19238 Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Proposed Rules 

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: Proposed rule. 

SUMMARY: To implement the vending 

machine labeling provisions of the 

Patient Protection and Affordable Care 

Act of 2010 (Affordable Care Act), the 

Food and Drug Administration (FDA) is 

proposing requirements for providing 

calorie information for certain articles of 

food sold from vending machines. The 

Affordable Care Act, in part, amended 

the Federal Food, Drug and Cosmetic 

Act (FD&C Act) to, among other things, 

require that for an article of 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, 

and is operated by a person engaged in 

the business of owning or operating 20 

or more vending machines, the vending 

machine operator must disclose the 

number of calories for the article of 

food. Vending machine operators not 

subject to the requirements of the 

Affordable Care Act may elect to be 

subject to the Federal requirements by 

registering with FDA. Providing calorie 

disclosures for food sold from vending 

machines would assist consumers in 

making healthier dietary choices. 

DATES: Submit either written or 

electronic comments on the proposed 

rule by July 5, 2011. Submit comments 

on the information collection issues 

under the Paperwork Reduction Act of 

1995 by May 6, 2011, (see the 

‘‘Paperwork Reduction Act of 1995’’ 

section of this document). 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2011–F– 

0171 and/or RIN 0910–AG56, by any of 

the following methods, except that 

comments on information collection 

issues under the Paperwork Reduction 

Act of 1995 must be submitted to the 

Office of Regulatory Affairs, Office of 

Management and Budget (OMB) (see the 

‘‘Paperwork Reduction Act of 1995’’ 

section of this document). 

Electronic Submissions 

Submit electronic comments in the 

following way: 

Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

FAX: 301–827–6870. 

Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

docket number and Regulatory 

Information Number (RIN) for this 

rulemaking. All comments received may 

be posted without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Y. Reese, Center for Food Safety 

and Applied Nutrition (HFS–820), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–2371. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Nutrition Labeling Requirements 

That Currently Apply to Packaged 

Foods 

The Nutrition Labeling and Education 

Act of 1990 (NLEA) amended the FD&C 

Act, in part, by adding section 403(q) 

(21 U.S.C. 343(q)), which specifies, in 

pertinent part and with certain 

exceptions, that a food is considered to 

be misbranded unless its label or 

labeling bears nutrition information. See 

21 U.S.C. 343(q)(1). When a food is in 

package form, the required nutrition 

information generally must appear on 

the label of the food. FDA’s final 

regulations establishing nutrition 

labeling requirements were published in 

1993 (58 FR 2079, January 6, 1993) and 

are found at Title 21 of the Code of 

Federal Regulations (21 CFR) section 

101.9. Regulations implementing the 

NLEA require nutrition information for 

a food product intended for human 

consumption and offered for sale unless 

an exemption is provided for the 

product (§ 101.9(a)). The declaration of 

nutrition information on the label and 

labeling of food generally must include 

information about the following 

nutrients: Total calories, calories from 

fat (unless the product contains less 

than 0.5 g of fat), total fat, saturated fat, 

trans fat, cholesterol, sodium, total 

carbohydrate, dietary fiber, sugars, 

protein, and certain vitamins and 

minerals (§ 101.9). 

The NLEA amendments to the FD&C 

Act included an exemption from 

nutrition labeling for food that is served 

in restaurants or other establishments in 

which food is served for immediate 

human consumption or sold for sale or 

use in such establishments (21 U.S.C. 

343 (q)(5)(A)(i)). The NLEA 

amendments to the FD&C Act also 

included an exemption from nutrition 

labeling for food that is processed and 

prepared primarily in a retail 

establishment, ready for human 

consumption, of the type of food 

described in section 403(q)(5)(A)(i) of 

the FD&C Act, offered for sale to 

consumers but not for immediate 

human consumption in such 

establishment, and not offered for sale 

outside such establishment (21 U.S.C. 

343(q)(5)(A)(ii)). However, these 

exemptions were contingent on there 

being no nutrient content claims or 

health claims made on the label or 

labeling, or in the advertising, for the 

food. In our regulations implementing 

these exemptions, we included vending 

machines among the examples of 

establishments in which food is served 

for immediate human consumption that 

generally are exempt from nutrition 

labeling requirements because like the 

other examples, vending machines offer 

food products that are generally 

consumed immediately where 

purchased or while the consumer is 

walking away. See § 101.9(j)(2). 

B. Requirements of Section 4205 of the 

Affordable Care Act 

On March 23, 2010, the Affordable 

Care Act (Pub. L. 111–148) was signed 

into law. Section 4205 of the Affordable 

Care Act (section 4205), amends section 

403(q) of the FD&C Act, which governs 

nutrition labeling requirements, 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. The Affordable 

Care Act requires FDA to issue proposed 

regulations to carry out section 

403(q)(5)(H) of the FD&C Act no later 

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Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Proposed Rules 19239 

than one year from the date of 

enactment. As amended, section 

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

requires that if an article of food is sold 

from a vending machine that does not 

permit a prospective purchaser to 

examine the Nutrition Facts Panel 

before purchasing the food or does not 

otherwise provide visible nutrition 

information at the point of purchase and 

the vending machine is operated by a 

person who is engaged in the business 

of owning or operating 20 or more 

vending machines, the vending machine 

operator must provide calorie 

information for the food. Specifically, 

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.’’ 

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

Act allows vending machine operators 

not subject to the requirements of 

section 4205 of the Affordable Care Act 

to voluntarily register with FDA to 

become subject to the Federal 

requirements. In the Federal Register of 

July 23, 2010, (75 FR 43182), FDA 

published a notice in the Federal 

Register specifying the terms and 

conditions for implementation of 

voluntary registration, pending 

promulgation of final regulations. See 

75 FR 43182. 

C. FDA Activities Related to 

Implementation of Section 4205 of the 

Affordable Care Act 

Section 4205 of the Affordable Care 

Act also requires certain restaurants and 

similar retail food establishments to 

provide calorie and other nutrition 

information for standard menu items, 

including food on display and selfservice food. Elsewhere in this issue of 

the Federal Register, FDA is proposing 

requirements to implement the menu 

labeling provisions of section 4205. As 

discussed in that proposal, FDA has 

published in the Federal Register a 

number of documents concerning 

section 4205. On July 7, 2010, FDA 

published a notice entitled ‘‘Disclosure 

of Nutrient Content Information for 

Standard Menu Items Offered for Sale at 

Chain Restaurants or Similar Retail 

Food Establishments and for Articles of 

Food Sold from Vending Machines’’ 

(‘‘docket notice’’) (75 FR 39026, July 7, 

2010) to solicit comments and 

suggestions on the new law. In response 

to this notice, FDA received 

approximately 875 letters and e-mails. 

Of those, approximately 60 contained 

one or more comments pertaining to 

vending machine calorie labeling. Many 

of these comments were general 

comments on the law itself and either 

supported or opposed the requirement 

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

Act that calorie information be provided 

for foods sold from vending machines. 

Comments in opposition stated that 

providing calorie information for foods 

sold from vending machines would be 

overly burdensome to the industry. FDA 

describes these comments in more detail 

and responds to those comments in this 

proposal. 

On July 23, 2010, FDA published the 

Federal Register notice entitled 

‘‘Voluntary Registration by Authorized 

Officials of Non-Covered Retail Food 

Establishments and Vending Machine 

Operators Electing to be Subject to the 

Menu and Vending Machine Labeling 

Requirements Established by Section 

4205 of the Patient Protection and 

Affordable Care Act of 2010’’ 

(‘‘registration notice’’) (75 FR 43182). 

FDA issued this registration notice to 

provide assistance for voluntary 

registration for restaurants, similar retail 

establishments, and vending machine 

operators that are not subject to the 

nutrition labeling requirements of 

section 4205 (e.g., restaurants and 

similar retail food establishments with 

fewer than 20 locations, and vending 

machine operators with fewer than 20 

machines). In the registration notice, 

FDA specified the terms and conditions 

for implementation of voluntary 

registration, pending promulgation of 

regulations. In response to the notice, 

FDA received 7 comments, none of 

which addressed registration. 

On August 25, 2010, FDA published 

a ‘‘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’’ (‘‘preemption guidance’’) 

(75 FR 52427, August 25, 2010). The 

preemption guidance discusses the 

preemptive effect of section 4205 and 

identifies the provisions of amended 

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

became requirements upon enactment. 

Our current thinking on the preemptive 

effect of section 4205 is set out in 

section VII of this document. 

Also on August 25, 2010, FDA 

published a ‘‘Draft Guidance for 

Industry: Questions and Answers 

Regarding the Menu Labeling Provisions 

of Section 4205 of the Patient Protection 

and Affordable Care Act of 2010; 

Availability’’ (‘‘draft implementation 

guidance’’) (75 FR 52426, August 25, 

2010). This draft guidance addressed 

only the menu labeling provisions of 

section 4205. It did not address the 

calorie labeling requirements for 

vending machine operators in section 

4205. FDA subsequently withdrew the 

draft implementation guidance (76 FR 

4360, January 25, 2011). 

II. Legal Authority 

As stated in section I.C. of this 

document, on March 23, 2010, the 

Affordable Care Act was signed into 

law. Section 4205 of the Affordable Care 

Act amended 403(q)(5) of the FD&C Act 

(21 U.S.C. 343(q)(5)) by amending 

section 403(q)(5)(A) and by creating new 

clause (H) to require, in relevant part, 

that vending machine operators provide 

calorie information for certain articles of 

food sold from vending machines. 

Under section 403(a)(1), such 

information must be truthful and 

nonmisleading. 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 

actually made in the labeling. Section 

403(q)(5)(H)(x) requires the Secretary of 

Health and Human Services (Secretary) 

to issue proposed regulations no later 

than 1 year after enactment . Thus, FDA 

has the authority to issue this proposed 

rule under sections 201(n), 403(a)(1), 

and 403(q)(5)(H), as well as under 

section 701(a) of the FD&C Act (21 

U.S.C. 371(a)), which vests the Secretary 

with the authority to issue regulations 

for the efficient enforcement of the 

FD&C Act. 

FDA is proposing requirements that 

vending machine operators provide 

calorie information for certain articles of 

food sold from vending machines. FDA 

is also proposing the terms and 

conditions for voluntary registration by 

vending machine operators not subject 

to the requirements of section 4205 of 

the Affordable Care Act that elect to 

become subject the requirements. FDA 

is proposing to set out these provisions 

in new § 101.8. 

III. The Proposal 

A. Definitions 

We are proposing in the introductory 

paragraph of § 101.8(a) that the terms 

defined in section 201 of the FD&C Act 

are applicable when these terms are 

used. Additional terms are defined 

alphabetically in the proposed codified 

and are discussed in alphabetical order 

in this section. ‘‘Act’’ is defined as the 

Federal Food, Drug, and Cosmetic Act. 

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19240 Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Proposed Rules 

1FDA regularly publishes the Food Code, which 

provides guidance on food safety, sanitation, and 

fair dealing that can be uniformly adopted by State 

and local governments for the retail segment of the 

food industry. The Food Code provisions are not 

Federal requirements; however, they are designed 

to be consistent with Federal food laws and 

regulations. The 2009 Food Code defined the term 

‘‘vending machine’’ to mean a ‘‘self-service device 

that, upon insertion of a coin, paper currency, 

token, card, or key, or by optional manual 

operation, dispenses unit servings of food in bulk 

or in packages without the necessity of replenishing 

the device between each vending operation.’’ (U.S. 

Public Health Service, FDA, 2009 Food Code, U.S. 

Department of Health and Human Services, Public 

Health Service, Food and Drug Administration, 

College Park, MD 20740, chapter 1, section 1–201.) 

http://www.fda.gov/Food/FoodSafety/RetailFood

Protection/FoodCode/FoodCode2009/

ucm186464.htm. 

