DEP~TME~
OF HEALTH AND RUMAN SERVICES
Public Health Setvim Food andDrug Adminlstraiion 5100 Paint Branch Parkway College park, Maryland 20740
SergCRMartinodi Agent for Natural& Inc. 37 Skyline Drive Groton#comlecti~l06340
. ‘ .I . ,‘ i . -. Dear Mr. Martinodj
AUG1 2 2005
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This is to inform y d that the notification,datedMay 24,2005, you submittedon behalfof your (2)@ection 413(a)(2)of the FederalFood, client, Naturaleaf,L c., pursuantto 21 U.S.C. 35Ob(a) Drug, and CosmeticAct (the Act)) was filed by the Food and Drug Administration(FDA) on June 1,2005. Your ~tification concerns substance the called“Cunari~ i&m nut oil” that youintendtomark&asanewdietaryingredient. Inc. intendstomarket the new dietary ingredient oil” in the form of soft gel or gel capsules.The notification statedthat yintakewillbeIdroporlcaps;lle3timesa?aywitheachmeal. This Thenotificationalsostatedthatthedietaryingredientwill Under 21 U.S.C. 3$&(a), the manufackmror distributor of a dietarysupplement containinga newdietaryingredi t,thasbasnotbeenpresentinthefoodsupplyasanarticleusedforfoodina foxminwhichthef tici has not beenchemicallyalteredmust submitto FDA, at least75 days introducedor deliveredfor introductioninto’ intemtatecommerce, which the manor distributorhas‘ concludad a that new dietary ingredientwill reasonably expected be be to eterminewhetherit providesan adequate basisfor such ,theremustbeahistoryofuseorothercvidenceof * whmusedundertheconditionsrecommended willreasonablybeexpeckdtobesafe. If dietary supplement considered be adulteratedunder is to then is inadequate informationto provide reasonable assurance that t&e new dietaryingredientdoesnot presenta signikant or unreasonable of illness or risk injury.
Page-2- Mr. SergeR Martinod
FDA has carefidly consideredthe information in your submissionsnd the agencyhas &ceks &out the evidence on which you rely to supportyour conclusionthat a dietary supplement . containing “C~ indicum nut oil” will reasonably expeckd to be saf& be to adequatelyidentify your new dietary ingredient, “CaMl’ jndicum ium notification includeda flow diagramof a manuktming process;this equatelyestablishthe identity of ‘ Yharium indhun n~$@l;? For a nutrient profile (TLC & CC) of ke fatty acidsfound iua typical nut by weight of saturatedf& 38% monosaturated 14% PUPA&13% fat, drates with small amounts of mineralsand vitamins), but provided no hqardhg the methodsof analysis,composition or purity of “Canur~ /is the subjectof your notification. In addition, the amount of. .+Ckarium indicum nut oil” in iaaunspecitkd volume of one drop that constitutesa serving size of your , I‘ product is unclear. ,’ . Your notification &ed then is a long history of us5 of Canarium indicum nuts knd.nut oil mixtures as food Asia, South WesternPacific,Melanesia,and New iZedand aiui you that discussthe safbtyof diets that contain nut mkturesj including Canatlum indicwn nut oil that is the subjectof your n@ificati* included safety data on nut oil mixturesbut not’ your proposed on ium indicwn nut oil,” or your dietary supplementcontaming your “Canarium indkum nut oil.” Therefore,it is not clear how th&su&mces cd scientific studiesare qualitatively or quantitatively similar to your. “Canarium indicum nut bil,” or how thesestudiesare relevantin your dietary supplementproduct comaining your new dietary .a, mmendedconditions of use. .. _. above, the information in your submissiondoesnot pro& a& that “Gmarium huikum nut oil,” when used under the conditions inthelabelingofyourproduct,willreasonablybeexpecteatobe t may be adulteratedunder 21 U.S.C. 342@(1)(B) as a dietary new dietary ingmdient for which there is inadequateinformation to provide reasonablekkance that suchingredient doesnot presenta significant or unrea&&le risk of illness or injury. Introduction of such a product into interstatecommerceis prohibited under 21 U.S.C. 33 k(a) and (v). confidential for 90 days after the filing date of June 1,200s. Afkr catron will be placed on public display at FDA’ Division of Docket s 958-0316. Prior to that date, you may wish to identify in writing on you believe is proprietary, trade secretor otherwise confidential
Pago-3- Mr. SergeR h4nrtinod
If you have any qwdstions concerning this matter, please contact Linda Pellicae, Ph.D. at (301) 436-2375.
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sincedy yours,
Susan J. Walker, M.D. Director Division of Dietary Supplement Proghms Oflice of Nutritional Products, Labeling and Dietary SUpplem&~ Fterfor FoodSafkty and AppliedNutrition