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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:

  1. FDA's initial deficiency letter (August 2024)
  2. Meeting memo summarizing FDA's clarification discussion with Phytolon and Intertek Health Sciences (September 2024)
  3. 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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