[Federal Register Volume 64, Number 124 (Tuesday, June 29, 1999)]
[Notices]
[Page 34816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-16527]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98C-0431]
EM Industries, Inc.; Filing of Color Additive Petition; Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is amending the filing
notice for a color additive petition filed by EM Industries, Inc., to
clarify that the petitioner's request is to amend the color additive
regulations to provide for the safe use of composite pigments made from
synthetic iron oxide, titanium dioxide, and mica to color ingested
drugs.
FOR FURTHER INFORMATION CONTACT: Aydin Orstan, Center for Food Safety
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-418-3076.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of June 22, 1998 (63 FR 33934), FDA announced that a color
additive petition (CAP 8C0257) had been filed by EM Industries, Inc., 7
Skyline Dr., Hawthorne, NY 10532. The petition proposed to amend the
color additive regulations to provide for the safe use of synthetic
iron oxide to color ingested drugs at levels higher than the current
limit and to provide for the safe use of mica to color ingested drugs.
The data in the petition indicated that the petitioner manufactured
color additives, to color ingested drugs, by combining synthetic iron
oxide, mica, and titanium dioxide. Based on these data, at the time of
the filing of the petition, FDA considered the color additive
combinations the petitioner prepared from synthetic iron oxide, mica,
and titanium dioxide to be color additive mixtures. Titanium dioxide
was already listed as a color additive for ingested drug use and the
petition did not propose to amend the existing regulation.
To more accurately describe the pigments that are the subjects of
this petition, FDA is amending the filing notice of June 22, 1998, to
indicate that the petition proposes to amend the color additive
regulations to provide for the safe use of composite pigments prepared
from synthetic iron oxide, mica, and titanium dioxide to color ingested
drugs.
The agency has determined under 21 CFR 25.32(r) 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.
Dated: June 2, 1999.
Alan M. Rulis,
Director, Office of Premarket Approval, Center for Food Safety and
Applied Nutrition.
[FR Doc. 99-16527 Filed 6-28-99; 8:45 am]
BILLING CODE 4160-01-F
