Tobacco product regulation: Context and issues

Food and Drug Law Journal

Volumn 53, Issue SUPPL., 1998, Pages 43-74

  Slade, John ^a   Henningfield, Jack E ^b,c  

^a ROBERT WOOD JOHNSON MEDICAL SCHOOL   (United States)

^b JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c PINNEY ASSOCIATES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CONFERENCE PAPER; FOOD AND DRUG ADMINISTRATION; LAW; SMOKING; TOBACCO INDUSTRY; UNITED STATES;

HUMANS; LEGISLATION, DRUG; MALE; MIDDLE AGED; NICOTINE; PLANTS, TOXIC; PUBLIC HEALTH; SMOKING; TOBACCO; TOBACCO INDUSTRY; TOBACCO USE DISORDER; TOBACCO, SMOKELESS; UNITED STATES; UNITED STATES FEDERAL TRADE COMMISSION;

NICOTIANA TABACUM;

EID: 0031850415     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (219)

1. J. Michael McGinnis & William H. Foege, Actual Causes of Death in the United States, 270 JAMA 2208 (1993).
2. OFFICE OF AIR & RADIATION, ENVIRONMENTAL PROTECTION AGENCY, RESPIRATORY HEALTH EFFECTS OF PASSIVE SMOKING: LUNG CANCER AND OTHER DISORDERS (EPA/600/6-90/006F) (1992); OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT, CALIFORNIA ENVIRONMENTAL PROTECTION AGENCY, HEALTH EFFECTS OF EXPOSURE TO ENVIRONMENTAL TOBACCO SMOKE (1997).
3. OFFICE OF AIR & RADIATION, ENVIRONMENTAL PROTECTION AGENCY, RESPIRATORY HEALTH EFFECTS OF PASSIVE SMOKING: LUNG CANCER AND OTHER DISORDERS (EPA/600/6-90/006F) (1992); OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT, CALIFORNIA ENVIRONMENTAL PROTECTION AGENCY, HEALTH EFFECTS OF EXPOSURE TO ENVIRONMENTAL TOBACCO SMOKE (1997).
4. A recent analysis has reported that more civilians "die in smoking-material fires than any other type of fire in the U.S." JOHN R. HALL, JR., THE U.S. SMOKING-MATERIAL FIRE PROBLEM THROUGH 1995 (1997). This amounted to more than 1000 deaths in 1995 (11% of those children) with 98% of deaths caused by cigarettes, and just 2% caused by cigars and pipes. The report strengthened the urgency of reducing the ignition potential of cigarettes as was the intent of the U.S. Fire Safe Cigarette Act of 1990, Pub. L. No. 101-352, 104 Stat. 405 (1990). To date, no changes in cigarette design to achieve such ends have been required.
5. A recent analysis has reported that more civilians "die in smoking-material fires than any other type of fire in the U.S." JOHN R. HALL, JR., THE U.S. SMOKING-MATERIAL FIRE PROBLEM THROUGH 1995 (1997). This amounted to more than 1000 deaths in 1995 (11% of those children) with 98% of deaths caused by cigarettes, and just 2% caused by cigars and pipes. The report strengthened the urgency of reducing the ignition potential of cigarettes as was the intent of the U.S. Fire Safe Cigarette Act of 1990, Pub. L. No. 101-352, 104 Stat. 405 (1990). To date, no changes in cigarette design to achieve such ends have been required.
6. John Slade, Gregory N. Connolly, Ronald M. Davis, Clifford E. Douglas, Jack E. Henningfield, John R. Hughes, Lynn T. Kozlowski & Matthew M. Myers, Report of the Tobacco Policy Research Study Group on Tobacco Products, 1 (Supp) TOBACCO CONTROL S4 (1992).
7. See, e.g., STANTON A. GLANTZ, JOHN SLADE, LISA A. BERO, PETER HANAUER & DEBORAH E. BARNES, THE CIGARETTE PAPERS chs. 2, 5, 6-10 (1996); RICHARD KLUGER, ASHES TO ASHES: AMERICA'S HUNDRED-YEAR CIGARETTE WAR, THE PUBLIC HEALTH, AND THE UNABASHED TRIUMPH OF PHILIP MORRIS 266-73 (1996); PHILIP J. HILTS, SMOKE SCREEN: THE TRUTH BEHIND THE TOBACCO INDUSTRY COVER-UP chs. 2, 3 (1996).
8. See, e.g., STANTON A. GLANTZ, JOHN SLADE, LISA A. BERO, PETER HANAUER & DEBORAH E. BARNES, THE CIGARETTE PAPERS chs. 2, 5, 6-10 (1996); RICHARD KLUGER, ASHES TO ASHES: AMERICA'S HUNDRED-YEAR CIGARETTE WAR, THE PUBLIC HEALTH, AND THE UNABASHED TRIUMPH OF PHILIP MORRIS 266-73 (1996); PHILIP J. HILTS, SMOKE SCREEN: THE TRUTH BEHIND THE TOBACCO INDUSTRY COVER-UP chs. 2, 3 (1996).
9. 26 U.S.C. § 5703 (1994).
10. Id. § 5723.
11. Pub. L. No. 95-575, 92 Stat. 2463 (1978) (codified at 18 U.S.C. §§ 2341-2346 (1994)).
12. NATIONAL CANCER INST., NATIONAL INST. OF HEALTH, THE FTC CIGARETTE TEST METHOD FOR DETERMINING TAR, NICOTINE, AND CARBON MONOXIDE YIELDS OF U.S. CIGARETTES: REPORT OF THE NCI EXPERT COMMITTEE (Smoking and Tobacco Control Monograph 7) (1996) (NIH Pub. No. 96-4028).
13. See Federal Cigarette Labeling and Advertising Act, Pub. L. No. 89-92, 79 Stat. 282 (1965) (codified at 15 U.S.C. § 1331-1341 (1994)). Specifically, supervision of the rotation of warnings falls under 15 U.S.C. § 1333(c).
14. In the Matter of R.J. Reynolds Tobacco Co., FTC Dkt. No. 9285 (1997).
15. FTC compiles annual reports under 15 U.S.C. § 1337. See, e.g., FEDERAL TRADE COMM'N, REPORT TO CONGRESS FOR 1996 PURSUANT TO THE FEDERAL CIGARETTE LABELING AND ADVERTISING ACT (1998).
16. 15 U.S.C. § 1335.
17. See 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, 61 Fed. Reg. 44,619, 45,219-22 (Aug. 28, 1996).
18. John Slade, Nicotine Delivery Devices, in NICOTINE ADDICTION: PRINCIPLES AND MANAGEMENT 18 (C. Tracy Orleans & John Slade eds. 1993).
19. 61 Fed. Reg. at 45,222 n.1160 (quoting U.S. Department of Agriculture Regulatory Announcements, No. 13 (1914)).
20. Analysis Regarding Food and Drug Administration's Jurisdiction Over Nicotine Containing Cigarettes and Smokeless Tobacco, 60 Fed. Reg. 41,453 (Aug. 11, 1995). See also 61 Fed. Reg. at 44,619.
21. Analysis Regarding Food and Drug Administration's Jurisdiction Over Nicotine Containing Cigarettes and Smokeless Tobacco, 60 Fed. Reg. 41,453 (Aug. 11, 1995). See also 61 Fed. Reg. at 44,619.
22. 21 C.F.R. pt. 801 et seq.; Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents; Final Rule, 61 Fed. Reg. 44,396 (Aug. 28,1996).
23. 61 Fed. Reg. at 44,422, 44,616.
24. See, e.g., id. at 44,463-64.
25. See, e.g., NATIONAL CANCER INST., supra note 9, at 1-11.
26. Slade, supra note 14, at 2-23.
27. U.S. DEP'T OF HEALTH & HUMAN SERVS., THE HEALTH CONSEQUENCES OF SMOKING. NICOTINE ADDICTION: A REPORT OF THE SURGEON GENERAL (1988) (DHHS Pub. No. (CDC) 88-8406); Gary A. Giovino, Jack E. Henningfield, Scott L. Tomar, Luis G. Escobedo & John Slade, Epidemiology of Tobacco Use and Dependence, 17 EPIDEMIOLOGIC REV. 48 (1995); 61 Fed. Reg. at 44,619.