1. Authorized Official of a Vending 

Machine Operator 

We are proposing in § 101.8(a) that 

the term ‘‘authorized official of a 

vending machine operator’’ means the 

owner, operator, or agent in charge of a 

vending machine, or any other person 

authorized by a vending machine 

operator not subject to the requirements 

of section 4205 of the Affordable Care 

Act to voluntarily register the vending 

machine operator with FDA to become 

subject to the requirements. For the 

purposes of this definition, the agent in 

charge would not be the person who is 

only in charge or in control of the 

location where the vending machine is 

located. 

2. Vending Machine Operator 

We are proposing in § 101.8(a) that 

the term ‘‘vending machine operator’’ 

means a person that controls or directs 

the function of the vending machine, 

including deciding which articles of 

food are sold from the vending 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. 

Section 201(e) of the FD&C Act defines 

‘‘person’’ to include an individual, 

partnership, corporation, and 

association. For example, a vending 

machine operator could be a corporation 

that manufacturers beverages and sells 

these products in its machines. A 

vending machine operator also could be 

an individual or a business that only 

operates and stocks vending machines, 

such as a private company with onsite 

vending machines. 

3. Vending Machine 

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

Act sets forth labeling requirements for 

certain vending machine food but does 

not define the term ‘‘vending machine.’’ 

We are proposing in § 101.8(a) that the 

term ‘‘vending machine’’ means a selfservice device that, upon insertion of a 

coin, paper currency, token, card, or 

key, or by optional manual operation, 

dispenses servings of food in bulk, in 

packages, or prepared by the machine, 

without the necessity of replenishing 

the device between each vending 

operation. This definition is almost 

identical to the definition of ‘‘vending 

machine’’ in the FDA Food Code 2009.1

Examples of food dispensed from 

vending machines may include 

prepackaged foods (e.g., candy, snacks, 

gum, bottled or canned soft drinks), 

unpackaged bulk foods (e.g., handful of 

gum, candy, or mixed nuts), prepared 

foods (e.g., sandwiches or fresh fruit), 

multi-serving foods (e.g., gallon of milk), 

or foods prepared in the machine and 

dispensed in bulk (e.g., coffee, soup, or 

popcorn). 

B. Who Must Comply With This Rule 

Section 4205 of the Affordable Care 

Act provides that ‘‘in the case of an 

article of 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, and is operated 

by a person engaged in the business of 

owning or operating 20 or more vending 

machines, the vending machine 

operator shall 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 of food.’’ Consistent with the 

requirements of section 4205, all 

vending machine operators with 20 or 

more vending machines, as defined in 

section III.A.3. of this document, will be 

subject to these requirements. Therefore, 

FDA is proposing in § 101.8(c)(1)(i)(A) 

and (B) that the labeling requirements of 

this proposed rule apply to vending 

machine operators that own or operate 

20 or more vending machines that do 

not allow a prospective purchaser to 

examine the Nutrition Facts Panel prior 

to purchase or do not otherwise provide 

visible nutrition information at the 

point of purchase. As discussed in 

below in section III.D. of this document, 

vending machine operators that are not 

subject to the requirements of the law 

may elect to be subject to the Federal 

requirements by voluntarily registering 

with FDA. 

Several comments requested that FDA 

apply the small business nutrition 

labeling exemption (§ 101.9(j)(1)) to 

vending machine operators. The 

comments said that: (1) 90–95 percent of 

vending machine operators have 20 or 

more machines, and therefore, would be 

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

FD&C Act and (2) 70 percent of vending 

machine operators have three or fewer 

employees, and would likely be 

generating sales less than $500,000. 

FDA is not proposing an exemption 

from the vending machine nutrition 

labeling requirements for small 

businesses. FDA notes that section 

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

include an exemption from the vending 

machine nutrition labeling requirements 

for small businesses. Section 

403(q)(5)(D) includes an exemption 

from the nutrition labeling requirements 

in sections 403(q)(1) through (q)(4) for 

small businesses. The requirement that 

vending machine operators disclose 

calories for covered vending machine 

food is not found in sections 403(q)(1) 

through (q)(4); instead, it is found in 

section 403(q)(5)(H)(viii). Therefore, the 

small business exemption in 

403(q)(5)(D) does not apply. We believe 

that the proposed rule provides 

adequate flexibility to allow these small 

businesses to comply with the proposed 

requirements in a cost-effective and 

equitable way. For example, the 

proposed requirements allow vending 

machine operators to choose from 

various approaches for compliance, 

including adopting less expensive 

measures as discussed below in section 

III.E. and section IV. of this document. 

We request comment on additional 

ways that FDA can make the 

requirements of this rule less 

burdensome on small businesses, while 

still meeting the requirements of section 

403(q)(5)(H). 

The Agency also received comments 

regarding operators of vending 

machines who are blind and operate 

vending machines through the Vending 

Facility Program operated by the U.S. 

Department of Education under the 

Randolph-Sheppard Act of 1936, 20 

U.S.C. 107 et seq. These comments 

suggested that regardless of the number 

of machines that were operated by an 

operator, all operators of vending 

machines under the Randolph-Sheppard 

Act would be covered. 

The Agency wishes to clarify its 

interpretation of the applicability of 

section 4205 of the Affordable Care Act 

to vending machine operators who fall 

under the Randolph-Sheppard Act. 

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

Act sets forth requirements for vending 

machine operators based on the number 

of machines that they operate. Thus, as 

with other operators, RandolphSheppard Act operators would only be 

covered by the disclosure requirements 

if they operate 20 or more vending 

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Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Proposed Rules 19241 

2As discussed in section I.B. of this document, 

vending machine operators that own or operate 

fewer than 20 vending machines could elect to be 

subject to the requirements of 403(q)(5)(H)(viii) of 

the FD&C Act by voluntarily registering with FDA. 

machines that dispense food or if they 

voluntarily register to be covered. 

These comments also stated that 

operators of vending machines who are 

blind ‘‘may place different products in 

the same row due to limited visual 

recognition and the similarity of 

product packaging.’’ These comments 

requested flexibility for posting calorie 

information. Specifically, the comments 

requested that the calorie disclosure 

requirements permit the ‘‘stacking of 

multiple products in the same coil.’’ 

FDA is proposing requirements that 

provide flexibility for vending machine 

operators to comply with the labeling 

requirements for covered vending 

machine food. As discussed later in this 

document, the required calorie 

information may be posted on a sign 

adjacent to the vending machine, so 

long as the sign is visible to the 

prospective purchaser at the same time 

as the food, its description, or its 

selection button is visible. 

C. Who Is Not Required to Comply With 

This Rule 

FDA is aware that many vending 

machine operators operate machines 

that dispense a variety of articles other 

than articles of food. For example, some 

vending machines may dispense 

detergent, compact discs, gift cards or 

toiletries. If a vending machine operator 

operated a total of 50 vending machines, 

only 15 of which sell articles of food, 

the vending machine operator would 

not be subject to the requirements of 

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

because the vending machine operator 

operates fewer than 20 vending 

machines that sell articles of food. 

Further, FDA tentatively concludes 

that vending machines that may 

dispense food as part of a game or other 

non-food related activity are not covered 

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

example, a vending machine may 

contain a variety of items ranging from 

small toys, coins, or individually 

wrapped candies that can be picked up 

by maneuvering a large claw arm. In this 

instance, the vending machine does not 

sell articles of food, even though in the 

course of maneuvering the arm, candies 

could be dispensed. The vending 

machine is selling the opportunity to 

play the game. FDA seeks comment on 

this tentative conclusion. 

Bulk vending machines dispense 

unpackaged articles of food in 

preselected amounts (e.g. gumball 

machines, mixed nut machines). FDA 

received a few comments suggesting 

that bulk vending machines are different 

from ‘‘more modern types of vending 

machines,’’ and therefore should be 

exempt from these disclosure 

requirements. The comments argued 

that bulk vending machines should be 

distinguished from other vending 

machines for three reasons. First, they 

noted that these machines do not have 

selection buttons, and as a result a 

vending machine operator could not 

place a sign ‘‘in close proximity to * * * 

the selection button’’ that includes the 

calorie information required by section 

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

Second, they argued that food sold from 

bulk vending machines represents only 

a small fraction of overall market sales 

of the vending machine industry. 

Finally, the comments stated that there 

is no reported association between foods 

sold from bulk vending machines and 

obesity. 

FDA notes that section 

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

not limit its applicability to vending 

machines for which there has been a 

reported association between the food 

vended by the machine and obesity. 

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

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.’’ FDA 

tentatively concludes that the reference 

to ‘‘selection button’’ in the statute can 

be read to mean that the types of 

vending machines subject to 

requirements in section 

403(q)(5)(H)(viii) are those with 

selection buttons. FDA is 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). FDA tentatively 

concludes that vending machines, 

including bulk vending machines, 

without any type of selection button are 

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

However, FDA tentatively concludes 

that a bulk vending machine that has a 

selection button, regardless of the type 

of food it dispenses, e.g., unpackaged 

articles of food such as soup, popcorn, 

or hot or cold beverages, is covered 

under section 403(q)(5)(H)(viii), if it 

meets the other statutory criteria. FDA 

is proposing in § 101.8(c)(1)(i)(C) that 

the nutrition labeling requirements of 

§ 101.8 apply to an article of food sold 

from a vending machine that, among 

other things, has a selection button. 

FDA seeks comment on these tentative 

conclusions. FDA is also interested in 

comments demonstrating any 

unintended adverse effect resulting from 

the exclusion of vending machines 

without selection buttons from the 

calorie labeling requirements. 

D. Voluntary Registration by a Vending 

Machine Operator That Is Not Subject to 

the Requirements of Section 4205 of the 

Affordable Care Act That Elects To Be 

Subject to the Requirements 

Section 4205 of the Affordable Care 

Act provides that vending machine 

operators not subject to the 

requirements of section 

403(q)(5)(H)(viii) 2 of the FD&C Act may 

elect to become subject to the 

requirements by registering ‘‘biannually’’ 

with FDA (21 U.S.C. 343(q)(5)(H)(ix)). 

As discussed below, operators that 

choose to be subject to the Federal 

requirements would not be subject to 

non-identical state or local nutrition 

labeling laws for food sold from vending 

machines. In the proposed rule entitled: 

Food Labeling; Nutrition Labeling of 

Standard Menu Items in Restaurants 

and Similar Retail Food Establishments, 

published elsewhere in this issue of the 

Federal Register, FDA explains that 

‘‘biannual’’ can be defined as occurring 

twice every year or as occurring every 

other year. (Ref. 1). FDA tentatively 

concludes that registration every other 

year is a more reasonable interpretation, 

because it does not seem warranted or 

necessary for a vending machine 

operator to tell FDA every 6 months that 

the operator wants to be subject to 

Federal requirements. FDA began 

accepting registrations on July 21, 2010, 

and will continue to accept them on a 

continuous basis. FDA is proposing in 

§ 101.8(d) that an authorized official for 

a vending machine operator that is not 

subject to the Federal requirements may 

register with FDA every other year by 

providing FDA the following 

information: 

• The contact information (including 

name, address, phone number, e-mail 

address), for the vending machine 

operator; 

• The address of the location of each 

vending machine owned or operated by 

the vending machine operator that is 

being registered; 

• 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. 

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19242 Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Proposed Rules 

An authorized official of a vending 

machine operator who elects to be 

subject to the Federal requirements can 

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

menulabeling. FDA has created a form 

that contains fields requesting the 

information in § 101.8(d) and made the 

form available at this Web site. 

Registrants must use this form to ensure 

that complete information is submitted. 

