Tobacco Documents Online

FDA Draws First in Tobac~o Wars Agency uses obscure section of 1976 law to declare cigarettes are `medical devices.' BY CLAUDIA MACLACNLAN NATtONAL LAW IOURNAL STAff O11fOOTIIN TIIE FOOD AND DRUG ADMINISTRATION's much anticipated deci- sion to regulate the sale and advertising of cigarettes is being questioned by some regulatory experts, who doubt that the gov- -Ernment can exert control over tobacco without triggering an outright ban. These experts say that the smoking issue will even- tually have to be resolved by Congress. Meanwhile, tobacco companies and advertisers were ready for the news and Bted suit just ilours ailer iiie rD:A annrm:.: cd proposed rules Aug. 10 to regulate clgarette and smokeless to- bacco. Among the proposals are a ban on vending machine sales and restrictions on advertising aimed at young people. The five leading tobacco companies along with a cigarette marketer called the FDA proposal 'unprecedented," and asked a U.S. district judge in Greensboro, N.C., for Injunctive relief (see sidebar). Coyne Beahm Inc. u FDA. 2:95CV00591. The ad- vertisers and manufacturers of smokeless tobacco filed similar complaints seeking injunctive relief. American Advertising Federation v. David A. Kessler, 2:95CV00593 (M.D.N.C.). i/. S. Tobacco Co. v. FDA. 3:95-0781 (M.D. Tenn.). The tobacco companies challenged the FI)A's jurisdiction. "Congress. in enacting the Federal Cigarette Labeling and Advertising Act, has reserved to itself the power to regulate cigarettes so as to main- tain an appropriate balance between informing the public of the risks which have been associated with smoking, the freedom of the Individ- ual to smoke If he or she chooses, and ;!.g glonipcwnt wrnnnmic inletests in- volve~in the manufacturing, distribu- tion and marketing of cigarettes." the companies said. "For more than eight decades. Congress has made clear that ciga- rettes are not subject to FDA Jurisdic- ssee4zse ,

