Tobacco-dependence medications: Public health and regulatory issues

Food and Drug Law Journal

Volumn 53, Issue SUPPL., 1998, Pages 75-114

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

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

^b PINNEY ASSOCIATES   (United States)

^c ROBERT WOOD JOHNSON MEDICAL SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CONFERENCE PAPER; LAW; POLICY; PUBLIC HEALTH; SMOKING; SMOKING CESSATION; SUBSTANCE ABUSE; TOBACCO; UNITED STATES;

DRUG DELIVERY SYSTEMS; HUMANS; LEGISLATION, DRUG; NICOTINE; PUBLIC HEALTH; SMOKING CESSATION; TOBACCO USE DISORDER; UNITED STATES;

NICOTIANA TABACUM;

EID: 0031825477     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (233)

1. RICHARD PETO, ALAN D. LOPEZ, JILLIAN BOREHAM, MICHAEL THUN & CLARK HEATH JR., MORTALITY FROM SMOKING IN DEVELOPED COUNTRIES 1950-2000 (1994).
2. Id.
3. John P. Pierce & Elizabeth A. Gilpin, How Long Will Today's New Adolescent Smoker Be Addicted to Cigarettes?, 86 AM. J. PUB. HEALTH 253 (1996).
4. Gary A. Giovino, Dana M. Shelton & Michael W. Schooley, Trends in Cigarette Smoking Cessation in the United States, 2 (Supp.) TOBACCO CONTROL S3 (1993).
5. Arthur J. Garvey, Ryan E. Bliss, Jan L. Hitchcock, Jerilyn W. Heinold & Bernard Rosner, Predictors of Smoking Relapse Among Self-Quitters: A Report From the Normative Aging Study, 17 ADDICTIVE BEHAV. 367 (1992).
6. John P. Pierce, Michael C. Fiore, Thomas E. Novotny, Evridiki J. Hatziandreu & Ronald M. Davis, Trends in Cigarette Smoking in the United Stales: Projections to the Year 2000, 261 JAMA 61 (1989).
7. GALLUP ORG., SMOKERS' ATTITUDES TOWARD QUITTING (1993).
8. 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).
9. For approval of OTC marketing of nicotine gum, see OTC Nicorette Will Be Available in Retail Stores By Late Spring Following Feb. 9 Approval, F-D-C REP. ("The Tan Sheet"), Feb. 12, 1996, at 4. For approval of OTC marketing for the two nicotine transdermal packages, see SmithKline Beecham's NicoDerm CQ Will Be the Second Transdermal Patch on the Market, F-D-C REP. ("The Tan Sheet"), Aug. 5, 1996, at 1.
10. For approval of OTC marketing of nicotine gum, see OTC Nicorette Will Be Available in Retail Stores By Late Spring Following Feb. 9 Approval, F-D-C REP. ("The Tan Sheet"), Feb. 12, 1996, at 4. For approval of OTC marketing for the two nicotine transdermal packages, see SmithKline Beecham's NicoDerm CQ Will Be the Second Transdermal Patch on the Market, F-D-C REP. ("The Tan Sheet"), Aug. 5, 1996, at 1.
11. Nancy A. Rigotti, Joseph R. Di Franza, Yuchiao Chang, Thelma Tisdale, Becky Kemp & Daniel E. Singer, The Effect of Enforcing Tobacco Sales Laws on Adolescents' Access to Tobacco and Smoking Behavior, 337 NEW ENG. J. MED. 1044 (1997); Eugene M. Lewit, Andrew Hyland, Nancy Kerrebrock, K. Michael Cummings, Price, Public Policy, and Smoking in Young People, 6 (Supp. 2) TOBACCO CONTROL S17 (1997).
12. Nancy A. Rigotti, Joseph R. Di Franza, Yuchiao Chang, Thelma Tisdale, Becky Kemp & Daniel E. Singer, The Effect of Enforcing Tobacco Sales Laws on Adolescents' Access to Tobacco and Smoking Behavior, 337 NEW ENG. J. MED. 1044 (1997); Eugene M. Lewit, Andrew Hyland, Nancy Kerrebrock, K. Michael Cummings, Price, Public Policy, and Smoking in Young People, 6 (Supp. 2) TOBACCO CONTROL S17 (1997).
13. Steven L. Burton, Katherine E. Kemper, Thomas A. Baxter, Saul Shiffman, Joe Gitchell & Cynthia Currence, Impact of Promotion of the Great American Smokeout and Availability of Over-the-Counter Nicotine Medications, 1996, 46 MORBIDITY & MORTALITY WKLY. REP. 867 (1997); Saul Shiffman, Joe Gitchell, John M. Pinney, Steven L. Burton, Katherine E. Kemper & Eduardo A. Lara, Public Health Benefit of Over-the-Counter Nicotine Medications, 6 TOBACCO CONTROL 306 (1997).
14. Steven L. Burton, Katherine E. Kemper, Thomas A. Baxter, Saul Shiffman, Joe Gitchell & Cynthia Currence, Impact of Promotion of the Great American Smokeout and Availability of Over-the-Counter Nicotine Medications, 1996, 46 MORBIDITY & MORTALITY WKLY. REP. 867 (1997); Saul Shiffman, Joe Gitchell, John M. Pinney, Steven L. Burton, Katherine E. Kemper & Eduardo A. Lara, Public Health Benefit of Over-the-Counter Nicotine Medications, 6 TOBACCO CONTROL 306 (1997).
