52426 Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0370] 

Draft Guidance for Industry: Questions 

and Answers Regarding 

Implementation of the Menu Labeling 

Provisions of Section 4205 of the 

Patient Protection and Affordable Care 

Act of 2010; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Guidance for Industry: 

Questions and Answers Regarding 

Implementation of the Menu Labeling 

Provisions of Section 4205 of the Patient 

Protection and Affordable Care Act of 

2010.’’ Section 4205 of the Patient 

Protection and Affordable Care Act 

(Affordable Care Act) requires certain 

chain restaurants and similar retail food 

establishments with 20 or more 

locations (hereinafter ‘‘chain retail food 

establishments’’) to provide calorie 

information, and other nutrition 

information, for standard menu items, 

food on display, and self-service food. 

Section 4205 also requires vending 

machine operators who own or operate 

20 or more machines (hereinafter ‘‘chain 

vending machine operators’’) to disclose 

calories for articles of food. Restaurants 

and similar retail food establishments 

with fewer than 20 locations and 

vending machine operators with fewer 

than 20 machines may elect to be 

subject to these Federal requirements by 

registering every other year with the 

FDA. 

Section 4205 of the Affordable Care 

Act became effective on the date the law 

was signed, March 23, 2010; however, 

some provisions specifically require 

FDA to issue rules before FDA 

implements them. Other provisions 

became requirements immediately upon 

enactment of the law. The draft 

guidance, when finalized, will explain 

how those provisions should be 

implemented. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on the draft 

guidance before it begins work on the 

final version of the guidance, submit 

electronic or written comments on the 

draft guidance by October 12, 2010. 

ADDRESSES: Submit electronic 

comments on the draft guidance to 

http://www.regulations.gov. Submit 

written comments on the draft guidance 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

written requests for single copies of the 

draft guidance to the Office of Nutrition, 

Labeling, and Dietary Supplements, 

Center for Food Safety and Applied 

Nutrition (HFS–820), Food and Drug 

Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740. Send 

two self-addressed adhesive labels to 

assist that office in processing your 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance. 

FOR FURTHER INFORMATION CONTACT: 

Geraldine A. June, 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 

FDA is announcing the availability of 

a draft guidance entitled ‘‘Guidance for 

Industry: Questions and Answers 

Regarding Implementation of the Menu 

Labeling Provisions of Section 4205 of 

the Patient Protection and Affordable 

Care Act of 2010.’’ 

The availability of nutrition 

information through menu and vending 

machine labeling would provide 

Americans with additional information 

to make informed choices about their 

diets. Studies show that providing 

nutrition information at restaurants can 

help people make healthier choices 

(Refs. 1 and 2). Responding to this 

demand for information, several States 

and localities have initiated a variety of 

legislative or regulatory efforts for menu 

labeling, which has resulted in differing 

requirements across jurisdictions. These 

differing requirements have created 

logistical challenges for restaurant 

chains that have locations in more than 

one jurisdiction (Ref. 3). 

On March 23, 2010, the President 

signed into law the Affordable Care Act 

(Public Law 111–148), which sets up a 

uniform nationwide approach to menu 

and vending machine labeling. Section 

4205 of the Affordable Care Act 

(hereinafter ‘‘section 4205’’) creates a 

new subparagraph (H) within section 

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

Cosmetic Act (the act), to be codified at 

21 U.S.C. 343(q)(5)(H), which requires 

certain chain retail food establishments 

to provide calorie information and other 

nutrition information for menu items, 

food on display, and self-service food. 

Section 4205 also requires chain 

vending machine operators to disclose 

calories for articles of food. Chain retail 

food establishments with fewer than 20 

locations (or other restaurants or similar 

retail food establishments not covered 

by section 4205) and vending machine 

operators with fewer than 20 machines 

may elect to be subject to these Federal 

requirements by registering every other 

year with the FDA. 

Section 4205 became effective on the 

date the law was signed, March 23, 

2010; however, some provisions require 

FDA to issue rules before FDA 

implements them. Other provisions 

must be implemented immediately 

upon enactment of the law. FDA is 

required to issue a proposed rule 

implementing section 4205 by March 

23, 2011. 

For chain retail food establishments, 

the provisions that became requirements 

immediately upon enactment of the law 

include: 

(1) Disclosing the number of calories 

in each standard menu item on menus 

and menu boards, 

(2) Making additional written 

nutrition information available to 

consumers upon request, 

(3) Providing a statement on menus 

and menu boards about the availability 

of the additional nutrition information, 

and 

(4) Providing calorie information (per 

serving or per food item) for most selfservice items and food on display, on a 

sign adjacent to each food item. 

In addition, the provision requiring 

chain vending machine operators to 

disclose, in a clear and conspicuous 

manner, calories of any article of food 

that does not permit a prospective 

purchaser to examine its Nutrition Facts 

panel before purchasing, or does not 

otherwise provide visible nutrition 

information at the point of purchase, 

became an immediate requirement upon 

enactment of the law. 

