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FDA CAP - Color Additive Petition No. 4C0332 - Prickly Pear Yellow, Phytolon Ltd
FDA CAP - Color Additive Petition No. 4C0332 - Prickly Pear Yellow, Phytolon Ltd
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FDA correspondence and deficiency letters for Color Additive Petition (CAP) No. 4C0332, Phytolon Ltd.'s petition to permit prickly pear yellow (indicaxanthin) as a food color additive.
Includes:
- FDA's initial deficiency letter (August 2024)
- Meeting memo summarizing FDA's clarification discussion with Phytolon and Intertek Health Sciences (September 2024)
- Deficiency letter following Phytolon's substantive amendment (July 2025).
Approximately 45-50% of content is redacted under (b)(4) trade secret and (b)(6) personal privacy exemptions; safety and toxicology narrative sections are largely withheld, while procedural content and FDA's regulatory citations remain visible.
17 pages
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