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#A *F .+* 7 : s K*=<,. fir DEPARTMENT OF HEALTH& HUMAN SERVICES z / G %**,<ra >~ Public Health Food and Washington, ~,lav I 8 Service Drug Administration DC 20204 ;;;’ ~ 376 ’98 NIV25 P2:23 Antonio C. Martinez, II., Esq. 8707 Brittany Drive P.O. BOX 2060 Wayne, New Jersey 07474-2069 Dear Mr. Martinez: This is in response to your letter of November 13, 1998, on behalf of American Specialty Health & Wellness of San Diego, California, to the Food and Drug Administration (FDA) pursuant to 21 U.S.C. 343(r)(6) (section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (the Act)). Your submission states that American Specialty Health & Wellness is making the following statements, among others, for the products: Astragulus Extract “.. promote healing... ” Vitamin Vitamin Vitamin E Plus C Complex C Ester C “.. healing of wounds” Daily Multi-Mineral Daily Multiple Vitamin + Mineral “.. for healing . . .and resistance to illness” 21 U.S.C. 343(r)(6) makes clear that a statement included in labeling under the authority of that section may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases. The statements that you are making for these products suggest that they are intended to treat, prevent, mitigate, or cure diseases, namely wound healing and general illnesses. These cIaims do not meet the requirements of 21 U.S. C. 343(r)(6). These claims suggest that these products are intended for use as drugs within the meaning of 21 U.S .C. 321(g)(l)(B), and that they are subject to regulation under the drug provisions of the Act. If you intend to make claims of this nature, you should contact FDA’s Center for Drug Evaluation and Research (CDER), Office of Compliance, HFD-3 10,7520 Standish Place, Rockville, Maryland 20855. 97s-G/~ Page 2- Antonio C. Martinez, II, Esq. Please contact us if we may be of further assistance. Sincerely, Lynn A. Larsen, Ph.D. Director Division of Programs and Enforcement Office of Special Nutritional Center for Food Safety and Applied Nutrition Copy: +. Policy Dr. Doug Metz American Specialty Health & Wellness 8989 Rio San Diego Drive Suite 250 San Diego, CA 92108 Copies: FDA, Center for Drug Evaluation and Research, Office of Compliance, HFD-300 FDA, Office of the Associate Commissioner for Regulatory Affairs, Office of Enforcement, HFC-200 FDA, Los Angeles District Office, Office of Compliance, HFR-PA240 cc: HFA-224 (w/incoming) HFA-305 (docket 97 S-0 163) HFS-22 [cCo) HFS-456 (file) HFS-450 (r/f, file) HFD-31 O (BWilliams) HFD-31 4 (Aronson) HFS-600 (Reynolds) HFS-605 (Bowers) GCF-1 (Nickerson, Dorsey) f/t: HFS-456:rjm:l l/17/98:docname:62292 .adv:disc33 C. AtWONIO GOVERNMENT AT LAW PUBLIC AFFAIRS AND 8707 BRmANY P.O. WAYNE, BoX NEW EWL. .JERSE7. NEW YORK. TONYMAKTINQ C+smwn OF COUJME!W COUNSEL DFUVE 2069 NJ 07474-2069 TEL 973305 FAX. Il.P.C. MARTINEZ, ATTORNH 973 I 235 305 3983 PARS &0t4w5EWE.COH November 13, 1998 Office of Special Nutritional U.S. Food & Drug Administration By Federal Express Courier Service, Tracking # 790165024108 Re: Statements of Nutritional Support Filings, American Specialty Health & Wellness, San Diego, CA Dear Sir/Madam: As counsel for American Specialty Health & Wellness (ASHW), enclosed please find an original and two copies of Statement of Nutritional for ninety three dietary supplement products distributed by ASHW. Should you have any questions or require any additional information, please do not hesitate to contact me. Yours truly, Antonio C. Martinez, Il. Esq. cc: Dr. Doug Metz, ASHW Anwican Specially HEAITH&WEllNES$ October 30, 1998 Office of Special Nutritional HFS-450 