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Philip Morris

Nicotine in Cigarettes and Smokeless Tobacco Is A Drug and These Products Are Nicotine Delivery Devices Under the Federal Food, Drug, and Cosmetic Act: Jurisdictional Determination

Date: Aug 1996
Length: 15 pages
2073227817-2073227831
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MARG, MARGINALIA
MISS, MISSING PAGES
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SCRT, REPORT, SCIENTIFIC
FOOT, FOOTNOTES
Site
R884
Area
WALK,ROGER/OFFICE
Litigation
Mile/Produced
Author (Organization)
FDA, Food and Drug Administration
Hhs, Dept of Health and Human Services
Named Person
A, A.K.
Colby, P.G.
Farone, W.A.
Kessler, D.
Sandefor, T.
T, D.M.
Waxman, H.A.
Weinstein, H.
Named Organization
Amer, American Tobacco
Applied Research
Batco
Bw, Brown & Williamson
Comm on Energy + Commerce
FDA, Food and Drug Administration
Ftc, Federal Trade Commission
Hhs, Dept of Health and Human Services
House
Lor, Lorillard
Los Angeles Time
Nature
Philip Morris
RJR, R.J.Reynolds
Subcomm on Health + the Environment
Wall Street Journal
Date Loaded
12 Jul 2002
Brand
Kool
Marlboro
Winston
UCSF Legacy ID
isy26c00

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Page 1: isy26c00
~~ gy: 8-23-96 ; 5: , ARNOLD & PORTER #11-~7252#11250171#121290;# 2 is. Annex Nicotine in Cigarettes and Smokeless Tobacco Is a Drug and These Products Are Nicotine Delivery Devices Under the Federal Food, Drug, and Cosmetic Act: Jurisdictional Determination a AuguK 1996 DEPARTMENT OF HBALTH AND HUMAN SERVICES 00 ® U.S. Food and Dng Admiaittndon ~ -4
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8-29-96 ; 7:10PM I; ARNOLD & pORTER #7-+ 212 907 5401;#15 F1 V~ -) (Z v, C 1LC.4. c The Manafaebursts Use Chanical Additives to Inaroeye the Deitvery o("Free" Nicotioe The evidence ia the iecord alao supports a fiadiag that the ciYaueece manubetares coouot and fnaaipulate nicaiae ddiveeies thwu;h atiemical maaipol9tinn. One way they do ft is thmoo the uwo of ammaoii sec6nolosies ttiat inmuse the deliveiy of "fire" mcadae to rmolrm by eaisiaa the a11o1>3Oiry or pH of mbacco smolx. "Red' aiwtine is aLo mmetiumes m5aued Co U"whw"emm=bie," a"mo*-ionAOd" nioooae. Me use of ammostia empom& io incsn®o pH is an ompowth of ft iaduatry's ptoduct de+neloQmmc teseaeeh to impcove the effieieoc an o[ smaka niaodae duaO pH iW{iYki1Mr Jii iRW" WWM M+1R The ma of.>am®ck oampomd~s is oouumea io rhe dpeeme indaary. Ammoma oompoMdt 11sve b= mgtila~y idmdfod 'm the Wt dci~odoe inrodiaus submined by die iadaMto the Depuamea of Haahh aad Hmrs< Seivioes."' Ideed, the comawM of *e c*neRe maau&GMM oooeedls tlsg seaed ammooia.roI&sod oampoood4 annmed in the m.nACMe ddpmms.m Aa ateich ia ft iVaSSowtdmrld dnat= ft aaeac dt6e iodmtry'i lelimnm ee ammoo's tedmoic~+.7O Aooon~ t@ 1Me aA+ida, ~'s bnod ao ts~o m~Or Bm~n 3c W~op ~etmpoeoE. Bsvsro ~~~omren.dds so~ oon~on~le eu "armass all" of its aonmndd 6woft $ram A WMMM YieWS ammcM exhaoiW a "the "'' ]ds CoMen dClpmr ltmeYaeom C1o.Nut 41s 2.1906). Val 1V. a st. Su AR (VoL 533 1994 1994 wr~ 'f" gieel t AM, Iopect bools; qbeseoIIessbas io. ammobspes ddivay dsiood®t. Wa1! Sns Jorrnd (Oa.1E,1993). S.e AS(VaL tD! Ret 1). 314