15. As concluded by the Roundtable of the United Nations Conference on Trade and Development in September 1997, "[e]xisting nicotine regulation aggravates the tobacco epidemic. It favours the most deadly nicotine delivery devices (cigarettes) and places the greatest constraints in the way of the least harmful products (pharmaceutical nicotine products). This has given a huge marketing advantage to the deadliest products, thereby expanding the tobacco epidemic." SOCIAL AND ECONOMIC ASPECTS OF REDUCTION OF TOBACCO SMOKING BY USE OF ALTERNATIVE NICOTINE DELIVERY SYSTEMS: SUMMARY REPORT OF A ROUNDTABLE ORGANISED BY THE UN 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, SEPTEMBER 22-24, 1997 at 18 (1998) [hereinafter UN ROUNDTABLE REPORT].
16. See Joseph A. Page, Federal Regulation of Tobacco Products and Products that Treat Tobacco Dependence: Are the Playing Fields Level?, 53 FOOD & DRUG L.J. 11 (Supp. 1998).
17. John Slade, Lisa A. Bero, Peter Hanauer, Deborah E. Barnes & Stanton A. Glantz, Nicotine and Addiction: The Brown and Williamson Documents, 274 JAMA 225 (1995). An additional store of previously withheld tobacco industry documents has been posted by Minnesota Attorney General's Office, Blue Cross Tobacco - Tobacco Litigation (visited May 21, 1998) 〈http://www.mnbluecrosstobacco.com/toblit/trialnews/docs/〉 and U.S. Congress, Committee on Commerce Tobacco Documents (visited May 21, 1998) 〈http:// www.house.gov/commerce/TobaccoDocs/documents.html〉 on the Internet.
18. John Slade, Lisa A. Bero, Peter Hanauer, Deborah E. Barnes & Stanton A. Glantz, Nicotine and Addiction: The Brown and Williamson Documents, 274 JAMA 225 (1995). An additional store of previously withheld tobacco industry documents has been posted by Minnesota Attorney General's Office, Blue Cross Tobacco - Tobacco Litigation (visited May 21, 1998) 〈http://www.mnbluecrosstobacco.com/toblit/trialnews/docs/〉 and U.S. Congress, Committee on Commerce Tobacco Documents (visited May 21, 1998) 〈http:// www.house.gov/commerce/TobaccoDocs/documents.html〉 on the Internet.
19. John Slade, Lisa A. Bero, Peter Hanauer, Deborah E. Barnes & Stanton A. Glantz, Nicotine and Addiction: The Brown and Williamson Documents, 274 JAMA 225 (1995). An additional store of previously withheld tobacco industry documents has been posted by Minnesota Attorney General's Office, Blue Cross Tobacco - Tobacco Litigation (visited May 21, 1998) 〈http://www.mnbluecrosstobacco.com/toblit/trialnews/docs/〉 and U.S. Congress, Committee on Commerce Tobacco Documents (visited May 21, 1998) 〈http:// www.house.gov/commerce/TobaccoDocs/documents.html〉 on the Internet.
20. For a discussion of issues related to tobacco products, see John Slade & Jack E. Henningfield, Tobacco Product Regulation: Context and Issues, 53 FOOD & DRUG L.J. 43 (Supp. 1998).
21. J. Michael McGinnis & William H. Foege, Actual Causes of Death in the United States, 270 JAMA 2207 (1993); Richard Peto, Alan Lopez, Jillian Boreham, Michael Thun & Clark Heath Jr., Health Effects of Tobacco Use: Global Estimates and Projections, in TOBACCO AND HEALTH (Karen Slama ed. 1995).
22. J. Michael McGinnis & William H. Foege, Actual Causes of Death in the United States, 270 JAMA 2207 (1993); Richard Peto, Alan Lopez, Jillian Boreham, Michael Thun & Clark Heath Jr., Health Effects of Tobacco Use: Global Estimates and Projections, in TOBACCO AND HEALTH (Karen Slama ed. 1995).
23. Peto et al., supra note 17.
24. U.S. DEP'T OF HEALTH AND HUMAN SERVS., AGENCY FOR HEALTH CARE POLICY AND RESEARCH, CLINICAL PRACTICE GUIDELINE NUMBER 18: SMOKING CESSATION (1996) (AHCPR Publication No. 96-0692); Richard D. Hurt, David P.L. Sachs, Elbert D. Glover, Kenneth P. Offord, J. Andrew Johnston, Lowell C. Dale, Moise A. Khayrallsh, Darrell R. Schroeder, Penny N. Glover, C. Rollynn Sullivan, Ivana T. Croghan & Pamela M. Sullivan, A Comparison of Sustained-Release Bupropion and Placebo for Smoking Cessation, 337 NEW ENG. J. MED. 1195 (1997).
25. U.S. DEP'T OF HEALTH AND HUMAN SERVS., AGENCY FOR HEALTH CARE POLICY AND RESEARCH, CLINICAL PRACTICE GUIDELINE NUMBER 18: SMOKING CESSATION (1996) (AHCPR Publication No. 96-0692); Richard D. Hurt, David P.L. Sachs, Elbert D. Glover, Kenneth P. Offord, J. Andrew Johnston, Lowell C. Dale, Moise A. Khayrallsh, Darrell R. Schroeder, Penny N. Glover, C. Rollynn Sullivan, Ivana T. Croghan & Pamela M. Sullivan, A Comparison of Sustained-Release Bupropion and Placebo for Smoking Cessation, 337 NEW ENG. J. MED. 1195 (1997).
26. Sheldon Cohen, Edward Lichtenstein, James O. Prochaska, Joseph F. Rossi, Ellen R. Gritz, Clifford R. Carr, C. Tracy Orleans, Victor J. Schoenbach, Lois Biener, David Abrams, Carlo DiClemente, Susan Curry, G. Alan Marlatt, K. Michael Cummings, Seth L. Emont, Gary Giovino & Deborah Ossip-Klein, Debunking Myths About Self-Quitting: Evidence From 10 Prospective Studies of Persons Who Attempt to Quit Smoking by Themselves, 44 AM. PSYCHOLOGIST 1355 (1989).
