95S-0316
RPT 240
Volume 175

Cover Letter

Letter from Patton Boggs to CFSAN

Letter from Susan D. Brienza to CFSAN

Letter from Patton Boggs to CFSAN

New Dietary Ingredient Notification: For Phyto-Derived Ceramides

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

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).

Brochure entitled Orvza Ceramide, Nutritional Sunnlement, from Oryza Oil & Fat Chemical Co. Ltd, called in the footer: ORYZA CERAMIDE CATALOG ver. 1.0EZ.

Chamlin, S.L. et al. Cerarnide-Dominant Barrier Repair Lipids Alleviate Childhood Atopic Dermatitis: Chances in Barrier Function Provide a Sensitive Indicator of Disease Activity, Journal of Am. Acad. Dermatol, Volume 47, pp. 198-208, No. 2, PR 198-208 (2002).

Ennagram’s Vegetal Ceramides: LD-50 Study, dated July 1999; and Ennagram Report dated November 1997.

Futerman, A., Ceramide Metabolism Compartmentalized in the Endonalsmic Reticulum and Golti apparatus, Current Topics in Membranes, Vol. 40, p. 93, (1994).

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

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. (Copy attached.) Tinyee Hoang is a Graduate Student in Food Science at Washington State University.

Imokawa, G., Structures and Functions of Stratum Comeum Lipids in the Skin, Journal Japan Oil Chem. Society, Vol. 44, No. 10, pp. 1-23 (1995).

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

Japanese promotional websites (excerpts), Winter 2003-2004.

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).

Kenko Corporation In-House Report for the Manufacturing Process of Cenmmide CERP50. (Confidential, Trade Secret information disclosed for the purpose of this Notification to the FDA only.)

Lati, E. New Research and Development in Moisture Retention Mechanism and Moisturizing Agents, Fragrance Journal, Vol. 23, No. 81 (1995).

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).

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

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

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

Orgretmen, B. Biochemical Mechanisms of the Generation of Endogenous Long Chain Ceramide to Exogenous Short Chain Ceramide in A549 Human Lung Adenocarcinoma Cell Line, J. of Bio. Chem., Vol 227, No. 15 (2002).

Oryza Oil & Fat Chemical Co., Ltd., Safety of Ceramide with oral administrations, [no date].

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

Richeux, F., BioHC Appendix 2, Renort to the Investigator TAO423-PH-03/0307 (1996); Appendix 2 (1997). [See cover letter of Report.]

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

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 (promotional brochure re a supplement with Phyto-Ceramide extracted from Konjac.]

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

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

Zetterstern, E. Optimal Ratios of Topical Stratum Corneum Lipids Improve Barrier Recovery in Chronologically Aged Skin, Journal of American Academy of Dermatology, Volume 37, Number 3, Part 1 (1997).