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.QISTATE OF NEW YORK DEPARTMENTOF HEALTHComingTow# The GavemuNelsonA. RockefellerEmplreSteh Pleza Albany,NewYork 12237

RichardF. Daines.M.D. Wendy E.Saunders Commissionei Chief o f Staff CITIZEN'S PETITION PURSUANT TO 21CFR 10.30TO THE SECRETARY OFHEALTH AND HUMAN SERVICES AND THEFOODAND DRUG ADMINISTRATION REQUlESTIlYG EXPANSION OF AVAILABILITYOFNICOTINE REPLACEMENT THERAPY TO CONSUMERS WHO USE TOBACCO Q

January 22.2008SecretaryMichael Leavitt D c p m e n t of Health and Humm Services Public Health Services 200 independence Ave SWWashington DC 20201Dr.Andrew C.von Eschenbach C/O Division of DocketsManagement Food and Drug Administration Department of Health and Human Services 5600Fisher's Lane, Rm 1061 RockvilleMD 20852 The undersigned submits this petition under 21 CFR 10.30of the Federal Fmd, D N ~ ,and CosmeticAct to request the Commissionerof the Food and Drug Administration to ( I ) allow the sale of over-thecounter (OTC)nicotine tepIa.cementtherapyMT)n all retail lacstions where cigarehes aresold, including in convenience scores, gas stations,tobacco specialty stores,grocery stores,an d otherretail businesses that seII tobacco; (2)albwOTCNRT to be sold in "daily" units (containing anamount ofNRT that would typically be consumed in a 24-hourpetiod) at prices competitive 4 t hone20-count pack of cigarettes;and (3 ) modify labeling requirements in order to W ly disclose tosmokers the benefits ofOTCNRT uw relative to continued cigarette use, with risks associated withOTC NRT compared to risks associatedwith continued cigarette use.A. Action requestedSpecifically, the undersigned requeststhe Cominissionerof the FDA to withdraw the conditionsspecified in Approval Letter to Application Number 18-612IS02S and 20-0GG/S007 &at (1) restrictdistributionofNRT to "drugstores, mass rncrchandisns and supermarketswhere other OTC drugsare sold. The ptoducts will not be distributed to other channels,including convenience stores andvending machines;" and (2) prohibit the offering of "Trial size" or "sample" packs (e-g.. packs smallenough o be priced competitivelywith cigarettes).

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Further, the undersigned requests the Commissioner issue a policy regarding the packaging and saleof OTC NR,T, includingthe following conditions. (1 ) OTCNRT may be sold wherever cigarettesarc sold; (2 ) OTCNRT may be packaged in units o f a size that can be competitively priced withcigarettes andor in units containing an amount of OTC NRT product that would typically beconsumed in a 24-hour period; (3) OTC NRT may be advantagmusfypositioned relalive tocigarettesand tobacco products in order to promote th e sale of thc OTC NRT product.Finally, the undersigned requests the Commissioner modify the required package labeling andwarnings ro recognize th e follewing. (1) OTC NRT is safe foruse by smokers and.safer for use thancontinued cigarette use; (2) OTC NRT i s appropriate for use in situations of temporaryabstinmcefrom cigarettes in order to moderatesymptoms of nicotinewithdrawal associated with periods ofsmoking restriction (e-g., in the work place); (3) Graverisks arenot associared with the use of OTCNRT for those who do not completely abstain from tobacco use.B. Statement of grounds1. Over the counter (OTC) nicotine replacement therapy (NRT) should bemore widely available tosmokers in order to increase use, increase quit attempts and, eventually, increase quit success.OTC NRT hould be well-positioned to compete with cigarettes in both price and availability (sizeof packaging and location of pwhasc). m e curr at restricted framework governing the packagingand sale of OTCNRT does not .adequatdybalance the benefits an d r i s k s of OTCNRT use in thecontext of the comparatively unrestricted sale and packaging of other hazardous sources of nicotine,such a s cigarettes. The benefits and risks ofOTC NRT use should be weighed against the benefitsand risks of continued use of cigarettes,use which will occur when access to OTCNRT is restricted(McNeiIl2001)- One of every two continuingsmokersdies prematurely as a direct result ofcigarette use (Doll 2004). The risks associated with nicotinc delivered without the smoke toxins arelower by several orders of magnitude (Benowitz 1998). suggesting that OTCNRT should beavailable at least aswidely and accessiblyas cigarettes,and should competewith cigarettes directlyon price and sales locations,While use of NRT increased substantially following the switch Erom prescription to over-the-counter availability (Shiffman 1997, Shiffman2007), currently too few smokers use OTC NRT forthese products to have a measurable impact on population behavior and health (Cummings 2005).nere are likely numerous factors responsible for low use ofOTCNRT.However, limitedavailability of thcproduct due to restrictions on the types of outlets that can offer OTC NRT,perceived high cost due to the largepackage size requirements, and concerns about safety resultingin part from onerous labeling requirements, all contribute to low utilization ofOTC NRT (Hyland2005, Cummings 2004. Kodowski 2007). Regulations that resPict only the safcst nicotine products,and rcmain largely silent on the most dangernus nicotine products are hard to justify (Gray 2005,Sumner 2005).2. J n c m e d availabilityofOTCNRT will not lead 1.0 increased abuse by adolescents.A study from Tennessee in 2003 tepcnted that five percent of youth self-reported ever using NRTand 18percent of these five pcrcentwere never smokers(or 0.9 pcrcent of youth) [Klcsges20031. Asubsequentstudy by the same in'vestigatorsreported that most stores that sold OTC NRT completedsales to minors, and that NRT vendors that also sold alcohol were less likely to complete an OTCNRT sale to a minor (Johnson 2004). Hyland et a1 (Hyland 2005) found NRT abuse tatcs among