28. U.S. DEP'T OF HEALTH & HUMAN SERVS., THE HEALTH CONSEQUENCES OF SMOKING. NICOTINE ADDICTION: A REPORT OF THE SURGEON GENERAL (1988) (DHHS Pub. No. (CDC) 88-8406); Gary A. Giovino, Jack E. Henningfield, Scott L. Tomar, Luis G. Escobedo & John Slade, Epidemiology of Tobacco Use and Dependence, 17 EPIDEMIOLOGIC REV. 48 (1995); 61 Fed. Reg. at 44,619.
29. U.S. DEP'T OF HEALTH & HUMAN SERVS., THE HEALTH CONSEQUENCES OF SMOKING. NICOTINE ADDICTION: A REPORT OF THE SURGEON GENERAL (1988) (DHHS Pub. No. (CDC) 88-8406); Gary A. Giovino, Jack E. Henningfield, Scott L. Tomar, Luis G. Escobedo & John Slade, Epidemiology of Tobacco Use and Dependence, 17 EPIDEMIOLOGIC REV. 48 (1995); 61 Fed. Reg. at 44,619.
30. Jack E. Henningfield & Robert M. Keenan, Nicotine Delivery Kinetics and Abuse Liability, 61 J. CONSULTING & CLINICAL PSYCHOLOGY 743 (1993).
31. Jack E. Henningfield, June M. Stapleton, Neal L. Benowitz, Roger F. Grayson & Edythe D. London, Higher Levels of Nicotine in Arterial than in Venous Blood After Cigarette Smoking, 33 DRUG & ALCOHOL DEPENDENCE 23 (1993).
32. Suzette M. Evans, Edward J. Cone & Jack E. Henningfield, Arterial and Venous Cocaine Plasma Concentrations in Humans: Relationship to Route of Administration, Cardiovascular Effects and Subjective Effects, 279 J. PHARMACOLOGY & EXPERIMENTAL THERAPEUTICS 1345 (1996).
33. ECONOMIC RESEARCH SERV., U.S. DEP'T OF AGRIC., TOBACCO SITUATION & OUTLOOK YEARBOOK tbl. 1 (1997) (TBS-240).
34. 61 Fed. Reg. at 44,937-38.
35. MASSACHUSETTS DEP'T OF PUB. HEALTH, NICOTINE INFORMATION (1997).
36. 61 Fed. Reg. at 44,463-64.
37. J. Doull, J.P. Frawley & W. Glorge, Ingredients Added to Tobacco in the Manufacture of Cigarettes by the Six Major American Cigarette Companies, reprinted in TOBACCO REP., July 1994, at 32.
38. See 61 Fed. Reg. at 44,970-75; R.J. REYNOLDS TOBACCO CO., NEW CIGARETTE PROTOTYPES THAT HEAT INSTEAD OF BURN TOBACCO: CHEMICAL AND BIOLOGICAL STUDIES (1988); I.C. Brown, DJ. Dittrich & R.T. Fiebelkorn, Smoking Articles, U.S. Patent No. 5,249,588 (issued Oct. 5, 1993) (assigned to British-American Tobacco Co.); COLIN L. BROWNE, THE DESIGN OF CIGARETTES (1990); Jeffrey Taylor, Tobacco Firm Releases Data about Enhancing Nicotine, WALL ST. J., Mar. 2, 1998. See also Plaintiff's Trial Exhibits 13,155, 10,096, 12,505, & 13,069 from the Minnesota AG trial, on the Website maintained by BlueCross/BlueShield of Minnesota, BlueCross Tobacco - Tobacco Litigation (visited May 22, 1998) 〈http://www.mnbluecrosstobacco.com/toblit/trialnews〉.
39. See 61 Fed. Reg. at 44,970-75; R.J. REYNOLDS TOBACCO CO., NEW CIGARETTE PROTOTYPES THAT HEAT INSTEAD OF BURN TOBACCO: CHEMICAL AND BIOLOGICAL STUDIES (1988); I.C. Brown, DJ. Dittrich & R.T. Fiebelkorn, Smoking Articles, U.S. Patent No. 5,249,588 (issued Oct. 5, 1993) (assigned to British-American Tobacco Co.); COLIN L. BROWNE, THE DESIGN OF CIGARETTES (1990); Jeffrey Taylor, Tobacco Firm Releases Data about Enhancing Nicotine, WALL ST. J., Mar. 2, 1998. See also Plaintiff's Trial Exhibits 13,155, 10,096, 12,505, & 13,069 from the Minnesota AG trial, on the Website maintained by BlueCross/BlueShield of Minnesota, BlueCross Tobacco - Tobacco Litigation (visited May 22, 1998) 〈http://www.mnbluecrosstobacco.com/toblit/trialnews〉.
40. See 61 Fed. Reg. at 44,970-75; R.J. REYNOLDS TOBACCO CO., NEW CIGARETTE PROTOTYPES THAT HEAT INSTEAD OF BURN TOBACCO: CHEMICAL AND BIOLOGICAL STUDIES (1988); I.C. Brown, DJ. Dittrich & R.T. Fiebelkorn, Smoking Articles, U.S. Patent No. 5,249,588 (issued Oct. 5, 1993) (assigned to British-American Tobacco Co.); COLIN L. BROWNE, THE DESIGN OF CIGARETTES (1990); Jeffrey Taylor, Tobacco Firm Releases Data about Enhancing Nicotine, WALL ST. J., Mar. 2, 1998. See also Plaintiff's Trial Exhibits 13,155, 10,096, 12,505, & 13,069 from the Minnesota AG trial, on the Website maintained by BlueCross/BlueShield of Minnesota, BlueCross Tobacco - Tobacco Litigation (visited May 22, 1998) 〈http://www.mnbluecrosstobacco.com/toblit/trialnews〉.
41. See 61 Fed. Reg. at 44,970-75; R.J. REYNOLDS TOBACCO CO., NEW CIGARETTE PROTOTYPES THAT HEAT INSTEAD OF BURN TOBACCO: CHEMICAL AND BIOLOGICAL STUDIES (1988); I.C. Brown, DJ. Dittrich & R.T. Fiebelkorn, Smoking Articles, U.S. Patent No. 5,249,588 (issued Oct. 5, 1993) (assigned to British-American Tobacco Co.); COLIN L. BROWNE, THE DESIGN OF CIGARETTES (1990); Jeffrey Taylor, Tobacco Firm Releases Data about Enhancing Nicotine, WALL ST. J., Mar. 2, 1998. See also Plaintiff's Trial Exhibits 13,155, 10,096, 12,505, & 13,069 from the Minnesota AG trial, on the Website maintained by BlueCross/BlueShield of Minnesota, BlueCross Tobacco - Tobacco Litigation (visited May 22, 1998) 〈http://www.mnbluecrosstobacco.com/toblit/trialnews〉.
42. See 61 Fed. Reg. at 44,970-75; R.J. REYNOLDS TOBACCO CO., NEW CIGARETTE PROTOTYPES THAT HEAT INSTEAD OF BURN TOBACCO: CHEMICAL AND BIOLOGICAL STUDIES (1988); I.C. Brown, DJ. Dittrich & R.T. Fiebelkorn, Smoking Articles, U.S. Patent No. 5,249,588 (issued Oct. 5, 1993) (assigned to British-American Tobacco Co.); COLIN L. BROWNE, THE DESIGN OF CIGARETTES (1990); Jeffrey Taylor, Tobacco Firm Releases Data about Enhancing Nicotine, WALL ST. J., Mar. 2, 1998. See also Plaintiff's Trial Exhibits 13,155, 10,096, 12,505, & 13,069 from the Minnesota AG trial, on the Website maintained by BlueCross/BlueShield of Minnesota, BlueCross Tobacco - Tobacco Litigation (visited May 22, 1998) 〈http://www.mnbluecrosstobacco.com/toblit/trialnews〉.
43. See 61 Fed. Reg. at 44,970-75; R.J. REYNOLDS TOBACCO CO., NEW CIGARETTE PROTOTYPES THAT HEAT INSTEAD OF BURN TOBACCO: CHEMICAL AND BIOLOGICAL STUDIES (1988); I.C. Brown, DJ. Dittrich & R.T. Fiebelkorn, Smoking Articles, U.S. Patent No. 5,249,588 (issued Oct. 5, 1993) (assigned to British-American Tobacco Co.); COLIN L. BROWNE, THE DESIGN OF CIGARETTES (1990); Jeffrey Taylor, Tobacco Firm Releases Data about Enhancing Nicotine, WALL ST. J., Mar. 2, 1998. See also Plaintiff's Trial Exhibits 13,155, 10,096, 12,505, & 13,069 from the Minnesota AG trial, on the Website maintained by BlueCross/BlueShield of Minnesota, BlueCross Tobacco - Tobacco Litigation (visited May 22, 1998) 〈http://www.mnbluecrosstobacco.com/toblit/trialnews〉.