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~jE7Yf By: 8-23-98 ; 7: 11P1N 1, ARNOLD & PORTER #7w 212 907 5401 #lfi a- ~ im II.C.4. sail of Mulboro" and "dse laey facrof thu "Matas Mulbao a Marlboro"; and Brown & WilWmson fomfd that 3aunoooi= OerhnOloV was alw uud by RIR, LaiAazd, and Aimaican To6.cco Co."° In oonpstiodal Mmo®y. Tb=u 5andefor, the CEO of Bmwn & WjllhmWn, aoofitmed the.videsprad tua of ammmia withia the eigataae indu~try, ~~ It is wNl esmbilahed 1huiLo addidan atammmack coampotm* to 1o6~aD iaa= pH. Ttds 9name namdams aiaxine dul is "boooc!' in m~ saft oo "!!Oe" nioodne."i MaSxc is detd3ed in Bto~o t WM=ma's 1991 "Hod6o®t uor Lnf Bleodett and PeOdnct DevElopW whict =x Wet "(ajwA*K wies addad ro a tobacco bJthat riaas witb 8is 6mBlawrs ainodas sa& aud libaaoespns mcomw ."'n Qpthe dm*at 2m dniaoda+s hai a bomd mlmdue a,it m Ses mfoodas hac sevml dgiOonc oomeqmaeea, aoeoaBag to t6e evldeom in t6e akmbdoadve te¢ocd. Flen, ic iasmmthe quaadty OI aioWmdmt is t~tel~ed ftmthe dmems w "' u "Ryrl.rtm ell.i.eee troiKa lhr sk N .e, a r 1*ne du Sviar.aYrr.. E.dat.wli. Sintrow.aMyfdYeC.adws.wiGawVawC.n.ema U2 Boarr4fA*rwariweR l0dCmll~. 2dS.u,?~Ad2S(J~23.1994~(~meaaYlf~s3~deloll. iwwlt(VaL7o91rat3~ 'RS.a+,le. At~ye AGlYASD1(, Ab~drieodws ia~e rd d~r~robe ~oqi ie an~N aueav. Jlfsav ~ J.a. 27.197a~iLcLil1~1~ l.r AttveL 4S F.L 2ft g.eyws Ci.emd'c ite~cey.191i ae29. s.r Alt Nd 1]! i~t t99Qa. n+~e„ ylrobexa rrd.a ttae3x u..+.asabrie,r.sLbcO.nbe..w rb" ..l*. ~~ El % #t,* lft f'ii[ani~ i U(aic ai~Al ~~ Zd HIOMp~~~~~~~COl~~1~1~16C~ati8107~~Waii~ ao~ommc Bm.*&wml.mw. ra6.ma cop. am.aMw.. 7,14l6), x37. Sra iue cva. s24 ReL 104 . 315 -
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FSETR' BY: 0 • 8-23-96 ; 7:11PM 4 ARNOLD & PORTFR #7~ 212 B07 5401;#17 ILC.4. the smolae. Accosdiny to Wi1Nam Fuoae,:he foaoa dinecwr of applied Ieseacch sc Philip Mor:is: THe u.u of ommonia ebenamy wns itepornmit m dae indwwy in MaimatMfig a&4lrateatic=ne dtldnejy 1v sdift smOktm T71e indk3trp xns able to deliver mave of dw available idcorine irs Ae blend so die anodrer by Uft auwarorao eaApowids. ... In tbe aomplex wafd oioobscco smoiae c6m6stty, by iawwiag the pH of the aelml in thc rosiastenm wooion;'mors of the a.rosof would be in fhe vapnr phsse and ba ia tbs Bqmd (ar mmdomud) phase. By frroeasirg Nie ratlo of vqpor plmse ro tiqstid pbest. aee iReseases ttW toral *~r ddtrery aaar du oondansa leaimsr ic less Ubsty to Prvivr tt,e fker med twe vip to dw lings. Sian7uiy, dooumew 6am the AsosoesA'17obsM CamM tt~ Zlkte tu been sn imaeu in bouft tbe s®ooat af Wcodae tlN is uansSarrod 5+wa d1e tfl6sow q tbe mmbm=m smain .rhils 1eavWSdie "aac" levet nocb.oVd. Smoe mcfsc ot m. sncams iQ m6acco is a non-w1sft ssl<, it VU doask rlN a PeM amu* Warrld mke p~lace rf Nie mbmaov was inade bmfe car" dw nieodne m volca(tu wliex tllt d4arsmt is The ssconl etfea of iaat~ t6e fto I+ioodna is oo iose,es dw mow d mtiutine abwptian ffiu o14s piwe a th. soul6. 1e is d.c 5ee nieadas is si~3wodymoieabsoeb.biet[timbouadffioad~.'x Assdyae196a.