27. Paul M. Cinciripini, David W. Wetter & Jennifer B. McClure, Scheduled Reduced Smoking: Effects on Smoking Abstinence and Potential Mechanisms of Action, 22 ADDICTIVE BEHAV. 759 (1997); Raine L. Riggs, Janine L. Pillitteri & John R. Hughes, A Comparison of Different Behavioral Strategies for Cigarette Reduction, Poster presented at Forth Annual Meeting of the Society for Research on Nicotine and Addiction, New Orleans, LA (Mar. 27-28,1998); Karl Olov Fagerström, Ronny Tejding, Ake Westin & Erik Lunell, Aiding Reduction of Smoking with Nicotine Replacement Medications: Hope for the Recalcitrant Smoker?, 6 TOBACCO CONTROL 311 (1997); H.H. Klech, Reduced Smoking - An Acceptable Goal for the Hopeless Heavy Smoker?, 11 EUR. RESPIRATORY J. 263 (1998); Carlos Jiminez-Ruiz, Michael Kunze & Karl Olov Fagerström, Nicotine Replacement: A New Approach to Reducing Tobacco-Related Harm, 11 EUR. RESPIRATORY J. 473 (1998).
28. Paul M. Cinciripini, David W. Wetter & Jennifer B. McClure, Scheduled Reduced Smoking: Effects on Smoking Abstinence and Potential Mechanisms of Action, 22 ADDICTIVE BEHAV. 759 (1997); Raine L. Riggs, Janine L. Pillitteri & John R. Hughes, A Comparison of Different Behavioral Strategies for Cigarette Reduction, Poster presented at Forth Annual Meeting of the Society for Research on Nicotine and Addiction, New Orleans, LA (Mar. 27-28,1998); Karl Olov Fagerström, Ronny Tejding, Ake Westin & Erik Lunell, Aiding Reduction of Smoking with Nicotine Replacement Medications: Hope for the Recalcitrant Smoker?, 6 TOBACCO CONTROL 311 (1997); H.H. Klech, Reduced Smoking - An Acceptable Goal for the Hopeless Heavy Smoker?, 11 EUR. RESPIRATORY J. 263 (1998); Carlos Jiminez-Ruiz, Michael Kunze & Karl Olov Fagerström, Nicotine Replacement: A New Approach to Reducing Tobacco-Related Harm, 11 EUR. RESPIRATORY J. 473 (1998).
29. Paul M. Cinciripini, David W. Wetter & Jennifer B. McClure, Scheduled Reduced Smoking: Effects on Smoking Abstinence and Potential Mechanisms of Action, 22 ADDICTIVE BEHAV. 759 (1997); Raine L. Riggs, Janine L. Pillitteri & John R. Hughes, A Comparison of Different Behavioral Strategies for Cigarette Reduction, Poster presented at Forth Annual Meeting of the Society for Research on Nicotine and Addiction, New Orleans, LA (Mar. 27-28,1998); Karl Olov Fagerström, Ronny Tejding, Ake Westin & Erik Lunell, Aiding Reduction of Smoking with Nicotine Replacement Medications: Hope for the Recalcitrant Smoker?, 6 TOBACCO CONTROL 311 (1997); H.H. Klech, Reduced Smoking - An Acceptable Goal for the Hopeless Heavy Smoker?, 11 EUR. RESPIRATORY J. 263 (1998); Carlos Jiminez-Ruiz, Michael Kunze & Karl Olov Fagerström, Nicotine Replacement: A New Approach to Reducing Tobacco-Related Harm, 11 EUR. RESPIRATORY J. 473 (1998).
30. Paul M. Cinciripini, David W. Wetter & Jennifer B. McClure, Scheduled Reduced Smoking: Effects on Smoking Abstinence and Potential Mechanisms of Action, 22 ADDICTIVE BEHAV. 759 (1997); Raine L. Riggs, Janine L. Pillitteri & John R. Hughes, A Comparison of Different Behavioral Strategies for Cigarette Reduction, Poster presented at Forth Annual Meeting of the Society for Research on Nicotine and Addiction, New Orleans, LA (Mar. 27-28,1998); Karl Olov Fagerström, Ronny Tejding, Ake Westin & Erik Lunell, Aiding Reduction of Smoking with Nicotine Replacement Medications: Hope for the Recalcitrant Smoker?, 6 TOBACCO CONTROL 311 (1997); H.H. Klech, Reduced Smoking - An Acceptable Goal for the Hopeless Heavy Smoker?, 11 EUR. RESPIRATORY J. 263 (1998); Carlos Jiminez-Ruiz, Michael Kunze & Karl Olov Fagerström, Nicotine Replacement: A New Approach to Reducing Tobacco-Related Harm, 11 EUR. RESPIRATORY J. 473 (1998).
31. Paul M. Cinciripini, David W. Wetter & Jennifer B. McClure, Scheduled Reduced Smoking: Effects on Smoking Abstinence and Potential Mechanisms of Action, 22 ADDICTIVE BEHAV. 759 (1997); Raine L. Riggs, Janine L. Pillitteri & John R. Hughes, A Comparison of Different Behavioral Strategies for Cigarette Reduction, Poster presented at Forth Annual Meeting of the Society for Research on Nicotine and Addiction, New Orleans, LA (Mar. 27-28,1998); Karl Olov Fagerström, Ronny Tejding, Ake Westin & Erik Lunell, Aiding Reduction of Smoking with Nicotine Replacement Medications: Hope for the Recalcitrant Smoker?, 6 TOBACCO CONTROL 311 (1997); H.H. Klech, Reduced Smoking - An Acceptable Goal for the Hopeless Heavy Smoker?, 11 EUR. RESPIRATORY J. 263 (1998); Carlos Jiminez-Ruiz, Michael Kunze & Karl Olov Fagerström, Nicotine Replacement: A New Approach to Reducing Tobacco-Related Harm, 11 EUR. RESPIRATORY J. 473 (1998).