Center for Food Safety and Applied Food and Drug Administration Us. 200 Nutrition c St.sw Washington DC 20204 Statement of Nutritional Support- DAILY MULTIPLE VITAMIN + MINERAL Pursuant to 21 CFR Part 101.93, American Specialty Health & Wellness (ASHW) files the following Statement of Nutritional Support for the Dietary Supplement marketed as: DAILY MULTIPLE VITAMIN + MINERAL 1) Name and Address Ste. 250, San Diego of Distributor: CA 92108 ASHW 8989 Rio San Diego Dr. 2) Text of Nutritional Support Statement being Made: “Daily Vitamin + Multiple Mineral is a combination of vitamins and minerals formulated to provide additional nutrient A complete, balanced supplementation to the daily diet. assortment of essential minerals and other nutrients is necessary tissue vitality and resistance to illness.” for healing, growth, 3) Nama.of 4) Brand dietary DAILY Name: 5) Substantiation corporate officer President. Yours truly, Dr . Doug Metz Vice President ingredient(s) MULTIPLE : See Attached VITAMIN Product Label + MINERAL information on file at the company office. who can certify same is Dr. Doug Metz, Vice , . 8989Rio San Diego Dr., Suite 250, San Diego, CA 92108 ● Phone 619/297-8100 ● Fax 619/209-6236 The Daily Multiple Vitamin + Minerals Description: anclrnincrals ~ormula(cd [oprovideacldi[ional nu[rienl sLkp~]lell~ellca[iol] Daily Multiple Vitamin Y Minera is a combination of vi[amins to ofessential vitamins, minerals and othernutrien(s isnecessary forhealing, growth.tissue the daily diet. A complete, balanc d assortment vitality and resistance to illness. Thesestatementhavenotbeenevaluated by theFood and Drug Administration (FDA).Thisproductisnotintended todiagnose, treat, cure or prevent any disease. Suoolcmcnl Facls DAIIY MUITlVITAMIN +MINERALS DIETARY 5UPP1ENIN1 90 CAPSULES I’fcmium hucfuc(sjur lbur //ccI//bG Ukllflrm ‘“ , American Specially HEAITHMIIIE1lNESS” october 30, 1998 Office of Special Nutritional HFS-450 Center for Food Safety and Applied U.S. Food and Drug Administration 200 c Nutrition St.sw Washington DC 20204 Statement of Nutritional Support- DAILY MULTI-MINERAL Specialty Health & Pursuant to 21 CFR Part 101.93, American Wellness (ASHW) files the following Statement of Nutritional Support for the Dietary Supplement marketed as: DAILY MULTIMINERAL 1 ) Name and Address Ste. 250, San Diego of Distributor: CA 92108 ASHW 8989 Rio San Diego Dr. 2) Text of Nutritional Support Statement being Made: of mineral “Daily Multiple Mineral is a unique combination nutrients formulated to provide additional nutrient A complete, balanced supplementation to the daily diet. assortment of essential minerals and other nutrients is necessary to illness.” for healing, growth, tissue vitality and resistance 3) Name of dietary ingredient(s) : See Attached Product Label -. 4) Brand Name: DAILY information on file at the company office. who can certify same is Dr. Doug Metz, Vice 5) Substantiation corporate officer President. Yours MULTI-MINEIWL The truly, /ZGJT~ Dr. Doug Metz Vice president & . &g.%4$ 8989 Rio San Diego Dr., Suite 250,San Diego,CA 92108@Phone619/297-8100”Fax619/209-6236 Daily Multiple Mineral 1 Description: Daily Multiple Mineral is a unique combination of mineral nu[rients formulated (o provide additional nutrient supplementation 10 the daily diet. A complete, balanced assortment of essential minerals and other nutrients is necessary for healing, growth, tissue vitality and resistance to illness. Thesestatements jlave notbeenevaluated by the Food and Drug Administration (FDA).Thisproductisnotintended todiagnose, treat, cureorpreventanydisease. DAIIY MUITI-MINERA1 Supplcmenl Facls Sewing Sile 3 Iablels - Se!vmgs PeI ComaIneI 30 ham! r.r !,nlnt 104L(,V,b, DIETARY $UPPL[HEHT dldakl MJ$lcg . ..