~st BATCO. alo.m!k Wiiliamam's pom.ms, aepoea~d tbrt towis a dieeet eCael~OO betw0ea smaic+e pH, smd aio®doesbsacptioa lo the monti, tYc "(*mlos Mmdcs 2PpM "`P1MVYA. zbsM.m0dria+slGser f/1SDK*w mr rw i.,IrDafp .dAAam0iavr d C78w.aer A Sden*ie Panp.ettw (INc i.1996), ri 1! (emple*+ddm& Sa At(VoL MAaL Zy. "' Bodmlumec NL (AmairaaToireoo?, LaL1OtMles MoOftgqPmfwlie. (ha ]0.19try1 N o (esomb .aadf. sse Aalva 27 Adt 3M '~SsR~4.At~mit~eAlE.7~ntD1EAk~ap~atfised#s~~mtdNe:ssdomsw~Mds w ooimec=` Nmwa Jio.27.197=de12274m Su AR(Vol4J IteL 251. V Siaqam Qeomt's Rtipae, I9fE, a 29 Sn AR(YaL I2! Rd 1M o 316
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8-23-96 ; 7:11P1d I; ARNOI.D & pARTER #7~ 212 907 5401;#18 II.C.a. to be depeadeat ptincipallY oa =obe pH and nitotino oontoat.:d" SbdlatfY. RIIt msearrhas have repoaed that [B1Y raising PH ... ftm 6.0 to 6.5 (in a low-tar cigareul you saise she kvei of nicodpe that is amsfee:ed to the nse budi and body tiukls in the mouth to the same level as arlth the higha tar cigarette. And bsmm nrn dion;b dYe wr (ewet kas 6sen dropped ftas 25 ing ro 10 mw by roEtina tHt pFl finnt 6~O~to 6-5. yo~c ii~creatr tht ntcoturt tr~oeasfitr in dk niord b.. ... s 0 This e.f%ct of laacmued aicaiAe ab®mptioo in the mouth agpna to be tekted to VUhat fOmL C1smxmma0.ubammdoutba. gsmolm....yar.." FbrCcamp1E. BlCWO & VvMbmzanlt HaadbOOlc Fa' Lxaf Bbedoa Moes dtt by adding s®ooic the ndo of mMicable a>oameID bamd t3calaa iu the oab mry be aUe+ed 'm favoc of amaccaftaiafdoa. As.re lmov. emoafbda LioQAC C0ndbunn 1@p1R iR CIs" QO ~' ad ddi is m1Y ammooia can aa as an impar,t boow.w RJR daexibes thic dfect s'Smooh ud&cW wltieb it disftwgha &am `15e a1pl0we p085W00" whwh "OpC1w f/m dIO 0caft WW& is emcad ...111 fhD ~M,,,~ wT~O •~~i~' TICthirdEffmotiampAwftD~CapQAAODIXtD~~t~Ot madOt of WOOdOC t® ihC b010L nL CnGL Ii dnowd is a$A1M Memb PW ''p Bw7 DR 7ie R.rndsn.jAiewds..dri.dsl. AN. M~ lfa.di (1M a37KW'-1169L SM AR (Naf. MSltd 7lAft 7x Smtar M(ltJ. Aalm" =btimomCOJ6 S.r 4pon qf&wAhi(14Y61197T1. ft7 (a*bi* Addedl SM AR (V04 700 Rd M *s 1a~pd.raRajr.M.asm No~as (~Inr 3x ~~rr,i. s.res.~se...~ B.dd~ ~r,Me 1d(Jus. Z1.1(aae maMP41:1101M). SWARl~VaL 7a9~ "'8®louli4(R7.ReyoofdeTabucaCa). S..elFMrn4fSroft (1976/1977).a7.9. S.rAR(Vai. 700 Rd 3931 317
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5-23-96 ; 7=12P1! G ARlVOLA & PORTER #7- 212 907 5401:#19 a i ILC.4. mcidlod "Furcher Wotk on Evaaable N3oociae,"71" Acoording to this sapoR, whea smoloe is inha]ed iso rhe lmgs, t}iae is vinuslly complet# Madm of sha awdJw, regudkss of wtrrther the nicoBne is in its &ee or bound tam. However, the rtporc bypothesius din the apud of absaaptioe is diffa= when fne ar excaerabk nicaine is ina+eased aad tdat "with a hia6er 'emasmbis' ni ooofae. nieorine rtochts the brain nwn 9n&WY•°"2 RJR rr,sacchas have aLo noovind tha pH Kdj#ametU iffeCt tbe speed of nuotiae Absorpdon, Mmmeaft thu io deswins apietoes for ww amokn "[tjhe nate of absorpaoa of nicoane sho®ld be loepc low by 6otdfna aH 4P*% 9dN6lr 6durv 6.""' FDA naa thu tha = d6emW to booK fee aicadae lards =7 raise the smamc of nisadne ddivaeed t0 dls mOtw tiitLOOia Conespoodb,g ioeiaai! itt nieotino pield, is meawted bythe P1t: nlo~oe. 1bttothe uaatl nioo0ioa deiivery to The smoixr $Om sOms budl my 6s highncrm Oe PZ+C yieid beeatmoa[*e eddition of amMOWLa simfltrcampomde to baNIM 6as Based on this avidaaoe, the Apa.7 ftft etre dVUM mudpuiw md ~ral m~ne degredot tl~ the aeaEimmoKa c~e~. 