Tobacco Documents Online

6,1051.4S91-

u ¢ Tues~y. June I& 19R5,Part V Links Clove Cigarettes Ingredient, Toxicity Experiment Yields Sdentif c Data BlamJag Eugenol for Lung Damage to A_nimals , L',. " :i By" DHNNIS Mc~4, 7"tmta St~H Prellralnary result* of Ln ongoing study of the posstble to:de el/eel2 of =rooking clove cigarettes show that ~~the mNor component of clove~--gan b~ lethal to anLmals whqg ~tered d~rcctly Into ~e l"~ngl The ~me~ h~ lem-ned. 'Fne Independent study by the A.mer- lean Health Foundatlon In VaLhalla, N.Y.. provldea the first ~cienU/Ic report ',.hat llnk~ eu~enol wlth obgervatlom by phyaiclar~ on the toxicity of the faddish, pungent-sme!11ng imported clg~ette.~ (tom/ndonesla. Between Ma:ch. 1984. and May, 1985, the Center~ for Dbease ConL-ol in Atlanta reported, It recorded 12 c~es of severe lllness po~Ibly ~sociated w~th smoking clove ciga.rettes. (The CDC did not mention the case of Tim Ci~law, a 17-year-old Newport Harbor High School student who developed short- ne~ of breath shortly after smoking a clove cigarette e~ly ]a~1. year =nd eventually died of re~ph-atory failure. .In March, Cl~law'l p~rent* filed s $25-mUllon l=wsult claiming that the =ellers, makers and Importers were, Ikmong other things, negligent in sup- plying "da.ngeroua and defccUve" ciga- rettes.) Symptoms in the 11 paUents who were hospltallzed, according to a CDC report, Included pulmonary edema (blood. or fluld.filled lungs), bmn- chc~rpasm (a cor~trictlon of the air pa~Lageway) and hemopty6i~ (cough- tn~ up blood). Minor mymptam~ rt.ported to Lhe CDC [rmlude rmu~ea and vomltlng, increued incidence of re~Iratory tract infections, Wr'~er wor~en.lng of ci'u'onlc bronchitl~ a.nd Increased Lncldence and eeverlty of a~'hma attack~. Mild coughing up o: blood, the report noted, ha~ been re- ported with parl.lcula.r frequency. "in a laboratory setting we've shown that symptorna reported by Indl'eiduala who smoked clove elgin'cites--such • pltt!ng up of blood and bronchopneu- monla--can also be obaerved w%h ani- mals Lhat have bee.n L-eated with cugenol,'" sa!d Edmond LaVoie, m~oci- ate d!v~lon chief of environmental ca:c!nogens at the American Health Foundation, a nonprgfit. Independent ~tudy on oLher an~ma~ and ~ rt"p.eat- t'~ it~ study on ra~. The rodent~ In the s~ud)' were given various do~e~ o! eugeno! Into the lung v~a the trachea, which LaVole ac- knowledges L~ not the ~arne ~ In.haJa- Uon. Although the =tudy ~ Lnclude e.xZ>e~,ment* on L~.~2ation of eu~enol. LaVole said that a~.'-t~ eu~;enol through the L"-achea 1~ "one of the most direct route~ we have avalla- ble for de,crmlnln8 the po~Ible tz::clc e'fect~ of a chernlcal In lung UL~rues for. small rodents. "The fact thst we see such evldent '7~e fac£ that we see such evident toMcity eat'manly raises a great deal of concern regarding the health effects of clove cigaret-;es,' an oj~cia! o fan independenr foundan'on said. research foundatlon funded primarlly through the National Instltute~ of Health. "We found e.xtenslve damage occur- flng to the lungs of the anlmala In which we have trmtllled vartou.~ do~es of eugenol," LaVole ttald. "TAb provlde~ further ev'ldence that the toxic effects reported for some Individuals may be related to the smoking of clove ciga- rettes." LaVole slLtd the rmLs that died during the exl>ertmenta generally died from hemorrhaging and s fluid build-up tn the lur~,s. He declined to reve~d what the leth~ doses of eugenol ire until the IotmdaUon has completed an addltlonal Lox:lclty certainly ral.~es ~ gr,¢~t de_,a.l of concern regard/n8 the health effect* of clove clgarette~." Dr. Sue Binder, a medical eplde- miologtst for the Center for Envt.ron- mental Health ~t the Centers for Dis. cane Control. acknowledged that "the findings that have been described to me suggest the symptoms of these ar~-n~ are stmtla.r to what han been described In ~ome of the ca~es that have been reported to un.'" But, she todd, the ~tudy's prellmirutry findings don't "prove that the observed In the cases reported to u.= ~re cau~'d by smoking clove cigarette,.'" "Animal experimenb cam be very 6405%4S92 g

