Recall of Philip Morris Cigarettes, May 1995-March 1996

On May 26, 1995, Philip Morris USA* announced a voluntary recallof 36 cigarette product lines (approximately 8 billion cigarettes)because, during production, the company detected unusual tastesand peculiar odors and identified methyl isothiocyanate (MITC)in the cigarette filters. During June 6-8, 1995, public healthofficials in Minnesota, Oregon, and Texas requested the assistanceof the Centers for Disease Control (CDC) in investigating consumerhealth complaints associated with smoking Philip Morris cigarettesnear the time of the recall. This report summarizes CDC's ongoinginvestigation, which suggests that prolonged cigarette smokingcaused most of the health complaints; in addition, the investigationhas not identified a distinguishing chemical characteristic ofthe recalled cigarettes.

Reports of cases of illness near the time of the recall were identifiedthrough passive surveillance by direct telephone calls to theCDC. The CDC used a standardized form to interview persons whoreported illness and, when possible, collected cigarette samples.To verify self-reported data, a medical records review was conducted.Cigarettes included in the recall had been manufactured duringMay 13-22. Philip Morris USA provided the CDC with samples ofrecalled cigarettes (manufactured on May 19, 1995) and, for comparativeanalyses, provided samples of cigarettes manufactured before (onMarch 3, 1995) and after (on June 12, 1995) the recall.

Reports of Illness

During June-July 1995, the CDC received reports of illness from72 persons in 27 states who had smoked Philip Morris cigarettebrands on or after May 13, 1995. The 72 persons comprised 36 menand 36 women; the mean age of these persons was 40 years (range,15 to 67 years). A total of 41 (57%) persons reported onsets ofillness before the recall, and 31 (43%) reported onsets afterthe recall. Of the 72 persons, 51 (71%) reported no preexistinghealth conditions; 42 (58%) reported experiencing serious healthproblems from smoking near the time of the recall. A case definitioncould not be developed because no common pattern of symptoms wasidentified; however, the most frequently reported manifestationwas at least one respiratory or nasopharyngeal symptom (61 [85%]);other frequently reported symptoms included headache (18 [25%]),dizziness (15 [21%]), and ophthalmologic problems (15 [21%]).A total of 59 (82%) persons sought medical treatment for theirsymptoms; 14 (19%) were hospitalized.

All 72 persons reported smoking cigarettes manufactured by PhilipMorris the day they became ill. Most persons (43 [60%]) smokedMarlboro brand cigarettes. The average duration of smoking was20 years (range, < 1 to 45 years), and the average number ofcigarettes smoked per day was 23 (range, <1 to 50 cigarettes).

Medical Records Review

Because a case definition could not be specified, further investigationwas restricted to 29 persons who reported no preexisting healthconditions and who reported experiencing serious health problemsassociated with smoking near the time of the recall. Of thesepersons, medical records were obtained for 20. Based on reviewof these records, the conditions most frequently diagnosed inthese persons near the time of the recall were pneumonia (fourpersons), exacerbation of asthma (four), bronchitis (three), chronicobstructive pulmonary disease (three), eosinophilic pneumonitis(two), and laryngitis (two). The review suggested that most (18[90%]) of these illnesses were associated with cigarette smoking,preexisting medical conditions resulting from prolonged cigarettesmoking, or infectious agents.

Laboratory Analyses

The CDC analyzed cigarette samples using high-resolution gas chromatography/high-resolutionmass spectrometry. Methyl isothiocynate was detected in samplesof filter and samples of tobacco and paper obtained from prerecall,recall, and postrecall cigarettes provided by Philip Morris. Levelsof MITC were higher in cigarettes packaged in hard packs thanin soft packs (eg, 102 vs 15 ng per filter, P < .01, N = 21[14 hard packs and 7 soft packs]). Methyl isothiocyanate alsowas detected in Philip Morris cigarettes produced at least 1 yearbefore the recall. Seven packs of cigarettes from five other manufacturerswere purchased at local stores in Atlanta; MITC was detected incigarettes from each of these packs.

Cigarettes obtained from Philip Morris were analyzed for the eightcompounds reported by Philip Morris** to have caused the tasteand odor problems. Of the eight compounds, three (butyric acid;1,2-propanediol diacetate; and 2-ethylhexyl acetate) were detectedin prerecall, recall, and post-recall cigarettes; the other fivecompounds were not detected. Compared with prerecall and post-recallcigarettes, there was no distinctive increase in one or more ofthese compounds in the recall cigarettes.

