82 FR 52036 - Menu Labeling: Supplemental Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 216 (November 9, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 216 (November 9, 2017)
| Page Range | 52036-52037 | |
| FR Document | 2017-24246 |
[Federal Register Volume 82, Number 216 (Thursday, November 9, 2017)] [Proposed Rules] [Pages 52036-52037] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24246] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 11 and 101 [Docket No. FDA-2011-F-0172] Menu Labeling: Supplemental Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Menu Labeling: Supplemental Guidance for Industry.'' The draft guidance, when finalized, will address concerns raised by stakeholders regarding the implementation of nutrition labeling required for foods sold in covered establishments. It includes expanded and new interpretations of policy, and identifies places where FDA intends to be more flexible in its approach. This draft guidance also includes many graphical depictions in order to convey our thinking on various topics and to provide examples of options for implementation. It addresses calorie disclosure signage for self-service foods, including buffets and grab-and-go foods; reasonable basis, and the criteria for considering the natural variation of foods; various methods for providing calorie disclosure information, including those for pizza; compliance and enforcement; and criteria for distinguishing between menus and other information presented to the consumer. DATES: Submit either electronic or written comments on the draft guidance by January 8, 2018 to ensure that the Agency considers your comment on the draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2011-F-0172 for ``Menu Labeling: Supplemental Guidance for Industry.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Office of Nutrition and Food Labeling, HFS-800, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 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: Ashley Rulffes, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2371. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a draft guidance for industry entitled ``Menu Labeling Supplemental Guidance for Industry.'' We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for any person, and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the [[Page 52037]] applicable statutes and regulations. This guidance is not subject to Executive Order 12866. In the Federal Register of December 1, 2014 (79 FR 71156), we published a final rule on nutrition labeling of standard menu items in restaurants and similar retail food establishments to implement the menu labeling provisions of section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(5)(H)). The menu labeling requirements are codified at Title 21 of the Code of Federal Regulations, Sec. 101.11 (21 CFR 101.11). In the Federal Register of May 4, 2017 (82 FR 20825), we published an interim final rule (IFR) extending the compliance date to May 7, 2018. Our goals are to ensure that consumers are provided with consistent nutrition information they can use to make informed choices for themselves and their families, and to guide industry in clearly understanding the flexible ways in which the requirements can be implemented. This draft guidance addresses concerns raised by stakeholders regarding the implementation of nutrition labeling required for foods sold in covered establishments. The draft guidance reflects extensive further analysis by FDA in light of the comments we received to the IFR. In addition, given extensive further analysis by the Agency, we are withdrawing Questions and Answers 5.17 and 5.18 in our previous guidance entitled ``A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods--Part II (Menu Labeling Requirements in Accordance With FDA's Food Labeling Regulations)'' announced in the Federal Register of May 5, 2016 (81 FR 27067). We address the issue of distinguishing between menus and other information presented to the consumer in this draft guidance, and once finalized, this will represent our current thinking on this topic. The draft guidance also includes many graphical depictions to further illustrate our thinking on various topics. As previously stated, although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), we do not intend to extend the comment period for the guidance, as we intend to finalize this guidance and provide clarity to the industry on these remaining questions ahead of the new compliance date of May 7, 2018. II. Paperwork Reduction Act of 1995 This 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 Sec. 101.11(b)(2), (c)(3), and (d) have been approved under OMB control number 0910-0783. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance. Dated: November 2, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-24246 Filed 11-7-17; 11:15 am] BILLING CODE 4164-01-P
![52036 Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Proposed Rules
* * * * * Comments submitted electronically, blacked out, will be available for public
By direction of the Commission. including attachments, to https:// viewing and posted on https://
Donald S. Clark, www.regulations.gov will be posted to www.regulations.gov. Submit both
the docket unchanged. Because your copies to the Dockets Management Staff.