'Alese aampounds tmadowbnund aioatina 1o bBe moodoa Aoaos to dro ndawy 's oars ~ CO140~ We d~t fa[ docome~s. flti< & " BAnA.Fii,atrrWe,tai'sta.eaArr'MaaA.QS6ftsswLrralteilcMqft*+aam4 a.• ARtVaL 62ZLE 3091. *~ Af. ~t ~ ~Mpil~il dily3 .1~OJOO~YCdCOD f.b.~. ~tl~ ~~AGAi1r11 MtSOlllf ~oMj~7 A~Nt '"TQS Ib GF. (lu Arew MwW+alatovaak•alvra.dtls~M& tt977?,a4taophusa~ s..Altcva.ysl ReE 12n, 318
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wFSENf BY: • 8-23-96 ; 7:12PM 4 ARNOLD & PORTEIt #7-' 907 5401;#20 1LGt. Purposes by: (1) inc~ the aawnnt of nicotiae that is nansferled from the wbacco ro the smoke; (2) iacroft the absocptioD of nicodoe in the mouth; and (3) Possibiy increasing the speed of nicotine aransfecto cda hrsinw d. Nicotinn Ddiverks Haar Iparonxd ia Raent Yeus by D.dga, EsPeciany in Low-Tar C*UGuft THe use of the methods desciibxd above; especially the use of nicainanch tobacco blMds and selective a~ wa vendlauon, baK lnwpsea ncotine atu.er;es to caocumerc. In the iuaisdiaiomi M.iys3t, FDA tbaaa dnc rtiodoe aeliverros as me.suied by the PTC smalao~ madrine have ban inwasg sim 198Z, with ft g/atest increases axmaiog in the ultra•low-tir atsetory. See 60 PR 41?27-41T30. Tlrcse ina+eases ha.e heea oxuaiag wichaut pttalid iaaeetcc in orde3iverves, tlsus iodicaft m indastry ~ wide Urad of desigaing Gipnetcea wih aI nacad rdoodne de8vemes. 1U sricatiwJqr raax ia lo.Nar ciooms reea7t these changes. The Asur.y's sLtiiGCil imlysis ShOWS thtt, a000t~ w 104 FEd@al Th& Commission dus. the bwast or pioduas Isa1 a mulm&y 6ijka ad® of akadoe to tar tlna ddt fOaod i® hig6ar ar prodvas. None of ths 163 psofta with 14 ar mms mM*uuof CAr(die hi;h-nc segment of tbe marlawt) had a mooI ip N o0o xlw~qff rhen 1101Z, By ooUMM 88 of the 93 pmdoas with b ar fe.aam9l8MM of ar(she nMm-loR-ut ~ment) had a mca6nohar atio woata than 1 to 12. See 60 FR d11ZA The indaty did aat chnlleep these Srm in tlew CommeML The increase in nieaonsltarndas 6es oaasled pimuIIy 9m the lasc two aacaaes. In compuilson with dle 1994 msaha, oeqr! ad'tbs 142 m.doemA c%snmes tudmea m ma FrCs sepoa far 197Z had a auaineWrnfa P=Ws(uw ito 12. 'l1mlk, the evWOM 319
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8-23-86 ; 7:45PM G ARNOID & PORTt7t #7- 21Z 507 54U1;#57 • ILC6. tar and nioociae deliveriea. A statisticat analysis of the cigamtes prepared for and released by Rep. waama® ccncluded tbst tde possibility that the cisarotm's enhanced aicotinokar ruio could be explained by random flucmaioos in rar and nu®dne loveis was vimully zero.'~' ni. Cr~nm~rs en ch~icx ELM:. in+~ 1. Cnnwm fmm the oobm= iodnaay seimowledQe that cigaleae mulu6ctutem add am== campoaads to to6.cm Howavar, the commeats argue that the additfoa of amIDmit does na b.ve phmCm.ooi*W tignaSctnoe bacuse virnnUy.ll oiaotine in eigareae cmel~ is a6soe6ed iaw the bloadmian leQacdiess of the pH of the smol= becauae subaeadal amouns af atrtmm wwld be iecpmed to aum smoire pH fsom 6.0 to 7.5 a&Q aod baaase ammoub aompomlda do not marase tho dftbncy of , the toasfer of aicadna fiom the aob.