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adoIescetlts to be low and to have remained unchanged followingthe switch toOTC availability.NRT abuse rates among youthwere far Iower than abuse rates of other medications routinelyavailable for sale (e.g., diet pills).3. OTC NRT i s safe and safer than cigarettes for all smokersThe three OTC NRT products (patches, gum and lozenges)constirutc safe nicotine delivery systems(Hughes 1993, Sh i fhan 2007), while cigarettes arean atrernelydangerousnicotine deliverysystem. Usc ofOTC NRT s safer than continued cigarette use for all smokers, including thosc withcardiovascular diseasc (CVD) (Marsh 1995, Murray 1.996,Bmowitz 1997,Hillis 2000, McRobbie2001, Joseph 2003a, Joseph 2003b), those who are pregnant (Bcnowitz 1991,Oncken 1996,Oncken1997)and adolescents aged 12 and older (Smith 1996,McNcill2001, Moolchan 2005). In fsct, boththeUnited Kingdom (UK) and France licenseOTCNRT far use by adolescent smokers, pregnantwomen who smoke and smokerswith cardiovascular disease (Shiffman 2007). For all p u p s , thebenefits ofusing NRT and stopping smoking shouldbe weighed againstcontinued use of cigarettes(McNeill2001). For pregnant women, additional research is needed to fully explicaterelative risksand benefits (Wisborg 2000,Oncken 2003)Unfortunately, smokcrshave insufficient information and misplaced concerns about the safety andemcacy ofNRT (Siahpush 2006). While only a small number of studies hasassesscd smokerknowledge of and attitudes toward medicinal nicotine products, these studies (Etter 2001, Bansal2004,Cummings 2004) found that smokers are rnisinfotm& about the safety of OTC NRT, believethat use of nicotine patches ismore likely than use of cigarettes to cause a heart attack, and wouldbenefit h m ore accurate comparisons regarding the relative s a f q of OTC NRT and cigarettes.4. Use of OTCNRT or situations of temporary smoking restriction in order to moderate transientwithdrawal, as a substitute for smoking, and concomitantlywith cigarette use in ordcr to reduccconsumption (and eventually quit) is safe and evendesirable lo advancep~blichealth.Several studies have found no evidente that concomitant use of NRT and cigarettes is associatedwith adverse health events or increased side effects(Murray1996, Marsh 2005). Two studiesinvestigated the use ofOTCNRT to reduce the numba of cigarettes smoked as a strategy to movesmokers toward cessation. W d k a et al (Wennika 2003) found that, among mokers unwilling toquit, study subjects assigned to use DTC NRT decrased the number of cigarettcssmoked daily andachieved a higha smoking cessation rate than those notusingOTC NRT. Intakc of smoke toxinswas lower than baseline lcvels,but higher than would be expected given the number of cigarettessmoked (suggesting some compensatory smoking was occurring). No adverse events were reportedand the authors concluded that OTC NRT promoted cessation in a population of smokersunwillingto quit. Batra et a1 (Batra 2005) reported similar findingsamongsmokers unwilling to quit. Thoseassigned to the OTCNRT study arm sustained greater reductions in consumption and poinrpwalencc abstinence from smoking,compared to those who did not use OTCNRT. In addition, theauthors found concomitantuse of OTCNRT and cigarettes to be well tolerated by study subjects.Sewera1counmcs, includingNorway, Austria, th t UK,France, and Sweden licmse OTC NRT foruse in conjunctionwith other tobacco products (McNeiIl2001, Shiffman 2007). Further,Iang-termuse of NRT can be appropriate for highly dependent smokers in order tomaintain abstinence&omsmoking (Hajek 2007). Thus, a complete andpermanent switch from cigarette smoking o long-termuse of OTCNRT would dramatically reduce the substantialhealth risks associatedwith smoking.

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These fiadings supporl the q u e s t to increaac availabilityofCrrC NRT by arpanding the typesof*tail outlds thatmayoff- OTCNRT h r sale,pe-mitcinga "daily"package sizc,andmodifyinglabeling reqwmmts ta accumelyaddress smokerrniamxeptloneb u t he relativerisks andbenefirs ofOTChRT use. These changeswill likely increasesmokms' access to and camfbnwithOTC NRT,i n m e he likelihood that srnokaswill use OTC NRT expdmmtally and, evmrually,thatOTCNRT will effictivelyconaibutct6mcasurablcpepuladon-lcvelbehavior change andreductions in ciprctte use. F a t i h to adequatelyaddress the imbalsmce in the regularion ofOTCNRT condemnsmillionsofNew Yorkm to completely avoidablesmoking-caused diseaseandpremature death.C.Envimnmental impact

The purposeofthis q u e s r s to posirioaOTCNRT mote competitively with cigarettes and makethanmore availableand amaaive tomnsumcrr as altern8tivtstodgamltes or otha tobaccoproducts. The anticipated ecunomic impoet is tom p d alesefOTCNRT,make them moreaffordable lo wmmmcrs, and reduceACSf ciguarres andotha tab- products.

The u n d e r s ip 4 cereifia, that, to the besthowlalge and belief ofthe u n d mi g n e 4 m is pelidonincludes a11 informationand viewson which the +tian relics, and that it includesnpresentaeive

Richatd F. D a i ~ e s ,M.D. Commissions ofHealth

Encl: Citat iw

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'ew York State De.partrnentof HealthEmpireSg t e Plaza. Coming tower, Room 710Albany, NewYork 922374676Telephone: 51-74-1515; Fa*: 5784861684

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