained that the 

requirements of section 

403(q)(5)(H)(viii) of the FD&C Act do 

not apply to vending machine operators 

who own or operate fewer than 20 

vending machines that sell articles of 

food (76 FR 19238 at 19241). Thus, even 

if a vending machine operator has 50 

vending machines, the operator is not 

subject to the requirements of section 

403(q)(5)(H)(viii) of the FD&C Act if 

fewer than 20 of those vending 

machines sell articles of food. 

One comment asked us to clarify that 

a vending machine that dispenses a mix 

of food and non-food items would be 

considered a vending machine that sells 

articles of food when determining 

whether the vending machine operator 

is covered. The comment sought to 

ensure that all vending machines that 

dispense some articles of food would be 

covered, if applicable. 

(Response 17) In general, § 101.8(a) 

defines a ‘‘vending machine’’ as a selfservice device that dispenses ‘‘servings 

of food in bulk or in packages, or 

prepared by the machine.’’ This 

definition includes vending machines 

that sell both food and non-food items. 

However, section 403(q)(5)(H)(viii) of 

the FD&C Act and § 101.8(c) only apply 

to certain vending machine foods and 

the operators of vending machines that 

sell such foods. A vending machine that 

sells an article of food will be counted 

towards the ‘‘20 or more’’ threshold for 

determining whether a vending machine 

operator is covered, even if the vending 

machine also sells non-food items, 

provided that such a vending machine 

does not dispense those food items as 

part of a game or other non-food related 

activity, as discussed further in the 

paragraphs that follow. 

We are aware that ‘‘game machines’’ 

sometimes dispense candy or other 

edible items as part of a game or other 

non-food related activity. However, we 

conclude that ‘‘game machines’’ are not 

covered by section 403(q)(5)(H)(viii) of 

the FD&C Act, and do not count towards 

the ‘‘20 or more’’ threshold for 

determining whether a vending machine 

operator is covered. As we discussed in 

the preamble to the proposed rule (76 

FR 19238 at 19241) and explain further 

in our response to comment 18, the 

primary purpose of a ‘‘game machine’’ 

is to sell a chance to play a game or to 

provide entertainment, and not to sell 

articles of food. 

(Comment 18) In the preamble to the 

proposed rule, we tentatively concluded 

that vending machines that may 

dispense food as part of a game or other 

non-food related activity are not covered 

by section 403(q)(5)(H)(viii) of the FD&C 

Act (76 FR 19238 at 19241). For 

example, as we discussed in the 

preamble to the proposed rule, if a 

vending machine contains small toys 

and individually wrapped candies that 

can be picked up by maneuvering a 

large claw arm, we tentatively 

concluded that the vending machine is 

selling the opportunity to play the game, 

and not selling articles of food (76 FR 

19238 at 19241). 

One comment disagreed with our 

tentative conclusion in the proposed 

rule to not cover vending machines that 

may dispense food as part of a game or 

other non-food related activity (e.g., 

claw games with candy prizes amongst 

other prizes). The comment claimed that 

a consumer playing a claw game could 

still maneuver the claw toward a 

healthier option if the calorie 

declarations for food prizes were 

available. 

(Response 18) We decline to apply the 

requirements of section 

403(q)(5)(H)(viii) of the FD&C Act to 

vending machines that may dispense 

food as part of a game or other non-food 

related activity. Section 

403(q)(5)(H)(viii) of the FD&C Act 

applies to ‘‘an article of food sold from 

a vending machine.’’ FDA concludes 

that an article of food that may be 

dispensed from a vending machine as 

part of a game or other non-food related 

activity does not constitute ‘‘an article 

of food sold from a vending machine’’ 

within the context of section 

403(q)(5)(H)(viii) of the FD&C Act. Game 

machines sell the opportunity to play a 

game or experience entertainment, and 

not the article of food itself. While the 

comment disagreeing with our 

conclusion indicated that calorie 

information might motivate an 

individual to ‘‘maneuver the game claw 

towards a healthier option,’’ the 

comment provided no basis to support 

this assumption. For these reasons, we 

are not amending the final rule to cover 

game machines, as suggested by the 

comment. 

(Comment 19) The preamble to the 

proposed rule noted that section 

403(q)(5)(H)(viii) of the FD&C Act 

provides that, for covered vending 

machine food, the vending machine 

operator must provide a sign disclosing 

the number of calories contained in the 

food ‘‘in close proximity to each article 

of food or the selection button’’ (76 FR 

19238 at 19241). We tentatively 

concluded that the reference to 

‘‘selection button’’ can be read to mean 

that only vending machines with 

selection buttons are subject to the 

requirements of section 

403(q)(5)(H)(viii) of the FD&C Act. We 

indicated that we were not aware of 

vending machines without selection 

buttons other than bulk vending 

machines that dispense, by use of a 

crank, single types of unpackaged 

articles of food in preselected amounts 

(e.g., a single piece of gum or a handful 

of candy or nuts). We tentatively 

concluded that vending machines 

without any type of selection button, 

including bulk vending machines, were 

not covered by section 403(q)(5)(H)(viii) 

of the FD&C Act, and we invited 

comment on this subject. 

Some comments agreed with our 

interpretation of the reference to 

‘‘selection button’’ in section 

403(q)(5)(H)(viii) of the FD&C Act. The 

comments stated that, for bulk vending 

machines, a consumer only would be 

choosing whether to buy the bulk 

product and would not be selecting 

among food items; therefore, the button 

on such a vending machine would not 

constitute a ‘‘selection button.’’ The 

comments noted that bulk foods tend to 

be lower in calories because of the 

vended size (such as a small handful of 

nuts or candies) compared to other 

foods (such as candy bars or bags of 

chips) sold in typical vending machines. 

One comment asked that we exempt 

‘‘turret-style’’ (turnstile) refrigerated 

food vending machines from the 

requirements of section 

403(q)(5)(H)(viii) of the FD&C Act 

because such machines do not have 

selection buttons. 

Other comments disagreed with our 

interpretation of the reference to 

‘‘selection button’’ in section 

403(q)(5)(H)(viii) of the FD&C Act, and 

argued that the lack of a selection button 

does not justify an exemption from the 

requirements of section 

403(q)(5)(H)(viii) of the FD&C Act. 

These comments also asserted that there 

would be no public health rationale for 

such an exemption. Some comments 

asserted that the mention of a selection 

button in section 403(q)(5)(H)(viii) of 

the FD&C Act was not intended to 

differentiate between ‘‘regular’’ vending 

machines (i.e., those that have selection 

buttons) and machines that use a device 


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other than a selection button. The 

comments said that the statute’s 

mention of a selection button was meant 

to refer to where the nutrition 

information should be placed. These 

comments also said that bulk items 

(usually candy and gumballs) are 

appealing to children, so calorie 

information should be made available. 

They also urged FDA to maintain 

consistency by requiring calorie labeling 

for all types of vending machines. In 

addition, one comment pointed out that 

excluding vending machines without a 

selection button would give bulk 

vending machines an unfair advantage 

over ‘‘traditional’’ (i.e., non-bulk) 

vending machines because the operators 

of bulk vending machines would not 

have to incur any expenses to 

implement the calorie declaration 

requirements. 

Other comments noted that 

complying with the calorie labeling 

requirements of section 

403(q)(5)(H)(viii) of the FD&C Act 

would not be burdensome for a bulk 

machine vending machine operator 

because such a machine generally only 

dispenses one product (e.g., nuts, 

gumballs), and consumers do not select 

between multiple items. Therefore, 

several comments asserted that a 

vending machine operator for a bulk 

vending machine would only have to 

affix one sticker or decal displaying the 

calorie declaration on the bulk machine. 

(Response 19) Section 

403(q)(5)(H)(viii) of the FD&C Act 

provides that, for covered vending 

machine food, the vending machine 

operator must provide a sign disclosing 

the number of calories contained in the 

food ‘‘in close proximity to each article 

of food or the selection button.’’ 

Although in the proposed rule, we 

tentatively concluded that vending 

machines without selection buttons are 

not covered, upon further consideration 

and in light of the comments asserting 

that the presence or absence of a 

selection button should not determine 

whether a vending machine is subject to 

the requirements of section 

403(q)(5)(H)(viii) of the FD&C Act, this 

final rule provides that covered vending 

machines also include those without 

selection buttons. 

In construing whether vending 

machines without selection buttons are 

within the scope of section 

403(q)(5)(H)(viii) of the FD&C Act, we 

are confronted with two questions. First, 

has Congress directly spoken to the 

precise question presented (‘‘Chevron 

step one’’) Chevron, U.S.A., Inc. v. 

NRDC., 467 U.S. 837, 842 (1984). If 

Congress has spoken directly and 

plainly, the Agency must implement 

Congress’s unambiguously expressed 

intent. Chevron, 467 U.S. at 842–843. If, 

however, Congress is silent or 

ambiguous as to the question, our 

interpretation will be upheld as long as 

it is based on a ‘‘permissible 

construction’’ of the statute. (‘‘Chevron 

step two’’). Chevron, 467 U.S. 843–844; 

FDA v. Brown & Williamson Tobacco 

Corp., 529 U.S. 120, 132 (2000). 

We have determined that, in enacting 

section 403(q)(5)(H)(viii), Congress did 

not speak directly and plainly to the 

question of whether vending machines 

without selection buttons are covered. 

In conducting the Chevron step one 

analysis, all the traditional tools of 

statutory construction are available, e.g., 

the statute’s text, structure, and 

legislative history. Pharmaceutical 

Research & Manufacturers of America v. 

Thompson, 251 F. 3d 219, 224 (D.C. Cir. 

2001). The term ‘‘vending machine’’ as 

used in section 403(q)(5)(H)(viii) is not 

specific as to whether it must have a 

selection button. The scant legislative 

history does not shed any light on 

whether Congress intended to limit 

covered vending machines only to those 

with selection buttons by virtue of the 

statutory provision regarding the 

placement of the calorie declaration sign 

in close proximity to the selection 

button. 

Having determined that Congress’s 

intent regarding whether vending 

machines without selection buttons are 

required to have calorie declaration 

signs is ambiguous, we have determined 

that the final rule’s interpretation of 

covered vending machine as any 

machine regardless of whether it has a 

selection button is a permissible 

construction of the statute. (Chevron 

step two). In conducting the Chevron 

step two analysis, the same tools of 

statutory construction are available as 

those for the step one analysis. 

The interpretation in the final rule is 

consistent with the plain meaning of the 

statute, which is the starting point of 

statutory construction. (See 2A 

Sutherland Statutory Construction 137 

(7th ed. 2007). Section 403(q)(5)(H)(viii) 

uses the term ‘‘vending machine’’ in 

three instances. It refers to ‘‘an article of 

food sold from a vending machine.’’ It 

refers to ‘‘a person who is engaged in 

the business of owning or operating 20 

or more vending machines.’’ Finally, the 

statute refers to ‘‘the vending machine 

operator.’’ In the two instances in which 

the statute refers to ‘‘vending 

machines,’’ it does so without 

qualification or limitation on the type of 

machine. 

Our interpretation is also consistent 

with the structure of the statute which 

identifies only two limitations that 

apply to the vending machines. Those 

limitations are set out in section 

403(q)(5)(H)(viii)(I)(aa) and (bb) of the 

FD&C Act. The provisions state that an 

article of food requires a calorie 

declaration if it is ‘‘from a vending 

machine that (aa) 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; and (bb) is operated 

by a person who is engaged in the 

business of owning or operating 20 or 

more vending machines.’’ That is, the 

vending machines not subject to the 

calorie labeling requirements of section 

403(q)(5)(H)(viii) of the FD&C Act are 

those that allow the prospective 

purchaser to examine the Nutrition 

Facts label or does not otherwise 

provide visible nutrition at the point of 

purchase or those that are operated by 

a person in the business of owning or 

operating less than 20 vending 

machines. Although these provisions 

address covered vending machines, they 

do not address a type of vending 

machine. 

Accordingly, we are interpreting 

section 403(q)(5)(H)(viii) of the FD&C 

Act to include vending machines with 

or without selection buttons. 

As for the comments asserting that 

vending machines without selection 

buttons should not be covered by the 

requirements of section 

403(q)(5)(H)(viii) of the FD&C Act 

because articles of food sold from bulk 

vending machines tend to contain fewer 

calories than foods sold in non-bulk 

vending machines, we clarify that 

section 403(q)(5)(H)(viii) of the FD&C 

Act does not exclude articles of food 

that contain low levels of calories from 

the calorie labeling requirements. 

Consistent with section 

403(q)(5)(H)(viii) of the FD&C Act’s 

general purpose to provide calorie 

information for foods sold from certain 

vending machines, we interpret section 

403(q)(5)(H)(viii) of the FD&C Act to 

apply to vending machines that sell 

articles of food regardless of the food’s 

caloric content and regardless of 

whether the vending machine has a 

selection button. 

Further, we agree with the comments 

asserting that excluding vending 

machines without selection buttons 

from the requirements of § 101.8(c) is 

not supported by a public health 

rationale. Providing such calorie 

declarations will make calorie 

information available to consumers in a 

direct and accessible manner to enable 

consumers to make informed and 

healthful dietary choices. In addition, 

we agree with the comments stating that 


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providing calorie information would not 

be overly burdensome for bulk vending 

machine operators because such 

operators can use single stickers or 

decals to provide the required calorie 

declarations. 

For these reasons, we have revised 

§ 101.8(c)(1) by removing the criterion 

that a food must be sold from a vending 

machine with a selection button to be 

covered by the requirements of section 

403(q)(5)(H)(viii) of the FD&C Act. 

Additionally, because the final rule 

covers vending machines regardless of 

whether they have selection buttons, we 

decline to exempt turret-style or 

turnstile vending machines. 

We also have revised § 101.8(c)(1)(i) 

and (ii), on our own initiative, to clarify 

the applicability of the rule. Proposed 

§ 101.8(c)(1)(i) would address vending 

machines operated by persons who 

must comply with section 

403(q)(5)(H)(viii) of the FD&C Act, and 

proposed § 101.8(c)(1)(ii) would address 

vending machines operated by persons 

who voluntarily register with FDA to 

become subject to section 

403(q)(5)(H)(viii) of the FD&C Act. 

However, the conditions under which 

an article of food would not be covered 

by the rule (if the article of food permits 

the prospective purchaser to examine 

the Nutrition Facts label before 

purchase as provided in proposed 

§ 101.8(b)(1), or otherwise provides 

visible nutrition information at the 

point of purchase as provided in 

proposed § 101.8(b)(2)), were contained 

in proposed § 101.8(c)(1)(i)(A) and 

therefore would not have appeared to be 

applied to persons who voluntarily 

registered with FDA. As a result, we 

have reorganized and revised 

§ 101.8(c)(1)(i) to describe the 

provisions in § 101.8(b) under which an 

article of food is not covered by the rule. 

We also have reorganized and revised 

§ 101.8(c)(1)(ii) to refer to the two types 

of vending machine operators that may 

be subject to the requirements of section 

403(q)(5)(H)(viii) of the FD&C Act (those 

required to comply by law and those 

who may register voluntarily to comply 

with the requirements). We have 

connected § 101.8(c)(1)(i) and (ii) with 

the conjunction ‘‘and’’ to specify that 

the provisions in § 101.8(b) may apply 

to both types of covered vending 

machine operators. 

On our own initiative, we also have 

made an editorial change to replace ‘‘the 

FDA’’ with ‘‘FDA.’’ Also, we have 

replaced ‘‘consumer’’ with ‘‘prospective 

purchaser’’ to be consistent with the rest 

of the final rule, and have specified 

paragraphs ‘‘(b)(1)’’ and ‘‘(b)(2)’’ where 

these provisions are summarized (rather 

than referring to them both as 

‘‘paragraph (b)’’), and we have changed 

‘‘Nutrition Facts Panel’’ to ‘‘Nutrition 

Facts label’’ to match terms used in the 

rest of the final rule. 

b. Calorie declaration. Proposed 

§ 101.8(c)(2) would establish 

requirements for calorie declarations for 

covered vending machine food. 

i. Calorie increments. 

Proposed § 101.8(c)(2)(i)(A) would 

require the calorie declaration to be 

‘‘clear and conspicuous’’ and declared 

to the ‘‘nearest 5-calorie increment up to 

and including 50 calories and 10-calorie 

increment above 50 calories, except that 

amounts less than 5 calories may be 

expressed as zero.’’ 

In the preamble to the proposed rule, 

we tentatively decided against allowing 

ranges for declaring calories for vending 

machine food that comes in different 

varieties and flavors (e.g., coffee or hot 

chocolate) (76 FR 19238 at 19242). We 

noted in the preamble of the proposed 

rule that a ‘‘vending machine operator 

could post a calorie declaration in close 

proximity to the selection button for a 

food that comes in different varieties 

and flavors that is sold in a vending 

machine that has selection buttons 

corresponding to the different options’’ 

(Id.). Therefore, the vending machine 

operator could provide calorie 

declarations for each variety or option 

adjacent to selection buttons 

corresponding to each option (Id.). 

Further, we tentatively concluded that 

calorie ranges are also not necessary 

within the context of vending machines 

because a vending machine operator 

would be able to disclose calorie 

information under other options (e.g., 

use of signs) (Id.). 

(Comment 20) Some comments agreed 

with FDA’s tentative conclusion in the 

proposed rule and stated that a range or 

an average would not be necessary. 

These comments stated that in 

situations where items are displayed 

such that multiple flavors or varieties 

exist in the same space, different 

selection buttons provide the 

opportunity for the operator to list 

separate calorie information for each 

item, and therefore ranges or averages 

for these vending machines would not 

be necessary. 

A few comments disagreed with 

FDA’s tentative conclusion in the 

proposed rule and recommended that 

we allow the use of ranges. The 

comments stated that slight variations 

will occur such as in fresh coffee 

vending machines where different types 

of creamer or flavoring may be used. 

Some comments asked that we 

exempt self-service, custom order 

vending machines that allow the 

customer to select size, type of drink, 

type of milk, and additional flavors from 

the requirements of section 

403(q)(5)(H)(viii) of the FD&C Act. The 

comments claimed it would not be 

feasible for operators of such vending 

machines to declare calories for all the 

possible customizations due to lack of 

space on the vending machine. 

According to one comment, disclosing 

calories for customizations can be 

inaccurate and misleading. For example, 

the comment asserted that adding syrup 

to a drink displaces a portion of the 

beverage that would have otherwise 

been included in the cup, and as a result 

some customizations do not add calories 

to the finished beverage. According to 

the comment, adding sugar-free syrup 

actually reduces the beverage’s calories. 