-- —— . .. —— . ..— . ..—. — .-.16b”L hk~bdcnum [?1 ammoCflP12[d \Omcg 61% Emcm(as ammochelalel Othcf Ixttdim($ G?lalm,CPIIuIose,cakwm phu~phalt al!)l!lo 5oomc g ..— ——-. _ ._‘ .———_ hy4wi, SlUIIC ac!d, ma~wsmm $Male arid $IIIcon dI!JI!dC 40JI~VJIUC IIC4 e>labk$hed Odlly hllhhkltlal IS !IW $Iifch, salt at!dJeJ\l 0! WIWJ1 CC)(I1 W, dJ,hf \,, C,O)t American Special[y HEAITH&VVEllNESS october 30, 1998 Office of Special Nutritional HFS-450 Center for Food Safety and Applied U.S. Food and Drug Administration 200 Nutrition c St.sw Washington DC 20204 Statement of Nutritional Support- VITAMIN C ESTER-C Specialty Health & Pursuant to 21 CFR Part 10I.93, American Wellness (ASHW) files the following Statement of Nutritional Support for the Dietary Supplement marketed as: VITAMIN C ESTER-C 1) Name and Address Ste. 250, San Diego of Distributor: CA 92108 ASHW 8989 Rio San Diego Dr. 2) Text of Nutritional Support Statement being Made: that “Vitamin C, also known as ascorbic acid, is an antioxidant is required for proper tissue growth and maintenance and adrenal Ester C has naturally bonded minerals that gland function. help the body absorb the Vitamin C more quickly. Vitamin C against bruising, and supports a healthy immune system, protects and the healing of assists in blood clotting, tissue formation wounds . Chewable C should be taken with food and chewed well, for best absorption.” -. 3) Name of dietary ingredient(s): See Attached Product Label 4) Brand 5) Name: VITAMIN Substantiation information corporate officer PresidentYours C ESTER-C on who can certify file same at the company is Dr. Doug The office. Metz, Vice truly, In /’L7?7q Dr. Doug Metz Vice President . ~ ~,z 8989 Rio San Diego Dr., Suite250, San Diego, CA 92108.Phone619/297-8100*Fax619/209-6236 y-z Ester Vitamin (Ascorbic I Acid, C Polyascorbate) Description: Vitamin C, also known as ascorbic acid,k an antioxidant that k required forpropertissue growthand maintenance and adrenalgland function. Ester C has naturally bonded minerals that help the body absorb the vitamin C more quickly. Vitamin C supports a healthy immune system, protects against bruising, and assists in blood clotting, tissue formation and the healing of woLmcis. ‘llese sia[cmen[s have not been evaluated by lhc Food and Drug Adlninis[mlion (l; DA). ‘1’1]]s produc[is11o[ il~[cncitd [odi:lgl~osc, [rea[, cure or prevent any disease. VITAMIN ( [STIR-(” DIITARY SUP PIE HENT lOOTABLETS I’rcrl!llllrl /’ro/url.s Jf)r )’f)ur Ilcfl l//]& Wull/1(,*.\ ‘“ Suuokmcn( facts Se;vIng SIZe 1 Iablel Wamm Sewmgs Pe! ComameI IMI h,-?. !4W %O+d,l*, ——— C (JJ[!ler-C@ caktum) $03mi 811% Cdrusbmllawootis ?CQmf (CI!IU$ [red, $Id]5% bwllavmwd!l .—. - ..—. —-—.—— — .Oliwrl~fedienti: (klalm, ccllukxt, CalCIUi-@’mpiIjIt American Specialty HEAITH&VVEllNESS october 30, 1998 Office of Special Nutritional HFS-450 Center for Food Safety and Applied Food and Drug Administration Us. 200 c Nutrition St-sw Washington DC 20204 Statement of Nutritional Support- VITAMIN C COMPLEX Pursuant to 21 CFR Part 101.93, American Specialty Health & Wellness (ASHW) files the following Statement of Nutritional Support for the Dietary Supplement marketed as: VITAMIN C COMPLEX of Distributor: CA 92108 1) Name and Address Ste. 250, San Diego ASHW 8989 Rio San Diego Dr. Support Statement being Made: 2) Text of Nutritional that “vitamin C, also known as ascorbic acid, is an antioxidant and adrenal is required for proper tissue growth and maintenance Vitamin C supports a healthy immune system, qland function. protects against bruising, and assists in blood clotting, tissue formation and the healing of wounds. Chewable C should be taken with food and chewed well, for best absorption.” 