E. Requirements for Vending Machine 

Operators Subject to This Rule and 

Operators That Elect To Be Subject to 

the Rule When Calorie Declarations Are 

Required 

Calorie Declaration for a Covered 

Vending Machine Food 

a. Calorie declaration. Section 

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

provides that, for a covered vending 

machine food, the vending machine 

operator must ‘‘provide a sign in close 

proximity to the article of food or the 

selection button that includes a clear 

and conspicuous statement disclosing 

the number of calories contained in the 

article.’’ FDA is proposing in 

§ 101.8(c)(2)(i)(A) to require that for a 

covered vending machine food, the 

statement of the number of calories in 

the food must be expressed to the 

nearest 5-calorie increment up to and 

including 50 calories, and 10-calorie 

increment above 50 calories. For a 

covered vending machine food that has 

fewer than 5 calories, the calorie 

declaration may be expressed as zero. 

These rounding rules are consistent 

with the declaration of calories for 

packaged foods as provided in 

§ 101.9(c)(1). 

In addition, FDA tentatively 

concludes that the number of calories 

must be accompanied by a term, e.g., 

‘‘calories,’’ to make clear what that 

number refers to. Consequently, FDA is 

proposing in § 101.8(c)(2)(i)(B) that the 

term ‘‘Calories’’ or ‘‘Cal’’ must appear 

adjacent to the number of calories for 

the covered vending machine food. This 

is the ‘‘calorie declaration.’’ We 

tentatively conclude that permitting the 

use of the abbreviation ‘‘Cal’’ will 

provide flexibility for vending machine 

operators, especially those that have 

limited space on their machines, in 

meeting the proposed requirements. 

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

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

food sold from a vending machine,’’ 

FDA tentatively concludes that calorie 

information must include the total 

calories present in the covered vending 

machine food as it is vended. For 

example, if a covered vending machine 

food, such as a sandwich, is dispensed 

with a single serving unit of a 

condiment, such as mayonnaise, the 

calorie declaration must include the 

number of calories contained in the 

sandwich and the package of 

mayonnaise. FDA also tentatively 

concludes that the number of calories 

declared for the article of food must be 

identical to the number of calories that 

are declared in the Nutrition Facts, if 

present. If the food contains multiple 

servings and bears a Nutrition Facts 

Panel, FDA tentatively concludes that 

the number of calories declared must be 

equal to the total number of calories 

contained in the food item as dispensed. 

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 states 80 calories per 

serving and 3 servings per container, the 

total number of calories in the entire 

package would be 240 calories. FDA 

tentatively concludes that for a covered 

vending machine food that contains 

multiple servings, a vending machine 

operator may voluntarily disclose 

calories per serving in addition to total 

calories for the food. 

Several comments requested that FDA 

permit the use of calorie ranges, similar 

to those provided for restaurants and 

similar retail food establishments under 

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

in declaring calorie information for 

covered vending machine foods that 

come in different flavors and varieties, 

e.g., coffee which comes in different 

flavors, brew strength, serving size, 

sweeteners or different types of 

sandwiches or fruit. The comments 

discussed the need for flexibility to 

provide calorie ranges for such items. 

FDA acknowledges that some articles 

of food sold from vending machines 

come in varieties, such as different 

flavors and types of hot beverages (e.g., 

coffee or hot chocolate). For some of 

these varieties, there could be a large 

range for calories. For example, calories 

for coffee could range from zero calories 

for a plain brewed coffee to over 400 

calories for a large mocha coffee with 

whole milk and whipped cream. We 

point out, however, 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. For example, if there 

is a button to select cream for a coffee, 

a vending machine operator would be 

able to post a calorie declaration for that 

cream item in close proximity to the 

selection button. FDA has considered 

vending machines that typically 

dispense fresh sandwiches and fruit 

(often these machines are turnstile 

type). FDA believes that such machines 

do not present a unique situation where 

the proposed options for declaring 

calorie information would not be 

appropriate. FDA tentatively concludes, 

therefore, that calorie ranges are not 

necessary within the context of vending 

machines because a vending machine 

operator would be able to disclose 

calorie information under other options, 

as explained below (e.g., use of signs 

including posters). 

b. Determination of calorie content. If 

a covered vending machine food does 

not bear Nutrition Facts, FDA 

anticipates that the manufacturer or 

supplier of the food may provide the 

number of total calories for the food to 

the vending machine operator so that 

the operator has the necessary calorie 

information to meet the calorie 

disclosure requirements of section 

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

notes that covered vending machine 

operators must ensure that the calorie 

declaration is truthful and not 

misleading in accordance with section 

403(a)(1) of the FD&C Act. In the event 

the calorie information is not available 

from the manufacturer of the food, FDA 

seeks comments on whether a vending 

machine operator may use nutrient 

databases, cookbooks, laboratory 

analyses, and other reasonable means. 

FDA notes that such flexibility is 

provided in § 101.10 and section 

403(q)(5)(H)(iv). Further, FDA seeks 

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. 

c. Placement and prominence of 

calorie declarations. Section 

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

provides that for a covered vending 

machine food, the vending machine 

operator must provide a sign in close 

proximity to the article of food or the 

selection button that includes a clear 

and conspicuous statement disclosing 

the number of calories contained in the 

food. FDA is interpreting the 

requirement that a sign be placed in 

close proximity to the article to mean 

that the sign is placed either in or on the 

vending machine itself or adjacent to 

the vending machine and near the food, 

its price, its selection number, or its 

selection button. 

Section 403(q)(5)(H)(viii) also requires 

that the calorie declaration be clear and 

conspicuous. FDA notes that to be clear 

and conspicuous the calorie declaration 

must be in a font size large enough to 

be seen and easily readable. However, 

FDA recognizes that vending machines 

come in a variety of sizes, shapes, and 

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3Here the discussion of ‘‘name’’ refers to the name 

of the food on or in the vending machine and not 

the name of the food on the label of the food 

package. 

styles. We also understand that vending 

machines will often have limited space. 

We think that it is important to provide 

businesses with flexibility while, at the 

same time, fulfilling the requirements of 

the statute. Therefore, we think it would 

not be appropriate to require one 

specific type size and font for calorie 

declarations for all covered vending 

machine food. Generally, if a calorie 

declaration is in a similar color as and 

a type size no smaller than the name 3

of the food, price of the food, or the 

selection number (e.g., A9 or E4), 

consumers should be able to read the 

calories in the same manner as they read 

the name and price of the food item. 

Therefore, FDA is proposing in 

§ 101.8(c)(2)(i)(C) that if the calorie 

declaration is in or on the vending 

machine itself, the calorie declaration 

for a covered vending machine food 

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. In 

addition, to help ensure that the calorie 

declaration is clear and conspicuous, 

FDA is proposing in § 101.8(c)(2)(i)(B) 

and § 101.8(c)(2)(i)(C) that the calorie 

declaration be made in the same color, 

or in a color at least as conspicuous, as 

the color of the name, price, or selection 

number of the food. Further, FDA 

proposes that the calorie declaration on 

the machine must have the same 

contrasting background as the name or 

price or selection number it is in closest 

proximity to. FDA notes that if a calorie 

declaration is presented in a color that 

is not sufficiently contrasted with its 

background or the declaration is in a 

type size that is too small to be read by 

a prospective purchaser, FDA 

tentatively concludes that the calorie 

declaration for a covered vending 

machine food is not disclosed in a clear 

and conspicuous manner, and the 

declaration would not be in compliance 

with the requirements of section 

403(q)(5)(H)(viii)(I). FDA requests 

comment on whether these 

requirements meet the conditions for 

‘‘clear and conspicuous’’ or whether the 

requirements should be more or less 

prescriptive. 

A number of comments suggested that 

calorie information be provided on a 

poster or sign near the machine, such as 

for a bank of several vending machines 

that may use a common singular 

payment acceptor. However, several 

comments noted a concern that calorie 

information would not be read by the 

consumer unless the calorie information 

were posted immediately next to each 

food item. The comments stated that 

‘‘vending menus’’ (such as a menu poster 

for a bank of vending machines) would 

not provide the buyer with easy access 

to the calorie information. 

FDA agrees with the comments 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. The Agency tentatively 

concludes that ‘‘close proximity’’ could 

mean adjacent to the vending machine, 

but not necessarily attached, so long as 

the sign adjacent to the machine is clear 

and conspicuous at the same time as the 

food, its name, or its selection button or 

selection number is visible. The Agency 

requests comments on this tentative 

conclusion. FDA is also proposing in 

§ 101.8(c)(2)(ii)(B) that if the sign 

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

the FD&C Act is placed adjacent to the 

vending machine, 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. The Agency is not 

proposing a minimum type size for the 

calorie declaration, but we request 

comment on this tentative decision. 

Comments should provide a rationale 

supporting their position and any 

supporting data, including consumer 

research. Where the vending machine 

only displays a vignette (i.e., picture of 

the food) or name of the food item, FDA 

is proposing in § 101.8(c)(2)(ii)(D) that 

the calorie disclosure sign must be in 

close proximity to the vignette or name 

or in close proximity to the selection 

button. 

For electronic vending machines (e.g., 

machines with digital or electronic or 

liquid crystal display (LCD) displays), 

FDA tentatively concludes that the 

calorie disclosure sign required by the 

statute may be displayed when the 

selection numbers are entered but before 

the selection is confirmed, as proposed 

in § 101.8(c)(2)(ii)(E). 

FDA tentatively concludes, 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. A sign 

may consist of a handwritten sticker in 

permanent marking that is affixed to the 

machine, provided that the statement is 

prominent, not crowded by other 

labeling on the machine and in a type 

size reasonably related to the largest 

print on the vending machine. 

F. When Calorie Declaration Is Not 

Required 

1. Examination of the Nutrition Facts 

Panel 

If the Nutrition Facts Panel of an 

article of food sold from a vending 

machine may be examined by a 

prospective purchaser before purchasing 

the article, the vending machine 

operator is not required to provide the 

calorie information. FDA is interpreting 

the term ‘‘Nutrition Facts Panel’’ to mean 

the nutrition information in the format 

required in § 101.9(c) and (d) on the 

label of the food. FDA tentatively 

concludes in order for the Nutrition 

Facts Panel to be examined, it must be 

visible in full, without obstruction, 

before purchase. For example, a vending 

machine’s automatic dispensing coil 

that holds the food in place or the 

placement of the package in the 

machine must not obscure, cover, or 

cause to be covered any portion of the 

Nutrition Facts Panel. To enable the 

prospective buyer to obtain the total 

number of calories of the article of food, 

the information that would be required 

to be made available on a sign by the 

vending machine operator if the 

provisions of section 

403(q)(5)(H)(viii)(I)(aa) are not met, the 

agency notes that, in most cases, the 

prospective purchaser must use several 

parts of the panel to determine the total 

number of calories for the article of 

food. This is one reason that it is critical 

that no portion of the Nutrition Facts 

Panel be obscured. 

In addition, the Nutrition Facts Panel 

must be in a size that permits the 

prospective purchaser to easily read the 

nutrition information while the food is 

in the vending machine. FDA 

regulations allow certain foods to bear 

Nutrition Facts in a modified or smaller 

format based on the composition of the 

food, the size of the food package or 

other factors (see § 101.9(d), (e), (f), (h) 

and (j)). Where the Nutrition Facts Panel 

is in a smaller format consistent with 

the regulations, a prospective purchaser 

is unlikely to be able to easily read it on 

the label of the article of food in the 

vending machine prior to purchase. In 

such cases, the Agency tentatively 

concludes that the prospective 

purchaser is not able to examine the 

Nutrition Facts Panel prior to purchase. 

FDA requests comment on these 

tentative conclusions. 

