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Dockets Management


RPT 275
Volumes 211, 212

Cover Page

Letter from CFSAN to Patton Boggs, LLP

Letter from Patton Boggs, LLP to CFSAN

New Dietary Ingredient Notification - Wheat germ-derived Ceramides

Ahn, Eun Hyun and Schroeder, Joseph J., Sphingoid Bases and Ceramide Induce Apoptosis in HT-29 and HCT-116 Human Colon Cancer Cells, Experimental Biology and Medicine 227: 345-353 (2002). Published Material

Applegate, Elizabeth and Grivetti, Louis, Search for the Competitive Edge: A History of Dietary Fades and Supplements, The Journal of Nutrition, 77:869S-873s (1997). Available at http://www.nutrition.org/cgi/content/full/127/5/869S. Published Material

Berra, B. et al., Dietary Sphingolipids in Colorectal Cancer Prevention, Eur. J. of Cancer Prev., Volume 11, pp. 193-197 (2002). Published Material

Bouwstra, J.A. et al., Role of ceramide 1 in the molecular organization of the stratum cormeum lipids. J. Lipid Res., 39 (1), pp. 186-96, Jan. 1998 (Abstract from PubMed). Published Material

Chamlin, S.L. et al., Ceramide-Dominant Barrier Repair Lipids Alleviate Childhood Atopic Dermatitis: Changes in Barrier Function Provide a Sensitive Indicator of Disease Activity, Journal of Am. Acad. Dermatol., Volume 47, pp. 198-208, Number 2, PR 198-208 (2002). Published Material

Di Sabatino, Antonio, et al., Ceramide involvement in the signal transduction leading to increased enterocyte apoptosis in Celiac Disease, Communications des Digestive Disease Week (May 2001). Published Material

Finnegan, Catherine M., et al., Ceramide a target for antiretroviral therapy, published online before print October 15, 2004, Proceedings of the National Academy of Sciences of the United States of America, Volume 101, Number 43, 15452-15457 (October 26, 2004). Published Material

Futerman, A., Ceramide Metabolism Compartmentalized in the Endopalsmic Reticulum and Golgi apparatus, Current Topics in Membranes, Volume 40, p. 93 (1994). Published Material

Goldstein, A., Ceramides in the Stratum Corneum: Structure, Function, and New Methods to Promote Repair, Int. J. of Derma., Volume 42, pp. 256-259 (2003). Published Material

Gossioux, P. United States Patent 5,817,646, "Polar lipid composition of plant origin," issued October 6, 1998.

Hoang, T., Sphingolipids (a Powerpoint presentation), March 28, 2002, p. 12; also citing to Vesper. Tinyee Hoang is a Graduate Student in Food Science at Washington State University.

Horibata, Yasuhiro et al., Unique Catabolic Pathway of Glycosphingolipids in a Hydrozoan, Hydra magnipapillata, Involving Endoglycoceramidase, J. Biol. Chem., Volume 279, Issue 32, pp. 33379-33389 (August 6, 2004). Published Material

Imokawa, G., Structures and Functions of Stratum Comeum Lipids in the Skin, Journal Japan Oil Chem. Society, Volume 44, Number 10, pp. 1-23 (1995). Published Material

International Business Strategies, Dietary Supplements in Japan, December 2001.

Kajimoto, O. et al., Clinical Investigation of the Skin Beautifying Effects of a Beauty Supplement Containing Rice Derived Ceramides-Objective Assessment of Dry Skin through Analysis of Three Dimensional Microscopy Images. Authors are affiliated with the Health Management Center, Osaka University of Foreign Studies; Dermatology Department, Faculty of Medicine, Osaka City University; and the Institute of Comprehensive Medical Science (undated publication). Published Material

Kohyama-Koganeya, Ayako, et al., Drosophila Glucosylceramide Synthase (A Negative Regulator of Cell Death Mediated by Proapoptotic Factors), Journal of Biological Chemistry, Volume 279, Issue 34, 35995-36002 (August 20, 2004). Published Material

Kondo, Tadakazu et al., Role of c-jun Expression Increased by Heat Shock- and Ceramide-activated Caspase-3 in HL-60 Cell Apoptosis, J. Biol. Chem., Volume 275, Issue 11, pp. 7668-7676 (March 17, 2000). Published Material

Kretchmer (a subsidiary of Quaker Oats), current label for Wheat Germ Oil. Published Material

Lati, E., New Research and Development in Moisture Retention Mechanism and Moisturizing Agents, Fragrance Journal, Volume 23, Number 81 (1995). Published Material

Lee, M., Analysis of Ceramides in Cosmetics by Revised-Phase Liquid Chromatography/Electrospray Ionization Mass Spectrometry with Collision-Induced Dissociation, Rapid Commun. Mass Spectrom., 17: 64-75 (2003). Published Material

Liu, Pingsheng and Anderson, Richard G.W., Compartmentalized Production of Ceramide at the Cell Surface, The American Society for Biochemistry and Molecular Biology, Inc.,Volume 270, Number 45, pp. 27179-27185 (November 10, 1995). Published Material

London, Megha and Erwin, Ceramide Selectively Displaces Cholesterol from Ordered Lipid Domains (Rafts); Implications for Lipid Raft Structure and Function, J. Biol. Chem., Volume 279, Issue 11, pp. 9997-10004 (March 12, 2004). Published Material

MacKichan, Mary Lee and DeFranco, Anthony L., Role of Ceramide in Lipopolysaccharide (LPS)-induced Signaling, J. Biol. Chem., Volume 274, Issue 3, pp. 1767-1775 (January 15, 1999). Published Material