44. 61 Fed. Reg. at 44,970-92.
45. See generally supra notes 10, 32.
46. In 1967, the director of research at Brown & Williamson, Dr. R.B. Griffith, noted that, in considering the possible toxicity of cigarette additives, the pyrolysis products of additives had to be taken into account. See GLANTZ, supra note 5, at ch. 6.
47. Dietrich Hoffmann & Ilse Hoffmann, The Changing Cigarette, 1950-1995, 50 J. TOXICOLOGY & ENVTL. HEALTH 307 (1997) (citing INTERNATIONAL AGENCY FOR RESEARCH ON CANCER, MONOGRAPHS ON THE EVALUATION OF CARCINOGENIC RISKS TO HUMANS UPDATE (Supp. 7 1987), vols. 43-66 (1988-1996)).
48. Dietrich Hoffmann & Ilse Hoffmann, The Changing Cigarette, 1950-1995, 50 J. TOXICOLOGY & ENVTL. HEALTH 307 (1997) (citing INTERNATIONAL AGENCY FOR RESEARCH ON CANCER, MONOGRAPHS ON THE EVALUATION OF CARCINOGENIC RISKS TO HUMANS UPDATE (Supp. 7 1987), vols. 43-66 (1988-1996)).
49. Richard Doll, Richard Peto, Keith Wheatley, Richard Gray & Isabelle Sutherland, Mortality in Relation to Smoking: 40 Years' Observations on Male British Doctors, 309 BRIT. MED. J. 901 (1994).
50. Harold C. Pillsbury, C.C. Bright, K.J. O'Connor & F.W. Irish, Tar and Nicotine in Cigarette Smoke, 52 J. ASSOC. OFFICIAL ANALYTICAL CHEMISTS 458 (1969); NATIONAL CANCER INST., supra note 9, at 1-8.
51. Alan Rodgman, A Short Explanation and Analysis of Methods for Measuring "Tar and Nicotine" in Cigarette Smoke, in ALAN RODGMAN, FTC SMOKING METHOD USED FOR "TAR" AND NICOTINE DATA app. B, 38 (Aug. 30, 1994).
52. U. S. DEP'T OF HEALTH & HUMAN SERVS., supra note 23, at 156-57 tbl. 2.
53. Lynn T. Kozlowski, Blocking of the Filter Vents of Cigarettes, 256 JAMA 3214 (1986).
54. MASSACHUSETTS DEP'T OF PUB. HEALTH, NICOTINE INFORMATION (1997).
55. Lynn T. Kozlowski, Tar and Nicotine Delivery: What a Difference a Puff Makes, 245 JAMA 158 (1981).
56. Browne, supra note 32, at 52-53; Slade, supra note 15, at 9-17. Another adverse effect of the use of burn accelerants is to increase the effectiveness of dropped or discarded cigarettes to cause fires. Cigarettes are thereby a major cause of residential fire-deaths, as discussed in HALL, supra note 3, at 1-44.
57. NATIONAL CANCER INST., supra note 9, at 15-37, 93-111; David B. Coultas, Christine A. Stidley & Jonathan M. Samet, Discrepancies Between Self-Reported and Validated Cigarette Smoking in a Community Survey of New Mexico Hispanics, 137 AM. REV. RESPIRATORY DISEASES 810 (1988).
58. Mirjana V. Djordjevic, Jingrun Fan, Saul Ferguson & Dietrich Hoffmann, Self-Regulation of Smoking Intensity. Smoke Yields of the Low-Nicotine, Low-"Tar" Cigarettes, 16 CARCINOGENESIS 2015 (1995).
59. Neal L. Benowitz, Sharon H. Hall, Ronald I. Herning, Peyton Jacob III, Reese T. Jones & Abdel-Latif Osman, Smokers of Low-Yield Cigarettes Do Not Consume Less Nicotine, 309 NEW ENG. J. MED. 139 (1983).
60. W.S. Rickert, Smoking Under Realistic Conditions: Development of Minimum and Maximum Values for Toxic Constituents in Tobacco Smoke (1996) (DSS File No. 35SS.H4078-5-C105).
61. Michael F. Borgerding, J.A. Bodnar, H.L. Chung, C.C. Morrison, C.H. Risner, D.F. Simmons, F.N. Wendelboe, D.E. Wingate & L.S. Winkler, Investigation of a New Cigarette which Primarily Heats Tobacco Using an Alternative Puffing Regimen, Speech at the 50th Tobacco Chemists Research Conference (Oct. 23, 1996); Mirjana V. Djordjevic, Lisbeth Eixarch & Dietrich Hoffmann, A Comparison of Selected Components in the Mainstream Smoke of the Leading U.S. and Japanese Cigarettes, in CORESTA CONGRESS PROCEEDINGS: GROUP OF SMOKE AND TECHNOLOGY 200 (Nov. 3-8, 1996).
62. Michael F. Borgerding, J.A. Bodnar, H.L. Chung, C.C. Morrison, C.H. Risner, D.F. Simmons, F.N. Wendelboe, D.E. Wingate & L.S. Winkler, Investigation of a New Cigarette which Primarily Heats Tobacco Using an Alternative Puffing Regimen, Speech at the 50th Tobacco Chemists Research Conference (Oct. 23, 1996); Mirjana V. Djordjevic, Lisbeth Eixarch & Dietrich Hoffmann, A Comparison of Selected Components in the Mainstream Smoke of the Leading U.S. and Japanese Cigarettes, in CORESTA CONGRESS PROCEEDINGS: GROUP OF SMOKE AND TECHNOLOGY 200 (Nov. 3-8, 1996).
63. A little-noticed feature of the June 20, 1997 proposed resolution is that it would impose a 12-milligram tar ceiling on cigarettes. See Proposed Settlement Agreement (June 20, 1997), available at 〈http:// www.tobaccorreekids.org/html/settlement_document.html〉. Were this provision to be included in federal law, a misleading test (FTC test) of a concept only indirectly (and inconsistently) indicative of toxicity (tar) would become embedded in statute. It would be far better, and far more typical of conventional regulatory practice, for FDA to establish what tests should be done and what should be reported.
64. NATIONAL CANCER INST., supra note 9, at 249-75; Rodgman, supra note 39; John Slade, Lisa A. Bero, Peter Hanover, Deborah E. Barnes & Stanton A. Glantz, Nicotine Addiction: The Brown and Williamson Documents, 274 JAMA 230 (1995); 61 Fed. Reg. at 44,918-19, 44,939-41, 44,963-79; 60 Fed. Reg. at 41,659-66.
65. NATIONAL CANCER INST., supra note 9, at 249-75; Rodgman, supra note 39; John Slade, Lisa A. Bero, Peter Hanover, Deborah E. Barnes & Stanton A. Glantz, Nicotine Addiction: The Brown and Williamson Documents, 274 JAMA 230 (1995); 61 Fed. Reg. at 44,918-19, 44,939-41, 44,963-79; 60 Fed. Reg. at 41,659-66.
66. NATIONAL CANCER INST., supra note 9, at 249-75; Rodgman, supra note 39; John Slade, Lisa A. Bero, Peter Hanover, Deborah E. Barnes & Stanton A. Glantz, Nicotine Addiction: The Brown and Williamson Documents, 274 JAMA 230 (1995); 61 Fed. Reg. at 44,918-19, 44,939-41, 44,963-79; 60 Fed. Reg. at 41,659-66.
67. 61 Fed. Reg. at 44,941.
68. John Slade, The Tobacco Epidemic: Lessons from History, 21 J. PSYCHOACTIVE DRUGS 281 (1989); KLUGER, supra note 5, at 241, 428-34.
69. Rodgman, supra note 39.
70. GLANTZ, supra note 5, at 128-30.
71. Id.
72. State v. Philip Morris, Inc., Case File No. 62-C1-94-008565 (Minn. 2d D. Ct. 1998) (special masters report).
73. Information about trial exhibits is posted on the Website maintained by BlueCross/BlueShield of Minnesota, supra note 32.
74. NATIONAL CLEARINGHOUSE ON TOBACCO & HEALTH, CANADA, SELECTED EXCERPTS FROM IMPERIAL TOBACCO LIMITED, INTERNAL DOCUMENTS 55 (1992).