FDA recognizes that ordinarily the 

vending machine operator is not 

responsible for the printing of the 

Nutrition Facts Panel. Nor is the 

vending machine operator required by 

section 403(q)(5)(H)(viii)(I) to make 

examination of the Nutrition Facts 

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possible by the prospective purchaser 

prior to purchase. However, food 

manufacturers may have an incentive to 

work with vending machine operators to 

find ways to have their packaged food 

displayed with the Nutrition Facts 

easily readable in the vending machine. 

In this way, potential purchasers would 

have more information about the 

manufacturers’ food than just calories. 

2. Visible Nutrition Information at the 

Point of Purchase 

The second prong of section 

403(q)(5)(H)(viii)(I)(aa) specifies that if a 

vending machine ‘‘otherwise provide[s] 

visible nutrition information at the 

point of purchase’’ for an article of food 

sold from the machine, the vending 

machine operator is not required to 

provide the calorie information. As with 

the Nutrition Facts Panel this alternative 

means of satisfying the requirement of 

section 403(q)(5)(H)(viii) is optional for 

vending machine operators. 

The terms ‘‘visible nutrition 

information’’ and ‘‘point of purchase’’ in 

section 403(q)(5)(H)(viii)(I)(aa) are not 

defined in the statute. FDA sees two 

possible ways to understand and apply 

the terms. One approach is to conclude 

that (1) ‘‘nutrition information’’ in this 

context means total calories in the 

article of food, because this is the 

information that the vending machine 

operator must provide by sign if the 

provisions in section 

403(q)(5)(H)(viii)(I)(aa) are not met; and 

(2) ‘‘otherwise provide[d] * * * at the 

point of purchase’’ suggests, in the 

context of the provision as a whole, that 

the information, like the Nutrition Facts 

Panel, should be on the article of food 

itself. FDA proposes this approach in 

proposed § 101.8(b). 

FDA received several comments 

supporting the use of ‘‘front of package’’ 

nutrition information contained on the 

food label as a means of ‘‘providing 

visible nutrition information at the 

point of purchase.’’ For example, some 

packaged food manufacturers 

voluntarily place certain nutrition 

information on the principal display 

panel that includes calorie and other 

nutrition information about the product. 

This type of nutrition information is 

sometimes referred to as ‘‘front of 

package’’ by industry, whereas Nutrition 

Facts typically appear on the 

information panel of a food label. FDA 

tentatively concludes that ‘‘front of 

package’’ nutrition information could be 

a way to provide visible nutrition 

information, so long as the criteria for 

color, font and type size are met and 

total calories in the article of food are 

included. If a nutrient content claim or 

a health claim for the article of food also 

is included on the front of the package, 

the claim must comply with relevant 

FDA regulations authorizing nutrient 

content claims (a claim on food labeling 

regarding the level of a nutrient, e.g., 

low fat) or health claims (a claim on 

food labeling regarding the relationship 

between a substance and a disease, e.g., 

calcium and osteoporosis), as 

applicable. 

FDA also received a few comments 

stating that the Nutrition Facts Panel 

and any ‘‘front of package’’ nutrition 

information may be small and difficult 

to read in a vending machine. FDA 

recognizes that a consumer may not be 

able to easily read some nutrition 

information in a vending machine and 

therefore this information may not 

inform the consumer about the number 

of total calories in the article of food. 

Section 101.8(b) of this proposed rule 

sets out the provisions regarding ‘‘visible 

nutrition information at the point of 

purchase’’ discussed above. 

Under proposed § 101.8(b), for the 

nutrition information on the label to be 

considered ‘‘visible,’’ it must be clear 

and conspicuous. To ensure that it is 

clear and conspicuous, it must be both 

(1) in a type size easily readable from 

the distance between the prospective 

purchaser and the label and (2) in print 

with sufficient color and contrasting 

background to be readily 

distinguishable from other types of 

information on the label. FDA 

tentatively concludes that the visible 

nutrition information presented on the 

label of the food at the point of purchase 

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. Generally, 

FDA has considered ‘‘reasonably 

related’’ to mean a type size that is at 

least 50 percent of the size of the largest 

print on the label. (Ref. 2). 

The alternative approach is to 

interpret the words ‘‘otherwise provide 

visible nutrition information at the 

point of purchase’’ by concluding that 

(1) ‘‘nutrition information’’ means 

something more than total calories, and 

(2) ‘‘point of purchase’’ means something 

more than on the package of the food 

itself. Under this interpretation, the 

non-Nutrition Facts Panel option in the 

statute would include information in 

addition to total calories because the 

broader term ‘‘nutrition information’’ 

was used instead of ‘‘calories.’’ Just as 

the Nutrition Facts Panel contains more 

than calorie information, so too, would 

‘‘visible nutrition information at the 

point of purchase.’’ This 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 as 

described in § 101.9 or 21 U.S.C. 

343(q)(1)(D) and (E). FDA seeks 

comment on what other nutrition 

information, if any, should be required 

if this alternative interpretation were 

adopted. FDA also notes that under this 

alternative interpretation, the vending 

machine operator could rely on any 

‘‘visible nutrition information at the 

point of purchase’’ that included total 

calories in addition to other nutrition 

information regardless of what entity 

supplied the information. 

Likewise, under the alternative 

approach, ‘‘point of purchase’’ would 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. 

In the case of the alternative 

interpretation, in which the ‘‘visible 

nutrition information at the point of 

purchase’’ appears other than on the 

label of the article of food, there are also 

the questions of where and through 

what means the information may be 

provided. The agency specifically 

requests 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’’ and we especially 

request any consumer studies or social 

scientific data on this issue. 

Regardless of the precise location or 

means of providing the nutrition 

information, under the alternative 

interpretation there would also be a 

question of ensuring that the 

information is adequately ‘‘visible.’’ At a 

minimum, the nutrition information 

should be clear and conspicuous and 

noticeable at the point of purchase, in 

the context of the surroundings. One 

way to ensure this visibility if the 

nutrition information is not on the label 

of the article of food would be to 

provide the information in type that is 

all black or one color, printed on a 

white or other neutral background that 

contrasts with the type color. Another 

way would be to also provide the 

information using a minimum type size. 

The agency requests comments on these 

and other ways to determine if the 

information is ‘‘visible.’’ 

Another aspect of whether 

information that is not on the food itself 

is visible to the consumer is where the 

information is placed relative to the 

‘‘point of purchase.’’ FDA requests 

comment on the meaning of ‘‘the point 

of purchase’’ in this context and on all 

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aspects of the alternative interpretation 

of ‘‘visible nutrition information at the 

point of purchase.’’ 

FDA seeks comment on the 

alternative approaches to interpreting 

and applying ‘‘otherwise provide visible 

nutrition information at the point of 

purchase.’’ 

G. Conforming Amendment 

FDA is proposing to exempt 

electronic signatures submitted to 

satisfy the requirements of this 

proposed section from the requirement 

to comply with Part 11—Electronic 

Records; Electronic Signatures (21 CFR 

part 11) and proposing to amend part 11 

to reflect this exemption. We expect this 

exemption to facilitate the registration 

process for those vending machine 

operators who voluntarily choose to 

register under section 403(q)(5)(H)(ix) of 

the FD&C Act. 

H. Effective Date 

FDA received a few comments 

regarding the effective date of the final 

rule that would issue based on this 

proposal. These comments suggested 

that vending machine operators would 

need 2 years to implement the 

requirements for calorie labeling for 

vending machines due to the costs of 

producing posters and driving to each 

site to post the information. 

FDA is proposing that the final rule 

become effective one year from the date 

of its publication. Because FDA is 

proposing flexibility for compliance, 

i.e., the use of signs in, on, or adjacent 

to vending machines, vending machine 

operators would be able to choose 

among a wide variety of less expensive 

avenues to achieve compliance, 

depending on their situation. Many 

foods sold from vending machines are 

packaged and have Nutrition Facts. 

Therefore, vending machine operators 

have the opportunity of orienting the 

food in the vending machine such that 

the prospective customer may examine 

the Nutrition Facts Panel. In this case, 

the operators would not need to provide 

calorie information required by 

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

the operator chooses not to orient the 

food such that the prospective customer 

may examine the Nutrition Facts Panel, 

or if it is not practicable to do so 

because the vending machine is not of 

the type where the food is visible, the 

operator may obtain the calorie 

information from the Nutrition Facts to 

place on the signs. Further, the 

proposed rule, if finalized, does not 

require any particular manner of 

obtaining calorie information. As 

discussed above in this document, FDA 

anticipates that, if a covered vending 

machine food does not bear Nutrition 

Facts because it falls under an 

exemption, the manufacturer or supplier 

of the food may provide the number of 

total calories for the food to the vending 

machine operator so that the operator 

has the necessary calorie information to 

meet the calorie disclosure requirements 

of section 403(q)(5)(H)(viii)(I). Because 

of the flexibility provided in this 

proposed rule, the Agency finds that it 

is reasonable to make the requirements 

effective in 1 year. Based on the 

comments and on what vending 

machine operators will need to do to 

come into compliance, the Agency 

tentatively finds that making the final 

rule effective 1 year after publication is 

practicable. The Agency seeks comment 

on the appropriateness of this 

timeframe. 

IV. Summary Preliminary Regulatory 

Impact Analysis 

The summary analysis of benefits and 

costs included in this document is 

drawn from the detailed Preliminary 

Regulatory Impact Analysis which is 

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

Docket No. FDA–2011–F–0171, and is 

also available on FDA’s Web site at 

http://www.fda.gov/Food/Labeling

Nutrition/ucm217762.htm. 

A. Introduction 

FDA has examined the impacts of the 

proposed rule under Executive Orders 

13563 and 12866, the Regulatory 

Flexibility Act (5 U.S.C. 601–612), and 

the Unfunded Mandates Reform Act of 

1995 (Pub. L. 104–4). Executive Orders 

13563 and 12866 direct agencies to 

assess all costs and benefits of available 

regulatory alternatives and, if regulation 

is necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). Executive Order 13563 

emphasizes the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. This 

proposed rule has been designated an 

‘‘economically’’ significant rule, under 

section 3(f)(1) of Executive Order 12866. 

Accordingly, the proposed rule has been 

reviewed by the Office of Management 

and Budget (OMB). 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Using the Small Business 

Administration (SBA) definition of 

small vending machine operators as 

classified by the North American 

Industry Classification System (NAICS 

45421), FDA estimates that a significant 

number of operators impacted by this 

proposed rule are small businesses. As 

directed by statute, the requirements of 

the proposed rule only apply to vending 

machine operators that own or operate 

20 or more vending machines. However, 

according to data from the Vending 

Times Census and from the National 

Automatic Merchandising Association 

(NAMA), the average annual revenue 

per machine is less than $7,000 (Refs. 3 

and 4). An operator with only 20 

machines may have vending machine 

revenue of less than $140,000. In order 

to exceed the SBA’s definition of a small 

vending machine operator, a firm would 

need at least $10 million in annual 

revenue (Ref. 5). This suggests that a 

firm with revenue exclusively from 

vending machine sales would need 

more than 1,400 machines to exceed the 

definition of small business. Based on 

the latest available U.S. Economic 

Census data that breaks down 

establishments by revenue, we project 

that 97 percent of firms selling covered 

vending machine food, as that term is 

used in this document, that identify 

primarily as vending machine operators 

that are engaged in the business of 

owning or operating 20 or more vending 

machines would be small businesses as 

defined by SBA. Therefore, the Agency 

believes that the proposed rule would 

have a significant economic impact on 

a substantial number of small entities. 

This impact is discussed further in 

section V of this document. 

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 $135 

million, using the most current (2009) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this proposed rule to result in any 1- 

year expenditure that would meet or 

exceed this amount. 