32. U.S. DEP'T OF HEALTH AND HUMAN SERVS., THE HEALTH BENEFITS OF SMOKING CESSATION: A REPORT OF THE SURGEON GENERAL (1990).
33. Id.
34. NATIONAL INST. OF HEALTH, NATIONAL CANCER INST., CHANCES IN CIGARETTE-RELATED DISEASE RISKS AND THEIR IMPLICATION FOR PREVENTION AND CONTROL (Smoking and Tobacco Control Monograph 8) (1997).
35. Id.; N.J. Wald & H.C. Watt, Prospective Study of Effect of Switching from Cigarettes to Pipes or Cigars on Mortality from Three Smoking Related Disease, 314 BRITISH MED. J. 1860 (1997).
36. Peto et al., supra note 17.
37. UN ROUNDTABLE REPORT, supra note 12, at 18.
38. David M. Burns, Estimating the Benefits of a Risk Reduction Strategy, Poster Session at the Third Annual Conference of the Society for Research on Nicotine and Tobacco, Nashville, TN (June 13-14, 1997).
39. Saul Shiffman, Kelly M. Mason & Jack E. Henningfield, Tobacco Dependence Treatments: Review and Prospectus, 19 ANN. REV. PUB. HEALTH 335 (1998).
40. Burns, supra note 28.
41. Jack E. Henningfield, Leslie M. Schuh & Murray E. Jarvik, Pathophysiology of Tobacco Dependence, in FLOYD E. BLOOM & DAVID J. KUPFER, PSYCHOPHARMACOLOGY: THE FOURTH GENERATION OF PROGRESS 1715 (1995); S. REP. No. 105-185, pt. 4 (1998) (Alan I. Leshner, testimony to the Senate Labor and Human Resources Committee); Jack E. Henningfield, Nicotine Medications for Smoking Cessation, 333 NEW ENG. J. MED. 1196 (1995); Alan I. Leshner, Addiction Is a Brain Disease, and It Matters, 278 Sci. 45 (1997).
42. Jack E. Henningfield, Leslie M. Schuh & Murray E. Jarvik, Pathophysiology of Tobacco Dependence, in FLOYD E. BLOOM & DAVID J. KUPFER, PSYCHOPHARMACOLOGY: THE FOURTH GENERATION OF PROGRESS 1715 (1995); S. REP. No. 105-185, pt. 4 (1998) (Alan I. Leshner, testimony to the Senate Labor and Human Resources Committee); Jack E. Henningfield, Nicotine Medications for Smoking Cessation, 333 NEW ENG. J. MED. 1196 (1995); Alan I. Leshner, Addiction Is a Brain Disease, and It Matters, 278 Sci. 45 (1997).
43. Jack E. Henningfield, Leslie M. Schuh & Murray E. Jarvik, Pathophysiology of Tobacco Dependence, in FLOYD E. BLOOM & DAVID J. KUPFER, PSYCHOPHARMACOLOGY: THE FOURTH GENERATION OF PROGRESS 1715 (1995); S. REP. No. 105-185, pt. 4 (1998) (Alan I. Leshner, testimony to the Senate Labor and Human Resources Committee); Jack E. Henningfield, Nicotine Medications for Smoking Cessation, 333 NEW ENG. J. MED. 1196 (1995); Alan I. Leshner, Addiction Is a Brain Disease, and It Matters, 278 Sci. 45 (1997).
44. Jack E. Henningfield, Leslie M. Schuh & Murray E. Jarvik, Pathophysiology of Tobacco Dependence, in FLOYD E. BLOOM & DAVID J. KUPFER, PSYCHOPHARMACOLOGY: THE FOURTH GENERATION OF PROGRESS 1715 (1995); S. REP. No. 105-185, pt. 4 (1998) (Alan I. Leshner, testimony to the Senate Labor and Human Resources Committee); Jack E. Henningfield, Nicotine Medications for Smoking Cessation, 333 NEW ENG. J. MED. 1196 (1995); Alan I. Leshner, Addiction Is a Brain Disease, and It Matters, 278 Sci. 45 (1997).
45. Moyers on Addiction: Close to Home (PBS television series Mar. 29, 1998) (statement of Alan I. Lescher).
46. Jack E. Henningfield, Side Effects of Nicotine Dependence, 85 N.J. MED. 108 (1988).
47. Charles P. O'Brien, Drug Addiction and Abuse, in GOODMAN & GILMAN'S THE PHARMACOLOGICAL BASIS OF THERAPEUTICS 557 (Joel G. Hardman & Lee E. Limbird eds., 9th ed 1995).
48. Shiffman et al., supra note 29.
49. John Slade, Nicotine Delivery Devices, in NICOTINE ADDICTION: PRINCIPLES AND MANAGEMENT 3 (C. Tracy Orleans & John Slade eds. 1993).
50. U.S. DEP'T OF HEALTH AND HUMAN SERVS., THE HEALTH CONSEQUENCES OF SMOKING, NICOTINE ADDICTION: A REPORT OF THE SURGEON GENERAL (1988); David A. Kessler, Ann M. Witt, Philip S. Barnett, Mitchell R. Zeller, Sharon L. Natanblut, Judith P. Wilkenfeld, Catherine C. Lorraine, Larry J. Thompson & William B. Schultz, The Food and Drug Administration's Regulation of Tobacco Products, 335 NEW ENG. J. MED. 988 (1996).
