Colorcon, Inc.; Filing of Color Additive Petition

 
CONTENT

Federal Register, Volume 82 Issue 216 (Thursday, November 9, 2017)

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

-----------------------------------------------------------------------

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