B. Need for This Regulation 

This proposed rule is necessary to 

implement section 4205 of the 

Affordable Care Act, which principally 

amends sections 403 and 403A of the 

FD&C Act, and requires operators of 20 

or more vending machines to disclose 

calorie information for covered vending 

machine food. The provision of calorie 

information for covered vending 

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machine food may help consumers 

make better informed dietary choices. 

Economic justifications for regulatory 

interventions in private markets rely on 

the presence of some market failure. In 

the case of food sold from a vending 

machine, the private market is 

particularly robust and competitive. 

Thousands of individual firms vie for 

consumer dollars in millions of vending 

machines across the United States (Ref. 

3). Low entry costs for firms and low 

switching costs for customers suggest 

that if a sizable fraction of consumers 

were willing to pay for—and 

discriminate based on—the visible 

calorie information at the point of 

purchase then the industry would 

provide it to them. In fact, some vending 

machine operators are voluntarily 

providing more healthful choices and 

additional information on machines 

(Refs. 4 and 6). 

Although many of the usual market 

failures that justify regulatory action, 

such as the existence of market power 

or of ill-defined property rights, do not 

apply here (Refs. 7 and 8), the primary 

support for regulatory intervention is 

that there are systematic biases in how 

consumers process information and 

weigh current benefits (from consuming 

higher calorie foods) against future costs 

(higher probability of obesity and its 

comorbidities). 

The bias is more directly related to 

the requirements of this proposed rule: 

Consumer demand for calorie 

information does not create incentives 

for the provision of calorie information 

at the vending machine. This market 

failure occurs because at the time of 

purchase, consumers do not value 

calorie information as much as they do 

later, when the effects of excess calorie 

consumption are evident. Studies have 

shown that consumers have presentbased preferences, meaning that they are 

continually optimistic about the 

healthfulness of their future choices 

(Ref. 9, 10 and 11). 

These studies suggest that calorie 

information often lacks salience, or 

relevance, for consumers at the time of 

purchase and consumption, even 

though they may experience regret 

about their decisions at a later date. This 

tendency may explain why consumers 

have not generally demanded calorie 

and other nutrition information for food 

sold from vending machines before, or 

at, the point of purchase, even if they 

may, at a later point in time, value that 

information. Because of competition for 

consumer time and attention vending 

machine operators have limited time 

and space in which to convey 

information to consumers. These limits 

mean that there is a substantial 

opportunity cost to the operator of 

providing calorie information. That is, 

just as an operator may have to decide 

which possible foods to leave out of a 

vending machine with limited space 

(thus giving up the opportunity to sell 

those items), it must choose which 

pieces of information about its foods it 

wants to convey. Adding an additional 

piece of information means that an 

operator may need to downplay or 

remove some other piece of information. 

This opportunity cost of information 

holds true whether the calorie 

information is displayed on the machine 

or, as with an increasing number of 

packaged foods, on the principal display 

panel of the package. 

The proposed requirements mitigate 

the apparent market failure in 

information provision stemming from 

present-biased preferences, although not 

necessarily the tendency of consumers 

to underutilize that information. 

Specifically, for a covered vending 

machine food, this proposed rule 

requires that the vending machine 

operator provide a sign in close 

proximity to the food or the 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 number. This information 

must be presented in a color that is 

sufficiently contrasted with the 

background, must be in close proximity 

to the vignette or name or in close 

proximity to the selection button when 

a name or vignette is displayed, and, for 

electronic vending machines, the calorie 

information may be displayed when the 

selection numbers are entered but before 

the selection is confirmed. These 

requirements are designed so that the 

calorie information is made available to 

consumers before they purchase such 

food. Providing the information will 

likely increase consumer awareness 

regarding the calorie content in covered 

vending machine food and increase the 

perceived relevance of that information 

to their decision making. Providing the 

information may serve to highlight the 

potential future costs of additional 

calorie consumption. This increased 

attention to the caloric content of 

covered vending machine food may 

then result in an increased availability 

of lower calorie options, and an 

increased demand for these options. 

C. Summary of Costs and Benefits of the 

Proposed Requirements and Regulatory 

Options 

In this section FDA describes the 

bases of benefits and costs of the 

proposed requirements and summarizes 

the results of the detailed Preliminary 

Regulatory Impact Analysis (PRIA). 

Benefits in response to the proposed 

requirements Obesity is a major public 

health concern in the United States and 

one of the top leading health indicators 

addressed by the United States Healthy 

People 2020 goals. Nationally 

representative data indicate an increase 

in the prevalence of obesity over the 

past three decades (Ref. 12). The 2007– 

2008 National Health and Nutrition 

Examination Survey (NHANES) data 

showed that 34 percent of the adult U.S. 

population is obese and 34 percent are 

overweight (Ref. 13). 

Excess body weight has many health 

(Ref. 14), social (Refs. 15 and 16), 

psychological (Refs. 17 and 18), and 

economic consequences (Ref. 19) for the 

affected individuals. Lower life 

expectancy, elevated risk of diabetes, 

hypertension, stroke and other 

cardiovascular diseases have been 

documented to rise simultaneously with 

the increased prevalence of obesity (Ref. 

14). The economic impact is especially 

evident in health-care costs in terms of 

greater health-care utilization and 

higher medical expenditures (Ref. 20). 

More specifically, medical expenditures 

attributable to overweight and obesity 

accounted for more than 9 percent of the 

total U.S. medical expenditures in 1998, 

or between $85.7 billion and $147 

billion (Ref. 20). Researchers have 

proposed various factors to explain this 

dramatic rise in obesity including 

declining food prices and physical 

requirements of labor (Refs. 21 and 22), 

declining time costs of food preparation 

(Ref. 23), fast-food restaurant density 

(Ref. 24) and social interactions (Refs. 

25). 

Although the relationship between 

obesity and poor dietary choices is 

multi-faceted, there is a general 

agreement in the literature that 

reduction in excess calories is helpful in 

preventing or delaying the onset of 

excess weight gain (Ref. 26). Vending 

machines are a likely source of highcalorie snack or discretionary foods, as 

well as some high-calorie meal items. 

Industry data indicate that there is 

approximately one vending machine for 

every 40 adults in the United States, and 

that up to 5 percent of the money 

consumers spend on food away from 

home is spent on vending machine food 

(Ref. 27). This suggests that providing 

calorie information for covered vending 

machine food to consumers may have a 

significant effect on calorie intake, the 

prevalence of obesity, and thus the cost 

of health care and lost productivity. 

To the extent that the proposed 

requirements mitigate the increase in 

the prevalence of obesity and the 

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prevalence of these costly comorbidities such as hypertension and 

diabetes, society gains the opportunity 

cost of the averted medical expenditures 

and an increase in productivity from 

averted debilitation and death. In 

addition to educating consumers about 

calorie content, major predicted 

elements of the consumer and industry 

response to this proposed rule are: 

1. Increased awareness regarding the 

caloric content in covered vending 

machine foods, and the perceived 

relevance of that information to decision 

making, which may help reduce the 

present-bias in preferences, and thus 

encourage the consumption of lower 

calorie options. 

2. Increased consumer interest in 

lower calorie options, and greater 

transparency in the caloric content of 

foods sold in vending machines, which 

may give manufacturers an incentive to: 

a. Reduce the calorie content of foods 

sold in vending machines through 

reformulation or by decreasing portion 

size. 

b. Provide additional items with 

lower calorie formulations. 

These changes may reduce 

consumers’ caloric intake from food 

sold in vending machines. Note that any 

reduction in calorie intake in these 

settings may be at least partially offset 

by increases in calorie intake during 

other meals or snacks. Because FDA 

lacks data on how consumers will 

substitute among caloric sources, the 

benefit estimations given here may be 

higher or lower than those that will be 

realized if the rule is finalized as 

proposed. 

Coverage of the proposed rule and 

industry overview. The proposed rule 

covers certain vending machine 

operators that are engaged in the 

business of owning or operating 20 or 

more vending machines and those 

vending machine operators that 

voluntarily register with FDA to become 

subject to the Federal requirements. The 

proposed rule does not cover vending 

machines without a selection button, 

including bulk vending machines that 

dispense gum, candy and nuts. Vending 

machines are operated both by food 

service firms and by firms in other 

businesses that operate machines for the 

benefit of their customers or employees 

and do not identify as vending machine 

operators. Because this latter group 

cannot be accurately counted, published 

estimates of the number of vending 

machine operators will generally 

undercount the number of covered 

operators under the proposed rule. For 

the purposes of this preliminary 

regulatory impact analysis, we will use 

the term ‘‘covered operators’’ or ‘‘covered 

vending machines’’ to refer to operators 

or machines that sell covered vending 

machine foods. According to the 

NAMA, there are approximately 13,500 

companies that operate vending 

machines in the United States (Ref. 4). 

Other estimates put the total closer to 

10,000 (Ref. 3). This total includes 5,000 

firms whose primary business 

identification is as vending machine 

operators (NAICS 4542), plus a variety 

of other firms that operate vending 

machines, but do not primarily identify 

as such. These other companies include, 

for example, beverage manufacturers 

and food service contractors. Because of 

the difficulty in determining which 

firms are covered, and because FDA has 

no data on the potentially significant 

number of covered vending machine 

operators that self-identify as businesses 

outside the food industry, we take 

NAMA’s higher estimate of 13,500 firms 

as the number of covered firms. 

FDA estimates that 97 percent of firms 

selling covered vending machine food 

that identify primarily as vending 

machine operators that are engaged in 

the business of owning or operating 20 

or more vending machines are small 

businesses as defined by the SBA. Other 

estimates indicate that more than 90 

percent of the firms covered by the 

proposed rule are defined as small 

businesses (Ref. 3). This percentage may 

be lower for firms that have primary 

business identification other than as 

vending machine operators, but the 

majority of covered businesses will 

likely still be defined as small 

businesses. Because very small, 

informal businesses that are not 

captured by economic census data 

might operate 20 or more machines, 

these figures may underestimate the 

number of affected small businesses. 

Conversely, approximately 72 percent of 

industry revenue—and thus a 

comparably large fraction of 

consumption—comes from firms with 

more than $10 million in annual sales, 

and 85 percent comes from firms with 

more than $5 million in revenue 

(Ref. 3). 

Vending machine operators together 

operate an estimated 5 to 7 million 

machines (Refs. 3 and 4) in at least 1.5 

million locations (Ref. 3). 

Approximately 70 percent of these 

machines sell packaged food, including 

beverages, that are required to bear 

nutrition labeling under section 

403(q)(1) of the FD&C Act and FDA 

regulations at § 101.9, and thus have 

Nutrition Facts. This 70 percent is 

comprised mostly of packaged beverage 

machines, which account for more than 

50 percent of all vending machines, 

with the remainder—approximately 20 

percent of all machines—selling 

packaged confections or snacks. Ten 

percent sell a variety of hot and cold 

cup beverages, frozen or fresh food 

products and miscellaneous other food 

products. The final 20 percent of 

machines are bulk candy, nut or gum 

machines that are not covered by 

section 403(q)(5)(H)(viii) and the 

proposed requirements because they 

lack selection buttons. While these bulk 

machines form a large percentage of 

vending machines, they account for less 

than 0.5 percent of vending machine 

sales (Ref. 4). 

Summary of costs and benefits of the 

proposed rule and regulatory options In 

this section we briefly summarize the 

costs and benefits of the proposed rule 

that are analyzed in the detailed PRIA. 

These estimates are collected in table 1. 

Costs of complying with the proposed 

requirements have been estimated for 

three major areas: Cost of nutrition 

analysis, cost of new signs, including 

posters, and labor costs. In the case of 

the proposed rule, FDA estimates that 

there would be approximately 10,800 

operators under the proposed 

requirements, controlling between 4 

million and 5.6 million machines that 

sell covered vending machine foods. 