= lo tbe smola.. The Agency dit~tees..i~h W~e oamma~ '11t~r coatlia with me evidence ~+am the ciWexoe iodusl:y docamct in ft mcad, n well a wu3 bsis wimattfio Qe>cp" The evideaee in t6e sxad tita ft dpcetae mmmifwtmm tdd ammoW& campowAg to , iS to p~noe wvasl eb= As de.cnbed in ttle indattegr doMOxM tbe SWOM p N' " of'addieg am>Oak campamdt to tnhaeao sle (1) 01 a," I ft totjft at tucotin4 flom 69 ciprm to the smft (2) to inaate the me o[ aieedna abwqcioa in ft maah; snd (3) pOSSibly to iacMase the sptad of llticodw atsoqxion to t!!e lm,gs. Sse sam3n 1LC4.a. • '3' Snoemeot o[wa=rs HA,141 CmS 3Lt 1009 (ds* d& kd. 3t,199S). Srs AR tVaL 27 Rd 37fia?. 419
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FV BY: 8-23-96 ; 7:45PN I; ARNOLD & PORTER #7" 212 907 5401;#98 i . . II.C.fi. Each of these three effects of adding am®onia compounds 3s sigaificani even if the indumy wcne cormt that the lungs absorb viswaUY W of (he rticadne that is inhaled"' The fits[ effed incneasittg the aansfier of oiootux from the ciSamae to tbe cmolaa-is si$nificant because it iIICreases the qaantity of nicroeine dslivared to the lungs. Most of the nicotine in a cigarette nevea enuas the mouth of a nnoloot. Ratha, it is trapped in the filur, lou w ebe armosphece; or desuayed or deca®posed by ft heat of the cigareae. ~' Acoomaiag to the statemont of Dr. Fafoaie, the fC~er P6ilip Maait Ditecooc of Applied ReMch,lwweve4 ft affixt of addin; ammoft compoauds it "ro delivar mose of c6e avalibie nioocne in the bkod to the malaes."4° Docwme= fmm die Ameann Tobaxo Comptny make a simi-lar poiat, issatit~ thet (6e nte ol aftiioe campo®ds will "incras(e] ft atnomt of nicadne dat is cous6 nd fiam the Sobom Oo tha tayiaaaeam snowK" The seoood eMa is litoewi3e *niSM tePMM olthedAdmCy of nisoaao absotpOOn 9n ibe 1m1g3. 11W egeot is so aaaeaao ft ano®c of aiooaw dut dia s®obr "~ Ia fic6 ieie noe cleatlrc dte ht~ ah~aeb *(mrAf a4 fwaioatfes iw k~i~bd Amudis o m muaI, "jdlepmxft an h6duft PwWw lwuta d.r. ad Rl11ed31olo0. rmofma sq fada ~~y a7v~~ia~ iWf ~~e tion 30y~iy a~r k/~.r r~p m 9/~0.~~r M1fL~ .F~ar am~e d~ ~~oo(~ yai~oo~R~e qa ~ NO ~ q+ .Rd.,s.~d~d~..~rri dw~a~al v~ia ~U ~W f~~pM14 Yi~ fivY MfL~.F a~ MWf° P~.av.=wft% md adMSSO6ar,opeDdwa. Saelu.rs lrR"'enar7N.fieir I919;a*99-332, K304. ,f.. AR(Vad 333 Rez JE14sA "' Mm3oR A1C bA&7l'P. OeoeP CR w d. Abaepfa a'd smbaBsm daioodae too dAieora. B++drJ, Aldlad.7oww.G 3M333-316. at 315 ('IN]o me dm 25% d &Lawl sic0dr eooomt af ihe apayteain~d~~Nd131R.Gf~67,1a ireiiemoe.+~ydr ~s GIdmMr~ASc*nd1tePn~y.edne~WML199ft1nAR(Wid=ftIG21. /° Hpdepp.mer NL (Aaamaa Tobueo~ 1at Sw4ea lAoom4i Repoaf6r Jm qa 30. i9fC4. S.r AR (VoL 27 ReL 3833. 420