51. U.S. DEP'T OF HEALTH AND HUMAN SERVS., THE HEALTH CONSEQUENCES OF SMOKING, NICOTINE ADDICTION: A REPORT OF THE SURGEON GENERAL (1988); David A. Kessler, Ann M. Witt, Philip S. Barnett, Mitchell R. Zeller, Sharon L. Natanblut, Judith P. Wilkenfeld, Catherine C. Lorraine, Larry J. Thompson & William B. Schultz, The Food and Drug Administration's Regulation of Tobacco Products, 335 NEW ENG. J. MED. 988 (1996).
52. Henningfield et al., Pathophysiology of Tobacco Dependence, supra note 31.
53. Scott L. Tomar & Jack E. Henningfield, Review of the Evidence that pH is a Determinant of Nicotine Dosage From Oral Use of Smokeless Tobacco, 6 TOBACCO CONTROL 219 (1997); 61 Fed. Reg. 44,396; Kessler et al., supra note 37.
54. Scott L. Tomar & Jack E. Henningfield, Review of the Evidence that pH is a Determinant of Nicotine Dosage From Oral Use of Smokeless Tobacco, 6 TOBACCO CONTROL 219 (1997); 61 Fed. Reg. 44,396; Kessler et al., supra note 37.
55. American Psychiatric Ass'n, American Psychiatric Association Practice Guidelines: Practice Guideline for the Treatment of Patients With Nicotine Dependence, 153 (Supp.) AM. J. PSYCHIATRY 1 (1996).
56. NEW DEVELOPMENTS IN NICOTINE DELIVERY SYSTEMS: PROCEEDINGS OF A CONFERENCE, JOHNS HOPKINS UNIVERSITY, SEPTEMBER 24, 1990 (Jack E. Henningfield & Maxine L. Stitzer eds. 1991).
57. Suein L. Hwang & Alix M. Freedman, B.A.T. Considered Patches But Stuck to Making Cigarettes: Documents Detail a Company Well Aware of the Allure of Nicotine to Smokers, WALL ST. J., Oct. 9, 1995, at B3.
58. STANTON A. GLANTZ, JOHN SLADE, LISA A. BERO, PETER HANAUER & DEBORAH E. BARNES, THE CIGARETTE PAPERS 93 (1996). This conclusion, however, is based on an interpretation of the memo by the authors of this article.
59. Henningfield, Nicotine Medications, supra note 31; Henningfield et al., Pathophysiology of Tobacco Dependence, supra note 31.
60. Henningfield, Nicotine Medications, supra note 31; Henningfield et al., Pathophysiology of Tobacco Dependence, supra note 31.
61. 61 Fed. Reg. 44,396; U.S. DEP'T OF HEALTH AND HUMAN SERVS., supra note 37.
62. AMERICAN PSYCHIATRIC ASS'N, DSM-IV: DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS 176 (4th ed. 1994).
63. Id. at 245.
64. Shiffman et al., supra note 29.
65. Kenneth E. Warner, John Slade & David T. Sweanor, The Emerging Market for Long-Term Nicotine Maintenance, 278 JAMA 1087 (1997); Jimenez-Ruiz et al., supra note 21; Shiffman et al., supra note 29.
66. In OUT OF SIGHT (Universal Pictures 1998), for example, the female protagonist, Karen Sisco (played by Jennifer Lopez) uses nicotine gum to help her quit smoking. Also in 1998, for example, several episodes of the popular prime time television program E.R. (NBC television broadcasts 1998) included a storyline in which one of the main characters, Dr. Mark Greene (played by Anthony Edwards), used the gum and later the patch in an attempt to quit smoking.
67. For an example of the nicotine patch being the subject of a cartoon in the popular press, see Do you have these in menthol?, cartoon by Victoria Roberts, THE NEW YORKER, Mar. 16, 1998, at 76.
68. See FDA Panel Defers Decision on Nicotine Patch Alerts, WALL ST. J., July 15, 1992, at B4; Suien L. Hwang & Michael Waldhoz, Heart Attacks Reported in Patch Users Still Smoking, WALL ST. J., June 10, 1992.
69. See FDA Panel Defers Decision on Nicotine Patch Alerts, WALL ST. J., July 15, 1992, at B4; Suien L. Hwang & Michael Waldhoz, Heart Attacks Reported in Patch Users Still Smoking, WALL ST. J., June 10, 1992.
70. John Schwartz, Anti-Smoking Measures Avenged: Philip Morris Fought Dow on Nicorette Gum "Propaganda," Documents Show, WASH. POST, Mar. 5, 1998, at A6.
71. Burton et al., supra note 11; Shiffman et al., supra note 11.
72. Henningfield et al., Pathophysiology of Tobacco Dependence, supra note 31.
73. Henningfield, Nicotine Medications, supra note 31; Kenneth E. Warner, Financial Implications, 4 (Supp. 2) TOBACCO CONTROL S52 (1995).
74. Henningfield, Nicotine Medications, supra note 31; Kenneth E. Warner, Financial Implications, 4 (Supp. 2) TOBACCO CONTROL S52 (1995).
75. Henningfield, Nicotine Medications, supra note 31; Kenneth E. Warner, Financial Implications, supra note 56.
76. Henningfield, Nicotine Medications, supra note 31; Kenneth E. Warner, Financial Implications, supra note 56.
77. Henningfield, Nicotine Medications, supra note 31.
78. Id.
79. Id.
80. This table is original, but contains information from: Henningfield, Nicotine Medications, supra note 31; AMERICAN PSYCHIATRIC ASS'N, PRACTICE GUIDELINE FOR THE TREATMENT OF PATIENTS WITH NICOTINE DEPENDENCE (Oct. 1996); U.S. DEP'T OF HEALTH AND HUMAN SERVS., PUB. HEALTH SERV., AGENCY FOR HEALTH CARE POLICY AND RESEARCH, CENTERS FOR DISEASE CONTROL AND PREVENTION, CLINICAL PRACTICE GUIDELINE NUMBER 18: SMOKING CESSATION (AHCPR Pub. No. 96-0692) (Apr. 1996) .