The initial mean estimated cost of 

complying with the proposed 

requirements is $25.8 million, with an 

estimated mean ongoing cost of $24.0 

million. Mean annualized costs are 

$24.5 million at a 7 percent discount 

rate, and $24.2 million at 3 percent 

discount rate. Per operator costs are 

estimated to be $2,400. FDA estimates 

that average per machine costs are less 

than $10 annually. 

FDA has not estimated the actual 

benefits associated with proposed 

requirements. Food choice and 

consumption decisions are complex and 

FDA is unaware of any comprehensive 

data allowing accurate predictions of 

the effect of the proposed requirements 

on consumer choice and vended foods. 

Therefore, FDA has constructed a 

plausible individual effect of the 

proposed rule, and has conducted a 

break-even analysis in order to 

determine the proportion of the U.S. 

obese adult population that would need 

to attain this minimal response in order 

for the proposed requirement to yield a 

positive net benefit. Using a 100 calorie 

per week reduction in intake as the 

benchmark effect, FDA estimates that at 

least 0.02 percent of the adult obese 

population would need to reach this 

benchmark in order for the rule to break 

even on the initial total cost. On an 

ongoing basis, again, at least 0.02 

percent of the adult obese population 

would need to reach this benchmark in 

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19248 Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Proposed Rules 

order for the rule to break even on the 

recurring annual costs. These effects are 

summarized in table 1 of this document. 

Finally, although registration by firms 

wishing to register with FDA in order to 

come under the proposed requirements 

and the associated preemption from 

State or local regulations is voluntary, 

and will only occur to the extent that 

the costs of registration and compliance 

with Federal regulation is lower than 

that of State or local laws, this 

registration constitutes a collection of 

information under the Paperwork 

Reduction Act of 1995. Therefore, FDA 

has also estimated the burden associated 

with this collection of information in 

the detailed analysis. 

TABLE 1—ACCOUNTING STATEMENT: ANNUALIZED COST AND BREAK-EVEN BENEFIT POINT FOR THE PROPOSED

REQUIREMENTS

Primary 

estimate 

Low 

estimate 

High 

estimate 

Year 

dollar 

Discount 

rate 

Period 

covered 

Benefits 

Annualized Monetized ($millions/year) ............................ Not Quantified 

Annualized Quantified: 

Qualitative: FDA estimates that at least 0.02 percent of the adult obese population would need to reduce caloric intake by at least 100 calories 

per week in order for benefits from the proposed requirements to reach a break even point on annualized costs (at either 3% or 7%) 

Costs 

Annualized Monetized ($millions/year) ............................ $24.5 $12.5 $39.8 2009 7% 10 

24.2 12.1 39.6 2009 3% 10 

Regulatory Options In addition to a 

baseline, FDA has identified four 

regulatory options for this proposed 

rule. The costs and benefits of these 

options are summarized in table 2 of 

this document. 

(0) Baseline for the purpose of 

analysis—No new Federal regulatory 

action. 

(1) Option 1, the proposed rule, 

allowing 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 number, and 

with an effective date of 1 year after 

publication of the final rule. 

(2) Option 2, similar to the proposed 

rule, but requiring that calorie 

declarations be immediately adjacent to 

the article of food or selection button for 

all calorie disclosures. For this option, 

FDA estimates the cost of individual 

signs for each article of food or selection 

button. 

(3) Option 3, Similar to the proposed 

rule, but with an additional year in 

compliance period for vendors with less 

than $500,000 in annual revenue from 

vending machines. 

(4) Option 4, similar to the proposed 

rule, but with coverage extended to bulk 

vending machines without selection 

buttons. 

TABLE 2—SUMMARY OF ESTIMATED ANNUALIZED COMPLIANCE COSTS FOR EACH OPTION

Summary of options 

Primary 

estimate 

(in millions) 

Low estimate 

(in millions) 

High estimate 

(in millions) 

Percent 

discount rate 

(10 year 

horizon) 

Proportional 

cost relative to 

primary 

estimate of the 

proposed 

requirements 

Proportional 

dollar sales of 

restaurant 

food relative to 

primary estimate of the 

proposed 

requirements 

(Baseline) ................................................. N/A N/A N/A N/A N/A 

Option 1: the Proposed Rule ................... $24.2 

24.5 

$12.1 

12.5 

$39.6 

39.8 

3% 

7% 

0.0% 0.0% 

Option 2: Individual Signs ........................ 81.8 

82.5 

36.1 

36.6 

140.4 

141.1 

3% 

7% 

+229.2% 0.0% 

Option 3: Longer Compliance Time for 

Small Businesses ................................. 24.2 

24.5 

12.1 

12.5 

39.6 

39.8 

3% 

7% 

0.0% 0.0% 

Option 4: Extended Scope to Include 

Bulk Machines ...................................... 30.2 

31.0 

15.1 

15.8 

49.4 

50.3 

3% 

7% 

+25.6% +0.5% 

FDA estimates that Option 2, which 

would require individual signs or labels 

for each covered vended food, has a tenyear annualized costs of between $36.1 

million per year and $140.4 million per 

year at a 3 percent discount rate, with 

a primary estimate of $81.8 million. 

Averaged over primary, low and high 

estimates, the costs of Option 2 are 

229.2 percent higher than those of the 

proposed requirements. These changes 

are discussed more fully in the detailed 

analysis. 

Option 3 which considers a longer 

compliance time for small businesses 

represents only a delay in the costs. 

This delay has a small positive impact 

on the annualized cost, but one that 

does not change the (rounded) estimate 

of costs for Option 3 from the estimate, 

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of costs for Option 1. Option 4, expands 

the scope of the requirements to include 

foods in bulk vending machines without 

selection buttons, has costs that are 25.6 

percent higher than the proposed 

option, and covers an additional 0.5 

percent of sales of vended foods. 

For full documentation and 

discussion of these estimated costs and 

benefits see the detailed Preliminary 

Regulatory Impact Analysis, available at 

http://www.regulations.gov, Docket No. 

FDA–2011–F–0171, and is also available 

on FDA’s Web site at http://www.

fda.gov/Food/LabelingNutrition/

ucm217762.htm. 

V. Initial Regulatory Flexibility 

Analysis 

FDA has examined the economic 

implications of this proposed rule as 

required by the Regulatory Flexibility 

Act (5 U.S.C. 601–612). If a rule has a 

significant economic impact on a 

substantial number of small entities, the 

Regulatory Flexibility Act requires 

agencies to analyze regulatory options 

that would lessen the economic effect of 

the rule on small entities consistent 

with statutory objectives. FDA 

tentatively concludes that this proposed 

rule will have a significant economic 

impact on a substantial number of small 

entities. 

However, FDA has built flexibility 

into the proposed rule. The proposed 

rule does not mandate a particular 

method for determining calorie 

disclosure; instead, the proposed rule 

provides options for how vending 

machine operators can determine 

calorie information for covered vending 

machine food. Further, the proposed 

rule does not prescribe the materials 

that may be used by vending machine 

operators in disclosing calorie 

information; instead, the proposed rule 

provides options for how vending 

machine operators can disclose calorie 

information for covered vending 

machine food. Therefore, vending 

machine operators may choose among a 

wide variety of less, or more, expensive 

avenues to achieve compliance, 

depending on their situation. Because 

no particular method for compliance is 

mandated, the proposed rule gives small 

businesses the leeway to use cheaper 

solutions that meet the requirements of 

the proposed rule (e.g., stickers). 

A general way to add flexibility for 

small firms during a rulemaking is to 

lengthen the time for these firms to 

comply with the rule. An example of a 

delayed compliance time for small 

businesses applied to this proposed rule 

is the option for vendors with less than 

$500,000 in annual revenue from 

vending machine food sales to have an 

additional year to comply. Generally, 

FDA uses the SBA’s definition of ‘‘small 

business’’ as it applies to the relevant 

economic sector, in this case, NAICS 

4542. However, as noted in the detailed 

Preliminary Regulatory Impact Analysis, 

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

Docket No. FDA–2011–F–0171, and is 

also available on FDA’s Web site at 

http://www.fda.gov/Food/Labeling

Nutrition/ucm217762.htm, SBA defines 

a small vending machine operator as 

one with annual revenue less than $10 

million, and this definition would cover 

at least 97 percent of the industry. 

Adding flexibility—such as a longer 

time to come into compliance— 

specifically for small firms would mean 

that most vending machine operators 

would be given that added flexibility. 

Therefore FDA has taken the approach 

of building substantial flexibility into 

the proposed rule for most vending 

machine operators in order to give the 

entire industry the opportunity to 

comply in the most cost-effective way. 

VI. Paperwork Reduction Act 

This proposed rule contains 

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). A description of 

these provisions is given in the 

following paragraphs with an estimate 

of the annual reporting and 

recordkeeping burden. Included in the 

estimate is the time for reviewing 

instructions, searching existing data 

sources, gathering and maintaining the 

data needed, and completing and 

reviewing each collection of 

information. 

The information collection provisions 

for all provisions of this proposed rule 

have been submitted to OMB for review 

as revisions of collections approved 

under OMB control numbers 0910–0664 

and 0910–0665. Interested persons are 

requested to fax comments regarding 

information collection by May 6, 2011, 

to the Office of Information and 

Regulatory Affairs, OMB. 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: 

202–395–5806. 

FDA invites comments on: (1) 

Whether the proposed collection of 

information is necessary for the proper 

performance of FDA’s functions, 

including whether the information will 

have practical utility; (2) the accuracy of 

FDA’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Vending Machine Labeling: 

Recordkeeping and Mandatory Third 

Party Disclosure Under Section 4205 of 

the Patient Protection and Affordable 

Care Act of 2010—(OMB Control 

Number 0910–0665)—Revision 

Section 4205 of the Affordable Care 

Act, which amends sections 403(q)(5) 

and 403A of the FD&C Act, requires 

disclosure of calorie and other nutrition 

information by restaurants and vending 

machine operators. Section 4205 

became effective on the date the law 

was signed, March 23, 2010. Restaurants 

and vending machine operators not 

subject to the requirements of section 

403(q)(5)(H) may elect to become subject 

to the requirements of section 

403(q)(5)(H) by registering biannually 

with FDA. Section 4205 required FDA 

to publish a notice in the Federal 

Register within 120 days of the date of 

enactment of section 4205, providing 

information on the terms and conditions 

for persons who voluntarily elect to be 

subject to nutrition disclosure 

requirements specified in the law. 

A. Statutory Compliance 

To comply with the PRA and with the 

statutory deadline under the provisions 

of section 4205 for publication of 

registration information, FDA initially 

obtained a 6-month OMB approval of 

the collection of information 

requirements under the emergency 

processing provisions of the PRA. With 

OMB approval of the collection of 

information requirements of section 

4205, FDA took several actions: (1) 

Developed an electronic form, ‘‘Menu 

And Vending Machine Labeling 

Voluntary Registration,’’ Form FDA 

3757, (2) as required by section 4205, 

published a notice in the Federal 

Register of July 23, 2010 (75 FR 43182) 

(the July 23, 2010, notice) to explain 

how retail food establishments and 

vending machine operators not 

otherwise subject to the provisions of 

section 4205 may voluntarily elect to 

become subject to them, and (3) 

developed and implemented the 

guidance 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 

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19250 Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Proposed Rules 

Laws.’’ This guidance among other 

things clarified section 4205’s effect on 

State and local menu and vending 

machine labeling laws, to ensure that 

industry and State and local government 

understood the immediate effects of the 

law. FDA’s current thinking on the 

preemptive effects of section 4205 is set 

out in the Federalism sections of the 

preamble to the proposed rule 

implementing menu labeling and this 

proposed rule. 