Secretary.
comment will be made public, you are If you do not wish your name and
[FR Doc. 2017–24381 Filed 11–8–17; 8:45 am]
solely responsible for ensuring that your contact information to be made publicly
BILLING CODE 6750–01–C comment does not include any available, you can provide this
confidential information that you or a information on the cover sheet and not
third party may not wish to be posted, in the body of your comments and you
DEPARTMENT OF HEALTH AND such as medical information, your or must identify this information as
HUMAN SERVICES anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked
confidential business information, such as ‘‘confidential’’ will not be disclosed
Food and Drug Administration as a manufacturing process. Please note except in accordance with 21 CFR 10.20
that if you include your name, contact and other applicable disclosure law. For
21 CFR Parts 11 and 101 information, or other information that more information about FDA’s posting
[Docket No. FDA–2011–F–0172] identifies you in the body of your of comments to public dockets, see 80
comments, that information will be FR 56469, September 18, 2015, or access
Menu Labeling: Supplemental posted on https://www.regulations.gov. the information at: https://www.gpo.gov/
Guidance for Industry; Availability • If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015-
with confidential information that you 23389.pdf.
AGENCY: Food and Drug Administration,
do not wish to be made available to the Docket: For access to the docket to
HHS. public, submit the comment as a
ACTION: Notification of availability. read background documents or the
written/paper submission and in the electronic and written/paper comments
SUMMARY: The Food and Drug manner detailed (see ‘‘Written/Paper received, go to https://
Administration (FDA or we) is Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the
announcing the availability of a draft Written/Paper Submissions docket number, found in brackets in the
guidance for industry entitled ‘‘Menu heading of this document, into the
Submit written/paper submissions as ‘‘Search’’ box and follow the prompts
Labeling: Supplemental Guidance for
follows: and/or go to the Dockets Management
Industry.’’ The draft guidance, when • Mail/Hand delivery/Courier (for
finalized, will address concerns raised Staff, 5630 Fishers Lane, Rm. 1061,
written/paper submissions): Dockets
by stakeholders regarding the Rockville, MD 20852.
Management Staff (HFA–305), Food and
implementation of nutrition labeling You may submit comments on any
Drug Administration, 5630 Fishers
required for foods sold in covered guidance at any time (see 21 CFR
Lane, Rm. 1061, Rockville, MD 20852.
establishments. It includes expanded 10.115(g)(5)).
• For written/paper comments
and new interpretations of policy, and Submit written requests for single
submitted to the Dockets Management
identifies places where FDA intends to copies of the draft guidance to the Office
Staff, FDA will post your comment, as
be more flexible in its approach. This of Nutrition and Food Labeling, HFS–
well as any attachments, except for
draft guidance also includes many 800, Center for Food Safety and Applied
information submitted, marked and
graphical depictions in order to convey Nutrition, Food and Drug
identified, as confidential, if submitted
our thinking on various topics and to Administration, 5001 Campus Dr.,
as detailed in ‘‘Instructions.’’
provide examples of options for Instructions: All submissions received College Park, MD 20740. Send two self-
implementation. It addresses calorie must include the Docket No. FDA– addressed adhesive labels to assist that
disclosure signage for self-service foods, 2011–F–0172 for ‘‘Menu Labeling: office in processing your request. See
including buffets and grab-and-go foods; Supplemental Guidance for Industry.’’ the SUPPLEMENTARY INFORMATION section
reasonable basis, and the criteria for Received comments will be placed in for electronic access to the draft
considering the natural variation of the docket and, except for those guidance.
foods; various methods for providing submitted as ‘‘Confidential FOR FURTHER INFORMATION CONTACT:
calorie disclosure information, Submissions,’’ publicly viewable at Ashley Rulffes, Center for Food Safety
including those for pizza; compliance https://www.regulations.gov or at the and Applied Nutrition (HFS–820), Food
and enforcement; and criteria for Dockets Management Staff between 9 and Drug Administration, 5001 Campus
distinguishing between menus and a.m. and 4 p.m., Monday through Dr., College Park, MD 20740, 240–402–
other information presented to the Friday. 2371.