81. This table is original, but contains information from: Henningfield, Nicotine Medications, supra note 31; AMERICAN PSYCHIATRIC ASS'N, PRACTICE GUIDELINE FOR THE TREATMENT OF PATIENTS WITH NICOTINE DEPENDENCE (Oct. 1996); U.S. DEP'T OF HEALTH AND HUMAN SERVS., PUB. HEALTH SERV., AGENCY FOR HEALTH CARE POLICY AND RESEARCH, CENTERS FOR DISEASE CONTROL AND PREVENTION, CLINICAL PRACTICE GUIDELINE NUMBER 18: SMOKING CESSATION (AHCPR Pub. No. 96-0692) (Apr. 1996) .
82. This table is original, but contains information from: Henningfield, Nicotine Medications, supra note 31; AMERICAN PSYCHIATRIC ASS'N, PRACTICE GUIDELINE FOR THE TREATMENT OF PATIENTS WITH NICOTINE DEPENDENCE (Oct. 1996); U.S. DEP'T OF HEALTH AND HUMAN SERVS., PUB. HEALTH SERV., AGENCY FOR HEALTH CARE POLICY AND RESEARCH, CENTERS FOR DISEASE CONTROL AND PREVENTION, CLINICAL PRACTICE GUIDELINE NUMBER 18: SMOKING CESSATION (AHCPR Pub. No. 96-0692) (Apr. 1996) .
83. Ove Ferno, The Development of a Chewing Gum Containing Nicotine and Some Comments on the Role Played by Nicotine in the Smoking Habit, in U.S. DEP'T OF HEALTH, EDUCATION, AND WELFARE, SMOKING AND HEALTH II: HEALTH CONSEQUENCES, EDUCATION, CESSATION ACTIVITIES, AND GOVERNMENTAL ACTION (DHEW Pub. No. NIH-77-1413) (1977).
84. Henningfield, Nicotine Medications, supra note 31.
85. Id.
86. Id.
87. See supra note 9.
88. Saul Shiffman, Joe G. Gitchell & Victor Stretcher, Real-World Efficacy of Computer-Tailored Smoking Cessation Material as a Supplement to Nicotine Replacement, paper presented at the Tenth World Conference on Tobacco or Health, Beijing, China (Aug. 24-28, 1997).
89. Burton et al., supra note 11; Shiffman et al., supra note 11 (summarizing the medical and public health implications of OTC nicotine gum and patch).
90. Nina G. Schneider, Richard Olmstead, Freny Vaghaiwalla Mody, Kim Doan, Mikael Franzon, Murray E. Jarvik & Craig Steinberg, Efficacy of a Nicotine Nasal Spray in Smoking Cessation: A Placebo-Controlled, Double-Blind Trial, 90 ADDICTION 1671 (1995); Henningfield, Nicotine Medications, supra note 31.
91. Nina G. Schneider, Richard Olmstead, Freny Vaghaiwalla Mody, Kim Doan, Mikael Franzon, Murray E. Jarvik & Craig Steinberg, Efficacy of a Nicotine Nasal Spray in Smoking Cessation: A Placebo-Controlled, Double-Blind Trial, 90 ADDICTION 1671 (1995); Henningfield, Nicotine Medications, supra note 31.
92. Steven G. Gourlay & Neal L. Benowitz, Arteriovenous Differences in Plasma Concentration of Nicotine and Catecholamines and Related Cardiovascular Effects After Smoking, Nicotine Nasal Spray, and Intravenous Nicotine, 62 CLINICAL PHARMACOLOGY & THERAPEUTICS 453 (1997).
93. Kory J. Schuh, Leslie M. Schuh, Jack E. Henningfield & Maxine L. Stitzer, Nicotine Nasal Spray and Vapor Inhaler: Abuse Liability Assessment, 130 PSYCHOPHARMACOLOGY 352 (1997).
94. Erik Lunell, L. Molander & S.B. Andersson, Temperature Dependency of the Release and Bioavailability of Nicotine From a Nicotine Vapor Inhaler; In Vitro/In Vivo Correlation, 52 EUR. J. CLINICAL PHARMACOLOGY 495 (1997).
95. Erik Lunell, Mats Berstrom, Gunnar Antoni, Bengt Langstrom & Agneta Nordberg, Nicotine Deposition and Body Distribution From a Nicotine Inhaler and a Cigarette Studied With Positron Emission Topography, 59 CLINICAL PHARMACOLOGY & THERAPEUTICS 593 (1996).
96. Schuh et al., supra note 71.
97. See supra note 61 and accompanying table.
98. Ross J. Baldessarini, Drugs and the Treatment of Psychiatric Disorders: Depression and Mania, in GOODMAN & GILMAN'S THE PHARMACOLOGICAL BASIS OF THERAPEUTICS 431 (Joel G. Hardman & Lee E. Limbard eds., 9th ed. 1996).
99. Hurt et al., supra note 19.
100. American Psychiatric Ass'n, supra note 40; U.S. DEP'T OF HEALTH AND HUMAN SERVS., supra note 19; Henningfield et al., supra note 61.
