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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health ServiceFood and Drug Administration
Memorandum
Date:
12/03/02
From:Subject:To:
Gloria Chang, IDS/Pharmacist,Division of Standardsand Labeling Regulations,Office of Nutritional Products,Labeling and Dietary Supplements,HFS-82075Day PremarketNotification of New Dietary IngredientsDockets ManagementBranch, HFA-305New Dietary Ingredient: BiovitafWBioVitabronch (Vitex negundo, L)Firm: Kelatron Corp.Date Received by FDA:90-Day Date:2/l l/O25/ 12/02In accordancewith the requirementsof section 413(a) of the Federal Food, Drug, andCosmetic Act, the attachedcorrespondence or the aforementioneddietary ingredient shouldbe placed on public display in docket number 95S-0316 as soon possible. Thank you foryour assistance.Attachments
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DEPARTMENT OF HEALTH 8sHUMAN SERVICES
Public Health ServiceFood and Drug AdministrationCollege Park, MD
Mary Ann Coral-ArnasifuenKelatron Corporation World Headquarters1675 West 2750 SouthOgden, Utah 84401Dear Ms. Coral-Amasifuen:This is in response o four separate otifications you submitted pursuant to 21 U.S.C.350b(a)(2).All four notifications were received by the Food and Drug Administration (FDA)on January 3,2OO2, ollowed by an addendumdated January 10,2002. In follow up, wecontacted you by telephone on January 14,2002 notifying you that the notifications wereincomplete (seebackground of follow up below).Subsequently,you sent addendumsdatedJanuary 18, and February 5,2002. We received your last addendum for your notificationsdated February 5,2002 on February 11,2002.Therefore, the effective filing date for all fournotifications is February 11,2002.As noted above, we contacted you by telephone on January 14,2002 notifying you that thenotifications were incomplete in that they did not contain levels of the dietary ingredients,conditions of use, or copies of the full-text journal articles corresponding to the abstractsyousent us. We explained that the requested nformation would have to be submitted in triplicate(3 copies) if we were to consider hese references n our review.On January 24,2002, wecalled you again and left a message hat the addendums hat you sent dated January 18,2002,did not contain the levels of the new dietary ingredients as requested.Each notification concerned a different botanical that you assert s a new dietary ingredient.The botanicals are isted below by the Latin binomial name, plant form, and product name asstated n your notifications.K&X negundo L. (pure leaf powder ) -- BioVitafluIBioVitabronch
BZumea balsamifea
L. (pure leaf power) -- BioRenal
Mormadica charantia
L. - Makiling v. (pure leaf powder) -- BioDiamed
Lagerstroemia specious
L. (pure leaf powder) -- BioDiamendThe law at 21 U.S.C. 350b(a)(2) requires that a manufacturer or distributor submit certaininformation to FDA at least 75 days before a new dietary ingredient or a dietary supplementcontaining it is introduced or delivered for introduction into interstate commerce. This.information must include the basis on which the manufacturer or distributor has concludedthat the new dietary ingredient or a dietary supplement containing it will reasonably beexpected o be safe. FDA reviews this information to determine whether it provides anadequatebasis or such a conclusion.Under 21 U.S.C. 350b(a)(2), there must be a history ofuse or other evidenceof safety establishing that the dietary ingredient, when used under theconditions recommendedor suggested n the product’s labeling, will reasonably be expected
 
Page2 - Ms. Mary Ann Coral-Amasifuento be safe. If this requirement s not met, the new dietary ingredient or dietary supplementcontaining it is deemed o be adulteratedunder 21 U.S.C. 342(f)(l)(B), because here isinadequate nformation to provide reasonable ssurancehat the new dietary ingredient doesnot present a significant or unreasonable isk of illness or injury.FDA has considered he information in your notification and has several significant concerns.Based on the information in your notification for all four botanical ingredients, FDA hasdetermined hat the information submitted suggests hat the intended uses mply or representtreatment of disease. The following are examples.
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The botanical ingredient Vitex negundo L., the product name“BioVitafWBioVitabronch” implies a recognizabledisease ondition, the “flu”. FDAconsidersa brand name that includes a disease ame or a clearly recognizablederivation of a diseasename to be a disease laim. (See 21 CFR 101.93(g)(2)(iv)(A).)
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Under the conditions of use for the botanical ingredient Blumeu balsamijkru L.(BioRenal) you state hat BioRenal might be effective as a diuretic and as an anti-urolithiasis agent (chronic formation of kidney stones).
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Under the conditions of use for the botanical ingredient Monnudicu churuntiu L.-Makiling v. (BioDiamed) you state hat the recommendeduse s that it may be helpfulfor blood sugar regulation and type II diabetesmellitus.
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Under the conditions of use for the botanical ingredient Lugerstroemiu specious L.-(BioDiamend) you state hat clinical trials indicated that BioDiamend may have someblood sugar owering properties n vivo and herefore the recommendeduse is that itmay be helpful for blood sugar egulation and type II diabetesmellitus.Pleasebe advised hat any representation hat a product is intended for the diagnosis, cure,mitigation, treatment or prevention of disease n man or animals suggests hat it is a drug, asdefined in 21 U.S.C. 6 321(g)(l)‘(B), and would be subject o regulation under the drugprovisions of the Federal Food, Drug and Cosmetic Act. All drugs must be approved by FDAbefore they can be marketed n the United States. f you wish to market your products asdrugs, you should contact FDA’s Center for Drug Evaluation and Research CDER), Office ofCompliance,HFD310,752O StandishPlace, Rockville, Maryland 20855.FDA also has concernsabout the evidence on which you rely to support your conclusion thatthe four botanical ngredients n your notifications will be reasonablyexpected o be safe orthe suggested r intended uses.Much of the history of use information you submitted appears o be selectedpages printedfrom commercialmagazinesor promotional literature. Some of the sourcesof these articles were not identified nor were the specific ingredients in your notifications mentioned in thearticles. Thesearticles primarily focus on anecdotaluse for diseaseconditions and do not address afety. The statements n these articles cannot be validated and are not corroborated
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