Because FDA proposed to not apply the 

nutrition labeling requirements of 

section 403(q)(5)(H)(i)–(vii) of the FD&C 

Act (relating to standard menu items 

offered for sale in restaurants and 

similar retail food establishments) to 

custom orders, the comments argued 

that we should similarly exempt custom 

beverage vending machines from the 

vending machine labeling requirements 

of section 403(q)(5)(H)(viii) of the FD&C 

Act. The comments said that if we do 

not exempt such vending machines, we 

should give vending machine operators 

the flexibility to choose the method of 

calorie information disclosure for highly 

customizable self-serve products. For 

example, vending machine operators 

should be permitted to simply disclose 

calorie content for the condiments 

offered for customization, e.g., calories 

per ounce of milk or per shot of syrup. 

(Response 20) We conclude that 

calorie ranges are not necessary for 

vending machine foods that come in 

different varieties and flavors. Unlike 

section 403(q)(5)(H)(v) of the FD&C 

Act—which pertains to nutrition 

labeling for standard menu items offered 

for sale in restaurants and similar retail 

food establishments and allows FDA to 

establish standards for disclosing the 

nutrient content for certain standard 

menu items that come in different 

flavors, varieties, or combinations, 

through means determined by FDA, 

including ranges, averages, or other 

methods—section 403(q)(5)(H)(viii) of 

the FD&C Act specifies that, if covered, 

a vending machine operator must 

provide a sign disclosing the number of 

calories contained in an article of food 

sold from a vending machine. 

We also decline to permit calorie 

ranges because, as noted by the 

comments, vending machine operators 

can declare calories for each ‘‘option’’ 

offered. For a vending machine that has 

selection buttons corresponding to 

different options, a vending machine 


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operator could post a calorie declaration 

in close proximity to the corresponding 

selection buttons. In addition, vending 

machines that dispense various flavors 

or varieties of beverages do so in 

measurable quantities; therefore, it is 

reasonable to require vending machine 

operators to provide calorie declarations 

for such options. To give vending 

machine operators flexibility, the final 

rule allows vending machine operators 

to declare calories per option or for the 

final vended products. For example, if 

a vending machine dispenses coffee 

products with options for adding skim 

milk, whole milk, cream, sugar, or sugar 

substitute, the vending machine 

operator could provide calorie 

declarations for each of those added 

options individually. If the vending 

machine operator chose to declare 

calories for the final vended products 

sold from the machine, the calorie 

declarations would be for all final 

vended coffee products sold from the 

machine, meaning all dispensed 

combinations of coffee, skim milk, 

whole milk, cream, sugar, and sugar 

substitute. Note that a vending machine 

operator could post calorie declarations 

next to each selection button, or on a 

sign in, on, or adjacent to the vending 

machine, as provided in § 101.8(c). 

We decline to exempt the types of 

self-service, custom-order vending 

machines described by the comments 

from the calorie labeling requirements 

for vending machine food of section 

403(q)(5)(H)(viii) of the FD&C Act. As a 

preliminary matter, we clarify that 

while section 403(q)(5)(H)(vii)(I)(bb) of 

the FD&C Act, which pertains to 

restaurants and similar retail food 

establishments, provides that the 

nutrition labeling requirements of 

sections 403(q)(5)(H)(i) through (vi) of 

the FD&C Act for standard menu items 

do not apply to ‘‘custom orders’’, the 

vending machine food labeling 

requirements of section 

403(q)(5)(H)(viii) of the FD&C Act do 

not provide for such an exclusion. 

Furthermore, in the proposed rule for 

nutrition labeling of standard menu 

items in restaurants and similar retail 

food establishments (76 FR 19192, April 

6, 2011), we proposed to define ‘‘custom 

order’’ as a food order that is prepared 

in a specific manner based on an 

individual customer’s request, which 

requires the restaurant or similar retail 

food establishment to deviate from its 

usual preparation of a menu item (76 FR 

19192 at 19233). The ‘‘custom orders’’ 

for purposes of nutrition labeling of 

standard menu items in restaurants and 

similar retail food establishments are 

not equivalent to vending machine 

foods that come in different varieties or 

flavors because such vending machine 

foods are not prepared in a way that 

deviates from a usual preparation of the 

item. Instead, vending machines 

offering articles of food in different 

varieties or flavors generally are 

programmed to dispense measurable 

quantities of beverages, flavors, or other 

varieties at the customer’s selection. As 

such, a vending machine operator can 

declare calories for each variety or 

flavor on a sign in close proximity to the 

selection buttons for such varieties and 

flavors or on a sign adjacent to the 

vending machine, as provided by 

§ 101.8(c). 

In consideration of the comments 

asking for flexibility for these products, 

and to provide clarity, we have added 

a new § 101.8(c)(2)(i)(D). (We have 

renumbered proposed § 101.8(c)(2)(i)(D) 

as § 101.8(c)(2)(i)(C) in the final rule, as 

will be discussed in response 23, and 

removed proposed § 101.8(c)(2)(i)(E) as 

will be discussed in response 24). 

Section 101.8(c)(2)(i)(D), as finalized, 

provides that if a covered vending 

machine food is one where the 

prospective purchaser selects among 

options to produce a final vended 

product (e.g., vended coffee, hot 

chocolate or tea with options for added 

sugar, sugar substitute, milk, and 

cream), calories must be declared per 

option or for the final vended products. 

Regarding the comments asserting 

that it would not be feasible for vending 

machine operators to declare calories for 

each variety or flavor due to lack of 

space on the vending machine, we note 

that vending machine operators may 

place a sign declaring calories adjacent 

to the vending machine, as provided in 

§ 101.8(c). We further discuss the 

placement of signs disclosing the 

number of calories in covered vending 

machine food in our response to 

comment 28. We also note that vending 

machine operators have flexibility to 

declare either the calories from each 

option or the calories for final vended 

products. 

Consequently, we have finalized 

§ 101.8(c)(2)(i)(A) without change. 

However, on our own initiative, we 

have moved the requirement in the 

introductory sentence of proposed 

§ 101.8(c)(2)(i) that the number of 

calories ‘‘must be clear and 

conspicuous,’’ and placed it instead in 

the introductory sentence of 

§ 101.8(c)(2)(ii) of the final rule. The 

‘‘clear and conspicuous’’ standard more 

appropriately reflects the requirements 

in § 101.8(c)(2)(ii), which focus on the 

placement and appearance of the calorie 

declarations, rather than the 

requirements of § 101.8(c)(2)(i), which 

focus on the content of the calorie 

declarations. 

ii. Use of the term ‘‘Calories’’ or 

‘‘Cal’’. 

Proposed § 101.8(c)(2)(i)(B) would 

require that the term ‘‘Calories’’ or ‘‘Cal’’ 

appear adjacent to the caloric content 

value for each food in the vending 

machine. 

We received no comments on this 

provision and have finalized it without 

change. 

iii. Calorie declaration type size, 

color, and contrast. 

Proposed § 101.8(c)(2)(i)(C) would 

specify the calorie declaration’s type 

size, color, and contrast. For calorie 

declarations in or on the vending 

machine, the proposal would require 

the calorie declaration to be in a type 

size no smaller than the name of the 

food on the machine, not the label, 

selection number, or price of the food as 

displayed on the vending machine, 

whichever is smallest, with the same 

prominence, i.e., the same color, or in a 

color at least as conspicuous, as the 

color of the name, if applicable, or price 

of the food or selection number, and the 

same contrasting background, as the 

item it is in closest proximity to, i.e., 

name, selection number, or price of the 

food item as displayed on the machine 

(76 FR 19238 at 19254). 

(Comment 21) Many comments agreed 

with the proposed requirements for type 

size, color, and contrast for calorie 

declarations in or on the vending 

machine. However, some comments 

argued that the calorie declaration 

should be more prominent. Several 

comments suggested that we revise the 

rule to state that ‘‘calorie labeling be as 

large as the name of the vended item if 

it is posted on the machine, selection 

number, or the price, whichever is 

largest.’’ One comment said that the 

font, size, and color of the calorie 

declaration should be no less prominent 

than the price, label (although the 

comment did not describe what it meant 

by ‘‘label’’), or item name. Another 

comment said that the calorie 

declaration must be large enough to read 

from a ‘‘normal standing posture.’’ 

Other comments said the proposed 

rule was too restrictive and wanted 

greater flexibility for the type size of the 

calorie declaration—whether on the 

vending machine or on the food itself. 

Several comments claimed that the 

proposed rule would force vending 

machine operators to make significant 

changes to the size of product brand 

names on smaller vending buttons or 

use ‘‘distractingly large’’ calorie 

declarations on certain larger vending 

buttons. (We interpret the comment’s 


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reference to ‘‘vending button’’ to be the 

same as a selection button.) 

Regarding the proposed requirement 

for contrasting background, one 

comment stated that the calorie 

declaration should have a contrasting 

background and be in a font color that 

is at least as visible as, rather than the 

same as, the background and the color 

of the selection number or price. 

(Response 21) The preamble to the 

proposed rule explained that for calorie 

declarations in or on the vending 

machine, the calorie declaration must be 

in a type size ‘‘no smaller than the 

name, selection number, or price of the 

food as displayed on the vending 

machine, whichever is smallest’’ (76 FR 

19238 at 19243). Proposed 

§ 101.8(c)(2)(i)(C) would state, in 

relevant part, that the declaration of 

calories must be in a type size no 

smaller than the name of the food on the 

machine, not the label, selection 

number, or price of the food as 

displayed on the vending machine, 

whichever is smallest. To further clarify 

that the type size of the calorie 

declarations must be in a type size no 

smaller than the name of the food on the 

machine, the selection number, or the 

price of the food as displayed on the 

vending machine, whichever is 

smallest, we have revised the provision 

that was proposed § 101.8(c)(2)(i)(C) 

(which is moved and consolidated as 

§ 101.8(c)(2)(ii)(B) in this final rule, as 

explained later in this response) to place 

the phrase ‘‘not the label’’ in 

parentheses. We are connecting the 

calorie declaration’s type size to the 

type size of other information on the 

vending machine that a prospective 

purchaser uses to make a selection (i.e., 

the name of the food on the machine, 

the selection number, the price of the 

food as displayed), in order to ensure 

that the calorie declaration is clear and 

conspicuous and similarly readable. 

We decline to make the changes 

requested by the comments to the 

requirements for size and color of the 

calorie declarations in or on the vending 

machine because the comments did not 

provide any specific information 

regarding the size or color of the calorie 

declarations, particularly information 

that would give us a basis to revise the 

rule. For example, the comments 

asserting that calorie declarations 

should be larger or more prominent did 

not provide any information to show 

that the proposed requirements would 

not ensure that the calorie declarations 

are clear and conspicuous and easily 

readable. 

In addition, with respect to the 

comment asserting that the calorie 

declaration must be large enough to be 

seen from a ‘‘normal standing posture,’’ 

such a standard would not take into 

account that there are different types of 

vending machines and that consumers 

vary in height and visual acuity. For 

example, calorie declarations at the top 

of a vending machine that a tall 

consumer might see easily could be 

difficult for a comparatively shorter 

consumer to see. 

As for the comments seeking greater 

flexibility for vending machine 

operators, the requirements for the type 

size, color, and contrast of calorie 

declarations in or on the vending 

machine provide vending machine 

operators with flexibility by linking 

such requirements to the information 

that prospective purchasers otherwise 

use to make selections. Vending 

machine operators can therefore use the 

information (i.e., the name of the food, 

selection number, or price of the food as 

displayed) that is already on their 

vending machines as a guide to comply 

with the type size, color, and contrast 

requirements for the calorie labeling 

requirements of section 

403(q)(5)(H)(viii) of the FD&C Act for 

calorie declarations in or on the vending 

machine. This flexibility should enable 

vending machine operators to develop 

signs declaring calories for calorie 

declarations in or on the vending 

machine regardless of the type of 

vending machine they have. In addition 

to providing flexibility, the 

requirements, as finalized, help ensure 

that calorie declarations are clear and 

conspicuous, as required by section 

403(q)(5)(H)(viii) of the FD&C Act. 

In consideration of the comment 

asking that the contrasting background 

be ‘‘at least as visible as’’ (rather than 

‘‘the same as’’) the background of the 

accompanying food item (i.e., its name, 

selection number, or price), we have 

revised the provision that was proposed 

§ 101.8(c)(2)(i)(C) (which is moved and 

consolidated as § 101.8(c)(2)(ii)(B) in 

this final rule, as explained later in this 

response) to require that the calorie 

declaration have the same contrasting 

background, or a background as least as 

contrasting as the background used for 

the item it is in the closest proximity to, 

i.e., name, selection number, or price of 

the food item as displayed on the 

machine. Revising the rule in this 

manner provides additional flexibility 

related to the prominence requirements, 

and parallels the rule’s requirement that 

the color of the calorie declaration be 

the same or ‘‘at least as conspicuous’’ as 

that of the accompanying food item’s 

name, price, or selection number on the 

vending machine. 

On our own initiative, we are also 

revising the rule to eliminate a duplicate 

requirement. Proposed § 101.8(c)(2)(i)(C) 

would describe the type size, color and 

contrast for calorie declarations in or on 

the vending machine, and proposed 

§ 101.8(c)(2)(ii)(B) would describe the 

color and contrast requirement for 

calorie information in or on the vending 

machine. Organizationally, proposed 

§ 101.8(c)(2)(i) would focus on the 

content of the calorie declarations, and 

proposed § 101.8(c)(2)(ii) would focus 

on the placement and appearance of the 

calorie declarations. Therefore, for 

clarity, we are moving and 

consolidating proposed 

§ 101.8(c)(2)(i)(C) with proposed 

§ 101.8(c)(2)(ii)(B) to eliminate the 

duplicate requirement, and renumbering 

subsequent paragraphs that were 

proposed § 101.8(c)(2)(i)(D) and (E) to be 

§ 101.8(c)(2)(i)(C) and (D) in the final 

rule. 

For these reasons, under 

§ 101.8(c)(2)(ii)(B) of the final rule, 

when the calorie declaration is in or on 

the vending machine, the calorie 

declaration must be in a type size no 

smaller than the name of the food on the 

machine (not the label), selection 

number, or price of the food as 

displayed on the vending machine, 

whichever is smallest, with the same 

prominence, i.e., the same color, or in a 

color at least as conspicuous, as the 

color of the name, if applicable, or price 

of the food or selection number, and the 

same contrasting background, or a 

background at least as contrasting as the 

background used for the item it is in 

closest proximity to, i.e., name, 

selection number, or price of the food 

item as displayed on the machine. 

iv. Calorie declarations for singleserving packaged food. 

Proposed § 101.8(c)(2)(i)(D) would 

state that the number of calories for 

single-serving packaged food declared 

on the sign must be identical to the 

number of calories that are declared in 

the Nutrition Facts, if applicable. 

Because section 403(q)(5)(H)(viii) of the 

FD&C Act refers to ‘‘an article of food 

sold from a vending machine,’’ the 

preamble to the proposed rule also 

indicated that calorie information must 

include the total calories present in the 

covered vending machine food as it is 

vended (76 FR 19238 at 19242). For 

example, for bundled items such as 

sandwiches that are dispensed with a 

single serving unit of a condiment (e.g., 

mayonnaise), the calorie declaration 

must include the total calories in the 

sandwich plus any condiment packets 

bundled with it as a vended article (76 

FR 19238 at 19242). 

(Comment 22) One comment stated 

that calorie ranges are necessary with 

certain foods, such as fresh fruit, cotton 


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candy, sandwiches, or pastries because 

such foods can have slight calorie 

variations. The comment stated that 

vending machine operators need 

flexibility to declare calories in ranges 

and that ranges will make it easier for 

vending machine operators to 

implement the calorie labeling 

requirements. 

(Response 22) We recognize that 

certain vending machine foods, such as 

fresh fruit, may have naturally occurring 

variations in calorie content depending 

on the size of the fruit and other factors. 

This is different from the situation of a 

food with various options that a 

consumer selects (as discussed in 

comment and response 20), and from 

the situation of a food that comes 

bundled with various components (as 

discussed in comment and response 23). 

We conclude that a range is not 

necessary for calorie declarations for 

vending machine foods that may have 

naturally occurring variations in calorie 

content depending on the size of the 

fruit or other factors. As discussed 

further in comment and response 34 in 

section III.D entitled ‘‘Determination of 

Calorie Content,’’ a vending machine 

operator may rely on a number of means 

to determine the calorie content of 

covered vending machine food. For 

example, a vending machine operator 

may obtain calorie information from 

nutrient databases, such as the ‘‘USDA 

National Nutrient Database for Standard 

Reference’’ (http://ndb.nal.usda.gov/) 

and use such information in declaring 

calories, provided that the calorie 

declarations are truthful and not 

misleading and otherwise in compliance 

with section 403(a)(1), (q)(5)(H)(viii), 

and (f) of the FD&C Act and § 101.8. 

With respect to a potential variation 

in prepared food such as cotton candy, 

sandwiches, and pastries, we also 

conclude that a range is not necessary 

for calorie declarations for such foods. 

As discussed further in comment and 

response 34 in section III.D entitled 

‘‘Determination of Calorie Content,’’ 

vending machine operators may be able 

to use various means to determine the 

calorie content for vending machine 

foods. For example, if the food is 

manufactured, the vending machine 

operator may be able to obtain the 

necessary calorie information from the 

food package’s Nutrition Facts label, the 

manufacturer, or nutrient databases. It is 

the vending machine operator’s 

responsibility to ensure that calorie 

declarations for foods are accurate and 

otherwise in compliance with section 

403(a)(1), (q)(5)(H)(viii), and (f) of the 

FD&C Act and § 101.8. 

(Comment 23) For vending machine 

foods such as sandwiches that consist of 

more than one separately packaged 

component and are sold as one unit in 

turnstile vending machines, one 

comment asked us to allow the vending 

machine operator to either: (1) Declare 

the total calories of the food as vended 

or (2) declare calories for each 

individual component. The comment 

said this would, for example, allow 

mayonnaise already on the sandwich to 

be included in the calories for the total 

package and also allow mayonnaise in 

a separate packet to be excluded from 

the calorie count of a sandwich that 

does not already have mayonnaise on it. 

The comment further stated that 

allowing vending machine operators to 

declare calories for the components of a 

covered vending machine food 

separately would give the consumer 

more information. (The comment 

referred to its suggestion as ‘‘itemized’’ 

calorie declaration.) For example, 

according to the comment, a 428 calorie 

turkey sandwich with two packets of 

mayonnaise and two packets of mustard 

derives 250 calories from the sandwich 

itself, 86 calories from each packet of 

mayonnaise, and 3 calories from each 

packet of mustard. The comment said 

that it would be simpler for the vending 

machine operator to declare the calories 

for the primary item and for each 

separately packaged item that is 

provided because the operator would 

not need multiple versions of posters, 

labels, etc. depending on the types and 

quantities of condiments provided. The 

comment argued that such an approach 

for articles of food with multiple 

components, like sandwiches, would be 

consistent with FDA’s approach to 

covered vending machine foods that 

come in different varieties and flavors, 

such as hot beverages, which FDA 

concluded, in the preamble to the 

proposed rule, could be declared per 

option (e.g., cream for coffee). The 

comment asked that we revise the rule 

to give turnstile vending machines 

flexibility to declare calories separately 

for condiments sold with a food item. 