i/ ¢/;i i:!i! !!i:!~iii~ /;iiiiii~i • i~i!Li~ i .,i • .'?.,'i, useful In lndicaLing p~.~ible toxic ef- [cc~ of chemicals In man," ~hc aald, ~notin~. however. Lha' roden~ may have different susceptibttlUes than man and that Lhe way eugenol w~ admlni~tered In the study waJ through the L-aches and not by l,~halaUon o/' cl~a.rette smoke. "Therefore" she ~ld, "'the resul~ of the~e small animal eXpe.'-imen~ do not prove that eugenol caused the tllnesa In our rel:>orted cases but suggest tt may have been re~ponalble." l.,.aVole agT'eed that the study does not prOve that eugenol caused the illnesses reported to the CDC but. he said, "'1 thlnk with the InformaUon In hand--the CDC report and the addl- UonaI data we have--you're getting to the point where there's enough in.for- matlon where there may be an Issue of responsibility and po~Jb]y llabiIRy. The health effect~ of clove cigarettes are being quesUoned. "'With regard to the possibility of a diHerence between administration through the trachea versus Inhalatlon, when you ace an acute toxic sheet by tracheal administration one cannot Ig- nore the likelihood that. a similar effect is likely to occur by InhdaUon. In each instance you're hitting the same target tissue." Clove cigarettes-also known as kre- tek-s--havc been sold In the United Slates since the late l,%0s, but It wasn't u.ntl] about four years ago that they became a fad among young Southern Californlans. The imports are now a nationwide phenomenon, wlth sales Jumping from an estimated 15 rnil. lion in 1980 to about 150 million in 1~84, according to indu~r~ sources. (Clove clgar~ttc s~Jcs ~ are :relaUvcly insignificant compared -to the estimated 650 btUlon con- venUooal c~garette~ sold in the U.S. annuM]y.) AJthough cortsldcred by many smokers to be a low-tobacco sub- ~tttute for conventional clgarette~. the imports actually contain about f~0% tobacco and about 40% ,clove~--and ~most twice ~ much tax and nicotine as moderate tar .American cigarettes. - ~'ugenol. a chemical that serves as a weak anesthetic asxl has been 'u&-,d by dcnUsts ~ a paln rellever, listed on the Pood m~d Drug "kdm~Uon's "Gcncr~y Rec- o g'n~ as S.~'e" ii~ of m~nces. "It I~, however, only presumed ~a/e when corummed ondly tn tt~ un- burned form. I,Jttle is known of Its ~mlety when burned In a c~,rette. ,.. "'Tt~ reJmoo why e~enol i~ gencr~y ~ u ga/e i~ because It't very non-I~0ck: wb~o taken oncUy M • #pl~ Io foods." s.ald I.~Vo~.. "It wmm't *,,~,-d that wh~m ~ via th~ ~ea tt would be thla taxle,." ' Dr. Tee GuJd~t~ • professor of occ~tlor~ m<-dlct~ at the U~- ve.~ty of ~ F'~/ty ~,, MedJ- clne in Edm~n~a, gpec,,~a~:~ in an FDA fact ~heet relented in May that It L~ poe~'ble that t.be beamed ex~cnol or ~ome byproducts ~-~at- ed when oth~- dove dg-a,'-etLe additives are ~ may L~.mobi- tJ.~c L~ee~on-fl,~attag c-eth, allow- Lag v'irt~e~ and bac~e,'qa ~'eady present i.n the lung~ to ~r~ad. There's ~ the po,smbilJty, he said. that the eugenol or other ingredl- en~ have a t~c effect or can trigger a.n acute al3erg"Ic reactlon. LaVole acknowledged that "'a lot more research has to be done, but right now to characten.ze the re- sult~ we do have, they are unex- p.ected and they. are sL"ikingly sirmlar'" to some Of the reports by physlciaxts. "'We know there ~ damage going on." he said. "We know certain doses will kill a.mma/s and certain doses will damage the lung,.'" LaVoie declined to idenfi/y the federal government agency that initiated the study and e.aid be will not do so until the study Los been completed and the "'hard ,'acts" are available, possibly by the end of June~ ~A Lot of Irnl>onder~ble~' ""These results indicate that ., dove cigarettes are by no means a sa/e sub.