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Dockets Management

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1995S-0316
RPT 280
Volume 217

Cover Page

Letter from CFSAN to W. Patrick Noonan

Letter from W. Patrick Noonan to CFSAN

Table of Contents

Section 1 - Names and complete addresses of the distributor and manufacturer of the new dietary ingredient

Section 2 - Name of the new dietary ingredient

Section 3 - Description of the new dietary ingredient

Section 4 - Level of the new dietary ingredient in the dietary supplement

Section 5 - The conditions of use recommended or suggested in the labeling of the dietary supplement

Section 6 - History of use or other evidence of safety establishing that the dietary ingredient Zeaxanthin Purified Concentrate as recommended in the labeling of dietary supplement

Attachment 1 - Zeaxanthin production process

Attachment 2 - Zeaxanthin Purified Concentrate (ZPC) proximate analysis

Attachment 3 - Report of Analysis, Final Report, Certificate of Analysis

Attachment 4 - Chrysantis material data safety sheet for ZPC

Attachment 5-12 Published Material

Attachment 13 - Joint FAO/WHO Expert Committee on Food Additives (JECFA) Sixty-Third Meeting, Geneva, 8-17, June 2004

Attachment 14-25 Published Material

Attachment 26 - Statement of safety for zeaxanthin when used as a dietary supplement in a water B soluble beadlet formulatio at a level of up to 10mg/person/day. Prepared for ZeaVision, LLP, by Dennis Giehart, Ph.D., March 12, 2002.

Attachment 27-30 Published Material

Section 7 - Summary

 


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