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Proposed Rule

Colorcon, Inc.; Filing of Color Additive Petition

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Food and Drug Administration, HHS.


Notification of petition.


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.


The color additive petition was filed on October 3, 2017.


For access to the docket to read background documents or comments received, go to 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.

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Molly A. Harry, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1075.

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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.

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Dated: November 6, 2017.

Anna K. Abram,

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

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