82 FR 52037 - Colorcon, Inc.; Filing of Color Additive Petition
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 | 52037-52037 | |
| FR Document | 2017-24421 |
[Federal Register Volume 82, Number 216 (Thursday, November 9, 2017)] [Proposed Rules] [Page 52037] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24421] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 73 [Docket No. FDA-2017-C-6238] Colorcon, Inc.; Filing of Color Additive Petition AGENCY: Food and Drug Administration, HHS. ACTION: Notification of petition. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Colorcon, Inc., proposing that the color additive regulations be amended by expanding the permitted uses of synthetic iron oxide as a color additive to include use in dietary supplement tablets and capsules. DATES: The color additive petition was filed on October 3, 2017. ADDRESSES: For access to the docket to read background documents or 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. FOR FURTHER INFORMATION CONTACT: Molly A. Harry, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1075. SUPPLEMENTARY INFORMATION: Under section 721(d)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379e(d)(1)), we are giving notice that we have filed a color additive petition (CAP 7C0308), submitted by Colorcon, Inc., 275 Ruth Rd., Harleysville, PA 19438. The petition proposes to amend the color additive regulations in Sec. 73.200 (21 CFR 73.200) Synthetic iron oxide by expanding the permitted uses of synthetic iron oxide as a color additive to include use in dietary supplement tablets and capsules with a proposed limit of 5 milligrams, calculated as elemental iron, per day for labeled dosages. We have determined under 21 CFR 25.32(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. Dated: November 6, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-24421 Filed 11-8-17; 8:45 am] BILLING CODE 4164-01-P
![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
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Document Created: 2018-10-25 10:29:42
Document Modified: 2018-10-25 10:29:42
| 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 petition. | |
| Dates | The color additive petition was filed on October 3, 2017. | |
| Contact | Molly A. Harry, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1075. | |
| FR Citation | 82 FR 52037 |
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