Unlock regulatory insights with Watson. Learn More
PRProposed Rule

Color Additive Petitions: Colorcon, Inc.

  • Posted: 11/08/2017
  • ID: FDA_FRDOC_0001-7884
  • Comment Period: Closed
  • Agency: Food And Drug Administration
  • Page Start - End: 52037
  • -52037
  • Federal Register Number: 2017-24421
DOCUMENT DETAIL
STATUS Posted
RECEIVED DATE November 08 2017, at 11.00 PM EST
CFR 21 CFR Part 73
PAGE COUNT 1
PAGE START - END 52037-52037
COMMENT START DATE November 08 2017, at 11.00 PM EST
Start Preamble

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.

Start Further Info

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.

End Further Info End Preamble Start Supplemental Information

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 § 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.

Start Signature

Dated: November 6, 2017.

Anna K. Abram,

Deputy Commissioner for Policy, Planning, Legislation, and Analysis.

End Signature End Supplemental Information

[FR Doc. 2017-24421 Filed 11-8-17; 8:45 am]

BILLING CODE 4164-01-P