Rule2023-01185
Listing of Color Additives Exempt From Certification; Calcium Carbonate; Confirmation of Effective Date
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 24, 2023
Effective
September 27, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 15 (Tuesday, January 24, 2023)</title>
</head>
<body><pre>
[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-01185]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
</pre></body>
</html>Indexed from Federal Register on January 24, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.