Uon,' the companies added. The FUA, backed by Pres- Ident Clinton. broke wlth Its long record of avoiding the tobacco debate and issued more than a thousand pages of Its proposed cigarette reg- ulalions and suppurting doc- umentallun. Bowing to political reality, the agency said it would not use Its drug control authority to regulate cigarettes. a move that would have almost certainly resulted In an out- right ban on tobacco prod- ucts. Rather. the FDA is rely- ing on an obscure. Iittle-used section of the Medical Device Amendments of 1976 to ex- erl advertising. sale and oth- er authority over cigarettes. classifying them as restrict- ed medical devices because they deliver a drug-namely, nicotine-to the blood- stream. Products classified as drugs have to be shown to be safe and effective before thsy can be sold, or, ln the case of dan- gerous but tberapeutic treatments such as chemotherapy drugs, the medical bene6ts they provide must outweigh the risks. 'in light of the accumulated data on 'the adverse health effects of tobacco, neither of these outcomes can be viewed as a realistic possibility In currentlY mar- keted products.' the FDA sald. reterring to safety and effectiveness showings. "r ~_ .._..a.....~ ,.,e,Jd hw onaooroved new drugs, and as such. FDA could require their removal from the market.' The agency, acknowledging that more than 50 mlllion Americans are addicted to cs arettes and smokeless tobacco, said that~f did not want to ban the products. 'Because of the high addiction rates and the dUlicultles smokers experience when they attempl to qult, there may be ad- verce health consequences for many in- dlviduals if the products were to be wlth- drawn suddenly from the marketplace," the FDA said In giving its reasons for not seeking a ban. The sgency's comments were Included In its Ien80iy proposed rule on cigarette regulsUon, p Aug. 11 tn the Federal Heglster. oo~e~,zse M.dioasl D.vto.a According to University of Florida Col- lege of 4aw Prof. f.ars Noah, the FDA has never successfully regulated a product under Sec. 520(e) of the Food Drug and Cosmetic Act-the secUon It fs applying to cigarettes. It first attempted to do so about 18 years ago, but was rebuffed by two courts of appeals for falLng 6rst to Issue regulations dedaing restricted de- vices. The FDA contlnues to assert that hearing aids are restricted medlcal• de- vlces, but It stUl has not luued regula- Uons, despite repeated assurances that proposals were imminent, sald Professor Noah. who teaches food and drug law. Professor Noah says be takes a dim view of the FDAs trying to regulate cigarettes and chewing to- bacco In th4 mannef and several lawyers noted it was an unusual approach subject to legal challenge. ftlchird 0. Wood, a partner at Chicago's Bur- ditt & Radstus, called the FDA move "very creative." adding. "Wltether It Is lawful or not remains to be determined by the courts because this surely will be litigated if finalized in Its current form." Peter 0. SaAr, a food and drug law partner at Washington. D.C.'s Klein- feld, Kaplan and Becker. said the FDAS only real choice was to go after tobacco as a medical device. "They can't go after It as a drug because that leads automatically to butning It,' he said. 'They have much more RexlbtUty on devlces, and It Is the only way to cou- trol the advertisinQ. Mr. Salir sald the approach. however, was risky. lie noted that the FDA plans to exempt cigarettes from some of the pro- visions covering restricted medical de- vices, notably one that requires manu- facturers to report to the FDA adverse reactions to their prod- - ucts. "1'here are Issues there in terms of whether you can label a product a restricted medlcal device solely for regulatini its advertis- ing and exempt it from any other devicu reguls- tlon," he said. Mr. Saftr said that the _00 FDA may be open- ing the door to ; public Interest groupror even eventually to the agency Itself-that might want to broaden the device regulation tnto a ban. "That's a big risk. Ultimately someone could le- r dmately say that -- - - I was an arbitrary decision and 11 should be regulated u a tiru~." Professor Noah, who caW the FDA approach 'abgtud: agreed. "You can't just leave It at advertls- Ing controls,' he said. 'You can't Just say these are restricted med- ical devices and stop Ihere. Sooner or later the agency or a public In- terest group will come in and try to enforce all of the other Wpitaqoas; he said, including good manufac- turing practice controls and some form of premarket cbarance or ap- proval from the agency. Professor Noah also said that the auernpt to decoupk n_kutine o~iu "gar ciies wuuid tat6 CYen it cigarettes are properly regulated as a restricted medical device, nicotlne hes nover been approved as a drug• and you can't show il's safe and effective for this use. 'Once yuu make tlse decision to call thi, a duvice, and nicotine is tlw drug component. I don't see how yuu avoid requiring drug ap- provai,' hu said. Professor Nouh emphusized that cigarettes are nu different frum nicotlne patches or nicutine chewing gum, both of which are regulated as drug prod- ucts-nut as medicas devices-by tho agr.ncy's Center for Drugs. "Agency policy clearly requires that primary jurisdiction over a combinatiun product such as ciga- 6) -- / 1 relles or patcbss resides within the Cen- ter for Drugs: he said. Professor Noah, who formerly prac- Uced at Washington, D.C.'s Covington & Burling, said he suspects that the FDA doesn't really expect Its proposal ever to bewme law. 'They know thb will never go to a final regulatlon,' he said. "It hits the bap back Into Congress' court. (FQA Commissioner Davidl Kessler has been pleading with Congress to give him some guldance. When that was not forthcum- Ing. Kessler decided to take the initiative, and Congress may be disinclined to say 'No' to restrictions on advertising to mi- nors." Conitr.asbnstl R.vierw Many observers expect the tobacco debate to end up back In Congress, but not because of tobacco companies' con- tenUoe that the FDA lacks jurisdicUon. "There /s going to be a deal in Congress, some kkld of a deal that limits advertis- Ing to childrep; said John P. Coale, of Washlogton, D.C.'s Coale & Van Sus- teren. Mr. Coale i firm Is one of about 60 p1alnWrs' drnm that have /Ued a massive class action agalnst the tobacco Industry In federal court In New Orleans. Castano a American 7bbocco, 94-1044. Mr. Coale sald plasadtfs' lawyers are delighted with the FDA move because the agency is tyleasin thousands of doc- uments It obta4ted w~sn it invesUgated whether tobacco should be regulated. "It a11 deals with what we're Interested In. --~ which is nicotine ad- dkUon; he said, adding that the doc- uments include lran- sufpts of interviews with current and for- mer tobacco Industry officials and work- Thst saves r~a ers. ' lot of time and nron- ey." University of Mis- sourl-Kansas t:ity. School of Law Prof. @dward Richards also expects con- gressional Involve- menl. Professor Richards noted that health food advo- cates cates successfully lobbied Congress for an exemption from FDA regulation a few years ago.

Rising from ASH Certainly the tobacco companies would prefer congressional oversight to FDA n:gulation-or at least that's what they argue in their lawsuit. In recounting the FDA's long avoidance of tobacco, the companies point out that in 1980 the agency actually fought an attempt by a private group-ASH. or Action on Stnok- ing and Heaith--to force tite agency to assert jurisdiction over ci,;arettes and regulate thim because of their nicotine content. In its brief for that case in the D.C. Cir- cuit Court of Appeals, the FDA argued that it did not have jurisdiction, saying that it 'has repeatedly ir,formed Con- gress that cigarettes are beyond the scope of the (Food and Drug Actl absent health claims establishing a therapeutic intent on behalf of the manufacturer or vendor.' Action on Smokin.g and Kealth a Harris. 655 F.2d 236. ASH founder John Banzizaf said that a lot had changed since then. 'in 1980 they did not have the evidence of nicotine addiction. Now they have overwhelming evidence.' he said, mentiDning nicotine experimentation studies fi•om the tobac- co industry's own files. 'ln 1980, when we were trying to force the agency, we had the uphill bat- tie,' he said. Now that burden has shifted to tobacco, said Mr. Banzhaf. a professor at George Washington Uni versity Nation- al Law Center in Washing:on, D.C. ® z (~ 3