75. Id. at 57.
76. Id. at 49.
77. Nowland Organization, Inc., SHF Cigarette Marketplace Opportunities Search and Situation Analysis, volume II, Management Report (1976) (management report prepared for Lorillard), available at 〈http:// www.mnbluecrosstobacco.com/toblit/trialnews/doc/TE17994.PDF〉 (Minnesota trial exhibit no. 17,994).
78. Id.
79. Letter from P.L. Short to Fred Haslam (Apr. 28, 1977), available at 〈http://www.mnbluecross.com/ toblit/trialnews/docs/TE10584.PDF〉 (Minnesota trial exhibit no. 10,584); BRITISH-AMERICAN TOBACCO CO., SMOKING AND HEALTH ITEM 7: THE EFFECT ON MARKETING (Apr. 28, 1977), available at 〈http:// www.mnbluecross.com/toblit/trialnews/docs/TE10585.PDF〉 (Minnesota trial exhibit no. 10,585).
80. Letter from P.L. Short to Fred Haslam (Apr. 28, 1977), available at 〈http://www.mnbluecross.com/ toblit/trialnews/docs/TE10584.PDF〉 (Minnesota trial exhibit no. 10,584); BRITISH-AMERICAN TOBACCO CO., SMOKING AND HEALTH ITEM 7: THE EFFECT ON MARKETING (Apr. 28, 1977), available at 〈http:// www.mnbluecross.com/toblit/trialnews/docs/TE10585.PDF〉 (Minnesota trial exhibit no. 10,585).
81. Memorandum from A.M. Ihrig to Dr. F.J. Schultz (July 19, 1977) (attachment).
82. FEDERAL TRADE COMM'N, supra note 12.
83. NATIONAL CANCER INST., supra note 9; Kenneth E. Warner, John Slade & David T. Sweanor, The Emerging Market for Long-Term Nicotine Maintenance, 278 JAMA 1087 (1997).
84. U.S. DEP'T OF HEALTH & HUMAN SERVS., THE HEALTH CONSEQUENCES OF SMOKING. THE CHANGING CIGARETTE: A REPORT OF THE SURGEON GENERAL (1981) (DHHS Pub. No. (PHS) 81-50156); U.S. DEP'T OF HEALTH & HUMAN SERVS., REDUCING THE HEALTH CONSEQUENCES OF SMOKING: 25 YEARS OF PROGRESS. A REPORT OF THE SURGEON GENERAL (1989) (DHHS Pub. No. (CDC) 89-8411); NATIONAL CANCER INST., supra note 9; Warner et al., supra note 67; Michael J. Thun, Cathy A. Lally, J.T. Flannery, Eugenia E. Calle, W. Dana Flanders & Clark W. Heath, Jr., Cigarette Smoking and Changes in the Histopathology of Lung Cancer, 89 J. NAT'L CANCER INST. 1580 (1997).
85. U.S. DEP'T OF HEALTH & HUMAN SERVS., THE HEALTH CONSEQUENCES OF SMOKING. THE CHANGING CIGARETTE: A REPORT OF THE SURGEON GENERAL (1981) (DHHS Pub. No. (PHS) 81-50156); U.S. DEP'T OF HEALTH & HUMAN SERVS., REDUCING THE HEALTH CONSEQUENCES OF SMOKING: 25 YEARS OF PROGRESS. A REPORT OF THE SURGEON GENERAL (1989) (DHHS Pub. No. (CDC) 89-8411); NATIONAL CANCER INST., supra note 9; Warner et al., supra note 67; Michael J. Thun, Cathy A. Lally, J.T. Flannery, Eugenia E. Calle, W. Dana Flanders & Clark W. Heath, Jr., Cigarette Smoking and Changes in the Histopathology of Lung Cancer, 89 J. NAT'L CANCER INST. 1580 (1997).
86. U.S. DEP'T OF HEALTH & HUMAN SERVS., THE HEALTH CONSEQUENCES OF SMOKING. THE CHANGING CIGARETTE: A REPORT OF THE SURGEON GENERAL (1981) (DHHS Pub. No. (PHS) 81-50156); U.S. DEP'T OF HEALTH & HUMAN SERVS., REDUCING THE HEALTH CONSEQUENCES OF SMOKING: 25 YEARS OF PROGRESS. A REPORT OF THE SURGEON GENERAL (1989) (DHHS Pub. No. (CDC) 89-8411); NATIONAL CANCER INST., supra note 9; Warner et al., supra note 67; Michael J. Thun, Cathy A. Lally, J.T. Flannery, Eugenia E. Calle, W. Dana Flanders & Clark W. Heath, Jr., Cigarette Smoking and Changes in the Histopathology of Lung Cancer, 89 J. NAT'L CANCER INST. 1580 (1997).
87. Thun et al., supra note 68. Changes in cigarette design intended to reduce the levels of polynuclear aromatic hydrocarbons in cigarette smoke had the untoward effect of increasing nitrosamine yields. Dietrich Hoffmann, Mirjana V. Djordjevic & K.D. Brunnemann, Changes in Cigarette Design and Composition Over Time and How They Influence the Yields of Smoke Constituents, 6 J. SMOKING-RELATED DISORDERS 9 (1995). This may have contributed to the shift in cell type because nitrosamines are potent causes of adenocarcinoma of the lung in animals. Dietrich Hoffmann, Abraham Rivenson, S.E. Murphy, Fung-Lung Chung, S. Amin & Stephen S. Hecht, Cigarette Smoking and Adenocarcinoma of the Lung: the Relevance of Nicotine-Derived N-nitrosamines, 4 J. SMOKING-RELATED DISORDERS 165 (1993).
88. Thun et al., supra note 68. Changes in cigarette design intended to reduce the levels of polynuclear aromatic hydrocarbons in cigarette smoke had the untoward effect of increasing nitrosamine yields. Dietrich Hoffmann, Mirjana V. Djordjevic & K.D. Brunnemann, Changes in Cigarette Design and Composition Over Time and How They Influence the Yields of Smoke Constituents, 6 J. SMOKING-RELATED DISORDERS 9 (1995). This may have contributed to the shift in cell type because nitrosamines are potent causes of adenocarcinoma of the lung in animals. Dietrich Hoffmann, Abraham Rivenson, S.E. Murphy, Fung-Lung Chung, S. Amin & Stephen S. Hecht, Cigarette Smoking and Adenocarcinoma of the Lung: the Relevance of Nicotine-Derived N-nitrosamines, 4 J. SMOKING-RELATED DISORDERS 165 (1993).
89. Kenneth E. Warner & John Slade, Low Tar. High Toll, 82 AM. J. PUB. HEALTH 17 (1992).
90. U.S. DEP'T OF HEALTH & HUMAN SERVS., THE HEALTH CONSEQUENCES OF SMOKING, supra note 68 (emphasis added).
91. See, e.g., Thomas A. Pearson, Smoking Cessation: Clinical Evaluation and Management of the Cigarette Smoker, in TEXTBOOK OF INTERNAL MEDICINE 1870-74 (William N. Kelley ed. 1992).
92. Gary A. Giovino, Scott L. Tomar, Murli N. Reddy, John P. Peddicord, Bao-Ping Zhu, Luis G. Escobar & Michael P. Eriksen, Attitudes, Knowledge, and Beliefs About Low Yield Cigarettes Among Adolescents and Adults, in NATIONAL CANCER INST., supra note 9, at 39.
93. NATIONAL CANCER INST., supra note 9; Warner et al., supra note 67.
94. In the present policy discussions about tobacco, the terms "reduced-risk" and "reduced-delivery" have been used to describe products for which manufacturers want to make health claims. Because these terms themselves would seem to be health claims, this article will describe tobacco products in this category as "potential health claim" products.
95. U.S. DEP'T OF HEALTH & HUMAN SERVS., THE HEALTH CONSEQUENCES OF USING SMOKELESS TOBACCO: A REPORT OF THE ADVISORY COMMITTEE OF THE SURGEON GENERAL (1979) (NIH Pub. No. 86-2874).
96. Dietrich Hoffmann, Mirjana V. Djordjevic, Jingrun Fan, Edith Zang, Thomas Glynn & Gregory N. Connolly, Five Leading U.S. Commercial Brands of Moist Snuff in 1994: Assessment of Carcinogenic N-Nitrosamines, 87 J. NAT'L CANCER INST. 1862 (1995).
97. U.S. DEP'T OF HEALTH & HUMAN SERVS., supra note 76.
98. U.S. DEP'T OF HEALTH & HUMAN SERVS., REDUCING THE HEALTH CONSEQUENCES OF SMOKING, supra note 66; Scott L. Tomar, Gary A. Giovino & Michael P. Eriksen, Smokeless Tobacco Brand Preference and Brand Switching Among U.S. Adolescents and Young Adults, 4 TOBACCO CONTROL 67 (1995).