Merrill, A.H., Jr. et al., Sphingolipid Uptake by Isolated Segments of the Rat Intestine, FASEB Journal, P. 3A, 469 (1989). Published Material

Merrill, A.H., Jr. et al., Importance of Sphingolipids and Inhibitors of Sphingolipid Metabolism as Components of Animal Diets, Journal of Nutrition, Volume 127, pp. 830S-833s (1997). Published Material

Motta, S. et al., Ceramide Compositions of the Psoratic Scale, Biochimica et Biophysics Acta, 1182: pp. 147-151 (1993). Published Material

Novgorodov, Sergei A., et al. Positively charged ceramide is a potent inducer of mitochondrial permeablization, Summary of article accepted for publication in Journal of Biological Chemistry (February 18, 2005); un-published as of March 4, 2005, and thus full article not available. Published Material

Nyberg, Lena et al., Localization and capacity of spingomyelin digestion in the rat intestinal tract, Journal of Nutritional Biochemistry, Volume 8, pp. 112-118, March 1997. Published Material

Orgretmen, B., Biochemical Mechanisms of the Generation of Endopenous Long Chain Ceramide to Exogenous Short Chain Ceramide in A549 Human Lung Adenocarcinoma Cell Line, J. of Bio. Chem., Volume 227, Number 15 (2002). Published Material

Pelle, E. et al., United States Patent 6,136,301, "Lipid mix for lip product," issued October 24, 2000.

Pfeuffer, M. and Schrezenmeir, J., Dietary sphingolipids: Metabolism and potential health implications, Institute of Physiology and Biochemistry of Nutrition, Federal Dairy Research Centre, Volume 53, pp. 31-42 (January 23, 2003). Published Material

Possemiers, Sam, Research: 1. Microbial metabolism of dietary sphinnolipids and its implications for human health. [no date] Report of Lab MET, the Laboratory of Microbial Ecology and Technology. Ghent University, Belgium. Available via the Internet. Published Material

Reiss, Ulrike, et al., Sphingosine-phosphate Lyase Enhances Stress-induced Ceramide Generation and Apoptosis, Journal of Biological Chemistry, Volume 279, Issue 2, pp. 1281-1290 (January 9, 2004). Published Material

Richeux, F., BioHC Appendix 2, Report to the Investigator TA0423-PH-03/0307 (1996);
Appendix 2 (1997). [See cover letter of Report.]

Scarlatti, Francesca et al., Ceramide-mediated Macroauthophagy Involves Inhibition of Protein Kinase B and Up-regulation of Beclin 1, J. Biol. Chem., Volume 279, Issue 18, pp. 18384-18391 (April 30, 2004). Published Material

Schmelz, E.V., Uptake and Metabolism of Sphingolipids in Isolated Intestinal Loops of Mice, J. of Nutrition, 124 (5): 702-712 (1994). Published Material

Schmelz, Eva M. et al., Experimental Therapeutics; Ceramide-D-D-Glucuronide; Synthesis, Digestion, and Suppression of Early Markers of Colon Carcinonenesis, Cancer Research 59, pp. 5768-5772 (November 15, 1999). Published Material

Stratford, Suzanne, et al., Regulation of Insulin Action by Ceramide (Dual Mechanisms Linking Ceramide Accumulation to the Inhibition of Akt/Protein Kinase B), Journal of Biological Chemistry, Volume 279, Issue 35, pp. 36608-36615 (August 27, 2004). Published Material

Sullards, M.C., et al., Structure determination of soybean and wheat glucosylceramides by tandem mass spectrometry, Journal of Mass Spectrometry, Volume 35, pp. 347-353 (2000). Published Material

Szweda, J.A. et al., United States Patent 5,667,770, "Long wearing lipstick," issued Sept. 16, 1997.

Unitika Ltd. Health & Amenity Business Dept., CERAMIDE: Clears the skin as YOU eat, a promotional brochure on a supplement with Phyto-Ceramide extracted from Konjac (no date).

Vaena de Avalos, Silvia, et al., Activation and Localization of Inositol Phosphosphingolipid Phospholipase C, Isc1p, to the Mitochondria during Growth of Saccharomvces cerevisiae, Journal of Biological Chemistry, Volume 279, Issue 12, pp. 11537-11545 (March 19, 2004). Published Material

Vesper, H. et al., Sphingolipids in Food and the Emerging; Importance of Sphingolipids to Nutrition, J. of Nutrition, 129: 1239-1250 (1999). Published Material

Wells, Gerald B. et al., Heat-induced Elevation of Ceramide in Saccharomyces cerevisiae via de Novo Synthesis, J. Biol. Chem., Volume 273, Issue 13, pp. 7235-7243 (March 27, 1998). Published Material

Yamamura, T. and Tekezuka, T., Change in sphingomyelinase activity in human epidermis during aging, Journal of Dermatological Science, 1 (2):79-84 (1990). Published Material

YBS Corporation, Wheat Germ Oil, Containing Vegetable Ceramides, including "Characteristics of 'Wheat Germ Oil-S'" (at page 3 of 4). Available on the Internet at www/ybsweb.co.jp/exhf5.html. Published Material

Zettersten, E., Optimal Ratios of Topical Stratum Comeum Lipids Improve Barrier Recovers in Chronologically Aged Skin, Journal of American Academy of Dermatology, Volume 37, Number 3, Part 1 (1997). Published Material

Zhou, Honglin et al. Inhibition of Akt Kinase by Cell-permeable Ceramide and its Implications for Ceramide-induced Apoptosis. J. Biol. Chem., vol. 273, Issue 26, pp. 16568-16575 (June 26, 1998). Published Material

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