FDA has requested a 3-year approval 

of the information collection 

requirements under the same assigned 

OMB Control Nos. 0910–0664 and 

0910–0665. In the Federal Register of 

January 31, 2011, FDA published two 

notices announcing the submission to 

OMB of the information collection 

requests for No. 0910–0664 (76 FR 5384) 

and No. 0910–0665 (76 FR 5380). 

Elsewhere in this Federal Register, FDA 

published a proposed rule entitled 

‘‘Food Labeling; Nutrition labeling of 

standard menu items in restaurants and 

similar retail food establishments’’ (the 

Menu Labeling proposed rule). As 

noted, the information collection 

requests previously submitted sought 

OMB approval of the reporting, 

recordkeeping, and third party 

disclosure burdens of section 4205, not 

the provisions of the Menu Labeling 

proposed rule. With that proposed rule, 

FDA submitted a revised information 

collection request seeking OMB 

approval of the changes caused by the 

Menu Labeling proposed rule to the 

collections approved under OMB 

Control Nos. 0910–0664 and 0910–0665. 

This proposed rule seeks further 

revision of those information collections 

with regard to the recordkeeping and 

third party disclosure burdens for 

vending machine operators caused by 

this proposed rule. 

B. Revision of OMB Control No. 0910– 

0665 by the Proposed Rule 

These estimated annual 

recordkeeping burdens have changed 

from the burdens estimated for the OMB 

control number 0910–0665 30 day 

notice (76 FR 5380, January 31, 2011). 

Total initial hours have risen by 1,920 

due to an increase in the estimated 

number of recordkeepers from 600 to 

915 and an increase in the number of 

hours per record from 2 hours to 4 

hours. The estimated burden of 

recurring hours increased by 8 hours to 

128 hours. This estimate of third party 

disclosure hours has decreased by 

approximately 13.2 million hours, from 

the 14 million hours estimate given in 

the 30-day notice. 

C. Consolidation of OMB Control No. 

0910–0664 Under 0910–0665 

The Menu Labeling proposed rule 

contains a revision request in which the 

burden hours for the information 

collection request under OMB control 

number 0910–0664, ‘‘Restaurant Menu 

and Vending Machine Labeling: 

Registration for Small Chains Under 

Section 4205 of the Patient Protection 

and Affordable Care Act of 2010’’ are 

being consolidated under the 

information collection request assigned 

OMB control number 0910– 

0665,’’Restaurant Menu and Vending 

Machine Labeling: Recordkeeping and 

Mandatory Third Party Disclosure 

Under Section 4205 of the Patient 

Protection and Affordable Care Act of 

2010.’’ In addition, this proposed rule is 

a revision request in which these two 

information collection requests will be 

further revised with regard to the 

estimated burden of the proposed rule 

on vending machine operators. The 

revised information collection request 

for 0910–0665 will be renamed 

‘‘Restaurant Menu and Vending Machine 

Labeling: Registration, Recordkeeping 

and Mandatory Third Party Disclosure 

Under Section 4205 of the Patient 

Protection and Affordable Care Act of 

2010.’’ Upon approval of this revision 

request, the information collection 

request for OMB control number 0910– 

0664 will be discontinued. 

D. Analysis of Changes in Burden 

Estimates Caused by the Proposed Rule 

Description of Respondents: The 

likely respondents to this information 

collection are operators of 20 or more 

vending machines. The following 

analysis provides FDA’s estimate of the 

changes caused by this proposed rule to 

the previously approved recordkeeping 

and third party disclosure burdens for 

vending machine operators. The 

analysis of burden included in this 

document is drawn from the detailed 

Preliminary Regulatory Impact Analysis 

which is available at http:// 

www.regulations.gov, Docket No. FDA– 

2011–F–0171, and is also available on 

FDA’s Web site at http://www.fda.gov/

Food/LabelingNutrition/

ucm217762.htm. 

Most food sold from vending 

machines is subject to nutrition labeling 

requirements under section 403(q) of the 

FD&C Act and § 101.9, which means 

that calorie content is already collected. 

A likely scenario in response to vending 

machine labeling is that food 

manufacturers will include a set of 

calorie label stickers in each case of 

product. This would be efficient both 

because most manufacturers will 

already have the calorie information 

available, and because economies of 

scale exist for the manufacturer. In this 

case, vending machine operators will 

not need to keep a record of calorie 

content. Instead, the burden for most 

operators will be limited to that of 

creating records and passing the existing 

information on to consumers. 

FDA estimates that there is an average 

of 600,000 machines that sell 

unpackaged products. FDA tentatively 

estimates that between 5 and 10 percent 

of all operators of vending machines 

with covered vending machine food, or 

an average of 810 operators, will need 

to acquire nutrition information for at 

least some covered vending machine 

food. FDA tentatively estimates that 

there are between 5 to 10 covered 

vending machine foods that do not 

include nutrition information per 

operator, so that the average number of 

possible new calorie analyses would be 

6,480 (8 items/firm x 810 firms). FDA 

requests comment on these estimates. 

Based on data from FDA’s 

Recordkeeping Cost Model (Ref. 28), we 

estimate approximately 4 hours as the 

time per covered vending machine food 

for creating the record of nutritional 

information. Although the proposed 

rule does not mandate recordkeeping, 

vending machine operators will likely 

need to be able to ensure that calorie 

disclosures for covered vending 

machine foods are accurate and 

consistent without needing to re-analyze 

these foods. The estimated number of 

hours required for new calorie analysis 

in the first year is then 25,920 hours. 

This number is displayed in the first 

row of table 3 of this document. 

FDA believes that the subgroup of 

covered vending machine foods sold in 

these vending machines is 

approximately constant. If there is 0.5 

percent growth or turnover in the 

number of firms providing these 

unpackaged foods, then approximately 

four new firms will become subject to 

section 4205 of the Affordable Care Act 

and the proposed requirements in a 

given year. The burden associated with 

these firms would be 128 hours (4 firms 

× 8 items/firm × 4 hours/item). This 

amount is given in second row of table 

7 of this document. 

These estimated annual 

recordkeeping burdens have changed 

from the burdens estimated for the OMB 

control number 0910–0665 30-day 

notice (76 FR 5380, January 31, 2011). 

Total initial hours have risen by 1,920 

due to an increase in the estimated 

number of recordkeepers from 600 to 

915 and an increase in the number of 

hours per record from 2 hours to 

4 hours. The estimated burden of 

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recurring hours increased by 8 hours to 

128 hours. This change is due to an 

increase in the estimated number of new 

operators (which stems from the 

increase in the number of initial 

recordkeepers), and the increase in the 

number of hours per record. These 

changes are due to additional data and 

analysis that FDA was able to collect in 

the interim. 

TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN: CALORIE ANALYSIS AND RECORDING

Type of response Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

(in hours) 

Total hours 

Total capital 

costs for 

recordkeeping 

Initial hours for vending operators ........ 810 8 6,480 4 25,920 $1.3 million. 

Recurring hours for vending operators 4 8 32 4 128 $6,400. 

Total ............................................... ........................ ........................ ........................ ........................ 26,048 

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

The third party disclosure burden for 

vending machine operators is the time 

necessary to install calorie displays on 

their vending machines. In the PRIA, 

FDA estimates an average, recurring 

hourly burden of 0.17 hours per 

machine per year to install and maintain 

the displays. FDA estimates an average 

of 4.8 million machines are serviced by 

10,800 operators, for an average number 

of machines per operator of 444 

machines. The estimated recurring 

hours needed for third party disclosure 

is then 816,000 hours (10,800 firms × 

444 machines/firm × 0.17 hours/ 

display). This amount is recurring in 

every year, and is given in table 4 of this 

document. 

These estimated annual third party 

disclosure burdens have changed from 

the burdens estimated for the OMB 

Control Number 0910–0665 30-day 

notice (76 FR 5380, (Jan. 31, 2011)). This 

estimate of third party disclosure hours 

has decreased by approximately 13.2 

million hours, from the 14 million hours 

estimate given in the 30-day notice. In 

addition, we no longer estimate any 

growth in the number of hours, given 

that data shows no significant increase 

in the number of vending machines over 

the last several years. These changes are 

due to additional data and analysis that 

FDA was able to collect in the interim. 

TABLE 4—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN: CALORIE CONTENT

Type of respondent Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

(in hours) 

Total hours Total capital 

costs 

Total operating 

costs 

Recurring burden 

for vending operators.

10,800 444 4,800,000 0.17 816,000 $4.8 million ....... $19.2 million. 

The current total reporting burden for 

menu labeling and vending machine 

operator registration as required by 

section 4205, now under review at OMB 

under No. 0910–0664, is 820 hours. The 

estimated reporting burden under the 

Menu Labeling proposed rule is 2,190 

hours, an increase of 1,370 hours. As 

described in the paperwork analysis in 

that proposed rule, this increase is due 

to an increase in the estimated number 

of respondents. This proposed rule does 

not further revise those estimates. 

In compliance with the PRA, the 

agency has submitted the information 

collection provisions of this proposed 

rule to OMB for review. Interested 

persons are requested to send comments 

regarding the information collection to 

OMB (see DATES and ADDRESSES sections 

of this document). 

VII. Federalism 

FDA has analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. Section 

4(a) of the Executive order requires 

agencies to ‘‘construe * * * a Federal 

statute to preempt State law only where 

the statute contains an express 

preemption provision or there is some 

other clear evidence that the Congress 

intended preemption of State law, or 

where the exercise of State authority 

conflicts with the exercise of Federal 

authority under the Federal statute.’’ 

Federal law includes an express 

preemption provision that preempts 

‘‘any requirement for nutrition labeling 

of food that is not identical to the 

requirement of section [21 U.S.C. 

343(q)]’’ (21 U.S.C. 343–1(a)(4)), 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 

voluntary provision of nutrition 

information requirements under [21 

U.S.C. 343(q)(5)(H)(ix)].’’ (21 U.S.C. 343– 

1(a)(4)). If this proposed rule is made 

final, the final rule would create 

requirements for nutrition labeling of 

food under 21 U.S.C. 343(q) that would 

preempt certain non-identical State and 

local nutrition labeling requirements. 

Section 4205 of the Affordable Care 

Act 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 

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19252 Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Proposed Rules 

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)].’’ 

(Pub. L. 111–148, § 4205(d), 124 Stat. 

119, 576 (2010)0. 

FDA interprets the provisions of 

Section 4205 of the Affordable Care Act 

related to preemption to mean that 

States and local governments may not 

impose nutrition labeling requirements 

for food sold in vending machines that 

must comply with the Federal 

requirements of 21 U.S.C. 343(q)(5)(H), 

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 21 U.S.C. 

343(q)(5)(H)(viii) or (2) from vending 

machines operated by a person not 

subject to the requirements of 21 U.S.C. 

343(q)(5)(H)(viii) who voluntarily elects 

to be subject to those requirements by 

registering biannually under 21 U.S.C. 

343(q)(5)(H)(ix). 

Otherwise, for food sold from vending 

machines not subject to the nutrition 

labeling requirements of 21 U.S.C. 

343(q)(5)(H)(viiii), States and localities 

may impose nutrition labeling 

requirements. Under FDA’s 

interpretation of the Rule of 

Construction in section 4205(d)(1) of the 

Affordable Care Act, nutrition labeling 

for food sold from these vending 

machines would not be ‘‘nutrient 

content disclosures of the type required 

under [21 U.S.C. 343(q)(5)(H)]’’ 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 21 

U.S.C. 343(q)(5). This interpretation is 

consistent with the fact that Congress 

included vending machine operators in 

the voluntary registration provision of 

21 U.S.C. 343(q)(5)(H)(ix). 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 nonidentical nutrition labeling for food sold 

from any vending machines. 