99. U.S. DEP'T OF HEALTH & HUMAN SERVS., REDUCING THE HEALTH CONSEQUENCES OF SMOKING, supra note 66; Scott L. Tomar, Gary A. Giovino & Michael P. Eriksen, Smokeless Tobacco Brand Preference and Brand Switching Among U.S. Adolescents and Young Adults, 4 TOBACCO CONTROL 67 (1995).
100. Gregory N. Connolly, The Marketing of Nicotine Addiction by Oral Snuff Manufacturers, 4 TOBACCO CONTROL 73 (1995).
101. Jack E. Henningfield, Aleksandras Radzius & Edward J. Cone, Estimation of Available Nicotine Content of Six Smokeless Tobacco Products, 4 TOBACCO CONTROL 57 (1995); Mirjana V. Djordjevic, Dietrich Hoffmann, Thomas Glynn & Gregory N. Connolly, U.S. Commercial Brands of Moist Snuff, 1994., 4 TOBACCO CONTROL 62 (1995).
102. Jack E. Henningfield, Aleksandras Radzius & Edward J. Cone, Estimation of Available Nicotine Content of Six Smokeless Tobacco Products, 4 TOBACCO CONTROL 57 (1995); Mirjana V. Djordjevic, Dietrich Hoffmann, Thomas Glynn & Gregory N. Connolly, U.S. Commercial Brands of Moist Snuff, 1994., 4 TOBACCO CONTROL 62 (1995).
103. 61 Fed. Reg. at 45,125.
104. Reginald V. Fant, Jack E. Henningfield, Richard Nelson & Wallace Pickworth, Pharmacokinetics of Five Commercial Brands of Smokeless Tobacco in Humans, Poster Session at Fourth Annual Meeting of the Society for Research on Nicotine and Tobacco, New Orleans, LA (Mar. 27-29, 1998).
105. Id.
106. Pub. L. No. 99-252, 100 Stat. 30 (1986) (codified at 15 U.S.C. §§ 4401-4408).
107. Scott L. Tomar & Jack E. Henningfield, Review of the Evidence that pH is a Determinate of Nicotine Dosage from Oral Use of Smokeless Tobacco, 6 TOBACCO CONTROL 220 (1997).
108. See id.; Regulations Restricting the Second Distribution of Cigarettes and Smokeless Tobacco Products to Protect Children and Adolescents; Proposed Rule, 60 Fed. Reg. 41,313 (Aug. 11, 1995); 61 Fed. Reg. at 44,396.
109. See id.; Regulations Restricting the Second Distribution of Cigarettes and Smokeless Tobacco Products to Protect Children and Adolescents; Proposed Rule, 60 Fed. Reg. 41,313 (Aug. 11, 1995); 61 Fed. Reg. at 44,396.
110. NATIONAL CANCER INST., NATIONAL INST. OF HEALTH, CIGARS: HEALTH EFFECTS AND TRENDS (NCI Smoking and Tobacco Control Monograph 9) (1998) (NIH Pub. No. 98-4302).
111. John S lade, Marketing and Promotion of Cigars, in NATIONAL CANCER INST., supra note 88, at 198-216.
112. See NATIONAL CANCER INST., supra note 88.
113. Office on Smoking and Health, Tobacco Use Among High School Students - United States, 1997, 47 MORBIDITY & MORTALITY WKLY REP. 229, 231 (Apr. 3, 1998).
114. NATIONAL CANCER INST., supra note 88; A. Petersen, A Study Warns of Cigars' Role in Some Heart Disease, WALL ST. J., Mar. 20, 1998, at B1; AMERICAN PSYCHIATRIC ASS'N, DSM-IV: DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS 242-47 (1994).
115. NATIONAL CANCER INST., supra note 88; A. Petersen, A Study Warns of Cigars' Role in Some Heart Disease, WALL ST. J., Mar. 20, 1998, at B1; AMERICAN PSYCHIATRIC ASS'N, DSM-IV: DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS 242-47 (1994).
116. NATIONAL CANCER INST., supra note 88; Jack E. Henningfield, M. Hariharan & Lynn T. Kozlowski, Nicotine Content and the Risks of Cigars, 276 JAMA 1857 (1996).
117. 61 Fed. Reg. at 44,422, 44,424.
118. NATIONAL CANCER INST., supra note 88.
119. 61 Fed. Reg. at 44,616 (codified at 21 C.F.R. § 897.14(e)).
120. Similar considerations apply to pipe tobacco and to nasal snuff.
121. In 1992, BAT briefly considered entering the nicotine patch market but decided against it. See Suein L. Hwang & Alix M. Freedman, B.A.T. Considered Patches but Stuck to Making Cigarettes, WALL ST. J., Oct. 9, 1995, at B3.
122. R.J. REYNOLDS TOBACCO CO., supra note 32; Eclipse and the Harm Reduction Strategy for Smoking, symposium at Duke University, Durham, NC (Aug. 23, 1996); P.M. Terpstra, W. Reininghaus & R.P. Solana, Evaluation of an Electrically Heated Cigarette, presentation at the Society of Toxicology, Seattle, WA (Mar. 5, 1998).
123. R.J. REYNOLDS TOBACCO CO., supra note 32; Eclipse and the Harm Reduction Strategy for Smoking, symposium at Duke University, Durham, NC (Aug. 23, 1996); P.M. Terpstra, W. Reininghaus & R.P. Solana, Evaluation of an Electrically Heated Cigarette, presentation at the Society of Toxicology, Seattle, WA (Mar. 5, 1998).
124. R.J. REYNOLDS TOBACCO CO., supra note 32.
125. See Edward J. Cone & Jack E. Henningfield, Premier "Smokeless Cigarettes" Can Be Used to Deliver Crack, 261 JAMA 41 (1989).
126. Id.
127. Id.
128. David Towsend, Testimony in Craig Dunn & Philip Wiley v. RJR Nabisco Holdings Corps. (Mar. 12, 1998), reprinted in 23 State of Indiana, County of Delaware in the Delaware County Superior Court; Slade, supra note 15, at 18.
129. D.M. Riggs, D.W. Beeson & B.T. Conner, Fuel Element Composition, U.S. Patent No. 5,551,451 (issued Sept. 3, 1996) (assigned to R.J. Reynolds Tobacco Co.).
130. John Slade, Innovative Nicotine Delivery Devices, presentation at the Alternative Nicotine Delivery Systems: Harm Reduction and Public Health Workshop, Addiction Research Foundation, Toronto, Ontario (Mar. 1997).
131. These claims could be found on the package labels for Eclipse in 1996 and 1997.
132. Slade, supra note 106.
133. Neal L. Benowitz, Peyton Jacob III & John Slade, Nicotine Content of the Eclipse Nicotine Delivery Device, 87 AM. J. PUB. HEALTH 1865 (1997).
134. Borgerding et al., supra note 49.
135. Moreover, the 1R4F appears not to be an unchanging standard. The 1R4F used by R.J. Reynolds for comparisons with a prototype of Premier in 1988 had a benzo(a)pyrene yield of 9.2 nanograms (ng), the NNN yield was 101 ng, and the NNK yield was 84 ng. See R.J. REYNOLDS TOBACCO CO., supra note 32, at 151. The comparable 1R4F yields in tests R.J. Reynolds used for comparisons with Eclipse in 1996 were approximately 5.7, 61, and 53. See Borgerding et al., supra note 49.
136. G. Collins, What Smoke? New Device Keeps Cigarette in a "Box," N.Y. TIMES, Oct. 23, 1997, at A1.
137. G.S. Fleischhauer, P.H. Hayes, C.H. Morgan, M.R. Hajaligol, M.L. Watkins & W.A. Nichols et al., Heater for Use in an Electrical Smoking System, U.S. Patent No. 5,591,368 (issued Jan. 7,1997) (assigned to Philip Morris, Inc.); J.M. Adams, M.S. Braunshteyn, M.E. Counts, G.M. Dale, C.W. Harris & D.H. Jones et al., Cigarette and Method of Manufacturing Cigarette for Electrical Smoking System, U.S. Patent No. 5,666,976 (issued Sept. 16, 1997) (assigned to Philip Morris Inc.).
