Zdrowie i gospodarka · 20/07/2006
Listing of Color Additives Exempt From Certification; Mica-Based Pearlescent Pigments
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.