FDA is issuing this draft guidance as 

Level 1 draft guidance consistent with 

FDA’s good guidance practices 

regulation (21 CFR 10.115). The draft 

guidance, when finalized, will represent 

the agency’s current thinking on the 

provisions in section 4205 related to 

chain retail food establishments that 

became requirements immediately upon 

enactment of the law. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternate approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. FDA is soliciting 

comments from interested parties on the 

entire document to better inform the 

agency as it develops further guidance. 


emcdonald on DSK2BSOYB1PROD with NOTICES2
Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Notices 52427 

II. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information 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). The collections 

of information in section 4205 of the 

Affordable Care Act have been approved 

under OMB Control No. 0910–0665 

(menu labeling third party disclosures 

and recordkeeping) and OMB Control 

No. 0910–0664 (voluntary registration 

program). 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding the draft guidance. 

It is only necessary to send one set of 

comments. It is no longer necessary to 

send two sets 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at http:// 

www.fda.gov/FoodGuidances. 

V. References 

FDA has placed the following 

references on display in the Division of 

Dockets Management (see ADDRESSES), 

and they may be seen by interested 

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

Monday through Friday. (FDA has 

verified the Web site addresses, but FDA 

is not responsible for any subsequesnt 

changes to the Web sites after this 

document publishes in the Federal 

Register.) 

1. Howlett, E.A., S. Burton, K. Bates, and 

K. Huggins, ‘‘Coming to a Restaurant Near 

You? Potential Consumer Responses to 

Nutrition Information Disclosure on Menus,’’ 

Journal of Consumer Research 36(3): 494– 

503, 2009. Available at http:// 

www.journals.uchicago.edu/doi/pdf/10.1086/ 

598799. 

2. Tandon, P.S., J.Wright, C. Zhou, C.B. 

Rogers, D.A. Christakis, ‘‘Nutrition Menu 

Labeling May Lead to Lower-Calorie 

Restaurant Meal Choices for Children,’’ 

Pediatrics 125(2): 244–248, 2010. 

3. Center for Science in the Public Interest, 

‘‘Comparison of Menu Labeling Policies,’’ 

Available at http://cspinet.org/new/pdf/ 

comparison_of_ml_policies_6-9.pdf. 

Dated: August 18, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–21065 Filed 8–24–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0354] 

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; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a 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 Laws.’’ Section 4205 of the 

Patient Protection and Affordable Care 

Act of 2010 (Affordable Care Act) 

establishes requirements for nutrition 

labeling of standard menu items for 

chain retail food establishments and 

chain vending machine operators. FDA 

is issuing this guidance to clarify 

section 4205’s effect on State and local 

menu and vending machine labeling 

laws, and to ensure that industry and 

State and local government understand 

the immediate effects of the law. 

DATES: Submit either electronic or 

written comments on the guidance at 

any time. 

ADDRESSES: Submit electronic 

comments on the guidance to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

written requests for single copies of the 

guidance to the Office of Nutrition, 

Labeling and Dietary Supplements, 

Center for Food Safety and Applied 

Nutrition (HFS–820), Food and Drug 

Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740. Send 

two self-addressed adhesive labels to 

assist that office in processing your 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

Felicia B. Billingslea, Center for Food 

Safety and Applied Nutrition (HFS– 

820), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, 301–436–2373. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a 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 

Laws.’’ FDA is issuing this guidance in 

a Questions and Answers format as an 

informational guide to industry and 

State and local governments affected by 

the enactment of section 4205 of the 

Affordable Care Act (Public Law 111– 

148), which became effective on March 

23, 2010. Section 4205 of the Affordable 

Care Act requires restaurants or similar 

retail food establishments with 20 or 

more locations doing business under the 

same name and offering for sale 

substantially the same menu items 

(‘‘chain retail food establishments’’) to 

disclose specific nutrition information 

about certain food items offered for sale. 

Section 4205 also requires vending 

machines operated by persons who own 

or operate 20 or more vending machines 

(‘‘chain vending machine operators’’) to 

disclose calorie information for certain 

food articles sold in vending machines. 

FDA is issuing this guidance to clarify 

section 4205’s effect on State and local 

menu and vending machine labeling 

laws, and to ensure that industry and 

State and local government understand 

the immediate effects of the law. 

FDA is issuing this guidance as level 

1 guidance consistent with FDA’s good 

guidance practices regulation (§ 10.115 

(21 CFR 10.115)). Consistent with FDA’s 

good guidance practices regulation, the 

agency will accept comment, but is 

implementing the guidance document 

immediately, in accordance with 

§ 10.115(g)(2), because the agency has 

determined that prior public 

participation is not feasible or 

appropriate in light of the need to 

respond expeditiously to the mandates 

in section 4205 of the Affordable Care 

Act, which was effective on March 23, 

2010. The guidance represents the 

agency’s current thinking on section 

4205’s effective date, and effect on State 

and local menu and vending machine 

labeling laws. It does not create or 

confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternate approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 


emcdonald on DSK2BSOYB1PROD with NOTICES2