Cigarette samples also were analyzed to identify a unique chemicalprofile that distinguished the recall cigarettes from the prerecallor post-recall cigarettes. Analysis of volatile organic compoundsfrom the filter and from the tobacco and paper of these cigarettesdid not identify such a profile. In addition, analysis of cigarettesmoke from recall cigarettes did not contain a unique chemicalpattern.

Laboratory analysis of cigarettes obtained from the 72 personswho reported illnesses is ongoing. However, as of March 22, 1996,no unique chemical pattern had been identified.

Editorial Note from the CDC

Based on the medical records review and laboratory analyses inthis report, prolonged cigarette smoking-rather than smoking contaminatedcigarettes-caused most of the health complaints from persons reportingillness associated with smoking Philip Morris cigarette brandsnear the time of the recall. Smoking is the leading preventablecause of diseases associated with premature death in the UnitedStates; in 1990, approximately 419,000 deaths were attributedto smoking. The estimated number of compounds in tobacco smokeexceeds 4,000, including many that are pharmacologically active,toxic, mutagenic, and carcinogenic.

Although Philip Morris reportedly recalled cigarettes, in part,because of the recent detection of MITC, the laboratory analysesin this report indicate that MITC was present in cigarettes manufacturedby Philip Morris up to 1 year before the recall and in cigarettesfrom other manufacturers. Methyl isocyanate is a decompositionproduct of 3,5-dimethyl-1,3,5,2H-tetrahydrothiadizine-2-thione,which is used as a preservative in the manufacture and coatingof paperboard*** and as a pesticide (dazomet) that can be usedas a soil fumigant on tobacco plants, turf, and ornamental plants.Methyl isocyanate also is a decomposition product of sodium N-methyldithiocarbamate,a pesticide with uses similar to dazomet. Although adverse healtheffects from MITC exposure (eg, mucosal irritation of the respiratoryand gastrointestinal tracts, conjunctival irritation, and neurologicsymptoms) have been documented, there have been no assessmentsof the possible health effects of burned and inhaled tobacco thatcontains the levels of MITC detected in this investigation orof inhaling heated MITC found in filters.

The findings of this investigation are subject to at least fourlimitations. First, reports of illness were identified by passivesurveillance; therefore, persons with health problems who contactedthe CDC may not be representative of all persons who smoked PhilipMorris cigarettes near the time of the recall and who may haveincurred related adverse effects. Second, the recalled cigarettesprovided by Philip Morris may not be representative of all thecigarettes eligible for recall. Third, because of the protractedtime between the occurrence of clinical manifestations and thedelivery of cigarette samples to the CDC, some of the volatilecomponents may have evaporated from the cigarettes. Fourth, identificationof possible contaminants was complicated by lack of access tothe manufacturer's cigarette brand ingredients. Although Section7 of the Cigarette Labeling and Advertising Act of 1996, as amended,requires that cigarette companies annually submit to the Secretaryof the US Department of Health and Human Services confidentiallists of ingredients added to tobacco in the manufacture of cigarettes,the law does not require companies to provide brand-specific informationabout additives or information about the quantity of each additiveused in the manufacture of cigarettes. Therefore, the CDC couldnot compare the standard brand ingredients with those in recalledcigarettes; the identification of either unusual chemicals orunusual quantities was based on comparisons between the recalledcigarettes and samples of cigarettes produced before or afterthe recall.

Other than the well-established health risks associated with smoking,this investigation did not detect additional health problems relatedto smoking cigarettes recalled by Philip Morris. Laboratory analysesof potential contaminants in cigarettes is ongoing. However, smokingcessation is the only effective strategy to reduce the risks associatedwith cigarette smoking.

Adapted from Morbidity and Mortality Weekly Report, vol45, no. 12, March 29, 1996.

* Use of trade names and commercial sources is for identificationonly and does not imply endorsement by the Public Health Serviceor the US Department of Health and Human Services.

** Butyric acid; methanediol diacetate; 1,1-ethanediol diacetate;1,2-ethanediol diacetate; 1,2-propanediol diacetate; 2-ethylhexylacetate; 1,2-butanediol diacetate; and 1,3-propanediol diacetatein one lot of plasticizer (a substance sprayed on cigarette filters)(M. Firestone, Philip Morris USA, personal communication, June30, 1995.

*** 21 CFR 176.230 Paperboard is used to produce hard-pack cigarettepackaging.