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October 1,2004 VJA FEDERAL EXPRESS AND FACSIMLLE (301) 436-2636 Ms. Linda Pellicore, PhD Division of Standards Labeling Regulations and Office of Nutritional Products,Labeling, and Dietary Supplements (HITS-820) Center for Food Safety and Applied Nutrition Food and Drug Administration 5 100 Paint Branch Parkway College Park, MD 20740-3835 Re: New Dietary Ingredient Notification for
Cnr4lhm4 Fimbriata
OCT 3 2004
Extract
Dear Ms. Pellicore: Per our telephoneconversationyesterday,I am confirming that GencorPacific, Inc. (“Gencor”) is a bulk manufacturerof raw ingredientsand doesnot mantiactnre fmished products. Gencor intends on distributing CwdZuma Fimhriafa Extract only in dried powdered form, as describedin the New Dietary Ingredient Notification submittedon August 24,2004. Gencor will not be manufacturing,selling, or distributing CeruNvmaFimbriatu Extract in capsule,tablet, s&gel or liquid form. If you have any further questions,pleasedo not hesitateto contact us. Very truly yours,