(Response 23) We disagree with the 

comment asking us to allow the vending 

machine operator to either: (1) Declare 

the total calories of a bundled vending 

machine food as vended, or (2) declare 

calories for each individual component 

of a bundled vending machine food as 

vended. The requirements of section 

403(q)(5)(H)(viii) of the FD&C Act apply, 

in relevant part, ‘‘in the case of an 

article of food sold from a vending 

machine.’’ Regarding a vending machine 

food that consists of more than one 

separately packaged component and is 

sold as one unit (e.g., sandwich 

dispensed with a single serving packet 

of condiment), the calorie declaration 

for the food must include the total 

calories present in the food as it is 

vended, including the calories present 

in single serving units of condiments. 

We consider a packaged or plasticwrapped sandwich including, if sold 

along with the sandwich, any packet(s) 

of condiments to be the ‘‘article of food’’ 

for purposes of applying the 

requirements of section 

403(q)(5)(H)(viii) of the FD&C Act. As 

such, the vending machine operator 

must provide a calorie declaration for 

the ‘‘article of food’’ as it is vended, 

which includes the calorie content of 

each component of the ‘‘article of food.’’ 

We will not object, however, if the 

vending machine operator voluntarily 

declares the calories for a bundled 

vending machine food that consists of 

more than one separately packaged 

component on a per packaged 

component basis, so long as the vending 

machine operator also provides the total 

calorie declaration for ‘‘the article of 

food’’ as it is vended. We note that 

condiment packets that are not 

dispensed with the sandwich (e.g., those 

condiments that are stocked in a 

common area near a bank of vending 

machines) are not part of ‘‘the article of 

food’’ for purposes of applying the 

requirements of section 

403(q)(5)(H)(viii) of the FD&C Act. In 

such an instance, the vending machine 

operator should not include the 

condiment packets in the total calories 

of the article of food. 

Further, contrary to the comment’s 

assertion, requiring the calorie 

declaration for a bundled vending 

machine food to include the total 

calories present in the food as it is 

vended is not inconsistent with the 

calorie labeling requirements for articles 

of vending machine food that come in 

different varieties or flavors (e.g., 

coffee), which we discussed in our 

response to comment 20. When the 

consumer affirmatively can choose the 

varieties or options dispensed with the 

food by pressing a selection button 

corresponding to each variety or option, 

the vending machine operator may 

display the calorie declarations for each 

variety or option in close proximity to 

the corresponding selection buttons for 

such varieties or options; however, 

when the consumer receives a bundled 

food item (such as a sandwich with a 

mayonnaise packet accompanying the 

sandwich), the consumer has selected to 

receive the food item as dispensed, and 

therefore, it is appropriate to label the 

calories for the entire bundled food 

item. 

We also disagree with the comment 

stating that calorie ranges are necessary 

for certain foods, such as sandwiches. In 


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the case of bundled items, the consumer 

is unable to customize the item that is 

vended until after it is dispensed, and, 

therefore, a declaration of total calories 

is appropriate rather than a range. In the 

case of bundled items, as we have 

indicated, we would not object to 

additional calorie declarations for each 

component of a bundled item, as long as 

the vending machine operator also 

provides the total calorie declaration for 

the bundled item, as it is vended. 

As discussed in response 21, we have 

moved what had been proposed as 

§ 101.8(c)(2)(i)(C) and therefore we are 

renumbering proposed 

§ 101.8(c)(2)(i)(D) as § 101.8(c)(2)(i)(C). 

Also, as discussed further in section 

III.C.4.b.v, we have made changes to 

renumbered § 101.8(c)(2)(i)(C) to further 

clarify that a calorie declaration for a 

covered vending machine food must 

include the total number of calories for 

the food, whether the food is a singleserving or multiple serving food. 

Section 101.8(c)(2)(i)(C) of this final rule 

provides that the number of calories for 

a covered vending machine food must 

include the total calories present in the 

food. As discussed in section III.D, a 

vending machine operator may 

determine the total calories contained in 

a covered vending machine food 

through a variety of methods, including 

obtaining the calorie information from 

the food package’s Nutrition Facts label, 

the manufacturer or supplier of the 

food, nutrient databases, cookbooks or 

laboratory analyses. Covered vending 

operators must ensure that the calorie 

declarations are truthful and not 

misleading, as required by section 

403(a)(1) of the FD&C Act, and 

otherwise comply with section 

403(q)(5)(H)(viii) and (f) of the FD&C 

Act and § 101.8. 

v. Calorie declarations for packaged 

food having multiple servings. 

Proposed § 101.8(c)(2)(i)(E) would 

require that the calorie declaration for a 

covered vending machine food that 

contains multiple servings include the 

total number of calories present in the 

vending machine food. Proposed 

§ 101.8(c)(2)(i)(E) would also allow 

vending machine operators to 

voluntarily disclose the calories per 

serving in addition to the total calories 

for the food. 

(Comment 24) Many comments stated 

that vending machine food, regardless of 

its serving size, is typically consumed in 

one occasion. The comments agreed 

with proposed § 101.8(c)(2)(i)(E) and 

said that section 403(q)(5)(H)(viii) of the 

FD&C Act’s reference to an ‘‘article of 

food sold from a vending machine’’ and 

disclosure of calories contained in the 

article indicates that a vending machine 

operator must declare the total calories 

contained in a vending machine food as 

it is packaged for sale, or otherwise sold 

from a vending machine, even if the 

food’s Nutrition Facts label states that 

the food contains more than one 

serving. Similarly, because vending 

machine food is typically consumed in 

one occasion, a few comments noted 

that declaring calories per serving could 

be potentially confusing to consumers. 

The comments stated that it would be 

deceptive, for example, to label a bag of 

chips as 160 calories (per one-ounce 

serving) on the vending machine, only 

to have people discover that the whole 

bag of chips contained 1.5 servings and 

240 calories. 

Other comments disagreed with 

proposed § 101.8(c)(2)(i)(E). The 

comments would base calorie 

declarations on the serving size listed 

on the Nutrition Facts label and said 

that doing so would be consistent with 

current nutrition labeling requirements. 

The comments pointed out that some 

commonly vended foods contain more 

than one serving and that, for those 

foods, the calories as listed per serving 

in the Nutrition Facts label would not 

be identical to the calorie declaration 

disclosing the number of calories 

contained in the entire article of food. 

In contrast to the comments asserting 

that vending machine foods typically 

are consumed in their entirety in one 

occasion, regardless of listed servings on 

the package, a few comments stated that 

labeling total calories for foods such as 

gum would be misleading because 

typically, people do not chew the entire 

pack of gum in one occasion and that 

calories should be allowed to be 

displayed per serving. 

Several comments supporting calorie 

declarations per serving noted that 

Congress used the term ‘‘item’’ for the 

nutrition labeling requirements for 

standard menu items offered for sale in 

restaurants and similar retail food 

establishments of section 4205 of the 

ACA, but used the term ‘‘article’’ for the 

vending machine food labeling 

requirements. One comment stated that 

because Congress used different words 

to express the two requirements, the 

words should have different meanings. 

The comment contended that ‘‘article,’’ 

which is used in the vending machine 

labeling requirements of section 4205 of 

the ACA, suggests that the number of 

calories per serving, and not the total 

number of calories contained in the 

food, must be declared. The comment 

also noted that the nutrition labeling 

requirements for packaged foods is per 

serving. According to the comment, if 

FDA thinks per serving calorie 

declarations are not sufficient, we 

should address the issue directly 

through our serving size regulations and 

not indirectly through the vending 

machine calorie declaration 

requirements. 

(Response 24) We decline to revise 

the rule to require the calorie 

declarations for covered vending 

machine food to be based on the serving 

size listed on the Nutrition Facts label. 

We agree with the comments asserting 

that many vending machine foods are 

typically consumed in one occasion. 

Further, we note that the requirements 

of section 403(q)(5)(H)(viii) of the FD&C 

Act apply to an ‘‘article of food sold 

from a vending machine,’’ and section 

403(q)(5)(H)(viii) of the FD&C Act 

requires a vending machine operator to 

disclose the ‘‘number of calories 

contained in the article [of food].’’ Thus, 

we conclude that section 

403(q)(5)(H)(viii) of the FD&C Act 

requires that the calorie declaration for 

an article of food sold from a vending 

machine, including foods that contains 

multiple servings, be equal to the total 

‘‘number of calories contained in the 

article [of food]’’ as dispensed, rather 

than the number of calories contained in 

the serving size, if applicable, for the 

food. The total number of calories can 

be determined by multiplying the 

number of calories per serving by the 

number of servings in the package. For 

example, if the Nutrition Facts for an 

article of food states 80 calories per 

serving and 3 servings per container, the 

total number of calories in the entire 

package would be 240 calories. 

Further, regarding the comments 

supporting calorie declarations per 

serving because Congress used the term 

‘‘item’’ for the nutrition labeling 

requirements for standard menu items 

offered for sale in restaurants and 

similar retail food establishments of 

section 4205 of the ACA, but used the 

term ‘‘article’’ for the vending machine 

food labeling requirements, we disagree 

with the comments. First, the language 

of section 403(q)(5)(H)(viii) of the FD&C 

Act generally provides, in relevant part, 

that ‘‘[i]n the case of an article of food 

sold from a vending machine . . . the 

vending machine operator shall provide 

a sign in close proximity to each article 

of food or the selection button that 

includes . . . the number of calories 

contained in the article [of food].’’ 

(Emphasis added.) Therefore, the calorie 

declaration must include the number of 

calories contained in the article of food, 

and not the number of calories per 

serving of the food. 

Second, the fact that Congress used 

the term ‘‘menu item’’ in section 

403(q)(5)(H)(i)–(vii) of the FD&C Act 

does not indicate that ‘‘article of food’’ 


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should be interpreted to mean ‘‘per 

serving’’ within the meaning of section 

403(q)(5)(H)(viii) of the FD&C Act. If 

Congress intended to require calories to 

be declared in serving size amounts, 

Congress could have used specific 

language to indicate this intent, as 

demonstrated elsewhere in section 

403(q) of the FD&C Act (‘‘serving size,’’ 

‘‘number of servings,’’ and ‘‘per serving’’ 

in section 403(q)(1)(A) and (q)(5)(H)(iii) 

of the FD&C Act). Such an omission 

indicates that declaring calories in 

serving size amounts was not the intent 

of Congress. E.g., Russello v. U.S., 464 

U.S. 16, 23 (1983) (‘‘[W]here Congress 

includes particular language in one 

section of a statute but omits it in 

another section of the same Act, it is 

generally presumed that Congress acts 

intentionally and purposely in the 

disparate inclusion or exclusion’’) 

(citation omitted). 

We reiterate, however, that proposed 

§ 101.8(c)(2)(i)(E) (which has been 

consolidated with proposed 

§ 101.8(c)(2)(i)(D) and renumbered as 

§ 101.8(c)(2)(i)(C) in the final rule, as 

explained further in the paragraphs that 

follow) would allow for the voluntary 

declaration of calories per serving for 

covered vending machine foods. 

Regarding the comment suggesting that 

we revise our serving size regulations, 

we clarify that this rule implements the 

requirements of section 

403(q)(5)(H)(viii) of the FD&C Act for 

foods sold in vending machines. For the 

purposes of this rule, calorie 

declarations for covered vending 

machine foods must be provided for the 

total number of calories contained in the 

article of food. 

As discussed in response 21 of this 

preamble, we have moved proposed 

§ 101.8(c)(2)(i)(C) and therefore have 

renumbered proposed § 101.8(c)(2)(i)(D) 

as § 101.8(c)(2)(i)(C). Additionally, for 

the reasons noted in the previous 

paragraphs, and as discussed in section 

III.C.4.b.iv, we have made changes to 

renumbered § 101.8(c)(2)(i)(C) to further 

clarify that a calorie declaration for a 

covered vending machine food must 

include the total number of calories for 

the food, whether the food is a single 

serving or multiple serving food. In 

addition, we have added a sentence to 

§ 101.8(c)(2)(i)(C) explaining that for a 

covered vending machine food with 

multiple servings a vending machine 

operator may voluntarily disclose 

calories per serving in addition to the 

total calories for the covered vending 

machine food. This sentence was 

originally included in § 101.8(c)(2)(i)(E). 

Because we have moved the sentence to 

§ 101.8(c)(2)(i)(C) and § 101.8(c)(2)(i)(C) 

now applies to both single- and 

multiple-serving covered vending 

machine foods, we have removed 

proposed § 101.8(c)(2)(i)(E). 

vi. Calorie declarations on signs in 

close proximity to the article of food or 

selection button. 

Proposed § 101.8(c)(2)(ii) would 

establish requirements pertaining to the 

placement of calorie declarations. 

Proposed § 101.8(c)(2)(ii)(A) would 

require the calorie declarations to be 

placed on a sign in close proximity to 

the article of food or selection button, 

i.e., in, on, or adjacent to the vending 

machine, but not necessarily attached to 

the vending machine, so long as the sign 

is visible at the same time as the food, 

its name, price, or selection button or 

selection number is visible. 

The preamble to the proposed rule 

explained that ‘‘a sign that is a poster 

may be an appropriate medium to 

convey the required calorie 

declarations, so long as the sign is in 

close proximity to the covered vending 

machine food or selection button’’ (76 

FR 19238 at 19243). We also tentatively 

concluded that for certain types of 

vending machines with a limited 

number of selections (e.g., popcorn with 

or without added butter), the sign with 

the statement of calories may appear 

anywhere on the front (or face) of the 

vending machine, and that ‘‘a sign may 

consist of a handwritten sticker in 

permanent marking that is affixed to the 

machine’’ (76 FR 19238 at 19243). 

(Comment 25) One comment asked 

that we permit a ‘‘static cling’’ type label 

(e.g., a plastic decal that sticks to a 

surface because of static electricity) to 

be placed on the outside of ‘‘closedfront’’ vending machines (i.e., vending 

machines that do not have transparent 

glass fronts). 

(Response 25) Section 

403(q)(5)(H)(viii) of the FD&C Act does 

not specify how a sign declaring calories 

is to be affixed to a vending machine or 

what materials are to be used for the 

sign. To give vending machine operators 

the greatest flexibility, the final rule also 

does not specify the type of material to 

be used as a sign or the manner in 

which the sign must be affixed to a 

vending machine. However, regardless 

of the material used for the sign, 

compliance with the calorie labeling 

requirements is contingent on the sign 

being in close proximity to each article 

of food or selection button and 

otherwise satisfying the requirements of 

section 403(a)(1), (f), and (q)(5)(H)(viii) 

of the FD&C Act and § 101.8. 

(Comment 26) Many comments 

supported proposed § 101.8(c)(2)(ii)(A), 

which would allow a vending machine 

operator to provide a sign in close 

proximity to each article of food or 

selection button that displays calorie 

declarations for multiple vending 

machine foods. These comments stated 

that allowing vending machine 

operators to provide a sign with calorie 

declarations in this manner would be 

the least expensive and least 

burdensome way for vending machine 

operators to comply with section 

403(q)(5)(H)(viii) of the FD&C Act. Some 

comments stated that a sign or poster 

could cost as little as $5 per vending 

machine and would be the ‘‘least 

burdensome’’ on small businesses. 

Other comments stated that allowing a 

vending machine operator to provide 

calorie declarations on a sign adjacent to 

or on the vending machine would 

reduce stocking errors by blind vending 

machine operators. 

Conversely, some comments claimed 

that section 403(q)(5)(H)(viii) of the 

FD&C Act requires calorie declarations 

to be on individual ‘‘signs’’ for each 

article of food and that posting calorie 

declarations for multiple foods on a 

single sign that is not adjacent to the 

corresponding article of food would not 

meet the statute’s requirements. One 

comment argued that if FDA permits 

calorie declarations for multiple 

vending machine foods on a single sign, 

we should at least prohibit such single 

signs from being placed adjacent to the 

vending machine, and ensure the close 

proximity of the single sign to each 

article of food or the selection button by 

revising the rule to read as follows: 

‘‘This calorie information must be 

placed on a sign next to the article of 

food or its selection button, or on a sign 

appended to the front of the vending 

machine at a similar height as the 

machine’s selection buttons.’’ 

(Response 26) Section 

403(q)(5)(H)(viii) of the FD&C Act 

expressly states, in relevant part, that a 

vending machine operator must provide 

‘‘a sign in close proximity to each article 

of food or the selection button that 

includes the number of calories 

contained in the article.’’ Section 

403(q)(5)(H)(viii) of the FD&C Act does 

not specify whether vending machine 

operators must use a single sign with 

calorie declarations for multiple articles 

of food, or multiple signs corresponding 

to each article of food or selection 

button. To give vending machine 

operators the greatest amount of 

flexibility and to take into consideration 

different types of vending machines, we 

interpret section 403(q)(5)(H)(viii) of the 

FD&C Act to allow vending machine 

operators to use one sign with calorie 

declarations for all of the covered 

vending machine food sold from the 

vending machine or a sign for each 

covered vending machine food sold 


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from the vending machine, or a 

combination of the two, as long as the 

sign or signs are in close proximity to 

the covered vending machine food or 

selection button, as provided in 

§ 101.8(c)(2), and otherwise satisfies the 

requirements of section 403(a)(1), (f), 

and (q)(5)(H)(viii) of the FD&C Act and 

§ 101.8. 

(Comment 27) Some comments asked 

us to clarify whether the rule would 

permit a vending machine operator to 

provide a sign adjacent to the vending 

machine that lists calorie declarations 

for all possible products that could be 

sold from the machine. The comments 

stated that such signs would be 

permanent in nature and would reduce 

the need to print new signs when 

different products are added to the 

vending machine. 

Other comments suggested that 

grouping vending machine food items 

on a sign by category will allow 

consumers to better compare products. 

(Response 27) We decline to revise 

§ 101.8(c)(2)(ii)(A) to allow a vending 

machine operator to provide a sign 

adjacent to the vending machine that 

lists all possible articles of food that 

could be sold from the machine. 

