Listing of Color Additives Exempt From Certification; Mica-Based Pearlescent Pigments
fda-food · Food and Drug Administration · Rule · Published 2006-07-20 · Effective 2005-08-23 · 71 FR 41125
Document
Document number
E6-11536
Federal Register citation
71 FR 41125
CFR reference
21 CFR 73
Type
Rule
Action
Final rule; response to objections; removal of stay.
Category
fda-food
Sub-agency
Food and Drug Administration
Publication date
2006-07-20
Effective date
2005-08-23
HHS docket
Docket No. 1998C-0431
Abstract
The Food and Drug Administration (FDA) is responding to two objections that it received on the final rule that amended the color additive regulations to provide for the safe use of mica-based pearlescent pigments as color additives in ingested drugs. After reviewing the objections, the agency has concluded that the objections do not raise issues of material fact that justify a hearing or otherwise provide a basis for revoking the amendment to the regulations. FDA is also establishing a new effective date for this color additive regulation, which was stayed by the filing of objections.