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1995S-0316
RPT 278
Volume 215

Cover Page, correspondence between CFSAN and U.S. Nutra, LLC, 75 Day Pre-Market notification

References

Appendix 1 - Certificate of analysis for Zanthin extract complex

Appendix 2 - Analytical comparison of Hamatococcus algae raw material and extract

Appendix 3 - Official analytical protocol for carotenoid and fatty acid analysis

Appendix 4 - (Confidential) Production methods for Algatechnologies Haematococcus algae

Appendix 5 - (Confidential) Haematococcus strain used in Algatechnologies algae production

Appendix 6i-6vi - Certificate of analysis of Haematococcus from Algatechnologies

Appendix 7 - Material Safety Data Sheet for Algatechnologies Haematococcus algae

Appendix 8 - (Confidential) Production methods for U.S. Nutra's CO2 Haematococcus extract

Appendix 9 - Analytical data on U.S. Nutra's product - pesticide, mineral content

Appendix 10i-10iii - Certificate of analysis - examples form different batches of U.S. Nutra's CO2 Haematococcus extract (Zanthin)

Appendix 11 - Stability data of Zanthin 5 mg astaxanthin complex vegetarian soft gel and stability data on U.S. Nutra's astaxanthin-rich carotenoid oleoresin extracted from Haematococcus pluvialis (Zanthin)

Appendix 11a - Stability data on the beadlet form of U.S. Nutra's astaxanthin-rich carotenoid oleoresin (Zanthin)

Appendix 11b - Product specification sheet on Zanthin 2.5% astaxanthin complex beadlet, including ingredient list for the beadlet form

Appendix 11c - Certificate of product compliance for Zanthin beadlet form stating that the product contains non bovine gelatine type A and that the product is GMO-free

Appendix 12 - Astacarotene's specification sheet for dried Haematococcus algae

Appendix 13 - Analytical comparison of Haematococcus algae from ALGATechnologies and Mera Pharmaceuticals

Appendix 14 - Microbiological load for U.S. Nutra's Astaxanthin-rich carotenoid oleoresin

Appendix 15 - Statement from Dr. Boon Chew on the safety of U.S. Nutra's Astaxanthin-rich carotenoid oleoresin from a recent clinical trial with Zanthin

Appendix 16 - Explanation and discussion on the changes for cis-trans in Haematococcus dried algae and U.S. Nutra's astaxanthin-rich carotenoid oleoresin (Zanthin)

Appendix 17 - Expert opinion on the phytochemical similarity of Haematococcus pluvialis algae obtained from different sources

Appendix 17a - Background and biography of the expert used in Appendix 17 (CV)

Appendix 18 - Statement from Algatechnologies that they supply large quantities of the same algae to both U.S. Nutra and Astacarotene

Appendix 19 - Summary of the similarities of the production methods used by both Algatechnologies and Astacarotene

Appendix 20 - Expert opinion confirming that both Algatechnologies and Astacarotene's production methods are very similar and would be expected to produce algae that contain very similar phytochemical profiles


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