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n , HEALTH & DEPARTMENT ~F Public Health Service HUMAN SERVICES _ ~~. j 2 Food and Drug Administration College Park, MD 20740 6PI, ~'i ~ `.i~ i"'~ ~~ ~~ MAR 2 9 2006 MD, MS Bioengineering Jeffrey L. Williams, Member Sciences, LLC Advanced Cardiac Life Road 4885-A McKnight suite 405 Pittsburgh, Pennsylvania 15237 ' ~stration the Food and Drug Admi to 2006 10, March letter of to Federal Food, Drug, and This is in response your.C . 343(r)(6) (section 403(r)(6) of the Life Sciences, U.S that Advanced Cardiac (FDA) p~'suant to 21 states submission Your _ CardiovanceTM : Cosmetic Act (the Act)). claim for the product following the LLC is making cholesterol and lowers a woman's total exercise and diet, «CardiovanceTM proper an average of 11% . LDL (bad) cholesterol authority in labeling under the included statement a a specific makes clear that treat, cure, or prevent mitigate, 21 U.S .C . 343(r)(6) diagnose, product to suggests ' on maY not claim are making for this P you of that section that statement . The not meet the disease or class of diseasesprevent, or mitigate disease .' This claim does is intended for to treat, this product that it is intended claim suggests that Dear Dr . Williams : : 343(r)(6) . This it is subject to requirements of 21 U.S .C 321(g)(1)(B), ~d that . .S.C U of 21 the meaning intend to make claims of this you use as a drug within If Act. the of provisions (CDER), regulation under the drug FDA's Center for Drug Evaluation and Research Rockville, contact Pike, II, 11919 Rockville nature, you should HFD-310, Montrose metro office of Compliance, Maryland 20852 . FR structure function claims (65 on rule final January 6, 2000 cholesterol," however 'In the preamble to the believe that "lowers to continues that "FDA 1000 at 1019) FDA stated disease claim." qualified, is an implied 97s 0163 tET $'AA , 3effrey L. Page 2 - Dr . Please contact Williams be of further us if we may assistance. sincerely yours, 5usan J . Walker, MD Director Dietary Programs Supplement of Labeling Division Products, office of Nutritional Supplements and Dietary Safety Center for Food and Applied Nutrition HFD-310 of Compliance, Office and Research, Regulatory Affairs, Office of Copies: Evaluation for Drug ' ioner for FDA, Center the Associate Conv~ss FDA, office ofHFC-200 Compliance, HFR-CE140 of Office einent, Bnforc District Office, FDA, Philade1ph Philadelphia . f~ ' - ~~ . . . . . 4~ : . . . . . . . . ' CARD I OVANC E'M . .. . . . . . _ . . . . l 01Vlarch 20 06 Office of Nutritional Products, Labeling and Dietary Supplements (HFS-810) Center for Food Safety and Applied Nutrition, Food and Drug Administration, S 1 00 Paint Branch Pkwy. College Park, MD 20740 301-436-2375 ~ ~ r~ ~ ,~c U ~ °' ~. 2. r~ 1 l~i` Sir or Madam: Advanced Cardiac Life Sciences, LLC files this notification of statements of nutritional support pursuant to section 403(r)(6) of the Federal Food, Drug, and Co smetic Act. This notification also includes the certification required by 21 CFR Part 101 .93(a)(3). 1 . Name and Address of Supplement Distributor: Advanced Cardiac Life Sciences, LLC, 4885-A McKnight Road, Suite 405, Pittsburgh, PA 15237 2. Text of the Statement that is Being Made : "CardiovanceTM, proper diet, and exercise ."1°2 lowers a woman's total cholesterol and LDL (bad) cholesterol an average of 11% ' 3. ' Name of the Dietary Ingredient or Supplement that is Subject of the Statement : CardiovanceTI". 4. Name of the Dietary Supplement (including Brand Name) in W11ose Labeling the Statement Occurs: CardiovanceTm S. -Substantiation information is on file in the sponsor's office . The company member that can certify same is Jeffrey L. Williams, MD, MS, Member. Furthermore, it is hereby certified that the information contained 'in this notice is complete and accurate, and that the notifying firm has substantiation that the statement is truthful and not misleading. Regards, ,1.._. Jeffre . Williams, MD, MS Bioengineering Member Advanced Cardiac Life Sciences; LLC : 'Cleeman JI (Corresponding Author), Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults, "Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel IlI)," JAMA, V. 285, No. 19 (May 16, 20(31}, pp. 2486-2497 . KA, Jones PJH, "Combination Diet and Exercise Interventions for the Treatment of Dyslipidemia: an Effective Preliminary Strategy to Lower Cholesterol Levels?" Journal of Nutrition, V : 135 (2005), pp. 1829-1835 . Advanced Cardiac Life Sciences, LlC " Phone/Fax: 877.490:6787 " 4885-A McKnight Road, Suite 405 " Pittsburgh, PA 15237 " infoC cardiovance.com " www.cardiovance.com