consumer. • Confidential Submissions—To SUPPLEMENTARY INFORMATION:
DATES: Submit either electronic or submit a comment with confidential
information that you do not wish to be I. Background
written comments on the draft guidance
by January 8, 2018 to ensure that the made publicly available, submit your We are announcing the availability of
Agency considers your comment on the comments only as a written/paper a draft guidance for industry entitled
draft guidance before it begins work on submission. You should submit two ‘‘Menu Labeling Supplemental
the final version of the guidance. copies total. One copy will include the Guidance for Industry.’’ We are issuing
information you claim to be confidential the draft guidance consistent with our
sradovich on DSK3GMQ082PROD with PROPOSALS
ADDRESSES: You may submit comments
on any guidance at any time as follows: with a heading or cover note that states good guidance practices regulation (21
‘‘THIS DOCUMENT CONTAINS CFR 10.115). The draft guidance, when
Electronic Submissions CONFIDENTIAL INFORMATION.’’ We finalized, will represent the current
Submit electronic comments in the will review this copy, including the thinking of FDA on this topic. It does
following way: claimed confidential information, in our not establish any rights for any person,
• Federal eRulemaking Portal: consideration of comments. The second and is not binding on FDA or the public.
https://www.regulations.gov. Follow the copy, which will have the claimed You can use an alternate approach if it
instructions for submitting comments. confidential information redacted/ satisfies the requirements of the
VerDate Sep<11>2014 17:09 Nov 08, 2017 Jkt 244001 PO 00000 Frm 00022 Fmt 4702 Sfmt 4702 E:\FR\FM\09NOP1.SGM 09NOP1](https://thefederalregister.org/doc/82_FR_52252/page/1.svg)
![Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Proposed Rules 52037
applicable statutes and regulations. This (see 21 CFR 10.115(g)(5)), we do not proposing that the color additive
guidance is not subject to Executive intend to extend the comment period for regulations be amended by expanding
Order 12866. the guidance, as we intend to finalize the permitted uses of synthetic iron
In the Federal Register of December 1, this guidance and provide clarity to the oxide as a color additive to include use
2014 (79 FR 71156), we published a industry on these remaining questions in dietary supplement tablets and
final rule on nutrition labeling of ahead of the new compliance date of capsules.
standard menu items in restaurants and May 7, 2018.
DATES: The color additive petition was
similar retail food establishments to
II. Paperwork Reduction Act of 1995 filed on October 3, 2017.
implement the menu labeling provisions
of section 403(q)(5)(H) of the Federal This guidance refers to previously ADDRESSES: For access to the docket to
Food, Drug, and Cosmetic Act (21 U.S.C. approved collections of information read background documents or
343(q)(5)(H)). The menu labeling found in FDA regulations. These comments received, go to https://
requirements are codified at Title 21 of collections of information are subject to www.regulations.gov and insert the
the Code of Federal Regulations, review by the Office of Management and docket number found in brackets in the
§ 101.11 (21 CFR 101.11). Budget (OMB) under the Paperwork heading of this document into the
In the Federal Register of May 4, 2017 Reduction Act of 1995 (44 U.S.C. 3501– ‘‘Search’’ box and follow the prompts,
(82 FR 20825), we published an interim 3520). The collections of information in and/or go to the Dockets Management
final rule (IFR) extending the § 101.11(b)(2), (c)(3), and (d) have been Staff, 5630 Fishers Lane, Rm. 1061,
compliance date to May 7, 2018. Our approved under OMB control number Rockville, MD 20852.
goals are to ensure that consumers are 0910–0783. FOR FURTHER INFORMATION CONTACT:
provided with consistent nutrition Molly A. Harry, Center for Food Safety
III. Electronic Access
information they can use to make and Applied Nutrition, Food and Drug
informed choices for themselves and Persons with access to the internet Administration, 5001 Campus Dr.,
their families, and to guide industry in may obtain the draft guidance at either College Park, MD 20740, 240–402–1075.
clearly understanding the flexible ways https://www.fda.gov/FoodGuidances or SUPPLEMENTARY INFORMATION: Under
in which the requirements can be https://www.regulations.gov. Use the section 721(d)(1) of the Federal Food,
implemented. FDA Web site listed in the previous Drug, and Cosmetic Act (21 U.S.C.