~tute for conventional cigarettes. The studies performed to date suggest that clove ciga- rettes are uniquely to~c and that their full adverse health effects have yet to be detcrmmed. "I hope," he added, "that people really consider not smoking the~e cigarettes until further toxicologi- caJ studies are done. I can't imagine that il the data holds up in addi- tlorud atudies that they would stll~ be sol&'" Panos Gcorgopulo, prt'sident of G.A. Gcorgopulo and Co.. a New York clove cigarette importer, sa~d he could not comment on the American Health Foundation's preliminary findings became he hann't seen a report of the study. "'We have to know how the te~t~ were conducted and a lot of tmpon- derabl~," he said. GcorgopuJo's company t~ a mem- ber of the newly formed SpeciaJty Tobacco Council. a trade L~ocia- Uon for the manufacture~ and Imporltrs of #pecialty cigarettes. The council was organized In the wake of media rcpona on the potential health hazard~ of ~-mok- tng clove ctgaretten and ~ of the O.slaw taw~rulk Georgopulo said the council. which ~ hired a Los Ange!e~ public relaLiorts f~'Tn, "wa~ formed t~ more or ]c~z a.nawe.r otu- deL-ac- t~rs in an mteU.igent way and t~ overcome the hystcrta t2mt's s-ur- rounding the ~sue. Mo~t of the ci~um_s (of illne~) have b.een cix- currtstamjal, and there's really no proof." Noting the w~des'pr-e.ad use of clove cigarettes In indonema. C,-eor- gopulo said, "We talked to some crf our I~doneshm cu3tomcrs, and they are a.sU~u.nded that they're hea.nng all this bad publicity about L,",~ts product." (Binder said the Centers for Disea_~e ConL"ol i~ e.x:plo.,'ing bhe possibility of conducing a fftudy of clove cigarettes i~ indoncsm ). Charles Ecker, In.format.ion d2- r~or for the Specialty Tobacco Council, said the council's "'mare item on the agenda ks t~ develop an educational program to convey fac,uaJ information on clove clga- rettes." Referring to a recent statewide ban of clove ciga.r~tt~s in New M~c~, Ecker said. "%Ve felt they have acted very ha.stiJy and taken a vc:'y dra.~'c step before ~er~ any scientific evldence'" demon- st:-ating a link between health problems and smoking clove ciga- rettes. Although several other 8~ate~ are cor~denng banning clove cig- arette sale~, a biLl co-authored by California state Aasemolyman Richard L. MountJoy (R-MoRro- via) falls short of caring for a of the imports In Caliform~ The bill, AB 25.59, which ks cu:'rentJy In Lhe Assembly Ways and Means CommAttee, cars for the st.ate Department o~ Health Servic- es to conduct a scien~fic study to determine Lf there i~ a causal relationship between smoking 640514S93

clove ct~a='etUes and luu~ LnJ~--ie~ a~d any other heaJth problcm.~. Responding to the p~limlnary findings of the American Health Foundation study, Ecker said. "the stud)', as ¢.xpla.Lned to me, does sot accurately reflect the method upon which eugenol b inhaled, it sounds like they're trying to make an hone...xt attempt, but on fu,'a't gl~nce it looks like they're comparing apples and or-~ngm." __~Dr. F'rederlck Schechter, t.be Whittier thoracic andcardlova_~-u- surgeon who operated on Tim Cislaw and who co-authored the CDC repo:'t on clove cigarette~, +d~.agrced. Wealth ot S-clzaIIIlc Studle= Schechter said the American