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~~~~"j~, ~t1`i L 151 = F tS-Za-t)tl ; 7:46eM c ARrypLD & PORTER #7~ 212 907 5401;#99 ILC6. •, absorbs thmagh the,noutl,-noc dM lungs. Adding ammonia compounds raises ft pH of the tobacco smoke. See saaron ILC4.e. A=ding to RJR nsexrh[s, by raisin8 pH in a low-tar cagatene from just 6.0 to 6.5.-y= inwean the nicoturc uwuftr in tlte nmmh."M The third effact is a possible inaease in the spood of niaocinc absoapdom in the lwigs. The incroase in pH caused by the addhioa of ammonia mmpomult inaeasat the proportion of "fiea" or "exnacobte" nicodne in the smoloe. See tection II.C4.c. Accordina co docnmpm trota BATCO, &owon &af08>m*oa's pumt ooa;M hypothesizad that "wuh a, higher'eattacabie' uieoda®. nicatin ta.chas tbe boia mae 9uiddY•n°O 11W BATCO nsnnbas fanhet po~ d.t"itt hamsn amoi~ a diffiaRace in the time of Weane aWotpcfm of teoths of i seoutd may be itapr:~nt.""'' . In ligitt of this evldenae 5am fat7aa dpmm imditry amplayeec and the indusny's own docame~s, ft hdaetty't wadora t6at addiag ao~ia hfs no plsuaatcobgical signtifixam ic noc aaIt Ie. The tob~xo itt~ay cao~t tLo ~ats ~x ~ a[atamaoia aompoundc ut needed to tane tbe pti af imalv 5om 6A va'fs a 8A. Ha.eMao eos aaemitic suppan is piov9ded tor tlsis tsadm Ma@ovm srm if el+e aaeee111ev ooaect, it would be Ia:gdy aseiswoc Signifteady audkr iMMM m smolZ pfl ate 19belY to have tbe phetmaeokVal effe= descrbW above. As nmd abore. SOe itOURM Sawr 1~+{~t14a6119?7~, at 7(sp6rsk ~dded) 'a Smlou AS (R.b Re9uslds Taheooo Co.j See All (VOL 700 HeL 393). "S BATCO, FwrhK Woak m•FSaraa.ite' Maadne. Savionpla ftdwd(19Qd). at 7. Srs AR (VoL 62 RnG 304 • "`Jda9. „ 421
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pp BY: 8-23-96 ; 7:46PM I; ARNOLD & PORTER #7. 212 907 5401;#00 • II.C.6. documents fmm RJR coseclude thu simply incaeasing the pH of smoioe from 6.0 to 63 ia suf5acet to 'noceease tlti abafllption of nicocine in tha mou¢bfp The Agency fiuther disagmes with the tobacco iodustiy cammeet that dw pH of ciplotie tobacco has no beating oe the efficiency of nicotine tlansfer fivm ft tobacco to the smole . 3t is a basic aeiealific pciaciple dw compoemds in free or unbound forms a:o vapasized more rndily dw compounds bo9od together ia saW" Stacbes of cocaine, for iaoance, show dml ahm cocaino is boand as a alt (as in aoaine hydraclLloeide), much of the coaioe is degmded during pytolysir, in can= whea the coraioe is convetlad to "Ylee fotm, the tt=Sft of the Waiao to tlW imoloe it maah VMrr."' 1ba tobacco iadosuy oammeat providrs no avid eooe oo C, these btos tcientift pcmdples or to idxt the evidaoce ia the leeocd showioa Wath. coavnaion of nicaolae flom 3ts bouod fcm to itt &ec fam inczasa tEe toaski d to smaW, '"sar=edat. r. aMdkvs Tdmoo Coa, Sam AWan 4rsmfta9M4rnM u a(ampb" .aav4 Ss AR (Vd 70aFaE 993b 'o l/oaron RT. HoqdJlN. Gmaate CJu.is76 7d M.19Q6r Is 8smttt G. CwMa CN eds.. Pi..ucaM.da mu[phwwAvddpMMudlsy*vww A+~p ARmcuft M=opqk Hiomedieai Pu6liadaos,ld addoR 19aS& at'6. S.. AR (Vai 711 Itd 141 „' CoakCg.7eR'm,cAR Paesdlqu)A Phraraaldmcks.Aei dm®isead piglcydkft i® m. aHameaQC3isCNl.dr.,phomwMaNjo ..t dPsydmL*+rDMsaA R..mar lig.eSrq*aieMOm®t pWbuCSIMr. 