Document ID: FDA-2017-C-6238-0001
Agency: fda
Document Type: Proposed Rule
Title: Colorcon, Inc.; Filing of Color Additive Petition
Posted Date: 2017-11-09T05:00Z

[Federal Register Volume 82, Number 216 (Thursday, November 9, 2017)]
[Proposed Rules]
[Page 52037]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24421]

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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.

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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