However, we would not object to a 

vending machine operator providing 

calorie declarations for articles of food 

that are typically offered for sale in the 

specific vending machine but may not 

be offered for sale at all times (for 

example, in cases where the article sells 

out, or is temporarily replaced by 

another item), provided that the calorie 

declarations are clear and conspicuous 

and placed prominently. The calorie 

labeling requirements of section 

403(q)(5)(H)(viii) of the FD&C Act apply 

‘‘[i]n the case of an article of food sold 

from a vending machine’’ (emphasis 

added). Accordingly, whether a vending 

machine operator provides individual 

signs for each article of food or selection 

button, or a sign with calorie 

declarations for multiple articles of 

food, section 403(q)(5)(H)(viii) of the 

FD&C Act requires vending machine 

operators to provide clear and 

conspicuous calorie declarations for 

those articles of food that are sold from 

the machine. Vending machine 

operators must also ensure that such 

calorie declarations are not false or 

misleading as required by section 

403(a)(1) of the FD&C Act and are 

prominently placed on signs with such 

conspicuousness and in such terms as to 

render the calorie declarations likely to 

be read and understood by the ordinary 

individual under customary conditions 

of purchase and use as required by 

section 403(f) of the FD&C Act. A long 

listing of food items, some of which are 

not available for sale in a vending 

machine, might make it more difficult 

for a prospective purchaser to locate the 

relevant calorie declarations for articles 

of food actually sold from the vending 

machine. In other words, depending on 

the number of foods listed on the sign 

and other factors, inclusion of calorie 

declarations for covered vending 

machine foods that are not sold from the 

particular vending machine, could 

result in the calorie declarations for 

covered vending machine foods actually 

sold from the vending machine no 

longer being clear and conspicuous, 

non-misleading, prominently placed 

and likely to be read and understood by 

the ordinary individual under 

customary conditions of purchase and 

use. 

Therefore, we have revised 

§ 101.8(c)(2)(ii)(A) to state that the list of 

covered vending machine food items on 

a sign must give calorie declarations for 

those articles of food that are sold from 

that particular vending machine. 

At the same time, we recognize that 

calorie declarations could, in some 

cases, be displayed for vending machine 

foods that are not available for sale in 

the machine at a given time. For 

example, the food may have been 

offered for sale in the vending machine 

but the vending machine may have sold 

out of that item at some point in time. 

As another example, a food that is 

typically stocked in a vending machine 

might be temporarily replaced by 

another item. Nevertheless, vending 

machine operators must continue to 

ensure that calorie declarations on such 

a sign are tailored to articles of food 

currently or typically sold from that 

particular vending machine and 

otherwise satisfy the requirements of 

section 403(a)(1), (f), and (q)(5)(H)(viii) 

of the FD&C Act and § 101.8. 

As for the comments suggesting that 

signs adjacent to the vending machines 

should group food items together, the 

final rule does not prescribe the manner 

in which articles of food and their 

associated calories are listed on a sign. 

Therefore, vending machine operators 

have the flexibility to organize the 

information on the signs as they wish, 

provided that the sign and the 

information on the sign comply with 

section 403(a)(1), (f), and (q)(5)(H)(viii) 

of the FD&C Act and § 101.8. 

(Comment 28) Many comments 

opposed allowing vending machine 

operators to declare calories on a sign 

adjacent to the vending machine. Some 

comments contended that consumers 

are unlikely to see calorie declarations 

on a sign adjacent to a vending machine, 

particularly compared to calorie 

declarations posted directly next to each 

vending machine food, but did not 

provide any data to support this 

contention. One comment suggested 

that we require a statement on the 

vending machine directing the 

consumer to the location of the sign 

adjacent to the machine. 

(Response 28) We disagree with those 

comments stating that we should not 

allow signs adjacent to the vending 

machine. Section 403(q)(5)(H)(viii) of 

the FD&C Act expressly states that ‘‘a 

vending machine operator shall provide 

a sign in close proximity to each article 

of food or the selection button . . . .’’ 

We have determined that a sign that is 

adjacent to the vending machine is ‘‘in 

close proximity,’’ to the covered 

vending machine food or selection 

button, so long as the calorie declaration 

on the sign is visible at the same time 

as the food, its name, or its selection 

button or selection number is visible. 

We also note that § 101.8(c)(2)(ii) 

requires that the sign be ‘‘placed 

prominently.’’ To help ensure that 

calorie declarations on a sign placed 

adjacent to the vending machine are 

clear and conspicuous, and placed 

prominently, § 101.8(c)(2)(ii)(C) requires 

that the calorie declaration must be in 

type that is all black or one color 

printed on a white or other neutral 

background that contrasts with the type 

color. Further, § 101.8(c)(2)(ii)(C) also 

helps to ensure that such calorie 

declarations are prominently placed on 

signs with such conspicuousness and in 

such terms as to render them likely to 

be read and understood by the 

prospective purchaser under customary 

conditions of purchase and use, 

consistent with section 403(f) of the 

FD&C Act. Considering our 

interpretation of ‘‘close proximity’’ and 

the requirement of § 101.8(c)(2)(ii), we 

conclude that an additional statement 

directing the consumer to the sign is not 

necessary. Therefore, we decline to 

amend the rule to require a statement on 

the vending machine that directs the 

consumer to the location of a sign 

adjacent to the vending machine. 

However, to further address the 

comments’ concern regarding the 

visibility of the calorie declarations on 

a sign adjacent to a vending machine, 

we have modified § 101.8(c)(2)(ii)(A) to 

specify that the calorie declaration must 

be visible at the same time as the food, 

its name, price, selection button, or 

selection number is visible (emphasis 

added). In addition, on our own 

initiative, we have replaced the 

reference to ‘‘[t]his calorie information’’ 

at the beginning of § 101.8(c)(2)(ii)(A) 

with ‘‘the calorie declarations’’ to be 

consistent with the rest of the final rule. 


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As discussed in response 20, we have 

also moved the requirement in the 

introductory sentence of proposed 

§ 101.8(c)(2)(i) that the number of 

calories ‘‘must be clear and 

conspicuous,’’ and placed it instead in 

the introductory sentence of 

§ 101.8(c)(2)(ii) for this final rule. The 

‘‘clear and conspicuous’’ standard more 

appropriately reflects the requirements 

in § 101.8(c)(2)(ii), which focus on the 

placement and appearance of the calorie 

declarations, rather than the 

requirements of § 101.8(c)(2)(i), which 

focus on the content of the calorie 

declarations. 

(Comment 29) One comment, opposed 

to allowing calorie declarations on signs 

adjacent to vending machines, 

compared such signs to stanchions at 

drive-through restaurants. The comment 

stated that, in the context of drivethrough restaurants, FDA has already 

taken the position in its proposed rule 

for nutrition labeling of standard menu 

items in restaurants and similar retail 

food establishments (76 FR 19192) that 

requiring consumers to look to one 

place (i.e., a menu board) for important 

food-selection information such as price 

and then to another (e.g., a stanchion) 

for calories, ‘‘is likely to be more 

difficult for customers attempting to use 

the declared calorie information at the 

point of selection’’ (76 FR 19192 at 

19206). The comment contended that it 

would be similarly difficult for 

consumers to use calorie information if 

consumers had to look at the food in the 

vending machine and at an adjacent 

sign for calorie declarations. 

(Response 29) We disagree with the 

comment. Section 403(q)(5)(H)(ii)(II)(aa) 

of the FD&C Act requires, in relevant 

part, that a covered restaurant or similar 

retail food establishment disclose the 

number of calories in a standard menu 

item ‘‘adjacent to the name of the 

standard menu item . . . on the menu 

board, including a drive-through menu 

board . . . .’’ (emphasis added). Section 

403(q)(5)(H)(viii) of the FD&C Act, in 

contrast, requires a covered vending 

machine operator to ‘‘provide a sign in 

close proximity to each article of food 

or the selection button . . . .’’ Thus, the 

placement of calorie declarations for 

covered vending machine food under 

section 403(q)(5)(H)(viii) of the FD&C 

Act is not directly analogous to the 

placement of calorie information for 

standard menu items under section 

403(q)(5)(H)(ii)(II)(aa) of the FD&C Act. 

Further, we do not consider vending 

machines to present a situation that is 

analogous to menu boards at drivethrough restaurants or similar retail food 

establishments. A menu board at a 

drive-through is distinguishable 

because, as we discussed in the 

proposed rule for nutrition labeling of 

standard menu items in restaurants and 

similar retail food establishments (76 FR 

19192 at 19206), customers have a 

restricted field of vision from their car 

windows while in a drive-through, and 

they may have a relatively short time to 

consider and review the menu board 

before ordering (76 FR 19192 at 19206). 

Vending machine consumers generally 

are not faced with similar restrictions. 

Accordingly, we interpret ‘‘a sign in 

close proximity to each article of food 

or the selection button’’ within the 

context of section 403(q)(5)(H)(viii) of 

the FD&C Act to mean adjacent to the 

vending machine in addition to in or on 

the vending machine. 

(Comment 30) Another comment 

noted that some localities prohibit the 

use of signs without permits and 

described certain jurisdictions that 

would levy a $25 fine for not obtaining 

a permit. According to the comment, 

such ordinances could be problematic 

for vending machine operators who 

would prefer to use signs adjacent to the 

vending machine to meet the calorie 

declaration requirements of section 

403(q)(5)(H)(viii) of the FD&C Act. 

(Response 30) This final rule gives 

vending machine operators the 

flexibility to comply with the calorie 

labeling requirements for vending 

machine foods in a way that minimizes 

burdens and that does not conflict with 

local requirements described by the 

comment. For example, where a State or 

local requirement regulates use of 

particular types of signs (e.g., large 

signs, free-standing signs), a vending 

machine operator could still comply 

with the requirements of section 

403(q)(5)(H)(viii) of the FD&C Act by 

providing a sign in or on the vending 

machine (e.g., using small individual 

signs or stickers). Alternatively, a 

vending machine operator could stock 

foods in a vending machine that permits 

a prospective purchaser to view the 

calories, serving size, and servings per 

container listed in the Nutrition Facts 

label on the foods, or in a reproduction 

of the Nutrition Facts label; or that 

otherwise provides visible nutrition 

information at the point of purchase, as 

provided in § 101.8(b). 

vii. Color and contrast for calorie 

declarations in or on the vending 

machine. 

Proposed § 101.8(c)(2)(ii)(B) would 

specify that when the calorie 

information is in or on the vending 

machine, the calorie declaration must be 

in the same color or a color at least as 

conspicuous as the color of the name or 

the price of the food or selection 

number. 

We received no comments on this 

provision. However, on our own 

initiative, as discussed in response 21, 

we have moved what was proposed as 

§ 101.8(c)(2)(i)(C) to § 101.8(c)(2)(ii)(B) 

of this final rule to eliminate a duplicate 

requirement on color and contrast for 

calorie declarations in or on the vending 

machine. Section 101.8(c)(2)(ii)(B) now 

specifies that when the calorie 

declaration is in or on the vending 

machine, the calorie declaration must be 

in a type size no smaller than the name 

of the food on the machine (not the 

label), selection number, or price of the 

food as displayed on the vending 

machine, whichever is smallest, with 

the same prominence, i.e., the same 

color, or in a color at least as 

conspicuous, as the color of the name, 

if applicable, or price of the food or 

selection number, and the same 

contrasting background, or a 

background at least as contrasting as the 

background used for the item it is in 

closest proximity to, i.e., name, 

selection number, or price of the food 

item as displayed on the machine. 

viii. Type size, color, and contrast for 

calorie declarations adjacent to the 

vending machine. 

When the calorie declaration is on a 

sign adjacent to the vending machine, 

proposed § 101.8(c)(2)(ii)(C) would 

require the calorie declaration to be in 

type that is ‘‘all black or one color 

printed on a white or other neutral 

background that contrasts with the type 

color’’ (76 FR 19238 at 19254). The 

preamble to the proposed rule explained 

that we were not proposing a minimum 

type size for the calorie declaration 

when it is on a sign adjacent to the 

vending machine (76 FR 19238 at 

19243), and we invited comment on this 

issue. 

(Comment 31) One comment asked 

that we establish additional 

requirements for size, type face, and 

color for the calorie declarations on the 

signs adjacent to the vending machine 

but the comment did not provide any 

specific suggestions. 

(Response 31) Unlike calorie 

declarations in or on the vending 

machine, calorie declarations on signs 

adjacent to a vending machine are not 

accompanied, or otherwise surrounded 

by, pre-existing text or colors to which 

we could link the requirements. We 

note however that section 

403(q)(5)(H)(viii) of the FD&C Act 

requires that calorie declarations be 

clear and conspicuous, and the 

requirement that the calorie declarations 

be clear and conspicuous also is 

codified in § 101.8(c)(2)(i). Further, 

section 403(f) of the FD&C Act requires, 

in relevant part, that any word, 


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statement, or other information required 

by or under the FD&C Act to appear in 

the labeling of food be prominently 

placed thereon with such 

conspicuousness 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. Thus, we conclude that a 

calorie declaration on a sign adjacent to 

a vending machine must be in a type 

size large enough to render it likely to 

be read and understood by the 

prospective purchaser under customary 

conditions of purchase and use, and we 

have revised § 101.8(c)(2)(ii)(C) 

accordingly. In addition, as discussed in 

response 28, we have modified 

§ 101.8(c)(2)(ii)(A) to specify that calorie 

declarations on signs adjacent to 

vending machines must be visible at the 

same time as the food, its name, price, 

selection button, or selection number is 

visible. 

On our own initiative, we have 

revised § 101.8(c)(2)(ii)(C) to replace the 

reference to calorie ‘‘information’’ with 

calorie ‘‘declaration’’ to be consistent 

with the rest of the final rule. 

ix. Vending machines displaying a 

picture or other representation of food. 

Proposed § 101.8(c)(2)(ii)(D) would 

require that, where the vending machine 

only displays a vignette or name of the 

food item, the calorie information must 

be in close proximity to the vignette or 

name or in close proximity to the 

selection button (76 FR 19238 at 19254). 

We received no comments on this 

provision. However, on our own 

initiative, we have revised 

§ 101.8(c)(2)(ii)(D) by inserting the 

words ‘‘picture or other representation’’ 

in place of ‘‘vignette’’ for plain language 

purposes, and by replacing the reference 

to calorie ‘‘information’’ with calorie 

‘‘declaration’’ to be consistent with the 

rest of the final rule. 

x. Electronic vending machines. 

Proposed § 101.8(c)(2)(ii)(E) would 

require that, for electronic vending 

machines (e.g., machines with digital or 

electronic or liquid crystal display 

(LCD) displays), the calorie information 

may be displayed when the selection 

numbers are entered but before the 

selection is confirmed. 

(Comment 32) Some comments 

supported proposed § 101.8(c)(2)(ii)(E) 

and stated that such electronic or LCD 

displays meet the requirements of 

section 403(q)(5)(H)(viii) of the FD&C 

Act. One comment stated that some 

electronic displays allow the consumer 

to view the full Nutrition Facts Panel 

and rotate a virtual image of the 

product, or otherwise allow consumers 

to compare the Nutrition Facts of two 

products side by side. 

Many comments opposed or would 

delete proposed § 101.8(c)(2)(ii)(E). 

Several comments noted that electronic 

displays would show calorie 

declarations for just one food item at a 

time. A few comments said that calorie 

declarations for all food items must be 

available to consumers at the same time 

before selection of an item so that 

consumers can compare calorie 

declarations for items simultaneously. 

Otherwise, the comments argued, 

consumers would have to keep track of 

the calorie declarations for each item 

until they made a final selection. 

One comment said that care should be 

taken in using the term ‘‘purchaser,’’ 

which the comment considered to be 

the person paying for the item. The 

comment said that the purchaser could 

be at a different location from the ‘‘user’’ 

of the vending machine. For example, 

some vending machines allow a 

‘‘purchaser’’ to pay for a vended item in 

one location while a ‘‘user’’ obtains the 

vended item in another location. This 

comment also suggested adding a new 

provision for clarity to read as follows: 

‘‘For vending machines retrofitted with 

digital or electronic or liquid crystal 

display (LCD) displays, the calorie 

information may be displayed at the 

user’s request before the purchase is 

confirmed by entering a selection ID, 

selecting a product image, searching by 

name, or filtering product based on 

specific criteria.’’ The comment did not 

explain why the new provision would 

focus on retrofitted vending machines. 

(Response 32) We disagree with the 

comments asserting that electronic 

vending machines cannot meet the 

requirements of section 

403(q)(5)(H)(viii) of the FD&C Act 

because electronic vending machines 

might be able to display calorie 

information for only one food item at a 

time. First, we note that electronic 

vending machines that provide calorie 

declarations in close proximity to 

vending machine foods or their 

selection buttons would comply with 

the calorie declaration requirements in 

section 403(q)(5)(H)(viii) of the FD&C 

Act, provided that such calorie 

declarations otherwise comply with 

section 403(a)(1) and (f) of the FD&C Act 

and § 101.8. Second, we understand that 

electronic vending machines have 

varying capabilities, and so to provide 

flexibility for vending machine 

operators to satisfy the requirements of 

section 403(q)(5)(H)(viii) of the FD&C 

Act, we are not requiring calorie 

declarations for electronic vending 

machines to be rendered 

simultaneously, although some 

electronic vending machines may have 

this capability. An electronic display 

that provides calorie declarations for 

one food at a time, allowing the 

prospective purchaser to cancel his or 

her initial selection, and then select 

other items in order to obtain the calorie 

declaration for each of them would 

constitute ‘‘a sign in close proximity to 

each article of food or the selection 

button . . . disclosing the number of 

calories contained in the article,’’ as 

required by section 403(q)(5)(H)(viii) of 

the FD&C Act. We therefore conclude 

that electronic vending machines may 

satisfy the calorie labeling requirements 

of section 403(q)(5)(H)(viii) of the FD&C 

Act. 

However, to further ensure that the 

prospective purchaser is able to view 

the calorie declaration before making a 

purchase, we have revised 

§ 101.8(c)(2)(ii)(E) on our own initiative 

to replace the proposed language with 

language stating that the calorie 

declaration must be displayed before the 

prospective purchaser makes his or her 

purchase. 

As discussed in response 13, we also 

note that an electronic reproduction of 

the Nutrition Facts label could be one 

way that a vending machine could 

permit a prospective purchaser to 

examine the Nutrition Facts Panel for an 

article of food to satisfy section 

403(q)(5)(H)(viii)(I)(aa) of the FD&C Act. 

Therefore, we have revised § 101.8(b)(2) 

by adding a new paragraph (b)(2)(ii) 

pertaining to electronic reproductions of 

the Nutrition Facts label. 

We decline to adopt the comment’s 

suggestion that we revise the final rule 

to distinguish between a vending 

machine ‘‘user’’ and ‘‘purchaser.’’ 

Section 403(q)(5)(H)(viii) of the FD&C 

Act uses the term ‘‘prospective 

purchaser’’ and does not make a 

distinction between a ‘‘prospective 

purchaser’’ and a vending machine 

‘‘user.’’ Accordingly, we decline to 

make such a distinction in the final rule. 

