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Dockets Management


RPT 274
Volume 210

New Dietary Notification for Astaxanthin present in Haematococcus pluvialis Algae biomass

Bang HO, Dyerberg J. Lipid Metabolism and Ischemic Heart Disease in Greenland Eskimos. In: Draper H ed. Advances in Nutrition Research. New York: Plenum Press. 1980; 1-22. Published Material

Hirai A, Hamazaki T, Terano T, Nishikawa T, Tamura Y, Kumagai A. Eicosapentanoic Acid and Platelet Function in Japanese. Lancet. 1980; 2: 1132-1133. Published Material

Kromann N, Green A. Epidemiological Studies in the Upernavik District, Greenland. Incidence of Some Chronic Diseases 1950-1974. Acta Med Scand. 1980; 208: 401-406. Published Material

Kagawa, Y, Nishizawa M, Suzuki M, Miyatake T, Hamamoto T, Goto K, Motonaga E, Izumikawa H, Hirata H, Ebihara A. Eicosapolyenoic Acids of Serum Lipids of Japanese Islanders with Low Incidence of Cardiovascular Diseases. J Nutr Sci Vitaminol. 1982; 28: 441-453. Published Material

Middaugh JP. Cardiovascular Deaths Anong Alaskan Natives, 1980-86. Am J Pub Health. 1990; (80) 3: 282-285. Published Material

Newman WP, Middaugh JP, Propst MT, Rogers DR. Atherosclerosis in Alaskan Natives and Non-Natives. Lancet. 1993; 341: 1056-57. Published Material

NEJAC. National Environmental Justice Advisory Committee Report to EPA. Fish Consumption and Environmental Justice 2002 185 pages on Web page visited 1/17/2005 at http://www.epa.gov/compliance/resources/publications/ej/fish_consump_report_1102.pdf

Cyanotech Corporation: Technical Bulletin #060, A technical review of Haematocococcus Algae. 1999.

RBM %950053Tos EG. Acute oral toxicity study in rats treated by oral route. Haematococcus pluvialis unicellular green algae. Instituto Ricerche Biomediceh. pp 1-21, Sept 1995.

Cyanotech Corporation: Technical Bulletin #060, A technical review of Haematocococcus Algae. 1999.

Scantox Test Report Lab#28708, Edwards CN: Haematococcus pluvialis Ames Test "Treat and Plate Test." pp 1-20, June 1998.

Scantox Test Report Lab#26832, Edwards CN: Haemaococcus pluvialis mouse micronucleus test. pp 1-14, April 1998.

Scantox Test Report Lab#28709 Edwards CN: Haematococcus pluvialis In vitro mammalian cell gene mutation test performance with mouse lymphoma cells (L5178Y). pp 1-15, April 1998.

RBM %9505101. Yu P, Maraschin R. 14-day oral toxicity study in rats. Haematococcus pluvialis, unicellular green algae. Instituto Ricerche Biomediceh. pp 1-31, Sept 1995.

MB Research Laboratories in Mera Pharmaceuticals, Inc.: Technical Report TR3005.001, Haematococcus pluvialis and astaxanthin safety for human consumption, 1999. Published Material

Covance Report Number 1840/002 Stewart JS: HPP: 13 week oral (dietary administration) toxicity study in the rat. (Final. pp 1-248) February 2001.

Nishikawa, Y., Minenaka, Y. and Ichimura, M. (1997) Physiological and biochemical effects of astaxanthin. Translated from Japanese Vol 25 pp. 19-25. Published Material

Murillo E. Hypercholesterolemic effect of canthaxanthin and astaxanthin in rats. Arch Latinoam Nutr 42: 409-413, 1992. Published Material

Ono A, Sekita K, Saitoh M, Umenmukra T, Ogawa Y, Furuya T, Kaneko T, Inoue T. A 13 week subchronic oral toxicity study of haematococcus color in F344 rats. Kokuritsu Iyakuhin Shokuhin Eisei Kenkyushjo Hokoku 117: 91-98, 1999. Published Material

Roche Vitamins and Fine Chemicals. Hoffman La Roche, Inc. Astaxanthin as a pigmenter in salmon feed. CAP 7CO211.

Iwamoto, T., Hosada, K., Hirano, R., Kurata, H., Matsumoto, A., Miki, W., Kamiyama, M., Itakura, H., Yamamoto, S. and Konda, K. Inhibition of oxidation of low density lipoprotein by astaxanthin. J Atherosclerosis and Thrombosis 2000 Vol 7, No. 4, pp 216-222. Published Material

Miki WW, Hosoda K, Kondo K, Itakura H. Astaxanthin-containing drink. Patent application number 10155459. Japanese Patent Office. Publication date 16 June 1998.

Mera Pharmaceuticals, Inc. Technical Report TR.3005.001, Haematococcus pluvialis and astaxanthin safety for human consumption. Published Material

Shimada Y. Human safety study: oral dosage between 2-12 mg per day of extracted astaxanthin from H pluvialis. Fuji Chemical Industry Co., Ltd. Internal Bulletin, 2003.

Spiller GA, Dewell A. Safety of an astaxanthin-rich Haematococcus pluvialis algal extract: A randomized clinical trial. J Med Food 6:51-56, 2003. Published Material

Keisuke S, Yoshigi H, Aoki K, Koikawa N, Azumane A, Kaneko K, Yamaguchi M. Sports performance benefits from taking natural astaxanthin. Rinshou Iyaku 18: 73-88, 2002. Published Material

Nagaki, Y., Hayasaka, S., Yamada, T., Hayasaka Y., Sanada, M. and Uonomi, T. Effects of astaxanthin on accommodation, critical flicker fusion, and pattern visual evoked potential in visual display terminal workers. J Trad Med 19: 170-173 2002. Published Material

Lignell A. Medicament for improvement of duration of muscle function or treatment of muscle disorder or diseases. Patent Cooperation Treaty application WO98/37874. AstaCarotene AB, Sweden.

Malmsten, C. (undated) Dietary supplemenation with Astaxanthin rich algal meal improves strength endurance. A double blind placebo controlled study on male students. Unpublished report.

Nagata N, Akiratajima, T, Hozukmi M. Effects of astaxanthin on metabolism, during aerobic exercise of human. Toyama International Research Center for Traditional Medicine. Fuji Internal Report, 2003.

Salonen, J. (2001) Effects of astaxanthin supplementation of men on plasma astaxanthin levels, lipid peroxidation, cytochrome P-450 induction, and oxidative damage of DNA: A double-masked randomized placebo-controlled trial. Unpublished report.

Kupcinskas, L., Lafolie, P., Wadstrom, T., Kludelis, G., Jonaitas, L. and Adamonis, K. (2003) Efficacy of astaxanthin-rich algal meal in the treatment of non-ulcer dyspepsia: a randomized double blind placebo controlled study. European Helicobacter Study Group XVIth International Workshop at www.helicobacter.org

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