An alternative to FDA’s interpretation 

of the provisions of section 4205 of the 

Affordable Care Act related to 

preemption 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 [21 U.S.C. 343(q)(5)(H)]’’ and 

would not fall within the exception to 

preemption in 21 U.S.C. 343–1(a)(4) 

(‘‘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 

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 

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 issued 

by FDA on August 25, 2010 (‘‘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)). Federal law 

provides that, upon petition, FDA may 

exempt State or local requirements from 

the express preemption provisions of 21 

U.S.C. 343–1(a) under certain 

conditions. 21 U.S.C. 343–1(b). FDA has 

promulgated regulations at 21 CFR 

100.1 describing the petition process 

that is available to State and local 

governments to request such 

exemptions from preemption. Under the 

interpretation being proposed by FDA, 

for food sold from vending machines 

that is not subject to the nutrition 

labeling requirements of 21 U.S.C. 

343(q)(5)(H), States and localities may 

establish or continue to impose 

nutrition labeling requirements. Under 

the alternative interpretation described 

above, there would be vending 

machines for which the Federal 

government has not required nutrition 

labeling and for which States and 

localities would also 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. 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 in the event states petition for 

exemption. 

FDA requests comments on the 

Agency’s interpretation of the 

provisions of section 4205 of the 

Affordable Care Act related to 

preemption, as well as on the alternative 

interpretation described in the 

Federalism section. FDA also requests 

comments on the use of the petition 

process in the context. In addition, the 

Agency requests comments on other 

potential interpretations that interested 

persons identify as appropriate given 

both the preemption-related language of 

section 4205 and the statutory goals. 

In addition, the express preemption 

provisions of 21 U.S.C. 343–1(a)(4) do 

not preempt any State or local 

requirement respecting a statement in 

the labeling of food that provides for a 

warning concerning the safety of the 

food or component of the food. This is 

clear from both the literal language of 21 

U.S.C. 343–1(a)(4) with respect to the 

scope of preemption and from the Rule 

of Construction at section 4205(d)(2) of 

the Affordable Care Act. 

VIII. Environmental Impact 

The Agency has 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. 

IX. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

X. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

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

through Friday. (FDA has verified the 

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Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Proposed Rules 19253 

Web site addresses, but FDA is not 

responsible for any subsequent changes 

to the Web sites after this document 

publishes in the Federal Register.) 

1. Merriam Webster Collegiate Dictionary, 

Tenth Edition, 1993. 

2. Food and Drug Administration, Food 

Labeling Guide, pg. 7, 2009. 

http://www.fda.gov/FoodLabelingGuide/

accessed, March 28, 2011. 

3. Automatic Merchandiser. ‘‘2010 State of 

the Vending Industry Report.’’ http://

www.vendingmarketwatch.com/content/

reports/ accessed, November 09, 2010. 

4. National Automatic Merchandising 

Association. ‘‘Comments of: The National 

Automatic Merchandising Association.’’ 

Docket No. FDA–2010–N–0298 2010. 

5. U.S. Small Business Administration. 

‘‘Table of Small Business Size Standards 

Matched to North American Industry 

Classification System Codes,’’ Effective 

November 5, 2010. http://www.sba.gov/

idc/groups/public/documents/sba_

homepage/serv_sstd_tablepdf.pdf, 

accessed 12/10/2010. 

6. Jed, E. ‘‘Operators Find Today’s Patrons 

Favor ‘Better-For-You’ Food Selections 

In Vending,’’ Vending Times, 41:8, 2001. 

7. Finkelstein, E.A. and K.L. Strombotne. 

‘‘The Economics of Obesity.’’ American 

Journal of Clinical Nutrition, 91(5): 

1520S–1524S, May 2010. 

8. Philipson, T. and R. Posner. ‘‘Is the Obesity 

Epidemic a Public Health Problem? A 

Decade of Research on the Economics of 

Obesity.’’ NBER Working Paper Series, 

14010, May 2008. 

9. Downs, J.S., G. Loewenstein and J. 

Wisdom. ‘‘Strategies for Promoting 

Healthier Food Choices.’’ American 

Economic Review: Papers and 

Proceedings, 99(2): 1–10, 2009. 

10. O’Donoghue, T. and M. Rabin. ‘‘The 

Economics of Immediate Gratification.’’ 

Journal of Behavioral Decision Making, 

13(2): 233–250, 2000. 

11. O’Donoghue, T. and M. Rabin. ‘‘Doing it 

Now or Later.’’ American Economic 

Review, 89(1): 103–124, 1999. 

12. Wang, Y., M.A. Beydoun, L. Liang, B. 

Cabellero and S.K. Kumanyika, ‘‘Will all 

Americans Become Overweight or 

Obese? Estimating the Progression and 

Cost of the US Obesity Epidemic.’’ 

Obesity, 16(10): 2323–2330, 2008. 

13. Ogden, C.L. and M.D. Carroll. ‘‘Prevalence 

of Overweight, Obesity, and Extreme 

Obesity Among Adults: United States, 

Trends 1976–1980 Through 2007–2008.’’ 

National Center for Health Statistics, 

June 2010. 

14. Sullivan, P.W., V. Ghusheyan, and R.H. 

Ben-Joseph. ‘‘The Effect of Obesity and 

Cardiometabolic Risk Factor on 

Expenditures and Productivity in the 

US.’’ Obesity, 16: 2155–2162, 2008. 

15. Ali, M.M., A. Amialchuk, and F. Renna. 

‘‘Social Network and Weight 

Misperception Among Adolescents’’. 

Southern Economic Journal, 

Forthcoming, (2010a). 

16. Cawley, J., K. Joyner, and J. Sobal. ‘‘Size 

Matters: The Influence of Adolescent’s 

Weight and Height on Dating and Sex.’’ 

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2006. 

17. Ali, M.M., H. Fang, and J. Rizzo. (2010b). 

‘‘Body Weight, Self-Perception and 

Mental Health among Adolescents.’’ 

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Economics, 13(2): 53–63 (2010b). 

18. Puhl, R., and K.D. Brownell. ‘‘Bias, 

Discrimination, and Obesity.’’ Obesity 

Research, 9(12): 788–805, 2001. 

19. Cawley, J. ‘‘The Impact of Obesity on 

Wages.’’ Journal of Human Resources, 

39(2): 451–474, 2004. 

20. Finkelstein, E.A., J.G. Trogdon, J.W. 

Cohen and W. Dietz. ‘‘Annual Medical 

Spending Attributable to Obesity: Payerand Service-Specific Estimates.’’ Health 

Affairs, 28(5): w822–w831, 2009. 

21. Lakdawalla, D. and T.J. Philipson. ‘‘The 

Growth of Obesity and Technological 

Change: A Theoretical and Empirical 

Examination,’’ NBER Working Paper No. 

8946, 2002. 

22. Philipson, T.J. and R.A. Posner, ‘‘The 

Long-Run Growth in Obesity as a 

Function of Technological Change.’’ 

NBER Working Paper No. 7423, 1999. 

23. Cutler, D.M., E.L. Glaeser, and J.M. 

Shapiro, ‘‘Why Have Americans Become 

More Obese?’’ Journal of Economic 

Perspectives, 17: 93–118, 2003. 

24. Chou, S-Y., M. Grossman, and H. Saffer. 

‘‘An Economic Analysis of Adult 

Obesity: Results from the Behavioral 

Risk Factor Surveillance System.’’ 

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587, 2004. 

25. Burke, M. and F. Heiland. ‘‘Social 

Dynamics of Obesity.’’ Economic Inquiry, 

45(3), 571–591, 2007. 

26. French, S.A., R.W. Jeffery, M. Story, P. 

Hannan, and P. Snyder. ‘‘A Pricing 

Strategy to Promote Low-Fat Snack 

Choices through Vending Machines’’. 

American Journal of Public Health, 87: 

849–851, 1997. 

27. U.S. Department of Agriculture Economic 

Research Service. ‘‘Table 15: Sales of 

meals and snacks away from home by 

type of outlet.’’ Food CPI and 

Expenditures: Food Expenditure Tables. 

http://www.ers.usda.gov/Briefing/

CPIFoodAndExpenditures/Data/ 

Accessed 10/8/2010. 

28. Eastern Research Group, Inc. ‘‘Evaluation 

of Recordkeeping Costs for Food 

Manufacturers, Final Report.’’ Prepared 

for Andy Estrin and Cristina McLaughlin 

of FDA’s Center for Food Safety and 

Applied Nutrition. Prepared by Aylin 

Sertkaya, Ayesha Berlind and Seda 

Erdem. Contract No. 223–01–2461, Task 

Order Number 5, February 2007. 

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, it is proposed that 

21 CFR parts 11 and 101 be 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 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 Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

343(q)(5)(H)) with FDA for purposes of 

paragraph (d) of this section. 

Vending machine means a self-service 

device 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 device 

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. 

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(b) Articles of food not covered. 

Articles of food dispensed from a 

vending machine are not covered 

vending machine food if: 

(1) The prospective purchaser can 

view the entire Nutrition Facts Panel on 

the label of the vended food without an 

obstruction. The Nutrition Facts Panel 

must be the information in the format 

required in § 101.9(c) and (d). The 

Nutrition Facts Panel must be 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. 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. 

(2) An article of food sold from a 

vending machine provides visible 

nutrition information at the point of 

purchase. The visible nutrition 

information at the point of purchase 

includes the total number of calories for 

the article of food, as dispensed, at the 

point of purchase. This visible nutrition 

information must appear on the food 

label itself. This visible nutrition 

information must 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. 

(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: 

(A) 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 

visible nutrition information at the 

point of purchase as provided in 

paragraph (b); 

(B) Is operated by a person engaged in 

the business of owning or operating 20 

or more vending machines; and 

(C) Is a vending machine with a 

selection button; or 

(ii) 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 the FDA 

under the provisions of paragraph (d) of 

this section. 

(2) Calorie declaration. (i) The 

number of calories must be clear and 

conspicuous for a covered vending 

machine food and 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) For calorie declarations in or on 

the vending machine, 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, 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. 

(D) The number of calories for singleserving packaged food declared on the 

sign must be identical to the number of 

calories that are declared in the 

Nutrition Facts, if applicable. 

(E) The number of calories for 

packaged foods that contain multiple 

servings must include the total calories 

present in the covered vending machine 

food. The vending machine operator 

may voluntarily disclose calories per 

serving in addition to the total calories 

for the food. 

(ii) Calorie information for covered 

vending machine food must be placed 

prominently in the following manner: 

(A) This calorie information 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 sign 

is visible at the same time as the food, 

its name, price, or selection button or 

selection number is visible. 

(B) 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. 

(C) When the calorie information is 

declared on a sign adjacent to the 

vending machine, 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. 

(D) 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. 

(E) 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. 

(F) For vending machines with 

limited choices, e.g., 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. 

(d) Voluntary provision of calorie 

labeling for foods sold from vending 

machines. 

(1) Applicability. An authorized 

official of 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 

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, e-mail 

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 e-mail by typing complete 

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Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Proposed Rules 19255 

information into the portable document 

format (PDF) form, saving it on the 

registrant’s computer, and sending it by 

e-mail to menulawregistration@fda.hhs. 

If e-mail 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, White Oak Building 22, 

Rm. 0209, 10903 New Hampshire Ave., 

Silver Spring, MD 20993. 

(vi) Authorized officials of a vending 

machine operator who elects to be 

subject to the Federal requirements can 

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

menulabeling. 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 

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. 

Dated: March 28, 2011. 

Margaret A. Hamburg, 

Commissioner of Food and Drugs. 

Kathleen Sebelius, 

Secretary of Health and Human Services. 

[FR Doc. 2011–8037 Filed 4–1–11; 4:15 pm] 

BILLING CODE 4160–01–P 

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