We also decline to adopt the 

comment’s suggested language regarding 

‘‘retrofitted’’ vending machines and the 

manner in which calorie information 

may be displayed. Section 

403(q)(5)(H)(viii) of the FD&C Act does 

not address retrofitting of vending 

machines with digital, electronic, or 

other displays, and does not distinguish 

between retrofitted vending machines 

with such displays and other vending 

machines. We also note that the 

comment’s suggested language, ‘‘may be 

displayed at the user’s request,’’ would 

make the display of calorie information 

discretionary, and such a result would 

be inconsistent with the statutory 

requirement of section 403(q)(5)(H)(viii) 

of the FD&C Act that a covered vending 

machine operator provide a sign 


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disclosing the number of calories 

contained in a covered vending machine 

food. 

xi. Vending machines with limited 

choices. 

Proposed § 101.8(c)(2)(ii)(F) would 

provide that for vending machines with 

limited choices, such as vending 

machines that dispense only popcorn, 

the declaration of calories may appear 

on the face of the machine so long as the 

declaration is prominent, not crowded 

by other labeling on the machine, and 

the type size is reasonably related to the 

largest print on the vending machine. 

We received no comments on this 

provision. However, as described in 

response 16 of this preamble, we revised 

§ 101.8(b)(2)(i), in response to comments 

regarding type size and prominence of 

the visible nutrition information on the 

label of the food, to replace the words 

‘‘reasonably related’’ with ‘‘at least 50 

percent of the size of the largest print on 

the label.’’ For consistency with our edit 

to § 101.8(b)(2)(i) and to provide 

additional clarity, we are revising 

§ 101.8(c)(2)(ii)(F). We considered 

whether to replace ‘‘reasonably related 

to the largest print on the vending 

machine’’ with ‘‘at least 50 percent of 

the size of the largest print on the 

vending machine.’’ However, we note 

that unlike § 101.8(b)(2)(i), where we are 

establishing a type size requirement 

based on other printed material on the 

label of a package of food, here we are 

establishing a type size requirement 

based on other printed material on the 

vending machine itself. Given the 

comparatively large surface area of 

vending machines, we are not requiring 

that the calorie declaration be 50 

percent of the size of the largest print on 

the face of the vending machine, as the 

largest print could potentially be very 

large. Instead, § 101.8(c)(2)(ii)(F), as 

finalized, provides that for vending 

machines with limited choices, the 

declaration of calories may appear on 

the face of the machine so long as the 

declaration is prominent, not crowded 

by other labeling on the machine, and 

the type size is no smaller than the 

name of the food on the machine (not 

the label), selection number, or price of 

the food as displayed on the vending 

machine, whichever is smallest. 

5. Voluntary Registration To Provide 

Calorie Labeling for Foods Sold From 

Vending Machines 

Proposed § 101.8(d) would provide 

that a vending machine operator that is 

not subject to section 403(q)(5)(H)(viii) 

of the FD&C Act may voluntarily 

register with FDA to be subject to the 

calorie labeling requirements 

established in § 101.8(c)(2). Proposed 

§ 101.8(d)(1) and (d)(2) would describe 

the applicability of the voluntary 

registration provision and who may 

register. Proposed § 101.8(d)(3)(i) 

through (d)(3)(iv) would list the 

information that a vending machine 

operator would be required to provide 

to FDA (i.e., contact information for the 

vending machine operator, address of 

the location of each vending machine, 

preferred mailing address, certification 

of the information submitted) in order to 

register voluntarily. Proposed 

§ 101.8(d)(3)(v) and (d)(3)(vi) also would 

describe the mechanism for submission 

of the information by email, fax, mail, 

or online form. Finally, proposed 

§ 101.8(d)(3)(vii) would require reregistration every other year within 60 

days prior to the expiration of the 

vending machine operator’s current 

registration with FDA. 

We received comments asking us to 

expand the voluntary database to 

require registration of all operators of 

covered vending machines, and we will 

address those comments in section 

III.C.6 of this preamble. We received no 

other comments on proposed § 101.8(d). 

However, on our own initiative, we 

have revised § 101.8(d) to clarify that 

the vending machine operator, rather 

than its authorized official, becomes 

subject to the requirements of section 

403(q)(5)(H)(viii) of the FD&C Act 

through voluntary registration, even if 

the authorized official voluntarily 

registered on the vending machine 

operator’s behalf. Also, for 

completeness, we have added ‘‘.gov’’ to 

the end of the email address provided 

for voluntary registration under 

§ 101.8(d). The complete email address 

now reads ‘‘menulawregistration@

fda.hhs.gov.’’ 

6. Vending Machine Operator Contact 

Information 

(Comment 33) Some comments said 

we should develop a database of 

covered vending machine operators and 

those who have elected to comply 

voluntarily with section 

403(q)(5)(H)(viii) of the FD&C Act. The 

comments stated that the database could 

enable state and local inspectors to 

determine which vending machines are 

subject to the calorie declaration 

requirements of section 

403(q)(5)(H)(viii) of the FD&C Act. 

Another comment suggested that, to 

help with enforcement, we could 

expand the voluntary registry in 

§ 101.8(d) to require all operators of 

covered vending machines to provide 

FDA with their names, contact 

information, and number and location 

of vending machines. The comment 

stated that we could share this 

information with States and localities 

that enforce local calorie labeling laws. 

As an alternative, the comment 

suggested that we require vending 

machine operators to post this 

information (name, contact information, 

etc.) on the front of each vending 

machine. 

(Response 33) The final rule, at 

§ 101.8(e)(1) and (e)(2), adds a 

requirement for vending machine 

operators to post their contact 

information for vending machines 

selling covered vending machine food. 

(We have renumbered proposed 

§ 101.8(e), which dealt with the topic of 

signatures, as § 101.8(f) in the final 

rule). As indicated by a comment, such 

a requirement is necessary for efficient 

enforcement of section 403(q)(5)(H)(viii) 

of the FD&C Act because it enables FDA 

to contact vending machine operators 

for enforcement purposes. Without such 

a requirement, we would not be able to 

contact vending machine operators 

subject to the requirements of section 

403(q)(5)(H)(viii) of the FD&C Act 

because such contact information would 

not always be readily available to the 

Agency. Section 101.8(e)(1) specifies 

that the contact information must list 

the vending machine operator’s name, 

telephone number, and mailing address 

or email address. 

Section 101.8(e)(2) specifies that the 

contact information must be readable 

and may be placed on the face of the 

vending machine, or otherwise must be 

placed with the calorie declarations 

described in § 101.8(c)(2)(ii) (i.e., on the 

sign in, on, or adjacent to the vending 

machine). We are providing flexibility 

to vending machine operators regarding 

where they can display the contact 

information. We note that some States 

have licensing requirements for vending 

machine operators, and some of these 

licensing requirements already require 

the vending machine operator’s license 

or contact information to be displayed 

on the vending machine. If the contact 

information displayed on a vending 

machine due to State or local 

requirements includes some but not all 

of the contact information required 

under § 101.8(e)(1), the vending 

machine operator must display the 

remaining contact information required 

under § 101.8(e)(1) in the manner 

specified under § 101.8(e)(2). In other 

words, rather than requiring the vending 

machine operator to display contact 

information twice, we are providing 

flexibility by allowing vending machine 

operators to display the remaining 

contact information in a manner 

permitted in § 101.8(e)(2). For example, 

if a vending machine operator is 

required to display its name and address 


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on the face of a vending machine under 

an applicable State or local requirement 

and the operator complied with such 

requirement, the operator could display 

the remaining contact information 

required under § 101.8(e)(1) (i.e., its 

phone number) on the face of the 

vending machine or on the sign listing 

calorie declarations in, on, or adjacent 

to the vending machine in order to 

comply with § 101.8(e). Regardless of 

the method that vending machine 

operators select to satisfy the 

requirements of § 101.8(e), they should 

ensure that the information being 

provided is their contact information. 

As for the comments requesting that 

all vending machine operators 

(including those who are subject to 

section 403(q)(5)(H)(viii) of the FD&C 

Act and those who voluntarily register 

to be subject to section 403(q)(5)(H)(viii) 

of the FD&C Act) register with FDA, we 

decline to establish such a database at 

this time. We believe it would be more 

practical to wait until we and vending 

machine operators have been able to 

implement the vending machine 

labeling requirements and see what 

issues arise as part of that 

implementation. 

7. Signatures 

Proposed § 101.8(e) would provide 

that signatures obtained under the 

voluntary registration provisions that 

meet the definition of electronic 

signatures in § 11.3(b)(7) are exempt 

from the requirements of part 11. 

The preamble to the proposed rule 

indicated that we expect this exemption 

for signatures to facilitate the voluntary 

registration process (76 FR 19238 at 

19245). 

We received no comments on this 

provision, however because we have 

added a new § 101.8(e) (contact 

information of vending machine 

operators for vending machines selling 

covered vending machine food), we 

have renumbered this provision as 

§ 101.8(f). 

D. Determination of Calorie Content 

Section 403(q)(5)(H)(viii) of the FD&C 

Act does not prescribe where or how 

covered vending machine operators 

must obtain the necessary calorie 

information to meet the calorie 

declaration requirements for covered 

vending machine foods. If a covered 

vending machine food does not bear 

Nutrition Facts, we anticipated in the 

preamble to the proposed rule, that the 

vending machine operator could obtain 

the calorie information from food 

manufacturers or suppliers (76 FR 

19238 at 19242). We invited comment 

on whether ‘‘a vending machine 

operator may use nutrient databases, 

cookbooks, laboratory analyses, and 

other reasonable means’’ if calorie 

information is not available from the 

food manufacturer or supplier (Id.). We 

also invited comment on ‘‘whether 

vending machine operators should be 

required to provide FDA the 

information on which they relied to 

determine the total calories posted for 

the vending machine food’’ (76 FR 

19238 at 19242). 

(Comment 34) One comment 

supported allowing covered vending 

machine operators to use nutrient 

databases and cookbooks as tools for 

determining calorie information if 

calorie information is not available from 

the food manufacturer or supplier. The 

comment also suggested allowing 

menus as a tool for determining calorie 

information. Further, the comment said 

that we should not require vending 

machine operators to give FDA the 

method or information on which the 

vending machine operators relied to 

determine the total calories posted for 

the vending machine food. The 

comment said that such a requirement 

would be an economic burden both for 

the vending machine operator to 

provide such information and for FDA 

to collect, record, and store such 

information. Another comment 

suggested that FDA require covered 

vending machine operators to have a 

reasonable basis for calorie declarations 

for vending machine foods, in 

accordance with the reasonable basis 

provision for nutrition labeling for 

standard menu items offered for sale in 

restaurants and similar retail food 

establishments in section 

403(q)(5)(H)(iv) of the FD&C Act. 

(Response 34) We agree with the 

comments supporting the use of 

nutrient databases and cookbooks to 

determine the total calories contained in 

a covered vending machine food. A 

vending machine operator may obtain 

the necessary calorie information from 

the food package’s Nutrition Facts label, 

the manufacturer or supplier of the 

food, nutrient databases, cookbooks, or 

laboratory analyses. We anticipate that, 

for most packaged foods, the vending 

machine operator will use the food 

package’s Nutrition Facts label to 

determine calorie information for the 

food. 

Menus likely would not be a reliable 

means of determining the calorie 

information for a vending machine food, 

because the ingredients, portion size, 

and method of preparing a food listed 

on a menu may differ from those used 

for a food sold from a vending machine. 

Such differences may result in a calorie 

declaration for a food listed on a menu 

that does not accurately reflect the 

calorie content of the same food sold 

from a vending machine. We recognize, 

however, that compliance ultimately is 

based on the accuracy of the declaration 

rather than just the method used to 

determine the calorie information. 

We anticipate that vending machine 

operators are likely to generate and 

maintain a record of the information on 

which they relied to determine the total 

calories posted for the vending machine 

food. We encourage vending machine 

operators to be prepared to share it with 

FDA upon our request during an 

inspection if we need to determine 

whether the calories declarations, 

posted by a vending machine operator 

under § 101.8(c), are truthful and not 

misleading. 

We disagree with the comment 

suggesting that we apply the reasonable 

basis provision in section 

403(q)(5)(H)(vi) of the FD&C Act to 

covered vending machine food. The 

reasonable basis requirement in section 

403(q)(5)(H)(vi) of the FD&C Act applies 

only to restaurants and similar retail 

food establishments covered by the 

requirements of section 403(q)(5)(H) of 

the FD&C Act, and does not apply to 

covered vending machine food. We note 

that covered vending machine operators 

must ensure that calorie declarations are 

truthful and not misleading under 

section 403(a)(1) of the FD&C Act, and 

otherwise comply with section 

403(q)(5)(H)(viii) and (f) of the FD&C 

Act and § 101.8. 

E. Effective Date 

The preamble to the proposed rule 

indicated that a final rule would become 

effective 1 year from the date of 

publication of the final rule in the 

Federal Register (76 FR 19238 at 

19245). 

(Comment 35) Many comments 

suggested that FDA make the final rule 

effective 6 months after its publication. 

Noting that we proposed a 6-month 

effective date in the proposed rule 

pertaining to nutrition labeling of 

standard menu items in restaurants and 

similar retail food establishments, the 

comments argued that labeling foods 

sold in vending machines with calorie 

information would be even less 

burdensome than restaurant menu 

labeling because a vending machine 

operator could simply post stickers 

listing calories to meet the 

requirements. The comments asserted 

that vending machine operators should 

be able to comply with the calorie 

labeling requirements within the same 

timeframe that we proposed in the 

proposed rule for nutrition labeling of 

standard menu items in restaurants and 


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similar retail food establishments (76 FR 

19192). 

Other comments—many from vending 

machine trade associations—requested a 

minimum of 2 years to come into 

compliance. The comments claimed that 

1 year was not sufficient time to come 

into compliance because more than 70 

percent of vending machine operators 

have three or fewer employees. Some 

comments said that because vending 

machine operators may have few 

employees, placing calorie declarations 

for all of their vending machines would 

be costly and time-consuming. 

A few comments asserted that a 2-year 

effective date is needed due to a lengthy 

design and test process for new vending 

machines, and to establish a 

relationship between vending machine 

operators and food manufacturers in 

order to develop ‘‘verification 

procedures’’ which typically do not 

exist at the present time. The comments 

did not explain what they meant by 

‘‘verification procedures.’’ 

Another comment suggested a 

phased-in implementation period to 

give vending machine operators a longer 

time to meet the calorie declaration 

requirements. The comment did not 

state how long the phased-in 

implementation period should be. 

A few comments said we should 

follow the same approach that we have 

taken historically for other food labeling 

changes and cited FDA’s uniform 

compliance date policy for food labeling 

regulations. The comments stated that 

the uniform compliance date for food 

labeling regulations issued between 

January 1, 2011, and December 31, 2012, 

is January 1, 2014 (75 FR 78155 

(December 15, 2010)), and we should, 

therefore, impose an effective date of 

January 1, 2014, assuming the final rule 

publishes before December 31, 2012. 

(Response 35) We recognize that 

vending machine operators may have 

few employees and resources. We also 

understand that vending machine 

manufacturers and food manufacturers 

are continuing to design new products, 

and that vending machine operators 

may wish to work with vending 

machine manufacturers and food 

manufacturers to develop ways to 

comply with section 403(q)(5)(H)(viii) of 

the FD&C Act. We are also taking into 

consideration FDA’s 2012 final rule (77 

FR 70885, November 28, 2012), which 

establishes January 1, 2016, as the next 

uniform compliance date for food 

labeling changes required by food 

labeling regulations that are issued 

between January 1, 2013, and December 

31, 2014. Because vending machine 

operators may display the Nutrition 

Facts label or other visible nutrition 

information in order to satisfy 

§ 101.8(b), it would be helpful for 

vending machine operators to see any 

changes that manufacturers may make 

to the labels of packaged foods which 

may be timed in accordance with the 

next uniform compliance date. For these 

reasons, we are revising the effective 

date of the final rule to 2 years from the 

date of its publication in the Federal 

Register, which will be after the January 

1, 2016 uniform compliance date. All 

covered vending machine operators 

must come into compliance with the 

requirements of this rule no later than 

2 years after the date of its publication. 

F. Enforcement 

(Comment 36) Some comments said 

we should devise a reporting 

mechanism for individuals to report 

possible violations of section 

403(q)(5)(H)(viii) of the FD&C Act and a 

regime of penalties for confirmed 

violations. These comments also 

suggested that we develop a protocol for 

checking the accuracy of the calorie 

information provided by covered 

vending machine operators. 

(Response 36) We decline to establish 

a reporting mechanism for individuals 

to report possible violations of section 

403(q)(5)(H)(viii) of the FD&C Act or the 

final rule. FDA’s regulations already 

provide individuals with mechanisms to 

communicate with the Agency. If an 

individual finds that the calorie 

declaration for an article of food sold 

from a vending machine is incorrect, he 

or she can contact FDA by calling the 

FDA complaint coordinator for their 

region (http://www.fda.gov/Safety/

ReportaProblem/

ConsumerComplaintCoordinators/

default.htm). 

As for the comments’ suggestion 

regarding penalties, penalties are 

already set forth in the FD&C Act. We 

are establishing these regulations under 

sections 201(n), 403(a)(1), (f), (q)(5)(H), 

and 701(a) of the FD&C Act. Therefore, 

we note that failure to comply with the 

regulations will render the covered 

vending machine food misbranded 

under section 403(a), (f), or (q) of the 

FD&C Act. Violations of § 101.8 may 

result in enforcement action. For 

example, introducing, delivering for 

introduction, or receiving a misbranded 

food in or into interstate commerce, or 

misbranding a food while it is in 

interstate commerce or being held for 

sale after shipment in interstate 

commerce, are prohibited acts under 

section 301 of the FD&C Act (21 U.S.C. 

331), carrying criminal penalties under 

section 303 of the FD&C Act (21 U.S.C. 

333). In addition, under section 302 of 

the FD&C Act (21 U.S.C. 332), the 

United States can bring a civil action in 

Federal court to enjoin a person who 

commits a prohibited act. Under section 

304(a)(1) of the FD&C Act (21 U.S.C. 

334(a)(1)), food that is misbranded when 

introduced into or while in interstate 

commerce or while held for sale after 

shipment in interstate commerce may be 

seized by order of a Federal court. 

With respect to the comments 

suggesting that we develop a protocol to 

check the accuracy of calorie 

information, we intend to develop an 

enforcement strategy as we gain more 

experience with the final rule. For 

example, we could first check to ensure 

that the calorie declaration provided by 

a covered vending machine operator 

matches the calorie information on the 

article of food from the food 

manufacturer or supplier, such as on the 

Nutrition Facts label. We could also use 

lab analyses to determine whether the 

calorie declaration for a given vending 

machine food is accurate. 