3) Name .. 4) Brand of dietary Name: VITAMIN 5) Substantiation corporate officer President. Yours ingredient(s): See Attached Product Label C COMPLEX The information on file at the company office. who can certify same is Dr. Doug Metz, Vice truly, /txL/@Dr. Doug Metz Vice President . ~ 8989 Rio San Diego Dr., Suite250, San Diego, CA 921080Phone619/297-81000Fax619/209-6236 Z.z’.?z Vitamin C Complex ! Description: Vitamin C, also known as ascorbic acid, is an antioxidant that is required for proper [issue growth anti m:iin(ellancc and adrcnai glumi function. Vitamin C supports a healthy immune system, protects against bruising, assists in blood clotting, tissue formation and the healing of wounds. Vitamin C Complex contains ascorbic acid, four forms of ascorbatc anti citrus bioilavcsnoicis. product is 1101in[endc~i u diagnose, trc:i~, Thesesta~en~cn{s,havc notbeen evaluated by he Food anLi Drug Adnli])islra[ion (FDA).‘H~iS cure or prtvent any disease. Dcectkm$ [01U\!W IIzbkl WI@ SWzfk Keeo IIIMIJ cb~ed in a cd, dq plact Cwliaw%@ & mlh ml !uppkmml. hcabm mcdialwa, daml w . i wfukPF MI M laflath~. a ywdt itto? chid Milhm[ctnwdlin~Jpl@cim h’olfi lhI$ @c( is mfulakd b~tht [(M JSJ diefaiy WSOPkmMIII ~W havt WI qU6h_0 JbDUlhw FXSkel mp@T@, cmlad /cwp@ii” ntatk hkiq this llJml MClalkin; i~ mchcalnm,hwt mj ISCJSC M Ilkwas,cmwll JWI ~sKlm bfkxt lakin~ Ibis FWJJUCI, Donol SIWM C!IMI? f!tscnbtd cnedKalimwilhwl Iht pami$aii M pmwiplim d w ph)’siciifi WIWI[ 081 m Boa WIUX Ylculll HUIM t Mllhl$ VITAMIN ( [OMP1[X DIETARY SUP PIEHENT Supplemcnl facls PeI C0n12meI Servmf Sue. 1 Tablet - Se!vln~i 100 hn.m, P,, hmq !. 04, lx”, ..— .— —.. . ——— . . . . .. . VdammC (as a$cublc acd. cabum ascmbalc,malncsmm asc~bale, pola$aium a~ctxbalc. Mwm a$ccxbak}WImg 811% CIIIUS biollawmcids [cIliu$ M W IYA biollawrmds) l@)m~ . —— O(hcrIngiedwnlt GclalmCCIIUIOX calwm pho@ulc hydlws, sleam acd,magnesmm Wa!ak and]d~m dIoudt ‘Datti Value notMablt>hti dally, >U($U5C \ld:[)l VilamwC Complex,sIlee 01wheal(oIll s’” 53x40M 0W41,UMIM 9s40 Hlt lOOTABLETS I’rcmlun] t’roduc/sJor Your Ileol[b 6 Wlttess ‘“ and ye351 Anwican Spwial[y HEAITH&VVEllNESS October 30, 1998 Office of Special Nutritional HFS-450 Center for Food Safety and Applied Food and Drug Administration Us. 200 Nutrition c St.sw Washington Statement Pursuant Wellness Support DC 20204 of Nutritional SupportVITAMIN E PLUS to 21 CFR Part 101 .93, American Specialty Health & (ASHW) files the following Statement of Nutritional for the Dietary Supplement marketed as: VITAMIN E PLUS 1) Name and Address Ste. 250, San Diego of Distributor: CA 92108 ASHW 8989 Rio San Diego Dr. 2) Text of Nutritional Support Statement being Made: “Vitamin E is a fat soluble vitamin that is a powerful protect tissue cells from damage caused antioxidant . Antioxidants radiation and overexposure to the sun. by toxic chemicals, Vitamin E is important in the body’s cardiovascular, immne, and endocrine system and the healing of wounds. Vitamin E works closely with zinc and other antioxidants to strengthen many functions of the body, including immunity.” 3) Name of dietary -, 4) Brand Name: VITAMIN Substantiation corporate officer President. 