2d.a"t9as, a 6ii-a swAReva nl tr414 'aAAer trscfoto dti o=MaperladPDA woei. tl aseuc dRAtdoco.asa<fta die1970's a dowm=FI ide MIa o s•d7sk A1& a owmnQ 3 WR t ; . .S r . oa{ a tsiavo Y ¢oaamodae &uc4p==masshcowen aba tha pii ddPMMsmofx o aaeao soa a®m[d"ees aioocioe" dre Is delivaod fD I6e tmoh atd dW tYis 3ueMe ia 'hes wiooiW ha a ' e~ac Ooe d deae doeva~n da~a~s ~77A s ifdsi tl~st dis pFi hd d 1LUmao sad Lool eip~ l b, I andianleLTOMMOCE b.dzwaslPiftwd7•wO ~P~mt la-fte¢doodma 0 cNiR k 6 . awoti QraU+~.a wd Ctaanmr&f&&a 1S, S.e AR fVdL ?11 Ral: M Me idoaMVKrirs w N ' Is atmre. a dvem is a s3 eem fa ddirery d.botoa o~e smoig i armcdrr, nsa[n{ f== At "aotmt" sssob piL au or bshw+b=6-a essmdsllY all af ihe amoao niwetns icbmia8i mmbioed .ib addGc N V 00 N V 9~kl
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2073227828 ~gg I to ~at~ ~ ~. . # ~~ ~,~ ~ ., ~ ..~.~ .~~~ ~ ~~~~}} ~ ~,,,~~~}~ ~, ~. 11.~ '~7 ~ ,~~ ~ ~
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~T BY: 8-23-96 ; 7=47PM 1; ARNOLD & PORTER #7- 212 807 5401;#02 F, •' • ILC.6. 2. Cummems from the tobacco indusuy argue do smmnia compounds ue added to tobscco to enhance the flavor cbatacteristics of cigarette smoloo and bind the tobacco together, but net for thir effecc on nicotine. Tbc Agency disagsees with this commeat. The teconi contains auoxaous iomcnal documeacs that indicate that the effax of adding smmonia compouads is to chaags tha ddivasy or absorption of aiCatiee. For uutance, the Brown & Wiltiamsoa's 1991 leaf blruding msrusl sntss that "Lalmanonta. when addsd to a tobacco blend reaas wiMt Hie bd'i~enons nicotirrc saits and liberans frse ntcorins.-O" Similstly, WilHim Faco36, sbe fatmss duex®r of applied xssearch at Ph~7ip Moais, states dsst "ltNu icx ofas~onta dwsrEstry wizs irapurmn ro rhe Wdu,my in mainmnirsg adequate nc+orvae dellwery m aati* spmkos""0 1Le 9nktmy's ssseRion dnt the use of ammoees is simpty tarn4te md hioft amat bz moooGi)ed wah this eridenea Even if ammonia does bsve iftwcompomm dds faa doos aot negsa: the evideoce in the recood nprdiog ammooWs aldea aa aicorim The [obscco indusay aita the adIMan of amnowoiz oompomsds to foeds as evitleace of ammoais's role in lhvoL '13e ase damasoois compaaxds in foods. however. is mc dispositive evide®ca of the me atmmowk a0mpa~ada iu robsex., booute do ammouu compmoods at eigugup aoae bamed snd uftW=dertNa Wosood. MoROVer, oarc Of t6e ragagrrited UMfo[lMMOW&P~nn;o: I Infoods is "pH oonaol." 21M "'Rssrlmlow njTabaeto P.alrcta ftor 3P Hewwp /I(n. dr. Srieo.rdaw aa Aatldi ad /6t Exvtip.wat q(dn CrsA:rere w S..p m[ Can.ures UA llaaae of Rqww2wVadV= 1(8d Cml.. 2d Sets. 21()m. 21, 1994) (suaciamet dDw1C [CY4at)(imph" addedx S.r A8 (VOL 709 Ret. 3). •* fltooe WA. z7,. xaapeiaAan ad edwsc yesmNw..W r.r iw sfe ordrt wW N..y*ave aj IXaantus A Sstirndfio hrrpeerive (Ma. i. 1996), at 19 (empboxis added?. See AR (VCL 638 RaL 2). 424