(Comment 37) Another comment 

asked us to provide training, guidance, 

and funding to State and local 

inspectors to facilitate enforcement. 

(Response 37) The final rule does not 

become effective until December 1, 

2016. During that period we will assess 

resources and consider conducting 

training or further outreach as 

necessary. 

IV. Analysis of Impacts—Final 

Regulatory Impact Analysis 

FDA has examined the impacts of this 

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 (Public Law 104–4). Executive 

Orders 12866 and 13563 direct Agencies 

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 detailed Regulatory 

Impact Analysis (RIA) that presents the 

benefits and costs of this final rule (Ref. 

1) which is available at http://

www.regulations.gov (enter Docket No. 

FDA–2011–F–0171). The full economic 

impact analyses of FDA regulations are 

no longer (as of April 2012) published 

in the Federal Register but are 

submitted to the docket and are 

available at http://www.regulations.gov. 

We also post the full economic impact 

analyses of FDA regulations at the 

following Web site: http://www.fda.gov/ 

AboutFDA/ReportsManualsForms/

Reports/EconomicAnalyses/default.htm. 


rljohnson on DSK3VPTVN1PROD with RULES2
71284 Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Rules and Regulations 

We believe that the final rule is an 

economically significant regulatory 

action as defined by Executive Order 

12866. 

The Regulatory Flexibility Act 

requires Agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. According to our analysis, we 

believe that the final rule will have a 

significant economic impact on a 

substantial number of small entities, 

and we have accordingly analyzed 

regulatory options that would minimize 

the economic impact of the rule on 

small entities consistent with statutory 

objectives. We have crafted the final 

rule to provide flexibility for 

compliance. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that Agencies 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 $141 

million, using the most current (2013) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

The analyses that we have performed 

to examine the impacts of this final rule 

under Executive Order 12866, Executive 

Order 13563, the Regulatory Flexibility 

Act, and the Unfunded Mandates 

Reform Act of 1995 are included in the 

RIA (Ref. 1). 

We had prepared a ‘‘Preliminary 

Regulatory Impact Analysis’’ (Ref. 2) in 

connection with the proposed rule. We 

also included sections titled ‘‘Summary 

Preliminary Regulatory Impact 

Analysis’’ and ‘‘Initial Regulatory 

Flexibility Analysis’’ in the preamble to 

the proposed rule (76 FR 19238 at 

19245–19249). We received comments 

on our analysis of the impacts presented 

in those sections, and the RIA (Ref. 1) 

contains our responses to those 

comments. 

V. Paperwork Reduction Act of 1995 

This final rule contains information 

collection provisions that are subject to 

review by OMB under the Paperwork 

Reduction Act of 1995 (the PRA) (44 

U.S.C. 3501–3520). A description of 

these provisions is given in this section 

of the document with estimates of the 

annual reporting and third-party 

disclosure burden. Included in each 

burden 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. 

We had included a section entitled 

‘‘Paperwork Reduction Act’’ in the 

preamble to the proposed rule (76 FR 

19238 at 19249–19251). We received the 

following comments on our analysis of 

the burdens presented in the proposed 

rule. 

(Comment 38) One comment stated 

that we did not calculate the burdens to 

the suppliers of vending machine food. 

The comment stated that these suppliers 

will bear the larger burden from the 

requirements of the final rule. 

(Response 38) Neither section 

403(q)(5)(H)(viii) of the FD&C Act nor 

the final rule applies to suppliers of 

vending machine food; instead, section 

403(q)(5)(H)(viii) of the FD&C Act and 

the final rule establish requirements for 

certain vending machine operators. We 

recognize that a supplier of covered 

vending machine food may provide 

calorie information on front-of-package 

labeling and such calorie information 

may constitute visible nutrition 

information in accordance with section 

403(q)(5)(H)(viii)(I)(aa) of the FD&C Act 

provided that the applicable 

requirements of § 101.8(b) are satisfied. 

However, neither section 

403(q)(5)(H)(viii) of the FD&C Act nor 

the final rule requires suppliers to 

provide such information. As such, the 

final rule does not impose burdens on 

suppliers of vending machine food. 

(Comment 39) One comment stated 

that posting calories would not be 

burdensome, as most foods sold in 

vending machines already provide 

calorie information on their Nutrition 

Facts labels, and for foods that do not 

already have calorie information, 

labeling to disclose calories can be 

accomplished easily by using stickers. 

Another comment stated that, in light of 

the major beverage companies’ prior 

commitment to putting calorie 

information on selection buttons, we 

should reduce our burden estimate. 

(Response 39) To the extent that foods 

sold from covered vending machines 

permit a prospective purchaser to 

examine the Nutrition Facts label before 

purchasing the food or otherwise 

provide visible nutrition information at 

the point of purchase in accordance 

with section 403(q)(5)(H)(viii) of the 

FD&C Act and § 101.8(b), the vending 

machine operator would not be required 

to provide calorie declarations for such 

foods. In addition, we recognize that the 

‘‘Clear on Calories’’ commitment by the 

American Beverage Association, which 

includes a pledge that calories will be 

displayed on selection buttons of 

‘‘company-controlled vending 

machines,’’ may be consistent with the 

calorie declaration requirements of 

section 403(q)(5)(H)(viii) of the FD&C 

Act. Our estimates of the burdens 

already account for the fact that many 

vending machine foods will not require 

additional nutrition analysis under this 

final rule. For example, we estimate in 

the RIA that only 723 to 963 covered 

vending machine operators will need to 

acquire nutrition information for at least 

some of their vending machine food 

(Ref. 1). 

Our estimate of the burdens and cost 

of nutrition analysis also takes into 

consideration that vending machine 

operators can comply with the 

requirements of the final rule by 

providing calorie declarations through 

less burdensome and less expensive 

means (e.g., a poster affixed to the front 

of the machine could cost, on average, 

$20 per machine per year) (Ref. 1). The 

final rule does not prescribe the types of 

materials through which calories must 

be declared, and a sticker, for example, 

could be an appropriate medium to 

convey a required calorie declaration. 

(Comment 40) One comment stated 

that our estimate on how frequently 

labeling would need to change is too 

low. The comment stated that in almost 

all cases, machines are restocked and 

serviced every 5 weeks, with busier 

locations stocked once or more per 

week. The comment stated that the 

restocking will require labeling changes 

because restocking may result in the 

substitution of certain products for other 

products or the addition of new 

products. The comment stated that 

relabeling would need to occur between 

10 and 17 times per year for each 

machine, with some machines requiring 

partial relabeling at least 50 times per 

year. 

(Response 40) In the preliminary RIA, 

we estimated an average recurring 

burden of between 5 and 15 minutes per 

vending machine per year to install or 

refresh the calorie displays. We said that 

signs would not always need to be 

updated every time a machine’s product 

mix (i.e., the assortment of vending 

machine foods offered for sale in a 

vending machine at a particular time) 

changed. 

We recognize that the product mix in 

a particular vending machine may 

change with each restocking. For each 

machine, the rule requires operators to 

declare the calorie information for those 

articles of food that are sold from that 

particular vending machine. However, 

we would not object to a vending 

machine operator providing calorie 


rljohnson on DSK3VPTVN1PROD with RULES2
Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Rules and Regulations 71285 

declarations for articles of food that are 

typically offered for sale in a vending 

machine but may not be offered for sale 

at all times (for example, in cases where 

the article sells out, or is temporarily 

replaced by another item), provided that 

the calorie declarations are clear and 

conspicuous and placed prominently. 

Thus, signs would not always need to be 

updated every time a machine’s product 

mix changed, so long as the sign 

declares the calories for each article of 

food sold from the covered vending 

machine. For example, if a particular 

article of food is sold out, the vending 

machine operator would not need to 

design and print a new sign to remove 

the calorie declaration for such food. In 

addition, to the extent that foods sold 

from covered vending machines permit 

a prospective purchaser to examine the 

Nutrition Facts label before purchasing 

the food or otherwise provide visible 

nutrition information at the point of 

purchase in accordance with section 

403(q)(5)(H)(viii)(I)(aa) of the FD&C Act 

and § 101.8(b), the vending machine 

operator would not be required to 

provide calorie declarations for such 

foods. Therefore, restocking of covered 

vending machines that sell such foods 

would not require the vending machine 

operator to update signs. Furthermore, 

in order to accommodate the occasional 

trial or experimental product, the sign 

template could, for example, be 

designed with blank space, on which 

the operator could handwrite the 

experimental product’s name and 

caloric value, or place a declarative 

sticker next to the new product within 

the machine (should it have a glass/

plexiglass front). The comment 

provided an estimate of the number of 

times a vending machine’s sign would 

likely need to be replaced, or 10 to 17 

times. We estimate that in accordance to 

the factors described in the earlier 

paragraphs of this response, calorie 

declaration signs would only need to be 

replaced between 1 and 4 times per year 

(or even zero for some products). This 

estimate also takes into consideration 

that vending machine operators have 

the flexibility to choose a medium (e.g., 

stickers, posters) and a format (e.g., 

individual signs per covered vending 

machine food; sign(s) in, on, or adjacent 

to the vending machine) for the calorie 

declaration that will make the most 

sense for a particular vending machine 

operator depending on the variability of 

products that the operator carries and 

the frequency of restocking. 

We invite comments on these topics: 

(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 through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Title: Information Collection Provisions 

of the Final Rule on Food Labeling; 

Calorie Labeling of Articles of Food in 

Vending Machines 

A. Reporting Requirements 

Description of Respondents 

The likely respondents to this 

information collection are vending 

machine operators that voluntarily elect 

to be subject to the Federal requirements 

of this rule by registering with FDA. 

Description 

Vending machine operators not 

subject to the requirements of the ACA 

may elect to be subject to the Federal 

requirements by registering with FDA. 

Vending machine operators that 

voluntarily register must provide FDA 

with their contact information, the 

address of the location of each vending 

machine owned or operated by the 

vending machine operator that is being 

registered, the preferred mailing address 

(if different from the vending machine 

operator address) for purposes of 

receiving correspondence, and 

certification that the information 

submitted is true and accurate, that the 

person or firm submitting it is 

authorized to do so, and that each 

registered vending machine will be 

subject to the requirements of § 101.8. In 

the proposed rule, the total reporting 

burden included both the reporting 

burden for menu labeling and vending 

machine operator voluntary registration 

(see 76 FR 19238 and 19251). For the 

final rule, these burdens are estimated 

separately for each rule. To keep the 

establishment’s registration active, the 

authorized official of the vending 

machine operator must register every 

other year within 60 days prior to the 

expiration of the vending machine 

operator’s current registration with 

FDA. Registration will automatically 

expire if not renewed. 

Vending machine operators that have 

voluntarily registered to become subject 

to the Federal requirements must satisfy 

the calorie labeling requirements of 

section 403(q)(5)(H)(viii) of the FD&C 

Act and § 101.8(c). We further note that 

an article of food sold from a vending 

machine operator who has voluntarily 

registered with FDA to be subject to the 

requirements of section 

403(q)(5)(H)(viii) of the FD&C Act is not 

required to provide calorie declarations 

for articles of food sold from a vending 

machine that permits the prospective 

purchaser to examine the Nutrition 

Facts label before purchasing the article 

as provided in § 101.8(b)(1), or 

otherwise provides visible nutrition 

information at the point of purchase as 

provided in § 101.8(b)(2). 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN: VOLUNTARY REGISTRATION 1

21 CFR part 101 Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(in hours) 

Total hours 

Initial Burden (annualized over 3 years): 

§ 101.8(d) Initial Registration .................................... 13 1 13 2 26 

Annual Burden: 

§ 101.8(d) Registration Renewal .............................. 19 1 19 2 0 .5 9 .5 

Total Burden Hours ........................................... ........................ ........................ ........................ .......................... 35 .5 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2 30 minutes. 


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71286 Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Rules and Regulations 

We lack data on the number of 

vending machine operators with fewer 

than 20 machines that might voluntarily 

register to comply with this final rule. 

We do not expect the net benefit for 

voluntary registration by any noncovered vending machine operators to 

be positive and in the RIA (Ref. 1) we 

indicate that as of the conducting of this 

analysis, no vending machine operators 

have voluntarily registered with FDA. 

Therefore we did not estimate a 

significant burden in the RIA (Ref. 1). 

However, in the event that a few will 

register anyway, or find some positive 

incentive to do so, for the purposes of 

this PRA analysis, we estimate the 

burden such operators will face. We 

estimate there are approximately 757 

vending machine operators with fewer 

than 20 machines; this number is based 

on the mean estimate of the low and 

high counts of firms with less than 

$50,000 in annual revenue from the RIA 

(Ref. 1). We estimate that 5 percent of 

vending machine operators with fewer 

than 20 machines may voluntarily 

register to become subject to the final 

requirements, or 38 operators. We 

estimate a burden of approximately 2 

hours per initial registration, which 

yields a total burden of 76 hours (38 

total operators × 2 hours per response). 

Annualizing this number over 3 years 

yields a rounded 13 respondents per 

year (5 percent × 757 operators/3 years). 

With an annualized estimate of 13 

vending machine operators and one 

registration per vending machine 

operator at 2 hours per registration, we 

estimate the initial hourly burden for 

these operators is 26 hours. 

We expect that renewal registrations 

after the first year will require 

substantially less time because operators 

are expected to be able to affirm or 

update the existing information in an 

online account in a way similar to other 

FDA firm registration systems. 

Therefore, we estimate that reregistration will take 0.5 hours for each 

registrant. This would indicate that 

biennial registration would impose a 

burden of 19 hours (38 operators × 0.5 

hours) every 2 years, or 9.5 hours every 

year (18 operators every year × 0.5 

hours). 

B. Recordkeeping Requirements 

The preamble to the proposed rule (76 

FR 19238 at 19249–19251) provided an 

estimate of the recordkeeping burden, 

which consisted of the burden 

associated with calorie analysis and the 

burden associated with generating, 

providing, or maintaining records. Upon 

further consideration, we have omitted 

the burden estimate associated with 

generating, providing, or maintaining 

records previously provided in table 3 

of the proposed rule because the rule 

does not require vending machine 

operators to generate, provide, or 

maintain records. Further, as discussed 

in section C of this analysis, we have 

included a burden estimate for calorie 

analysis as part of the third party 

disclosure burden, since the ‘‘total time, 

effort, or financial resources expended 

by [covered vending machine 

operators]’’ (5 CFR 1320.3(b)) to declare 

calories for covered vending machine 

food likely includes time, effort, or 

financial resources to determine the 

calorie content of such food. 

C. Third-Party Disclosure Requirements 

Description of Respondents 

The likely respondents to this 

information collection are vending 

machine operators that are subject to the 

ACA’s requirements and those that 

choose to voluntarily register to comply 

with the disclosure requirements. 

Description 

We calculate two types of third party 

disclosure burdens under the rule. The 

first burden is the time and effort 

expended by vending machine operators 

to determine the calorie content of 

covered vending machine food for the 

required calorie declarations, which we 

refer to as ‘‘Calorie Analysis.’’ 

Vending machine operators must also 

provide calorie declarations for covered 

vending machine foods on signs in, on, 

or adjacent to vending machines. The 

second burden is the cost of materials 

and the time expended by vending 

machine operators to physically 

produce and install the signs for the 

calorie declarations, which we refer to 

as ‘‘Calorie Declaration Signs.’’ We 

estimate the burden of signage for nonbulk and bulk vending machines 

separately. We provide our estimates of 

the third party disclosure burdens in 

table 2. 

TABLE 2—THIRD PARTY DISCLOSURE BURDEN

21 CFR part 101 Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

(in hours) 

Total hours Capital costs 

§ 101.8(c)(2)(i), Calorie Analysis ...... 282 11 3,102 1 ............................ 3,102 ........................

§ 101.8(c)(2)(ii), Template Design .... 3,279 5 16,395 2 ............................ 32,790 ........................

§ 101.8(c)(2)(ii), Sign Creation ......... 3,279 125 409,875 0.475 (28.5 min.) .. 194,710 $4,671,047 

§ 101.8(e)(1), Contact Information .... 3,279 125 409,875 0.025 (1.5 min.) .... 10,248 ........................

§ 101.8(c)(2)(ii), Sign Installation ...... 1,868,419 1 1,868,419 0.083 (5 min.) ....... 155,079 ........................

§ 101.8(c)(2)(ii), Sign Information 

Update.

511,576 2 1,023,152 0.5 (30 min.) ......... 511,576 ........................

§ 101.8(c)(2)(ii), Sign Replacement .. 1,755,986 2 3,511,972 0.17 (10 min.) ....... 597,035 ........................

§ 101.8(c)(2)(ii), Bulk Machine Signage.128,533 1 128,533 0.025 (1.5 min.) .... 3,213 ........................

Total Burden .............................. ........................ ........................ ........................ ............................... 1,507,753 4,671,047 

Third-Party Disclosure Requirements: 

Calorie Analysis 

A calorie analysis entails the burden 

of determining calorie content for 

covered vending machine food. Most 

foods sold from vending machines 

provide the nutrition labeling required 

by section 403(q) of the FD&C Act and 

§ 101.9, including calorie content 

information, which means that calorie 

content for many covered vending 

machine foods is already available on 

the Nutrition Facts labels for such foods. 

In that case, vending machine operators 

will not need to determine the calorie 

content of such foods because they can 

simply declare the calorie information 

they find on the Nutrition Facts label. 

Nevertheless, some operators may need 

to determine calorie information for 

those vending machine foods that may 

not bear Nutrition Facts labels or 

otherwise provide visible nutrition 

information at the point of purchase in 


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accordance with section 

403(q)(5)(H)(viii)(I)(aa) of the FD&C Act 

and § 101.8(b). An operator may obtain 

the necessary calorie information from 

nutrient databases, cookbooks, or 

laboratory analyses. Calorie analysis 

will most likely only be needed for 

vended food items such as refrigerated, 

frozen, can/bowl, or other shelf-stable 

main meal items, hot cup beverages, and 

cold cup beverages. We anticipate that 

vending machine operators are likely to 

generate and maintain a record of the 

information on which they relied to 

determine the total calories posted for 

the vending machine food. 

As stated in the RIA (Ref. 1), we 

estimate the mean number of vending 

machine operators that need calorie 

analysis to be 847. Annualizing this 

estimate over 3 years yields 282 

operators. We also estimate the range of 

products available in a typical machine 

for each of the three most commonly 

sold product categories that are likely to 

require a calorie analysis, or 3 percent 

of food items, 5 percent of hot 

beverages, and 1 percent of cold cup 

beverages. We estimate that food 

machines typically offer between 10 and 

25 different items, and both hot 

beverage and cold cup beverage 

machines typically offer between 5 and 

10 items. From this, we estimate each 

vending machine operator will require a 

calorie analysis for 11 items, on average. 

