Document ID: FDA-2017-C-6238-0006
Agency: fda
Document Type: Rule
Title: Listing of Color Additives Exempt From Certification; Synthetic Iron Oxide; Confirmation of Effective Date
Posted Date: 2019-04-18T04:00Z

[Federal Register Volume 84, Number 75 (Thursday, April 18, 2019)]
[Rules and Regulations]
[Page 16205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07829]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2017-C-6238]

Listing of Color Additives Exempt From Certification; Synthetic 
Iron Oxide; Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; confirmation of effective date.

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

SUMMARY: The Food and Drug Administration (FDA or we) is confirming the 
effective date of December 4, 2018, for the final rule that appeared in 
the Federal Register of November 1, 2018, and that amended the color 
additive regulations to provide for the expanded safe use of synthetic 
iron oxides as color additives to include use in dietary supplement 
tablets and capsules.

DATES: Effective date of final rule published in the Federal Register 
of November 1, 2018 (83 FR 54869) confirmed: December 4, 2018.

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 final rule 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: In the Federal Register of November 1, 2018 
(83 FR 54869), we amended the color additive regulations in Sec.  
73.200, ``Synthetic iron oxide'' (21 CFR 73.200), to provide for the 
expanded safe use of synthetic iron oxides as color additives in 
dietary supplement tablets and capsules, including coatings and 
printing inks, such that the total amount of elemental iron per day for 
labeled dosages does not exceed 5 milligrams.
    We gave interested persons until December 3, 2018, to file 
objections or requests for a hearing. We received no objections or 
requests for a hearing on the final rule. Therefore, we find that the 
effective date of the final rule that published in the Federal Register 
of November 1, 2018, should be confirmed.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Foods, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e) and 
under authority delegated to the Commissioner of Food and Drugs, we are 
giving notice that no objections or requests for a hearing were filed 
in response to the November 1, 2018, final rule. Accordingly, the 
amendments issued in the final rule became effective December 4, 2018.

    Dated: April 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07829 Filed 4-17-19; 8:45 am]
 BILLING CODE 4164-01-P