138. G.S. Fleischhauer, P.H. Hayes, C.H. Morgan, M.R. Hajaligol, M.L. Watkins & W.A. Nichols et al., Heater for Use in an Electrical Smoking System, U.S. Patent No. 5,591,368 (issued Jan. 7,1997) (assigned to Philip Morris, Inc.); J.M. Adams, M.S. Braunshteyn, M.E. Counts, G.M. Dale, C.W. Harris & D.H. Jones et al., Cigarette and Method of Manufacturing Cigarette for Electrical Smoking System, U.S. Patent No. 5,666,976 (issued Sept. 16, 1997) (assigned to Philip Morris Inc.).
139. C. Glass, Virtually Smoke Free: Philip Morris Introduces a New Smoking System, 124 TOBACCO REP. 20 (Dec. 1997).
140. Philip Morris USA, Press Kit on Accord (Oct. 22, 1997).
141. P.M. Terpstra, W. Reininghaus & R.P. Solana, Evaluation of an Electrically Heated Cigarette, presented at the Society of Toxicology, Seattle, WA (Mar. 5, 1998).
142. The method used to analyze cotinine is the same as that described in William J. Sandborn, William J. Tremaine, Kenneth P. Offord, George M. Lawson, Bret T. Petersen, Kenneth P. Batts, Ivana T. Croghan, Lowell C. Dale, Darrell R. Schroeder & Richard D. Hurt, Transdermal Nicotine for Mildly to Moderately Active Ulcerative Colitis: A Randomized, Double-Blind, Placebo-Controlled Trial, 126 ANNALS INTERNAL MED. 364 (1997).
143. Neal L. Benowitz, The Human Pharmacology of Nicotine, 9 RES. ADVANCES ALCOHOL & DRUG PROBS. 1 (1986).
144. J. Robinson, Human Smoking Behavior Studies, presentation at Eclipse and the Harm Reduction Strategy for Smoking symposium at Duke University, Durham, NC (Aug. 23, 1996).
145. Slade, supra note 106.
146. Borgerding et al., supra note 49.
147. Hoffmann & Hoffmann, supra note 36.
148. There is a marked increase in expired carbon dioxide levels among subjects when using Eclipse compared to when they use their usual brands of cigarette. Karl Fagerström, A Comparison of Regular Cigarettes with a Nicotine Replacement Inhaler and Eclipse on Smoking Behavior, Attitudes and Exposure in Smokers Not Willing to Quit, presentation at the Fourth Annual Meeting of the Society for Research on Nicotine and Tobacco, New Orleans, LA (Mar. 27-29, 1998).
149. This is despite the fact that senior officials at these companies actually may hold the conventional view in private. See, for example, considerations of nicotine as an addictive drug dating from the early 1960s at BAT and Brown & Williamson in material reviewed in GLANTZ, supra note 5, at 58-107, and the universal understanding among industry scientists interviewed throughout the United States and Canada in 1958 that cigarette smoke was a cause of lung cancer. See H.R. Bentley, D.G.I. Felton & W.W. Reid, Report on Visit to U.S.A. and Canada, 17th April- 12th May 1958 (June 11, 1958) available at 〈http://www.mnbluecrosstobacco.com/toblit/ trialnews/docs/TE11028.PDF〉.
150. Letter from Steven F. Goldstone, CEO, RJR Nabsico, to shareholders (July 23, 1997) (available in RJR NABSICO, SECOND QUARTER REPORT (1997)).
151. Proposed Settlement Agreement, supra note 50.
152. Light brands are distinguished for the consumer by more than their names. Advertising for Marlboro Lights, for instance, usually dresses the cowboy in an emblematic yellow rain slicker. The packs are designed with color and white space related to the FTC tar rating, and the cigarettes themselves have either cork-colored tipping paper or white tipping paper, depending on the impression that the company wants to make on the consumer about the expected tar and nicotine delivery. To provide consistent public health messages to consumers, it likely will be just as important to regulate these cues as the words "light" and "mild" themselves.
153. Hearings on Regulation of Tobacco Products Before the Subcomm. on Health and the Environment of the House Comm. on Energy and Commerce, 103d Cong., 2d Sess. 619-21, 628; Towsend, supra note 104; Philip Morris, Case File No. 62-C1-94-008565.
154. David E. Rosenbaum, Tobacco Leaders Refuse to Budge on Pact, N.Y. TIMES, Feb. 25, 1998, at A16.
155. 21 C.F.R. pt. 801 et seq.; 61 Fed. Reg. at 44,396.
156. U.K. DEP'T OF HEALTH, DEP'T OF HEALTH & SOCIAL SERVS., N. IRE., SCOT. OFFICE, DEP'T OF HEALTH, WELSH OFFICE, REPORT OF THE SCIENTIFIC COMMITTEE ON TOBACCO AND HEALTH (Mar. 9-10, 1998).
157. Id.
158. A committee chaired by Dr. C. Everett Koop and Dr. David A. Kessler (see C. EVERETT KOOP & DAVID A. KESSLER, FINAL REPORT OF THE ADVISORY COMMITTEE ON TOBACCO POLICY AND PUBLIC HEALTH (1997)) and a report of several public health researchers have discussed several potential conditions that should be met as a part of any sort of settlement of litigation with the tobacco industry. See David Burns, Neal L. Benowitz, Gregory N. Connolly, K. Michael Cummings, Ronald M. Davis, Jack E. Henningfield, Donald R. Shopland & Kenneth E. Warner, What Should Be the Elements of Any Settlement with the Tobacco Industry?, 6 TOBACCO CONTROL 1 (1997).
159. While the discussion that follows is focused mostly on regulating the product itself, other aspects of regulation (such as labeling, marketing, and distribution) are essential tools and must be coordinated closely with product regulation. This would be best accomplished by having FDA be responsible for all of these aspects.
160. See, e.g., PETER TAYLOR, THE SMOKE RING: TOBACCO, MONEY & MULTINATIONAL POLITICS (1985); KLUGER, supra note 5, at 266-73.
161. Hearings on Tobacco Settlement Before the Senate Comm. on Labor and Human Resources, 105th Cong., 2d Sess. (Feb. 24, 1998) (statement by Jack E. Henningfield); Letter from Jack E. Henningfield to Sen. James M. Jeffords (R-VT), Chairman, Senate Comm. on Labor and Human Resources (Mar. 6, 1998).
162. KLUGER, supra note 5, at 643-44.
163. S. 1368, 105th Cong., 2d Sess. (1998).
164. See 61 Fed. Reg. at 44,619.
165. Coyne Beahm, Inc. v. U.S. Food & Drug Admin., 958 F. Supp. 1060 (M.D.N.C. 1997). Industry, however, has appealed the district court's decision.
166. The June 20, 1997 proposed resolution (Proposed Settlement Agreement, supra note 50) envisioned cigarettes and smokeless tobacco products being treated as drugs and devices under the Federal Food, Drug, and Cosmetic Act, Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended 21 U.S.C.§§ 301 et seq. (1994)).
167. Warner et al., supra note 67, at 1088.
168. SOCIAL AND ECONOMIC ASPECTS OF REDUCTION OF TOBACCO SMOKING BY USE OF ALTERNATIVE NICOTINE DELIVERY SYSTEMS (summary report of a roundtable organized by the United Nations Focal Point on Tobacco or Health in collaboration with the International Council on Alcohol and Addictions and the European Medical Association Smoking or Health, Geneva, Switzerland (Sept. 22-24, 1997)); U.K. HEALTH EDUC. AUTH., REGULATING NICOTINE DELIVERY SYSTEMS: HARM REDUCTION AND THE PREVENTION OF SMOKING-RELATED DISEASE (1997) (summary of meeting held at the Health Education Authority, London, U.K. (Nov. 1996)); U.S. DEP'T OF HEALTH & HUMAN SERVS., supra note 68, at 5-26; Ernst L. Wynder & Dietrich Hoffman, Smoking and Lung Cancer: Scientific Challenges and Opportunities, 54 CANCER RESEARCH 5284 (1994).
169. SOCIAL AND ECONOMIC ASPECTS OF REDUCTION OF TOBACCO SMOKING BY USE OF ALTERNATIVE NICOTINE DELIVERY SYSTEMS (summary report of a roundtable organized by the United Nations Focal Point on Tobacco or Health in collaboration with the International Council on Alcohol and Addictions and the European Medical Association Smoking or Health, Geneva, Switzerland (Sept. 22-24, 1997)); U.K. HEALTH EDUC. AUTH., REGULATING NICOTINE DELIVERY SYSTEMS: HARM REDUCTION AND THE PREVENTION OF SMOKING-RELATED DISEASE (1997) (summary of meeting held at the Health Education Authority, London, U.K. (Nov. 1996)); U.S. DEP'T OF HEALTH & HUMAN SERVS., supra note 68, at 5-26; Ernst L. Wynder & Dietrich Hoffman, Smoking and Lung Cancer: Scientific Challenges and Opportunities, 54 CANCER RESEARCH 5284 (1994).