These estimates were based upon 

conversations with vending machine 

operators (Ref. 3) and our survey of 

various vending machine models that 

vend these types of food and beverage 

(Ref. 4). Based on data from FDA’s 

Recordkeeping Cost Model (Ref. 5), we 

estimate the time needed to determine 

the calorie content of each covered 

vending machine food to be 

approximately 1 hour. Our estimate for 

the burden hours that would be required 

for new calorie analysis is then 9,317 

hours (847 operators × 11 products 

needing analysis × 1 hour per analysis). 

Annualizing this value over 3 years 

yields 3,102 hours (847 operators/3 

years × 11 products needing analysis × 

4 hours per analysis). (847 operators/3 

years = 282 operators per year.) There 

will not be capital costs associated with 

a calorie analysis. 

Third-Party Disclosure Requirements: 

Calorie Declaration Signs 

Under this rule, covered vending 

machine operators with 20 or more 

vending machines and vending machine 

operators that voluntarily register to 

become subject to the Federal 

requirements, must disclose calorie 

information by providing calorie 

declaration signs in, on, or adjacent to 

their vending machines to a third party 

who will most often be the prospective 

purchaser or consumer. Our burden 

estimate for the calorie declaration signs 

is based on the total time it takes for 

vending machine operators to produce 

and install the calorie declaration signs. 

We separately estimate the burden for 

two kinds of vending machines, nonbulk and bulk machines. For non-bulk 

vending machines, we estimate the 

burden to operators as the initial time it 

takes them to develop the calorie 

disclosure signage, which includes the 

time for the sign template design (i.e. 

the creation of generalized sign 

templates), sign creation (i.e. using 

templates to design machine-specific 

signs), and installation; and then the 

time for the recurring burden, which 

includes the time to update or change 

calorie information and the physical 

replacement of the disclosure signage 

when the product mix of the machine 

changes. For bulk machines, we 

estimate the burden to operators for the 

cost of individual calorie labels. (We 

assume that individual calorie 

declaration stickers will be placed on 

the face of each individual bulk vending 

machine, since each machine only 

vends a single product.) Recurring 

updates to signage will only likely be 

required for non-bulk, non-beverage 

machines since the product mixes of 

these machines are changed regularly, 

while the product mix for bulk 

machines is unlikely to change. 

We estimate there is an average of 

9,838 (9,800 covered non-bulk + 38 

voluntary) vending machine operators 

subject to the rule. (9,838/3 = 3,279 

annualized). Our estimate for the 

average number of non-bulk vending 

machines that will require declaration 

signage is based upon data obtained 

from the Vending Times Survey and 

National Automatic Merchandising 

Association (NAMA) and the Economic 

Census, and as summarized in table 8 of 

the final RIA (Refs. 1, 6 to 8). We 

estimate there is an average of 5.61 

million non-bulk vending machines. 

Digital signage is an emerging 

technology, and according to NAMA 

approximately 0.1 percent of all vending 

machines in operation currently have 

electronic video displays capable of 

providing calorie information, or 

approximately 4,014 to 5,670 vending 

machines (Ref. 3). Subtracting the 

number of vending machines with the 

electronic video from the total machine 

count yields an average of 5.611 million 

vending machines that will need 

signage. We expect the number of 

vending machines that will require 

signage to decline over time as 

manufacturers continue to add the 

required calorie information to the 

principal display panel of the package 

as part of ‘‘front of package labeling,’’ 

and because we anticipate greater use of 

electronic video displays on vending 

machines. In addition, to the extent that 

covered vending machines sell foods 

that permit prospective purchasers to 

examine the Nutrition Facts label before 

purchase or otherwise provide visible 

nutrition information at the point of 

purchase in accordance with section 

403(q)(5)(H)(viii)(I)(aa) of the FD&C Act 

and § 101.8(b), this analysis may 

overestimate the burden estimate for 

calorie declaration signs. 

We estimate the time it takes for the 

one-time design of a calorie disclosure 

sign template to be 2 hours. The number 

of templates a given firm would need to 

design to produce signs that comply 

with the rule may vary based upon the 

number of different types of products 

the firm purveys. We estimate a range of 

one to ten templates would be 

necessary. We base this range on the 

eight general food and beverage vending 

categories monitored by the Vending 

Times Census, plus two additional 

templates to account for the existence of 

combination machines, which vend 

more than one general product type (e.g. 

snacks and cold canned beverages)—see 

table 4 of the final RIA (Refs. 1, 6). Since 

not all firms will sell items from each 

of the general food categories, we 

estimate that on average, firms will sell 

items from approximately four general 

food categories and operate one set of 

combination machines, requiring the 

need to develop (on average) five 

templates. At 2 hours per template, the 

total initial burden for designing 

templates comes to an estimated 98,380 

hours (9,838 operators × 5 templates × 

2 hours per template). Annualizing this 

value over 3 years yields a burden of 

32,790 hours (9,838 operators/3 years × 

5 templates × 2 hours per template). 

There are no capital costs associated 

with template design. 

We estimate the time it takes to enter 

calorie information into a single sign 

template and prepare it for printing to 

be 0.475 hours. Again, we estimate the 

number of machine configurations to be 

125. The count of machine 

configurations is a general estimate of 

the number of different types of 

machines an operator uses to sell its 

products, and takes into account that 

fact that a machine’s specific product 

mix will depend on locational 

characteristics (e.g. office vs. hotel) and 

the type of machine (e.g. beverage vs. 

snack). We estimate the total initial 

burden for sign creation using the 

predesigned templates to be 584,131 


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hours (9,838 operators × 125 sign 

formats × 0.475 hours per sign). 

Annualized over 3 years, this burden 

becomes 194,710 hours (9,838 

operators/3 years × 125 signs × 0.475 

hours per sign). Capital costs associated 

with sign creation correspond to the 

cost of paper and ink for printing the 

signs. As estimated in the RIA (Ref. 1), 

the capital costs are $2.50 per sign, 

which results in a total capital cost of 

$14,013,143 [(5,604,914 covered nonbulk machines + 343 voluntarily 

registered machines) × $2.50 per 

machine]. Annualized over 3 years, this 

value becomes $4,671,048 (5,605,257 

machines/3 years × $2.50 per machine). 

Vending machine operators must also 

provide their contact information on 

each vending machine selling covered 

vending machine food as required under 

§ 101.8(e)(1). We assume that venders 

that do not already have a sign or label 

with their contact information will add 

their contact information into the initial 

sign design. We estimate the time it 

takes to include contact information is 

1.5 minutes (0.025 hours) for each sign. 

We estimate the total initial burden for 

including contact information on the 

predesigned templates to be 30,744 

hours (9,838 operators × 125 sign 

formats × 0.025 hours per sign). 

Annualized over 3 years, this burden 

becomes 10,248 hours (9,838 operators/ 

3 years × 125 signs × 0.025 hours per 

sign). There are no capital costs 

associated with adding contact 

information. (Some States have 

licensing requirements for vending 

machine operators, and some of these 

licensing requirements already require 

the vending machine operator’s license 

or contact information to be displayed 

on the vending machine. If the contact 

information displayed on a vending 

machine due to State or local 

requirements includes some but not all 

of the contact information required 

under § 101.8(e)(1), the vending 

machine operator is required to display 

the remaining contact information 

required under § 101.8(e)(1) in a manner 

specified under § 101.8(e)(1). We do not 

have an estimate of the number of 

machines already in compliance; to the 

extent that some operators are already in 

compliance, we overestimate the burden 

of third-party disclosure.) 

We estimate the time it takes to install 

a sign onto a single machine to be 5 

minutes (0.083 hours) for each sign. 

With 5,605,257 machines (5,604,914 

covered machines + 343 voluntarily 

registered machines), we estimate the 

annual burden for initial sign 

installation to be 465,236 hours 

(5,605,257 machines × 1 sign per 

machine × 0.083 hours installation). 

Annualized over 3 years, this burden 

becomes 155,079 hours (5,605,257 

machines/3 years × 1 sign per machine 

× 0.083 hours installation). (5,605,257 

machines/3 years = 1,868,419 machines 

per year.) There are no capital costs 

associated with sign installation. 

We divide the estimates for the 

recurring burden of non-bulk third-party 

disclosure into two parts: Updating 

calorie sign information for changes in 

the product mix (which involves 

updating the digital format) and 

physical sign replacement (which 

involves printing and installation). We 

estimate the average number of product 

configurations for machines that will 

experience regular changes to their 

product mix to be 52. This value is 

lower than the overall average of 125 

since some machines (such as beverage 

machines) do not experience regular 

changes to the product mix. We estimate 

the average number of times that calorie 

signs will need to be updated to be 

twice per year. Finally, we estimate the 

time it takes to update a single sign 

using the predesigned template to be 0.5 

hours. Thus, the total burden for 

updating sign information is 511,576 

hours [511,576 records (made up of 

9,838 operators × 52 product 

configurations) × 2 updates per year × 

0.5 hours per update]. 

We estimate the annual number of 

covered machines that will need regular 

sign replacement to be 1,755,986 

machines (1,755,879 covered machines 

+ 107 voluntarily registered machines). 

We estimate the time it takes to remove 

and replace old signs with new signs to 

be 0.17 hours (10 minutes). Thus, the 

total annual burden for replacing signs 

is 597,035 hours (1,755,986 machines × 

2 replacements per year × 0.17 hours per 

replacement). There are no capital costs 

associated with updating sign 

information or physical sign 

replacement. 

We estimate there is an average of 

385,600 covered bulk vending 

machines, based on data obtained from 

the Vending Times Census and NAMA 

(Refs. 6, 8). We assume each bulk 

machine vends a single bulk product, 

and we further assume they will choose 

the most economical signage, which 

means they are likely to use a small 

sticker on the face of each machine. We 

estimate the time to print and apply 

each sticker is 1.5 minutes (0.025 

hours). Thus, the total burden for bulk 

machine signage is 9,640 hours (385,600 

bulk machines × 0.025 hours per 

machine). Annualized over 3 years, this 

value becomes 3,213 hours (385,600/3 

years × 0.025 hours per machine). 

(385,600/3 years) = 128,533 machines 

per year.) 

To ensure that comments on 

information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

title ‘‘Information Collection Provisions 

of the Final Rule on Food Labeling; 

Calorie Labeling of Articles of Food in 

Vending Machines.’’ 

In compliance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 

3507(d)), we have resubmitted the 

information collection provisions of this 

final rule to OMB for review, because 

the final rule provides an additional 

modification to § 101.8. These 

requirements will not be effective until 

we obtain OMB approval. Interested 

persons are requested to submit 

comments regarding information 

collection to OMB (see DATES and 

ADDRESSES). 

Prior to the effective and compliance 

date of this final rule, we will publish 

a notice in the Federal Register 

announcing OMB’s decision to approve, 

modify, or disapprove the information 

collection provisions in this final rule. 

An Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. 

VI. Federalism 

We have analyzed this final 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 requirement for nutrition labeling 

of food that is not identical to the 

requirement of section 403(q) [of the 

FD&C Act [21 U.S.C. 343(q)]]’’, 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 

(regardless of the type of ownership of 

the locations) and offering for sale 

substantially the same menu items 

unless such restaurant or similar retail 

food establishment complies with the 


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voluntary provision of nutrition 

information requirements under section 

403(q)(5)(H)(ix) [of the FD&C Act]’’ (21 

U.S.C. 343(q)(5)(H)(ix)). The final rule 

creates requirements for nutrition 

labeling of food under section 403(q) of 

the FD&C Act that would preempt 

certain non-identical State and local 

nutrition labeling requirements. 

Section 4205 of the ACA also 

included a Rule of Construction 

providing that nothing in the 

amendments made by [section 4205] 

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 Federal Food, Drug, 

and Cosmetic Act [21 U.S.C. 

343(q)(5)(H)] (as added by subsection(b)) 

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 Federal Food, Drug, and Cosmetic 

Act [21 U.S.C. 343(q)(5)(H)(ix)] (as 

added by subsection (b)), 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 

such Act [21 U.S.C. 343(q)(5)(H)(i)]. (See 

Public Law 111–148, Sec. 4205(d), 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 the Rule of 

Construction in 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 which 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. 

The preamble to the proposed rule (76 

FR 19238 at 19252) described an 

alternative interpretation of section 

4205 of the ACA that could leave less 

room for States and localities to require 

nutrition labeling for food sold from 

vending machines. Under this 

alternative interpretation, State or local 

nutrition labeling requirements for food 

sold from vending machines would be 

preempted because such nutrition 

labeling requirements would be 

‘‘nutrition content disclosures of the 

type required under section 403(q)(5)(H) 

[of the FD&C Act ]’’ and would not fall 

within the exception to preemption in 

section 403A(a)(4) of the FD&C Act 

(‘‘except that this paragraph 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 . . .’’). 

Under this alternative interpretation, 

States and localities could not have 

nutrition labeling requirements for food 

sold in vending machines that were not 

identical to the Federal requirements, 

unless they successfully petitioned 

FDA. The position that no State or 

locality may have a vending machine 

food nutrition labeling requirement not 

identical to the Federal requirements, 

regardless of how many vending 

machines the operator owns or operates, 

was the position in the guidance we 

issued (entitled ‘‘Guidance for Industry: 

Questions and Answers Regarding the 

Effect of Section 4205 of the Patient 

Protection and Affordable Care Act of 

2010 on State and Local Menu and 

Vending Machine Labeling Laws’’ (75 

FR 52427, August 25, 2010)). Federal 

law provides that, upon petition, we 

may exempt State or local requirements 

from the express preemption provisions 

of section 403A(a) of the FD&C Act 

under certain conditions (21 U.S.C. 

343–1(b)). We have issued regulations at 

§ 100.1 (21 CFR 100.1) describing the 

petition process that is available to State 

and local governments to request such 

exemptions from preemption. Under our 

proposed interpretation, for food sold 

from vending machines that is not 

subject to the nutrition labeling 

requirements of section 403(q)(5)(H) of 

the FD&C Act, States and localities may 

establish or continue to impose 

nutrition labeling requirements. Under 

the alternative interpretation, there 

would be food sold in vending 

machines for which the Federal 

Government has not required nutrition 

labeling and for which States and 

localities would be precluded from 

establishing such labeling requirements 

unless they successfully petitioned FDA 

and a rulemaking was completed. This 

approach would risk creating a 

regulatory gap that would be 

inconsistent with the purposes of 

section 4205 of the ACA. It would also 

impose a restriction and burden on the 

States and localities that is inconsistent 

with the Federalism principles 

expressed in Executive Order 13132, as 

well as a substantial administrative 

burden on FDA if States petition for 

exemption. 

We invited comments on our 

interpretation of section 4205 of the 

ACA related to preemption, as well as 

on the alternative interpretation 

described in the Federalism section. We 

also requested comments on the use of 

the petition process in this context and 

on other potential interpretations that 

interested persons identify as 

appropriate given both the preemptionrelated language of section 4205 of the 

ACA and the statutory goals. 

(Comment 41) Several comments 

supported the preemptive scope being 

limited to State and local requirements 

imposing additional or different 

nutritional labeling requirements for 

food sold from covered vending 

machines, including food sold from 

machines operated by a person who has 

elected to be subject to the requirements 

of section 403(q)(5)(H) of the FD&C Act 

(76 FR 19238 at 19251–19252). Some 

comments stated that the alternative 

interpretation, that no State or locality 

may have a vending machine food 

nutrition labeling requirement that is 

not identical to the Federal 

requirements regardless of how many 

vending machines the operator owns or 

operates, would restrict State and local 


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authorities and create a ‘‘regulatory 

vacuum’’ because the Federal system 

exempts vending machine operators 

with fewer than 20 machines. A few 

comments stated that the alternative 

interpretation, which would create a gap 

in coverage of vending machines, would 

be inconsistent with the purposes and 

language of section 4205 of the ACA. 

These comments also stated that 

imposing a restriction on States and 

localities is inconsistent with 

Federalism principles expressed in 

Executive Order 13132. Another 

comment stated that section 4205 of the 

ACA intends that States and localities 

have authority to regulate nutritional 

information for machines that do not 

come under the purview of the Federal 

law. 

Several comments would have us 

revise the rule to clarify that ‘‘identical’’ 

does not mean verbatim in wording 

rather in effect. One comment suggested 

the following language: ‘‘The specific 

words of the State or local requirements 

need not be the same. State or local 

requirements that are worded differently 

from the Federal requirements and/or 

provide for different enforcement 

schemes may still be ‘identical’ under 

[section 4205 of the ACA].’’ 

Other comments noted that the 

savings clause for warnings about the 

safety of food is included in the Rule of 

Construction in section 4205(d) of the 

ACA. A few comments suggested that 

we codify the Rule of Construction 

because its omission from the rule may 

lead to confusion over how the statute 

should be interpreted. The comments 

noted that the lack of a codified 

statement for a similar rule of 

construction in the NLEA has led to 

confusion and to court decisions that 

did not take that rule of construction 

into account. One comment stated that 

we should include a savings clause that 

expressly identifies that nutrition 

labeling for less than 20 machines is not 

preempted in the absence of voluntary 

compliance by non-covered vending 

machine operators. 

(Response 41) We agree with the 

comments asserting that the preemptive 

effect of the Federal nutrition labeling 

requirements of section 4205 of the ACA 

for food sold from vending machines is 

limited to State and local requirements 

that impose additional or different 

nutrition labeling requirements for food 

sold from vending machines that are 

covered by the Federal requirements of 

section 403(q)(5)(H) of the FD&C Act 

and § 101.8. We also agree that the 

alternative interpretation described in 

the proposed rule (76 FR 19238 at 19251 

through 19252), that no State or locality 

may have a nutrition labeling 

requirement for food sold from vending 

machines that is not identical to the 

Federal requirements regardless of how 

many vending machines the operator 

owns or operates, would restrict State 

and local authorities and create a 

regulatory gap that would be 

inconsistent with the purposes and 

language of section 4205 of the ACA and 

the Federalism principles expressed in 

Executive Order 13132. In addition, as 

we noted in the preamble to the 

proposed rule (76 FR 19238 at 19251 

through 19252), there would be no 

reason for Congress to include vending 

machine operators in the voluntary 

registration provision of section 

403(q)(5)(H)(ix) of the FD&C Act, which 

allows vending machine operators not 

subject to the requirements of section 

403(q)(5)(H) of the FD&C Act to opt into 

the Federal requirements if State and 

local governments could not otherwise 

require non-identical nutrition labeling 

for food sold from any vending 

machines. 