101. GumTech International, No Smoking Allowed!, CONTINENTAL AIRLINES (in-flight magazine), Oct. 1997 (print advertisement). CigArrest was a lobeline-containing OTC medication marketed until 1993, when FDA removed it from the market because it had not been proved effective. A subsequent clinical trial also found lobeline lacking in efficacy. Elbert D. Glover, Scott J. Leischow, Steven I. Rennard, Penny N. Glover, David Daughton, John N. Quiring, F. Howard Schneider & Peter J. Mione, A Smoking Cessation Trial With Lobeline Sulfate: A Pilot Study, 22 AM. J. HEALTH BEHAV. 62 (1998). The product was reformulated with trace amounts of lobeline's parent substance, lobelia, and without providing evidence of efficacy, relaunched in 1997 as a homeopathic remedy and advertised for smoking cessation, reduction, and other applications. See generally Page, supranote 13 (summarizing the complexities of regulating these products).
102. GumTech International, No Smoking Allowed!, CONTINENTAL AIRLINES (in-flight magazine), Oct. 1997 (print advertisement). CigArrest was a lobeline-containing OTC medication marketed until 1993, when FDA removed it from the market because it had not been proved effective. A subsequent clinical trial also found lobeline lacking in efficacy. Elbert D. Glover, Scott J. Leischow, Steven I. Rennard, Penny N. Glover, David Daughton, John N. Quiring, F. Howard Schneider & Peter J. Mione, A Smoking Cessation Trial With Lobeline Sulfate: A Pilot Study, 22 AM. J. HEALTH BEHAV. 62 (1998). The product was reformulated with trace amounts of lobeline's parent substance, lobelia, and without providing evidence of efficacy, relaunched in 1997 as a homeopathic remedy and advertised for smoking cessation, reduction, and other applications. See generally Page, supranote 13 (summarizing the complexities of regulating these products).
103. New Citrol Oral Spray for Smokers: An Important Dietary Supplement and Smoking Alternative Is Introduced, MGA Development Corp., Press Release (Nov. 17, 1997).
104. Jack E. Henningfield, Role of Nicotine in Tobacco Use: Treatment Implications, in NEW DEVELOPMENTS IN NICOTINE-DELIVERY SYSTEMS, supra note 41, at 23-33; Charles W. Gorodetzky, Product Implications, 4 (Supp. 2) TOBACCO CONTROL S57 (1995).
105. Jack E. Henningfield, Role of Nicotine in Tobacco Use: Treatment Implications, in NEW DEVELOPMENTS IN NICOTINE-DELIVERY SYSTEMS, supra note 41, at 23-33; Charles W. Gorodetzky, Product Implications, 4 (Supp. 2) TOBACCO CONTROL S57 (1995).
106. In addition, it is equally plausible that much progress could be made with greater research on behavioral treatments, as has been discussed elsewhere. See Shiffman et al., supra note 29; CENTER FOR THE ADVANCEMENT OF HEALTH, TREATING TOBACCO DEPENDENCE IN THE U.S.: AD HOC GROUP FINDINGS AND RECOMMENDATIONS (1998).
107. See, e.g., Selected Excerpts from Conference Proceedings, 53 FOOD AND DRUG L.J. 115, 126 (SUPP. 1998) (comments of Jed Rose).
108. Food and Drug Admin., Drug Abuse Advisory Committee Meeting (Aug. 2, 1994).
109. Pub. L. No. 91-513, 84 Stat. 1236 (1970) (codified at 21 U.S.C. §§ 801 et seq. (1994)) The CSA provides for substantial restrictions on the prescribing, marketing, advertising, transport and use of drugs with a documented liability to cause abuse or dependence. Drug manufacturers know that regulating a drug as a controlled substance imposes a substantial obstacle to both inappropriate and appropriate use by patients in need because of certain limitations. These limits include extra documentation requirements placed on prescribing physicians, and the additional concern about the drug held by consumers. There are several levels of what is commonly termed "scheduling of psychoactive substance of abuse," ranging from the least-restrictive Schedule V (e.g., certain codeine-containing cough syrup formulations) to the most-restrictive Schedule I drugs, which are highly addictive and have no approved medical use (e.g., heroin). Anxiolytics and sedatives are generally Schedule IV or III, and highly abusable opioid-based pain medications and amphetamine-like stimulants are Schedule II. See Frank J. Vocci, Jr., The Necessity and Utility of Abuse Liability Evaluations in Human Subjects: The FDA Perspective, in TESTING FOR ABUSE LIABILITY OF DRUGS IN HUMANS 7 (Nat'l Inst. of Drug Abuse Research Monograph 92) (Marian W. Fishman & Nancy K. Mello eds. 1989); Howard McClain, Jr. & Frank Sapienza, The Role of Abuse Liability Testing in Drug Control Procedures, in TESTING FOR ABUSE LIABILITY OF DRUGS IN HUMANS, supra, at 21.
110. Pub. L. No. 91-513, 84 Stat. 1236 (1970) (codified at 21 U.S.C. §§ 801 et seq. (1994)) The CSA provides for substantial restrictions on the prescribing, marketing, advertising, transport and use of drugs with a documented liability to cause abuse or dependence. Drug manufacturers know that regulating a drug as a controlled substance imposes a substantial obstacle to both inappropriate and appropriate use by patients in need because of certain limitations. These limits include extra documentation requirements placed on prescribing physicians, and the additional concern about the drug held by consumers. There are several levels of what is commonly termed "scheduling of psychoactive substance of abuse," ranging from the least-restrictive Schedule V (e.g., certain codeine-containing cough syrup formulations) to the most-restrictive Schedule I drugs, which are highly addictive and have no approved medical use (e.g., heroin). Anxiolytics and sedatives are generally Schedule IV or III, and highly abusable opioid-based pain medications and amphetamine-like stimulants are Schedule II. See Frank J. Vocci, Jr., The Necessity and Utility of Abuse Liability Evaluations in Human Subjects: The FDA Perspective, in TESTING FOR ABUSE LIABILITY OF DRUGS IN HUMANS 7 (Nat'l Inst. of Drug Abuse Research Monograph 92) (Marian W. Fishman & Nancy K. Mello eds. 1989); Howard McClain, Jr. & Frank Sapienza, The Role of Abuse Liability Testing in Drug Control Procedures, in TESTING FOR ABUSE LIABILITY OF DRUGS IN HUMANS, supra, at 21.
