| | Federal Register - 70FR 42271 July 22, 2005: Listing of Color Additives Exempt from Certification; Mica-Based ... |
 | | 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. |
 | | At the time of the filing of the petition, FDA considered the pigments that are the subjects of this petition to be color additive mixtures of synthetic iron oxide, mica, and titanium dioxide. |
 | | Considering the chemical nature of the pigments, and their expected low solubility and bioavailability, the agency concludes that there is no toxic potential when ingested at levels estimated by the agency, based on their proposed use in coloring ingested drugs. |
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