170. SOCIAL AND ECONOMIC ASPECTS OF REDUCTION OF TOBACCO SMOKING BY USE OF ALTERNATIVE NICOTINE DELIVERY SYSTEMS (summary report of a roundtable organized by the United Nations Focal Point on Tobacco or Health in collaboration with the International Council on Alcohol and Addictions and the European Medical Association Smoking or Health, Geneva, Switzerland (Sept. 22-24, 1997)); U.K. HEALTH EDUC. AUTH., REGULATING NICOTINE DELIVERY SYSTEMS: HARM REDUCTION AND THE PREVENTION OF SMOKING-RELATED DISEASE (1997) (summary of meeting held at the Health Education Authority, London, U.K. (Nov. 1996)); U.S. DEP'T OF HEALTH & HUMAN SERVS., supra note 68, at 5-26; Ernst L. Wynder & Dietrich Hoffman, Smoking and Lung Cancer: Scientific Challenges and Opportunities, 54 CANCER RESEARCH 5284 (1994).
171. See 21 U.S.C. § 355(b)(1).
172. See supra note 143.
173. COUNCIL ON SCIENTIFIC AFFAIRS, AMERICAN MED. ASS'N, REDUCING ILLNESS AND DEATH CAUSED BY CIGARETTES BY REDUCING THEIR NICOTINE CONTENT (1998) (CSA Rep. 9-A-98); Warner et al., supra note 67.
174. A key exception to trade secret protection should be that anything that the agency learns in the course of its work on tobacco products that, if applied, can make tobacco products less dangerous, should be available for its use in regulating these products.
175. The FTC test is inadequate for this assignment. Besides giving misleading quantitative results, it lumps all nonwater, nonnicotine particulate matter into the category of tar. See NATIONAL CANCER INST., supra note 9.
176. This approach is the reverse of what has been the model in tobacco control. Under the new model, testing primarily serves a regulatory function. Until now, testing supposedly has served a public education function, although the results have been misleading.
177. See Wynder & Hoffmann, supra note 143, at 5284-95.
178. There are reports of tobacco company experiments with a variety of catalysts, the purpose of which was to reduce yields of toxins such as carbon monoxide (R.J. Reynolds) and polycyclic aromatic hydrocarbons (Liggett & Myers). A centrally active nicotine antagonist added to tobacco products might reduce the reinforcing qualities of nicotine without affecting any of its sensory (taste and flavor) characteristics. The carcinogenesis of the potent tobacco-specific nitrosamine NNK can be inhibited by a selenium compound. Bogdan Prokopezyk, Shantu Amin, Dhimant H. Desai, Christine Kurtze, Pramod Upadhyaya & Karam El-Bayoumy, Effects of 1, 4-Phenylenebis (Methylene) Selenocyanate and Selenmethionine on 4-(Methylnitrosamino)-1-(3-Pyridyl)-1-Butanone-Induced Tumorigenesis in A/J Mouse Lung, 18 CARCINOGENESIS 1855-57 (1997). This observation raises the possibility that using such a compound as an additive in tobacco products that deliver NNK might reduce their toxicity.
179. Commercial cigarettes in Germany and Japan have lower nitrosamine levels than those sold in the United States. See Borgerding et al., supra note 49; Djordjevic, supra note 49, at 200. Lung cancer rates associated with smoking are lower in Japan than in the United States. See Djordjevic, supra note 49, at 200. While there are a number of different explanations for lung cancer rates among smokers being lower in Japan than in the United States (including differences in overall smoking burden, differences in genetics, and differences in diet) differences in cigarette design may also be a factor. One company, Star Tobacco and Pharmaceutical, claims to have a process that eliminates nitrosamines from tobacco. Star Tobacco & Pharmaceuticals, Inc., Star Tobacco & Pharmaceuticals Technology for Removal of TSNA from Tobacco Validated, Press Release (Mar. 5, 1998).
180. See supra note 32.
181. John Slade, Are Tobacco Products Drugs? Evidence from US Tobacco, 4 TOBACCO CONTROL 1 (1995).
182. J.W. Lawson, B.R. Bullings & T.A. Perfetti, Cigarette, U.S. Patent No. 4,836,224 (issued Dec. 24, 1987) (assigned to R.J. Reynolds Tobacco Co.).
183. See R.J. REYNOLDS TOBACCO CO., supra note 32.
184. 60 Fed. Reg. at 41,759-62.
185. In Sweden, certain processes are used in the manufacturing and distribution of snuffs that significantly lower TSNA levels compared to levels in moist snuff in the United States. See U.S. DEP'T OF HEALTH & HUMAN SERVS., THE HEALTH CONSEQUENCES OF USING SMOKELESS TOBACCO. A REPORT OF THE ADVISORY COMMITTEE OF THE SURGEON GENERAL (NIH Pub. No. 86-2874) (1979). The potential for completely TSNA-free products also should be explored. See Star Tobacco and Pharmaceutical, Inc., supra note 152.
186. In actuality, FDA concluded that the current state of scientific knowledge is not sufficient to warrant and guide a strategy to eliminate nicotine from the products or to eliminate tobacco products themselves. 61 Fed. Reg. at 41,348; John Swartz, Tobacco Pact's Fine Print Limits Action on Nicotine: FDA Authority Threatened, Opponents Say, WASH. POST, July 8, 1997, at A4; Henry Weinstein, Scientists Warn Against Rapid Reduction of Nicotine Levels; Tobacco: White House Is Told that Curtailment Could Prompt Smokers to Inhale More Deeply, With Public Health Consequences, L.A. TIMES, July 24, 1997, at D1; COUNCIL ON SCIENTIFIC AFFAIRS, supra note 146.
187. In actuality, FDA concluded that the current state of scientific knowledge is not sufficient to warrant and guide a strategy to eliminate nicotine from the products or to eliminate tobacco products themselves. 61 Fed. Reg. at 41,348; John Swartz, Tobacco Pact's Fine Print Limits Action on Nicotine: FDA Authority Threatened, Opponents Say, WASH. POST, July 8, 1997, at A4; Henry Weinstein, Scientists Warn Against Rapid Reduction of Nicotine Levels; Tobacco: White House Is Told that Curtailment Could Prompt Smokers to Inhale More Deeply, With Public Health Consequences, L.A. TIMES, July 24, 1997, at D1; COUNCIL ON SCIENTIFIC AFFAIRS, supra note 146.
188. In actuality, FDA concluded that the current state of scientific knowledge is not sufficient to warrant and guide a strategy to eliminate nicotine from the products or to eliminate tobacco products themselves. 61 Fed. Reg. at 41,348; John Swartz, Tobacco Pact's Fine Print Limits Action on Nicotine: FDA Authority Threatened, Opponents Say, WASH. POST, July 8, 1997, at A4; Henry Weinstein, Scientists Warn Against Rapid Reduction of Nicotine Levels; Tobacco: White House Is Told that Curtailment Could Prompt Smokers to Inhale More Deeply, With Public Health Consequences, L.A. TIMES, July 24, 1997, at D1; COUNCIL ON SCIENTIFIC AFFAIRS, supra note 146.
189. Swartz, supra note 159 (citing David A. Kessler).
190. See supra table accompanying note 29.
191. U.S. DEP'T OF HEALTH & HUMAN SERVS., supra note 23.
192. COUNCIL ON SCIENTIFIC AFFAIRS, supra note 146, at 1.
193. Id.
194. There have been suggestions in the press recently that cigarette makers are not innocent bystanders in the conduct of smuggling operations that are aimed at evading excise taxes. The underlying magnitude of this traffic is indicated by the fact that 30% of cigarette exports are never officially imported, but rather appear to be manufactured and labeled so as to facilitate illicit import. See Raymond Bonner & Christopher Drew, Cigarette Makers Are
195. There have been suggestions in the press recently that cigarette makers are not innocent bystanders in the conduct of smuggling operations that are aimed at evading excise taxes. The underlying magnitude of this traffic is indicated by the fact that 30% of cigarette exports are never officially imported, but rather appear to be manufactured and labeled so as to facilitate illicit import. See Raymond Bonner & Christopher Drew, Cigarette Makers Are Seen as Aiding Rise in Smuggling, N.Y. TIMES, Aug. 25, 1997, at A1; Victor Malarek, Juian Sher & Paul Webster, The Smoke Ring (The Fifth Estate, Canadian Broadcasting Corp., Jan. 20, 1998); David Sweanor, Testimony Before the Senate Judiciary Committee (Apr. 30, 1998).