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SZ~"Tf BY : 8-23-96 ; 7:47PM I; ARNOLD & pOR1ER #7~ 212 907 5401;#03 ILC.6. 184.1133-184.1143, which is the same use of ammoaii compounds described in the itueraal tobacco company docnmema. 3. C.ummears from ft tobscco indosrry aryne that FDA has aakea a cormadiaory position in the Jmisdfaionsl Anilysis by f ndiag bocbh dw ciaueae manufttoners add ammonii compomds to inaeus ft pH of tobacco and that ciaaretca maaufsca¢ers add acida to ieduee the hushoas of ®oir- FDA!s poddorw aie not aConsiscmk. The Jurisdictional An.lysis found, based on the avideace them avaiLble. dot w6m me U&M tmt Ptodaoe Umaity high PH leveg in smoke ortlac have mmQUy hiO nicodm waMA the mrmIfI'cpaas somaimes faft tbe problem tbat the ctigataRS smake ccoWn mo mssh maoane and is soo hais6. In thae sitoasia®s, dhe iecasrl ierBCM thst hare developed ways o0 tednce lunhneas, iaatndioII bwaina PA. Ste Amlysii, 60 FR 41711- 41713. In peher siw.oons, mmnb=a bue the opposi9e pioblom o[ ciptetfe ssub dw may not ddiva eno* alcodne. la thete WW elt011tiaell, sbo cecad iodiealles thac atamtfaames a+lIl sahaflCx mcom de}k.erim Whig mmook oomponnds p 0 laite the Pi oit6e tobaxo and the smds. wl:ich iesMas tre delivety d$ae sdootine o rhe smoioer. SeCseetion II.C.4.e. 4. Broam &W311is=aa mdms tu0ao®®eM tag 1' gdsamiCal msnipu>adoa. Fiut. Bnown dt WMiaamm® assats tmt i1s iamt! dompats show is lmowledge thu pH level does not aPfecs aiaodae ddivesy Secand, Browa & vVilliaMen MOId dw iii mu'11a doomitts show dot the adftDR of 2121001111 Compounds is simply a booamr of smolce "imput." 0
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5EdT BY : B-23-96 ; 7:47PDi I; ARNOID & POR7II2 #7. 212 907 5401 404 ILC.6. •. The Agmry disagrees with Brown & WiIIiamson's eharacterizasiun of its docubxmts. Contraey to Brown & Williamson's commonb the adminisuative recold shows that xzsernhecs aor]dng for Biown & Wiltaamaan and Brown & WiIliamson's paltnt, BATCO, have comisundy undenaaad that pH ievels affxc nicaine delivery. As mrly as 1969. BATCO ssseatohms wroGs that "(n]icoane retenmt oppems to be deparduu priruipalty on smoke pAm.d aienofne coumm"sn Ses sxtions II.C.3.C.i.. RC3.c.iv.. II.C.4.c. ia fact. one of dx doannaqa amd by Bto.~m &WMamaoe ==uHctsks assertion. 1n a pusap Ba qaooed by &owe & WMhnw& the document le(us ro rhe 'pti dapende,u e,~'iecr ofldcorina." raemer vhe oo~y'a mda,amding of the ieistiaaship betwaea pH and nioodae."rs The Agency does ag.ee.vidh Beowa & WilBamoa tltitthe 1991 bleod+ea haudbook lintcs the additian of ammoois oompouA m tbe "imPcC" d smolaa. FloWOvac. the docvrnent maloes a c6ar thtc "imp,d' ia dmptp a tnaogaoe term Eas niaoana detivesy. sntmg tbat drc ammonia campoaads mame"ihe ssit! oteznctibla aioodsr m boaod IIIGOCDC in the imO[<'C";*ft °ceenctabb 030I coaWbum qft imWGE iII dpmm smuim"; and that "dlis is bow ammmia na aat ts sbpm booroae m 2d Ssss. 21(JvLZ1 ,1994) (mmmmt OfDavld r.asi~d. SmAA (VoL 709R411 "~ BAT(70: SirR.oev!®n afMoo:.e e.1A..ds iAr lLaai (19Qi}, stSN•W!'I101(vmpiUAf addedA Su AR (NOL 4aS Re 7593). "' Aynea Q BATi:O). Naa 4am the (iNkDC Pioafw Glssa~fa Pwn.dMp d t!e 8moid.t v~oor-M~ Caafass~ S~s#an>II (JrL 9d~.19iq, t gvWiilb4MC (=Vbm3ds +dded). Sr AR JV# .k!.kE t'1Lk m Rsrstmiae ofTobaeco Produersp (~P~6rt 3J; fl~a.~r8ep ~ Ttfsee~ee dis S.&ea~asY. .a~d~ m[e~~~s.,~~ ~7bMfUf Of lill (.~01ltl~RRC dl r.llrr$y ~ wwwn.~. U..~. ~f! Ofy.~r~~-.-~.^ t~ n1 ~ 10~ "^.~s." 426

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