5) Yours ingredient(s) E PLUS Information on who can certify : See Attached Product Label ‘ file at the company office. same is Dr. Doug Metz, Vice truly, Xntqjl’ Dr - Doug Metz Vice President 8989 Rio San Diego Dr., Suite 250,San Diego, CA 92108*Phone619/297-8100*Fax619/209-6236 The Vitamin E Plus Description: Vitamin E is a fat-soluble vitamin that is a powerful antioxidant. Antioxidants protect tissue cells from damage caused toxic chemicals, radiation and overexposure to the sun. Vitamin E is importan[ in the body’s carcliovascular, immune, and cnciocrinc system and the healing of wounds. Vitamin E works closely with zinc and other antioxidants to strengthen many functions of the body, including immunity, Vitamin E Plus also contains the mineral selenium. These statements have not been evaluated by the Food and Drug Administration cure or prevent any disease. (FDA). This product is not intended to diagnose, treat, VITAMIN EPLUS DIETARY SUPPLEMENT 90 /’rcmium CAPSULES i’rochctsjor I’ourllcahb & w\hIcss’” American Special[y HEAITHMIIIE1lNES$ October 30, 1998 Office of Special Nutritional HFS-450 Center for Food Safety and Applied Food and Drug Administration Us. 200 Nutrition c St.sw Washington DC 20204 Stat-ement of Nutritional SupportASTRAGULUS EXTRACT Pursuant to 21 CFR Part 101 .93, American Specialty Health Wellness (ASHW) files the following Statement of Nutritional Support for the Dietary Supplement marketed as: ASTRAGULUS EXTRACT 1) Name and Address San Diego Ste. 250, of Distributor: CA 92108 ASHW 8989 & Rio San Diego Dr. 2) Text of Nutritional Support Statementbeing Made: also known as milk–vetech root is considered a “Ast_ragulus, The root of the plant is used to support a general tonic. healthy immune system, promote healing, and counteract fatigue. General tonics such as astragulus are believed to enhance the body’ ability to cope and adapt to stressful conditions.” 3) Name 4) Brand of dietary -. Name: Substantiation corporate officer President. 5) Yours ingredient(s): ASTRAGULUS See Attached Product Label EXTRACT information on who can certify file at the company office. same is Dr. Doug Metz, Vice The truly, ZY+&7 Dr. Doug Metz Vice President .“,~ 6227 8989 Rio San Diego Dr., Suile250, San Diego, CA 92108*Phone619/297-8100*Fax619/209-6236 7 . * Astragalus Extract 1 Description: As[ragalus, also known as milk-vetch root, is considered a general tonic. The root Oftheplantisusedtosupporta IwIIL1]Y immune system, promotehealing and counteract fatigue. Generaltonics suchasas[ragalus arebelieved toenhancethe body’s ability 10 cope and adapt to stressful conditions. These statements have not been evaluated by tlw Food and Drug Administra cure or prevent any disease. Oireclions for (l$?: lake I capsule w day Slorage: KeepIlghlly closed m J cd, d~ place. CwlimA4arnirrg: As wdh any supplement, he(b of rnedicalion, do ncd use il while pie nanl 01Iaclalmg, CMp(ovide il 10a child wAhout consulting a pt“ystclan, Hola: lhis product is fegulaled by Ihe [DA as a dtelary sup Iemenl. II ~u have any queslions akul how )uu Ieel whl“fe Iaking Ihls supplement, conlacl yJur physician. II you any medication, haveany disease w illness, consull a{e Iaking w physician belofe lakmg ihi$ product. !Io nol slop or change prescflbed medication wilhoul [he pxmission 01p{emphon o! w phySKIM. 061R18UI[0B!MRICPA W’CCL4117 MIH u Po601WKMo,w O!fco,9?IWW0 6 VITLMISS’” ion (FDA). This produc Lis not in[endc(l K)ci:agnusc, treat, Supplement Facts ServinR SIZC I Cdpsulc - Se(vmgs PCI Co(llalllcl ASTRAGAIUS [XTRA(T hmounl PtI hrnnf % 08,1, 10 V,lu, Asllagalus ed(acl (Askagalus memb(anaceusmol, sld 16% ashagalosides) 450mg ‘ —. Olhcr Ingredients: Gelahn, cellulose, calcwm phosphale hrdrous, slearic acid, magnesium slea[ale and slhcon dlol!de DIETARY SUPPLEMENT ‘Dady Value nol eslabhshed Asl!a~alu! [dfacl IS[l??01whcal, coIn, SOY,dwy. ;IICIO:C slalch, sail and ~a~l.