196. There have been suggestions in the press recently that cigarette makers are not innocent bystanders in the conduct of smuggling operations that are aimed at evading excise taxes. The underlying magnitude of this traffic is indicated by the fact that 30% of cigarette exports are never officially imported, but rather appear to be manufactured and labeled so as to facilitate illicit import. See Raymond Bonner & Christopher Drew, Cigarette Makers Are Seen as Aiding Rise in Smuggling, N.Y. TIMES, Aug. 25, 1997, at A1; Victor Malarek, Juian Sher & Paul Webster, The Smoke Ring (The Fifth Estate, Canadian Broadcasting Corp., Jan. 20, 1998); David Sweanor, Testimony Before the Senate Judiciary Committee (Apr. 30, 1998).
197. Producers whose products make unproven or false health claims (such as light, mild, and low-tar) should be prevented from doing so, both by limiting the use of words and limiting the use of nonverbal cues in packaging, advertising, and product design that falsely communicate safety. This reform will be especially important in an environment in which some products have FDA approval to advance health claims.
198. These products also will exist in competition with nicotine-containing medications. Another aspect of their premarket and postmarket evaluations should be a consideration of how these tobacco products might affect the use of what presumably will be even less hazardous, nicotine-containing medications for smoking reduction if this becomes an approved indication for the latter products.
199. NICOTINE SAFETY AND TOXICITY (Neal L. Benowitz ed., forthcoming in Aug. 1998).
200. W.S. Choi, C.A. Patten, J.C. Gillin, R.M. Kaplan & J.P. Pierce, Cigarette Smoking Predicts Development of Depressive Symptoms Among U.S. Adolescents, 19 ANNALS BEHAVIORAL MED. 42 (1997); Naomi Breslau, Edward L. Peterson, Lonni R. Schultz, Howard D. Chilcoat & Patricia Andreski, Nicotine Dependence and Major Depression: New Evidence From a Prospective Investigation, 50 ARCHIVES GEN. PSYCHIATRY 31 (1998).
201. W.S. Choi, C.A. Patten, J.C. Gillin, R.M. Kaplan & J.P. Pierce, Cigarette Smoking Predicts Development of Depressive Symptoms Among U.S. Adolescents, 19 ANNALS BEHAVIORAL MED. 42 (1997); Naomi Breslau, Edward L. Peterson, Lonni R. Schultz, Howard D. Chilcoat & Patricia Andreski, Nicotine Dependence and Major Depression: New Evidence From a Prospective Investigation, 50 ARCHIVES GEN. PSYCHIATRY 31 (1998).
202. A.C. Parrott, Nesbitt's Paradox Resolved? Stress and Arousal Modulation During Cigarette Smoking, 93 ADDICTION 27 (1998).
203. Elizabeth B. Stuyt, Recovery Rates After Treatment for Alcohol/Drug Dependence- Tobacco Users vs. Non-Tobacco Users, 6 AM. J. ADDICTIONS 159 (1997).
204. A. Ott, L.J. Launer, K. Andersen, M. Dewey, L. Letenneur, J-F. Dartigues, P. Kragh-Sorensen, L. Amaducci, C. Brayne, A. Lobo, J-M. Martinez-Lage & A. Hofman, Smoking is a Risk Factor for Cognitive Decline in Non-Demented Elderly, presentation at the American Academy of Neurology 50th Anniversary Annual Meeting, Minneapolis, MN (Apr. 29, 1998).
205. John Slade, Smoking, Alcohol and Neuromuscular Function in Older Women, 273 JAMA 1333 (1995).
206. Theodore A. Slotkin, The Impact of Fetal Nicotine Exposure on Nervous System Development and its Role in Sudden Infant Death Syndrome (SIDS), in NICOTINE SAFETY AND TOXICITY, supra note 168, at 89-98; Theodore A. Slotkin, H.A. Navarro, E.C. McCook & F.J. Seidler, Impact of Fetal Nicotine Exposure on Development of Rat Brain Regions: Critical Sensitive Periods or Effects of Withdrawal?, 31 BRAIN RES. BULL. 319 (1993); Theodore A. Slotkin, S.E. Lappi & F.J. Seidler, Fetal Nicotine Exposure Products Postnatal Up-Regulation of Adneylate Cyclase Activity in Peripheral Tissues, 47 LIFE SCI. 1561 (1990).
207. Theodore A. Slotkin, The Impact of Fetal Nicotine Exposure on Nervous System Development and its Role in Sudden Infant Death Syndrome (SIDS), in NICOTINE SAFETY AND TOXICITY, supra note 168, at 89-98; Theodore A. Slotkin, H.A. Navarro, E.C. McCook & F.J. Seidler, Impact of Fetal Nicotine Exposure on Development of Rat Brain Regions: Critical Sensitive Periods or Effects of Withdrawal?, 31 BRAIN RES. BULL. 319 (1993); Theodore A. Slotkin, S.E. Lappi & F.J. Seidler, Fetal Nicotine Exposure Products Postnatal Up-Regulation of Adneylate Cyclase Activity in Peripheral Tissues, 47 LIFE SCI. 1561 (1990).
208. Theodore A. Slotkin, The Impact of Fetal Nicotine Exposure on Nervous System Development and its Role in Sudden Infant Death Syndrome (SIDS), in NICOTINE SAFETY AND TOXICITY, supra note 168, at 89-98; Theodore A. Slotkin, H.A. Navarro, E.C. McCook & F.J. Seidler, Impact of Fetal Nicotine Exposure on Development of Rat Brain Regions: Critical Sensitive Periods or Effects of Withdrawal?, 31 BRAIN RES. BULL. 319 (1993); Theodore A. Slotkin, S.E. Lappi & F.J. Seidler, Fetal Nicotine Exposure Products Postnatal Up-Regulation of Adneylate Cyclase Activity in Peripheral Tissues, 47 LIFE SCI. 1561 (1990).
209. Denise B. Kandel, Ping Wu & Mark Davies, Maternal Smoking During Pregnancy and Smoking by Adolescent Daughters, 84 AM. J. PUB. HEALTH 1407 (1994).
210. George J. Spilich, Smoking Appears to Impair Performance of Some Complex Tasks, 15 CLINICAL PSYCHIATRY NEWS 5 (1987); George J. Spilich, Lorraine June & Judith Renner, Cigarette Smoking and Cognitive Performance, 87 BRIT. J. ADDICTION 1313 (1992).
211. George J. Spilich, Smoking Appears to Impair Performance of Some Complex Tasks, 15 CLINICAL PSYCHIATRY NEWS 5 (1987); George J. Spilich, Lorraine June & Judith Renner, Cigarette Smoking and Cognitive Performance, 87 BRIT. J. ADDICTION 1313 (1992).
212. W.M. LONDON, E.M. WHELAN & A.G. CASE, CIGARETTES: WHAT THE WARNING LABEL DOESN'T TELL YOU: THE FIRST COMPREHENSIVE GUIDE TO THE HEALTH CONSEQUENCES OF SMOKING (1996).
213. There are two sorts of concerns here: First, are there unintended consequences such as the recruitment of new users? If so, how extensive is it? Second, does the product reduce tobacco-caused morbidity and mortality among those for whom it is intended in the first place, and to what extent? Both of these concerns pose difficult research challenges. The studies to answer these questions should be set up in advance in cooperation with FDA rather than post hoc, and their funding should be the responsibility of the manufacturers.
214. A regulatory approach to encourage PHC products from the tobacco industry would have the potential to undercut treatment developed by placing PHC products under much less restrictive regulations, because they would be sponsored by tobacco companies and they might retain substantial toxicity. Jack E. Henningfield & John Slade, Tobacco Dependence Medications: Public Health and Regulatory Issues, 53 FOOD & DRUG L.J. 75 (Supp. 1998).
215. See KOOP & KESSLER, supra note 133.
216. See Henningfield & Slade, supra note 179.
217. These postmarketing studies should be the responsibility of the sponsor. Dependence on other sources for this work, including the government, will lead to gaps in the conduct of the necessary studies and to unnecessary delays. Only the sponsor has both the resources and the incentive to do the work.
218. See Henningfield & Slade, supra note 179.
219. Warner et al., supra note 67.