This draft guidance addresses sentence to find the most current 379e(d)(1)), we are giving notice that we
concerns raised by stakeholders version of the guidance. have filed a color additive petition (CAP
regarding the implementation of Dated: November 2, 2017. 7C0308), submitted by Colorcon, Inc.,
nutrition labeling required for foods Anna K. Abram, 275 Ruth Rd., Harleysville, PA 19438.
sold in covered establishments. The The petition proposes to amend the
Deputy Commissioner for Policy, Planning,
draft guidance reflects extensive further Legislation, and Analysis. color additive regulations in § 73.200
analysis by FDA in light of the (21 CFR 73.200) Synthetic iron oxide by
[FR Doc. 2017–24246 Filed 11–7–17; 11:15 am]
comments we received to the IFR. In expanding the permitted uses of
BILLING CODE 4164–01–P
addition, given extensive further synthetic iron oxide as a color additive
analysis by the Agency, we are to include use in dietary supplement
withdrawing Questions and Answers DEPARTMENT OF HEALTH AND tablets and capsules with a proposed
5.17 and 5.18 in our previous guidance HUMAN SERVICES limit of 5 milligrams, calculated as
entitled ‘‘A Labeling Guide for elemental iron, per day for labeled
Restaurants and Retail Establishments Food and Drug Administration dosages.
Selling Away-From-Home Foods—Part We have determined under 21 CFR
II (Menu Labeling Requirements in 21 CFR Part 73 25.32(k) that this action is of a type that
Accordance With FDA’s Food Labeling does not individually or cumulatively
Regulations)’’ announced in the Federal [Docket No. FDA–2017–C–6238]
have a significant effect on the human
Register of May 5, 2016 (81 FR 27067). environment. Therefore, neither an
Colorcon, Inc.; Filing of Color Additive
We address the issue of distinguishing environmental assessment nor an
Petition
between menus and other information environmental impact statement is
presented to the consumer in this draft AGENCY: Food and Drug Administration, required.
guidance, and once finalized, this will HHS.
represent our current thinking on this Dated: November 6, 2017.
ACTION: Notification of petition.
topic. The draft guidance also includes Anna K. Abram,
many graphical depictions to further SUMMARY: The Food and Drug Deputy Commissioner for Policy, Planning,
illustrate our thinking on various topics. Administration (FDA or we) is Legislation, and Analysis.
As previously stated, although you can announcing that we have filed a [FR Doc. 2017–24421 Filed 11–8–17; 8:45 am]
comment on any guidance at any time petition, submitted by Colorcon, Inc., BILLING CODE 4164–01–P
sradovich on DSK3GMQ082PROD with PROPOSALS
VerDate Sep<11>2014 17:09 Nov 08, 2017 Jkt 244001 PO 00000 Frm 00023 Fmt 4702 Sfmt 9990 E:\FR\FM\09NOP1.SGM 09NOP1](https://thefederalregister.org/doc/82_FR_52252/page/2.svg)
Document Created: 2018-10-25 10:30:42
Document Modified: 2018-10-25 10:30:42
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Notification of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by January 8, 2018 to ensure that the Agency considers your comment on the draft guidance before it begins work on the final version of the guidance. | |
| Contact | Ashley Rulffes, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2371. | |
| FR Citation | 82 FR 52036 | |
| CFR Citation | 21
CFR
101 21 CFR 11 |
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