Health Foundation study "for~ the pathological ba~ for the find- ing: in these c,hildren admitted into the hospital as well as explains the symptoms of those who called with complaln Ls." He was r~ferr~ng to the nearly 200 phone ca~s he received from clove cigarette smokers aJter a story on the C~law case appeared in The Times last December. "The arumal studies show that you can reproduce many of the rrfic.:-o~copic charactedJtics of the damage done to the lungs in the ho~rpitallmed Indiwiduab," Schech- ter said. adding that he has re- cclved permission from the Ctalaw family to send alld¢~ of biop~es Lakcn from Tim Ci~w'a dise.ased lungs to the American Health FoundaUon for comparison with lung ti_~ues of the dead rata. Slncc December. Schechter has discovered a wealth of aclenth'- Ic studies that have been conducted on eugenol. E'ugeoo[~ according u~ 5c_hecbter. h~ been documented to be toxic to cekL~ and phac~acologlcally active on the cenL'-al nervou.s sy~1.em (eUgenol and lt~ derivaUves bein~ developed ~ a.nU-epfleptJc agenLS). He said eugenol ~ ts ae_.r~t.~ng (it ca~ hnduce the de- velopment of an ailergy aga.m~ lt.~el~) z~d it ha~ produced sever~ aJJerglc reacUorta In dental pa- tlent~, ~anl/eSted by whee~ng and shortne"3~ of breath. The A,merica.n Health Founda- tion study's preliminary data, S¢.hec_.ht.er said. "'just add~ fuel to the fu-e. R'~ rtt~ ~ddltlon~ 1~!o._'-~_2=: UPn that o.~p~ in) the enUre au~- ~(~n of chemical additives to tooad- "Hc-~ we have one product on the FDA's "Crener~y Recognized a.s Sal'e list that ia sa/e to ingest but b tax~c In the aj_r-way. Up to now it was always presauned that the materials on the FI)A 'GRAS' because they were considered sale /or ingestion, were considered sa/e m be added to cigarettes for inhala- Lion- This i~ the f~'~t t~e we have at least prelL~RnarY evidence that material from that ~ was shown not be to be safe for Inhalation." Schechter, one of the moat out- ~aoken criUcs of dove cigarettes, wants to see the Legislature ban the sale of clove cigarettes In Cali/omta- "If adults wa, nt to smoke them that's one th£ng~ but I think this ta a teen-age habit, and I thln.k the importers and retailers are prcylng on the gullibility of tecn-agcrs. They're atlowing kids to be the ~ea pigs--they'refle|d testing the elgin-cites on the kJds. We want dove cigarettes out of the coun- Ll'y." 640514S94 C

/ii!i:i :,L'. 1365. l,",d r__nqro==,~d ~* dlv-izlon iz A~--~or'~=~ ~o ~r~scri~:~ au~ ~ro~ulqa~e ~cciGn 2. %~c~1o~ 859.09 ix cr~c.<~ ~o r,,ad: ~9.D9 Pz'~h/bi~ioc aqai~t clc-,~ clqar'~t,=.--W~o 418;>oee of c!q~r~%-* or ~imilar ~r~uc%* de~i~-n,~d or in-.¢nd-~ ~or ~oklsq, mad~ 15 vhol- or Im pa~.r" cm. or cootai~mq. cloy.., cloy. oil. euq,ool or ~ny dmrlva~.v, r-hereof. S~c=ion 3. Thor, !* h~r--by appro~rla:ed i~ flsc~! year 1985-1986 ~o "--h~ Division of Alcoholic Beverage= ~nd ToDacco 13 ~o,!:i0ns i.~d $?30,528.00 from --%e C, mn~ral Revenu~ :'h.~-.d for The ad.~-.Z-__i*~ra%ion of t.~is aC~. S*C%ion 4. i: ¢~i%inq ma.nus~r~t for ~.he next ~i~ion of T-he .rlorlda S~a%~a%¢*, v-he Sta~'Jtor-y ~evision D!'.'i*iom of r.hc Joi_-~ Leqlslativ~ Ma_naqe.men% Co~-ni~tce ~.%al! ch~ge "chapter" :0 "part" whet.vet it appearm in ~ar--~ [ of cha~er 210, Ylor~.dz 5~a~u~*. S~c:ion 5. Th.i= *-_~ ~hall take ~5~'cC% July I, 1985. 640524895

5- [~ [.a*c~*d bT ~h. 5~qi,lat-ur- o~ r.2~. S~*C, of Elorida L' who violate~ v.~%e~*n~ uhe prov=slons of ~%i= section i~ ~Aa~ b~ q%~il~y Of • mim~cmeanOr of t..hc second de~re~, puni:h~bl¢ ms provldcd in s. 775.052~ or s. 775.083, or =. 775.084. Sec~lon 2. 5co:ion 859.07. ~lori~, S~atu~no, I. h*r~by rsp*al,~. SeC=ion 3. l'h_i~ act ,Lh~ll ~ak* effec~ O~:ob.r ~ 1985 r!; 640514896 C