Document ID: FDA-2017-C-6238-0017
Agency: fda
Document Type: Rule
Title: Listing of Color Additives Exempt From Certification; Calcium Carbonate; Confirmation of Effective Date
Posted Date: 2023-01-24T05:00Z

[Federal Register Volume 88, Number 15 (Tuesday, January 24, 2023)]
[Rules and Regulations]
[Pages 4085-4086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01185]

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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; Calcium 
Carbonate; Confirmation of Effective Date

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Final rule; confirmation of effective date.

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SUMMARY: The Food and Drug Administration (FDA or we) is confirming the 
effective date of October 28, 2022, for the final rule that appeared in 
the Federal Register of September 27, 2022, and that amended the color 
additive regulations to provide for the safe use of calcium carbonate 
in dietary supplement tablets and capsules.

DATES: Effective date of final rule published in the Federal Register 
of September 27, 2022 (87 FR 58445) confirmed: October 28, 2022.

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: Christopher Kampmeyer, Center for

[[Page 4086]]

Food Safety and Applied Nutrition, Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-1255.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 27, 
2022 (87 FR 58445), we amended the color additive regulations in Sec.  
73.70 (21 CFR 73.70) ``Calcium Carbonate'' by expanding the permitted 
uses of calcium carbonate to include use in dietary supplement tablets 
and capsules, including coatings and printing inks, in amounts 
consistent with good manufacturing practice.
    We gave interested persons until October 27, 2022, to file 
objections or requests for a hearing. We received no objections or 
requests for a hearing on the final rule. We received a comment 
requesting a revision to the regulation that would account for a 
possible change to the standard of identity for chocolate. We note, 
however, that the rule already contains language to allow the use of 
calcium carbonate if the standard of identity for chocolate changes in 
the future, and that the rule's text is more precise than that 
requested by the comment because ``added color'' (21 CFR 73.70(c)) 
refers back to calcium carbonate only, whereas the comment's suggested 
change could be interpreted as covering additional color additives. 
Therefore, we find that the effective date of the final rule that 
published in the Federal Register of September 27, 2022, should be 
confirmed.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Foods, Incorporation by 
reference, 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 September 27, 2022, final rule. Accordingly, the 
amendments issued thereby became effective October 28, 2022.

    Dated: January 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01185 Filed 1-23-23; 8:45 am]
BILLING CODE 4164-01-P