1995S-0316
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