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U.S. Department of Health and Human Services

Advisory Committees

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Food Advisory Committee Meeting Materials - Interim Toxicology Review Memorandum (Certified Color Additives)

September 1, 2010

Subject: Citizen Petition from the Center for Science in the Public Interest (CSPI) requesting the revocation of the color additive approvals of eight synthetic dyes for use in food – Interim Toxicology Review Memorandum

Docket No. FDA-2008-P-0349
Correspondence No. 84566

The findings and conclusions in this report have not been formally disseminated by FDA and should not be construed to represent any agency determination or policy.

  • Memorandum and all attachments for printing (PDF, 5.4MB)
  • Memorandum (PDF, 251KB)
    • Attachment 1: Review Criteria and Search Terms Used in ORNL literature search (PDF, 373KB)
    • Attachment 2: Finalized Review of 2007 Southampton Study - ORNL (Study Evaluation Report) (PDF, 1.3MB)
    • Attachment 3: Finalized Review of 2004 Scab and Trinh Publication - ORNL (Addendum Review) (PDF, 805KB)
    • Attachment 4: Finalized Review and Analysis of the Literature - ORNL (Overview and Evaluation) (PDF, 1.1MB)
      • Exhibit 1: Reviews and Critiques (PDF, 808KB)
      • Exhibit 2: Bibliography (PDF, 601KB)
      • Exhibit 3: Table 1 - Summary of Reviewed Clinical Trials (PDF, 603KB)