For these reasons, we interpret the 

provisions of section 4205 of the ACA 

related to preemption to mean that 

States and local governments may not 

establish or continue into effect 

nutrition labeling requirements for food 

sold from vending machines covered by 

the Federal requirements of section 

403(q)(5)(H) of the FD&C Act and 

§ 101.8, unless the State or local 

requirements are identical to the Federal 

requirements of section 403(q)(5)(H) of 

the FD&C Act and § 101.8. In other 

words, States and localities cannot have 

additional or different nutrition labeling 

requirements for food sold either from: 

(1) 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 and § 101.8; or (2) vending 

machines operated by a person not 

otherwise subject to the requirements of 

section 403(q)(5)(H)(viii) of the FD&C 

Act and § 101.8 who voluntarily elects 

to be subject to those requirements by 

registering biannually with FDA in 

accordance with section 403(q)(5)(H)(ix) 

of the FD&C Act and § 101.8(d). 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. 

In response to the comments asserting 

that we revise the rule to clarify the 

meaning of ‘‘identical’’ within the 

context of section 403A(a)(4) of the 

FD&C Act, we note that we have already 

issued a regulation at § 100.1 that 

explains the meaning of ‘‘not identical 

to’’ in the context of section 403A of the 

FD&C Act in describing the petition 

process available to State and local 

governments to request an exemption 

from the express preemption provisions 

of section 403A of the FD&C Act under 

section 403A(b) of the FD&C Act. FDA 

regulations, at § 100.1(c)(4), provide, in 

relevant part, that, within the context of 

section 403A of FD&C Act, ‘‘not 

identical to’’ does not refer to the 

specific words in the State or local 

requirement but instead means that the 

State or local requirement directly or 

indirectly imposes obligations or 

contains provisions concerning the 

labeling of food that: (1) Are not 

imposed by or contained in the 

applicable provision (including any 

implementing regulation) of section 403 

of the FD&C Act or (2) differ from those 

specifically imposed by or contained in 

the applicable provision (including any 

implementing regulation) of section 403 

of the FD&C Act. Accordingly, a State or 

local nutrition labeling requirement for 

food sold from vending machines 

covered by the requirements of section 

403(q)(5)(H)(viii) of the FD&C Act and 

§ 101.8 that directly or indirectly 

imposes obligations or contains labeling 

provisions that: (1) Are not imposed by 

or contained in section 403(q) of the 

FD&C Act and § 101.8; or (2) differ from 

those specifically imposed by or 

contained in section 403(q) of the FD&C 

Act and § 101.8 would be ‘‘not identical 

to’’ the Federal requirements and 

therefore would be preempted under 

section 403A(a)(4) of the FD&C Act. 

Because the meaning of the phrase ‘‘not 

identical to,’’ within the context of 

section 403A of the FD&C Act, is 

already described in § 100.1 and is 

further clarified here in the context of 

vending machines, we decline to revise 

the rule to clarify the meaning of 

‘‘identical’’ as suggested by the 

comments. 

We decline to amend § 101.8 to restate 

the Rule of Construction at section 

4205(d) of the ACA or to add a savings 

clause that expressly provides that 

nutrition labeling for fewer than 20 

vending machines is not preempted in 

the absence of voluntary compliance. As 

discussed in section III.C.4.a of this 

preamble, and specified in § 101.8(c)(1), 

§ 101.8 only applies to food sold from a 

vending machine that: (1) Is operated by 

a person engaged in the business of 

owning or operating 20 or more 

machines; or (2) is operated by a 

vending machine operator that has 

voluntarily elected to be subject to 

§ 101.8 by registering with FDA in 

accordance with § 101.8(d). In addition, 

we explain our interpretation of the 

provisions of section 4205 of the ACA 


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related to preemption mentioned 

previously, including our interpretation 

that State and local governments may 

impose nutrition labeling requirements 

for food sold from vending machines 

not subject to the requirements of 

section 403(q)(5)(H) of the FD&C Act, 

which would include vending machines 

operated by a person engaged in the 

business of owning or operating fewer 

than 20 vending machines. Because 

§ 101.8(c)(1) specifies what foods and 

vending machines are covered by the 

requirements of section 403(q)(5)(H) and 

§ 101.8, and we have described the Rule 

of Construction at section 4205(d) of the 

ACA and explained our interpretation of 

the provisions of section 4205 of the 

ACA related to preemption mentioned 

previously, we decline to revise § 101.8 

as suggested by the comments. 

VII. 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. References 

The following references have been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852, 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday, and are available 

electronically at http://

www.regulations.gov. 

1. FDA/CFSAN, ‘‘Food Labeling: Calorie 

Labeling of Articles of Food in Vending 

Machines, Regulatory Impact Analysis,’’ 

2014. 

2. FDA/CFSAN, ‘‘Food Labeling: Calorie 

Labeling of Articles of Food in Vending 

Machines NPRM, Preliminary Regulatory 

Impact Analysis,’’ 2011. 

3. Memo to File. Correspondence with Eric 

Dell of the National Automatic 

Merchandising Association. April 10, 

2013. 

4. Memo to File. Correspondence with Eric 

Dell of the National Automatic 

Merchandising Association. April 13, 

2013. 

5. Eastern Research Group I. ‘‘Evaluation of 

Recordkeeping Costs for Food 

Manufacturers, Final Report,’’ A. 

Sertkaya, A. Berlind, and S. Erdem, Eds. 

Contract No. 223–01–2461, Task Order 

Number 5. 2007. 

6. ‘‘2012 Census of the Industry,’’ Vending 

Times, 2012; 52(12). 

7. 2012 State of the Vending Industry Report, 

2013,’’ Automatic Merchandiser. 

8. National Automatic Merchandising 

Association. Comments of: The National 

Automatic Merchandising Association. 

Docket No. FDA–2010–N–0298. 2010. 

List of Subjects 

21 CFR Part 11 

Administrative practice and 

procedure, Computer technology, 

Reporting and recordkeeping 

requirements. 

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, 21 CFR parts 11 and 

101 are amended as follows: 

PART 11—ELECTRONIC RECORDS; 

ELECTRONIC SIGNATURES 

■ 1. The authority citation for 21 CFR 

part 11 continues to read as follows: 

Authority: 21 U.S.C. 321–393; 42 U.S.C. 

262. 

■ 2. Section 11.1 is amended by adding 

paragraph (h) to read as follows: 

§ 11.1 Scope. 

* * * * * 

(h) This part does not apply to 

electronic signatures obtained under 

§ 101.8(d) of this chapter. 

PART 101—FOOD LABELING 

■ 3. 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; 42 U.S.C. 

243, 264, 271. 

■ 4. Section 101.8 is added to subpart A 

to read as follows: 

§ 101.8 Vending machines. 

(a) Definitions. The definitions of 

terms in section 201 of the Federal 

Food, Drug, and Cosmetic Act apply to 

such terms when used in this section. In 

addition, for the purposes of this 

section: 

Authorized official of a vending 

machine operator means an owner, 

operator, agent in charge, or any other 

person authorized by a vending 

machine operator who is not otherwise 

subject to section 403(q)(5)(H)(viii) of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 343(q)(5)(H)(viii)), to 

register the vending machine operator 

with the Food and Drug Administration 

(‘‘FDA’’) for purposes of paragraph (d) of 

this section. 

Vending machine means a self-service 

machine that, upon insertion of a coin, 

paper currency, token, card, or key, or 

by optional manual operation, dispenses 

servings of food in bulk or in packages, 

or prepared by the machine, without the 

necessity of replenishing the machine 

between each vending operation. 

Vending machine operator means a 

person(s) or entity that controls or 

directs the function of the vending 

machine, including deciding which 

articles of food are sold from the 

machine or the placement of the articles 

of food within the vending machine, 

and is compensated for the control or 

direction of the function of the vending 

machine. 

(b) Articles of food not covered. 

Articles of food sold from a vending 

machine are not covered vending 

machine food if: 

(1) The prospective purchaser can 

view: 

(i) The calories, serving size, and 

servings per container listed in the 

Nutrition Facts label on the vending 

machine food without any obstruction. 

The Nutrition Facts label must be in the 

format required in § 101.9(c) and (d). 

The Nutrition Facts label must be in a 

size that permits the prospective 

purchaser to be able to easily read the 

nutrition information contained in the 

Nutrition Facts label on the article of 

food in the vending machine. Smaller 

formats allowed for Nutrition Facts for 

certain food labeling under FDA 

regulation at § 101.9 are not considered 

to be a size that a prospective purchaser 

is able to easily read; or 

(ii) The calories, serving size, and 

servings per container listed in a 

reproduction of the Nutrition Facts label 

on the vending machine food, provided 

that the reproduction is a reproduction 

of an actual Nutrition Facts label that 

complies with § 101.9 for a vending 

machine food, is presented in a size that 

permits the prospective purchaser to be 

able to easily read the nutrition 

information, and the calories, serving 

size, and servings per container are 

displayed by the vending machine 

before the prospective purchaser makes 

his or her purchase; or 

(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 

vending machine, 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 


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to permit the perspective purchaser to 

clearly distinguish the information. 

(c) Requirements for calorie labeling 

for certain food sold from vending 

machines—(1) Applicability; covered 

vending machine food. For the purposes 

of this section, the term ‘‘covered 

vending machine food’’ means an article 

of food that is: 

(i) Sold from a vending machine that 

does not permit the prospective 

purchaser to examine the Nutrition 

Facts label prior to purchase as 

provided in paragraph (b)(1) of this 

section or otherwise provide visible 

nutrition information at the point of 

purchase as provided in paragraph (b)(2) 

of this section; and 

(ii) Sold from a vending machine that: 

(A) Is operated by a person engaged in 

the business of owning or operating 20 

or more vending machines; or 

(B) Is operated by a vending machine 

operator that has voluntarily elected to 

be subject to the requirements of this 

section by registering with FDA under 

paragraph (d) of this section. 

(2) Calorie declaration. (i) The 

number of calories for a covered 

vending machine food must be declared 

in the following manner: 

(A) To the nearest 5-calorie increment 

up to and including 50 calories and 10- 

calorie increment above 50 calories, 

except that amounts less than 5 calories 

may be expressed as zero. 

(B) The term ‘‘Calories’’ or ‘‘Cal’’ must 

appear adjacent to the caloric content 

value for each food in the vending 

machine. 

(C) The calorie declaration for a 

packaged food must include the total 

calories present in the packaged food, 

regardless of whether the packaged food 

contains a single serving or multiple 

servings. The vending machine operator 

may voluntarily disclose calories per 

serving in addition to the total calories 

for the food. 

(D) If a covered vending machine food 

is one where the prospective purchaser 

selects among options to produce a final 

vended product (e.g., vended coffee, hot 

chocolate or tea with options for added 

sugar, sugar substitute, milk, and 

cream), calories must be declared per 

option or for the final vended products. 

(ii) Calorie declarations for covered 

vending machine food must be clear and 

conspicuous and placed prominently in 

the following manner: 

(A) The calorie declarations may be 

placed on a sign in close proximity to 

the article of food or selection button, 

i.e., in, on, or adjacent to the vending 

machine, but not necessarily attached to 

the vending machine, 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. The sign must give calorie 

declarations for those articles of food 

that are sold from that particular 

vending machine. 

(B) When the calorie declaration is in 

or on the vending machine, the calorie 

declaration must be in a type size no 

smaller than the name of the food on the 

machine (not the label), selection 

number, or price of the food as 

displayed on the vending machine, 

whichever is smallest, with the same 

prominence, i.e., the same color, or in a 

color at least as conspicuous, as the 

color of the name, if applicable, or price 

of the food or selection number, and the 

same contrasting background, or a 

background at least as contrasting as the 

background used for the item it is in 

closest proximity to, i.e., name, 

selection number, or price of the food 

item as displayed on the machine. 

(C) When the calorie declaration is on 

a sign adjacent to the vending machine, 

the calorie declaration must be in a type 

size large enough to render it likely to 

be read and understood by the 

prospective purchaser under customary 

conditions of purchase and use, and in 

a type that is all black or one color on 

a white or other neutral background that 

contrasts with the type color. 

(D) Where the vending machine only 

displays a picture or other 

representation or name of the food item, 

the calorie declaration must be in close 

proximity to the picture or other 

representation or name, or in close 

proximity to the selection button. 

(E) For electronic vending machines 

(e.g., machines with digital or electronic 

or liquid crystal display (LCD) displays), 

the calorie declaration must be 

displayed before the prospective 

purchaser makes his or her purchase. 

(F) For vending machines with few 

choices, e.g., popcorn, the calorie 

declaration may appear on the face of 

the machine so long as the declaration 

is prominent, not crowded by other 

labeling on the machine, and the type 

size is no smaller than the name of the 

food on the machine (not the label), 

selection number, or price of the food as 

displayed on the vending machine, 

whichever is smallest. 

(d) Voluntary provision of calorie 

labeling for foods sold from vending 

machines—(1) Applicability. A vending 

machine operator that is not subject to 

the requirements of section 

403(q)(5)(H)(viii) of the Federal Food, 

Drug, and Cosmetic Act may, through its 

authorized official, voluntarily register 

with FDA to be subject to the 

requirements established in paragraph 

(c)(2) of this section. An authorized 

official of a vending machine operator 

that voluntarily registers cannot be 

subject to any State or local nutrition 

labeling requirements that are not 

identical to the requirements in 

403(q)(5)(H) of the Federal Food, Drug, 

and Cosmetic Act. 

(2) Who may register? A vending 

machine operator that is not otherwise 

subject to the requirements of section 

403(q)(5)(H) of the Federal Food, Drug, 

and Cosmetic Act may register with 

FDA. 

(3) What information is required? The 

vending machine operator must provide 

FDA with the following information: 

(i) The contact information (including 

name, address, phone number, email 

address), for the vending machine 

operator; 

(ii) The address of the location of each 

vending machine owned or operated by 

the vending machine operator that is 

being registered; 

(iii) Preferred mailing address (if 

different from the vending machine 

operator address), for purposes of 

receiving correspondence; and 

(iv) Certification that the information 

submitted is true and accurate, that the 

person or firm submitting it is 

authorized to do so, and that each 

registered vending machine will be 

subject to the requirements of this 

section. 

(v) Information should be submitted 

by email by typing complete 

information into the portable document 

format (PDF) form, saving it on the 

registrant’s computer, and sending it by 

email to menulawregistration@

fda.hhs.gov. If email is not available, the 

registrant can either fill in the PDF form 

and print it out (or print out the blank 

PDF and fill in the information by hand 

or typewriter), and either fax the 

completed form to 301–436–2804 or 

mail it to FDA, CFSAN Menu and 

Vending Machine Labeling Registration, 

White Oak Building 22, rm. 0209, 10903 

New Hampshire Ave., Silver Spring, MD 

20993. 

(vi) Authorized officials of a vending 

machine operator who elect to be 

subject to the Federal requirements can 

register by visiting http://www.fda.gov/

food/ingredientspackaginglabeling/

labelingnutrition/ucm217762.htm. FDA 

has created a form that contains fields 

requesting the information in paragraph 

(d) of this section and made the form 

available at this Web site. Registrants 

must use this form to ensure that 

complete information is submitted. 

(vii) To keep the establishment’s 

registration active, the authorized 

official of the vending machine operator 

must register every other year within 60 

days prior to the expiration of the 

vending machine operator’s current 


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registration with FDA. Registration will 

automatically expire if not renewed. 

(e) Vending machine operator contact 

information. (1) A vending machine 

operator that is subject to section 

403(q)(5)(H)(viii) of the Federal Food, 

Drug, and Cosmetic Act or a vending 

machine operator that voluntarily 

registers to be subject to the 

requirements under paragraph (d) of this 

section must provide its contact 

information for vending machines 

selling covered vending machine food. 

The contact information must list the 

vending machine operator’s name, 

telephone number, and mailing address 

or email address. 

(2) The contact information must be 

readable and may be placed on the face 

of the vending machine, or otherwise 

must be placed with the calorie 

declarations as described in paragraph 

(c)(2)(ii) of this section (i.e., on the sign 

in, on, or adjacent to the vending 

machine). 

(f) Signatures. Signatures obtained 

under paragraph (d) of this section that 

meet the definition of electronic 

signatures in § 11.3(b)(7) of this chapter 

are exempt from the requirements of 

part 11 of this chapter. 

■ 5. In § 101.9, revise paragraphs 

(j)(2)(ii) and (j)(4) and the introductory 

text of paragraph (j)(13)(i) to read as 

follows: 

§ 101.9 Nutrition labeling of food. 

* * * * * 

(j) * * * 

(2) * * * 

(ii) Served in other establishments in 

which food is served for immediate 

human consumption (e.g., institutional 

food service establishments, such as 

schools, hospitals, and cafeterias; 

transportation carriers, such as trains 

and airplanes; bakeries, delicatessens, 

and retail confectionery stores where 

there are facilities for immediate 

consumption on the premises; food 

service vendors, such as lunch wagons, 

ice cream shops, mall cookie counters, 

vending machines, and sidewalk carts 

where foods are generally consumed 

immediately where purchased or while 

the consumer is walking away, 

including similar foods sold from 

convenience stores; and food delivery 

systems or establishments where readyto-eat foods are delivered to homes or 

offices), Provided, That the food bears 

no nutrition claims or other nutrition 

information in any context on the label 

or in labeling or advertising, except as 

provided in § 101.8(c). Claims or other 

nutrition information, except as 

provided in § 101.8(c), subject the food 

to the provisions of this section; 

* * * * * 

(4) Foods that contain insignificant 

amounts of all of the nutrients and food 

components required to be included in 

the declaration of nutrition information 

under paragraph (c) of this section, 

Provided, That the food bears no 

nutrition claims or other nutrition 

information in any context on the label 

or in labeling or advertising, except as 

provided in § 101.8(c). Claims or other 

nutrition information, except as 

provided in § 101.8(c), subject the food 

to the provisions of this section. An 

insignificant amount of a nutrient or 

food component shall be that amount 

that allows a declaration of zero in 

nutrition labeling, except that for total 

carbohydrate, dietary fiber, and protein, 

it shall be an amount that allows a 

declaration of ‘‘less than 1 gram.’’ 

Examples of foods that are exempt 

under this paragraph include coffee 

beans (whole or ground), tea leaves, 

plain unsweetened instant coffee and 

tea, condiment-type dehydrated 

vegetables, flavor extracts, and food 

colors. 

* * * * * 

(13)(i) Foods in small packages that 

have a total surface area available to 

bear labeling of less than 12 square 

inches, Provided, That the labels for 

these foods bear no nutrition claims or 

other nutrition information in any 

context on the label or in labeling or 

advertising, except as provided in 

§ 101.8(c). Claims or other nutrition 

information, except as provided in 

§ 101.8(c), subject the food to the 

provisions of this section. 

* * * * * 

Dated: November 19, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–27834 Filed 11–25–14; 8:45 am] 

BILLING CODE 4164–01–P 


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