111. See 21 U.S.C. § 802(6).
112. Food and Drug Administration, Center for Drug Evaluation and Research, Drug Abuse Advisory Committee Meeting No. 27, Abuse Liability of Nicotine Nasal Spray 150-60 (Aug. 1, 1994) (testimony of Michael Klein, Ph.D.).
113. U.S. Dep't of Health and Human Servs., Food and Drug Admin., Regulations Requiring Manufacturer to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients; Proposed Rule, 62 Fed. Reg. 43,899 (Aug. 15, 1997). See also COLLEGE ON PROBLEMS OF DRUG DEPENDENCE, COMMENT ON PROPOSED PEDIATRIC RULE REQUIRING MANUFACTURERS TO ASSESS THE SAFETY AND EFFECTIVENESS OF NEW DRUGS AND BIOLOGICAL PRODUCTS IN PEDIATRIC PATIENTS (1998).
114. U.S. Dep't of Health and Human Servs., Food and Drug Admin., Regulations Requiring Manufacturer to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients; Proposed Rule, 62 Fed. Reg. 43,899 (Aug. 15, 1997). See also COLLEGE ON PROBLEMS OF DRUG DEPENDENCE, COMMENT ON PROPOSED PEDIATRIC RULE REQUIRING MANUFACTURERS TO ASSESS THE SAFETY AND EFFECTIVENESS OF NEW DRUGS AND BIOLOGICAL PRODUCTS IN PEDIATRIC PATIENTS (1998).
115. JACK E. HENNINGFIELD, NEAL BENOWITZ & JOHN SLADE, REPORT TO THE AMERICAN MEDICAL ASSOCIATION: REDUCING ILLNESS AND DEATH CAUSED BY CIGARETTES BY REDUCING THEIR NICOTINE CONTENT (1997).
116. Warner et al., supra note 49.
117. Id. at 1091.
118. Id.
119. NICOTINE ADDICTION, supra note 36, at 18; Suein Hwang & Alix Freedman, Smokers May Mistake "Clean" Cigarettes for Safe, WALL ST. J., Apr. 30, 1996, at B1; R.J. REYNOLDS TOBACCO COMPANY, CHEMICAL AND BIOLOGICAL STUDIES: NEW CIGARETTE PROTOTYPES THAT HEAT INSTEAD OF BURN TOBACCO (monograph) (1988).
120. NICOTINE ADDICTION, supra note 36, at 18; Suein Hwang & Alix Freedman, Smokers May Mistake "Clean" Cigarettes for Safe, WALL ST. J., Apr. 30, 1996, at B1; R.J. REYNOLDS TOBACCO COMPANY, CHEMICAL AND BIOLOGICAL STUDIES: NEW CIGARETTE PROTOTYPES THAT HEAT INSTEAD OF BURN TOBACCO (monograph) (1988).
121. NICOTINE ADDICTION, supra note 36, at 18; Suein Hwang & Alix Freedman, Smokers May Mistake "Clean" Cigarettes for Safe, WALL ST. J., Apr. 30, 1996, at B1; R.J. REYNOLDS TOBACCO COMPANY, CHEMICAL AND BIOLOGICAL STUDIES: NEW CIGARETTE PROTOTYPES THAT HEAT INSTEAD OF BURN TOBACCO (monograph) (1988).
122. The Institute of Medicine recently conducted three extensive reviews of the importance of biomedical research to provide the foundation for treatment development for drug dependence disorders. These reviews provide a wealth of observations that should be considered in ensuring that treatment development can advance as expeditiously as possible. COMMITTEE TO STUDY MEDICATION DEV. AND RESEARCH, NAT'L INST. OF DRUG ABUSE, DIV. OF BEHAVIORAL SCIENCES AND MENTAL DISORDERS, INST. OF MED., THE DEVELOPMENT OF MEDICATIONS FOR THE TREATMENT OF OPIATE AND COCAINE ADDICTIONS: ISSUES FOR THE GOVERNMENT AND PRIVATE SECTOR (Carolyn E. Fulco, Catharyn T. Liverman & Laurence E. Early eds. 1995); COMMITTEE ON OPPORTUNITIES IN DRUG ABUSE RESEARCH, DIV. OF NEUROSCIENCE AND BEHAVIORAL HEALTH, INST. OF MED., PATHWAYS OF ADDICTION: OPPORTUNITIES IN DRUG ABUSE RESEARCH (1996); COMMITTEE TO IDENTIFY STRATEGIES TO RAISE THE PROFILE OF SUBSTANCE ABUSE AND ALCOHOLISM RESEARCH, DIV. OF NEUROSCIENCE AND BEHAVIORAL HEALTH, DIV. OF HEALTH PROMOTION AND DISEASE PREVENTION, INST. OF MED., DISPELLING THE MYTHS ABOUT ADDICTION: STRATEGIES TO INCREASE UNDERSTANDING AND STRENGTHEN RESEARCH (1997).
123. The Institute of Medicine recently conducted three extensive reviews of the importance of biomedical research to provide the foundation for treatment development for drug dependence disorders. These reviews provide a wealth of observations that should be considered in ensuring that treatment development can advance as expeditiously as possible. COMMITTEE TO STUDY MEDICATION DEV. AND RESEARCH, NAT'L INST. OF DRUG ABUSE, DIV. OF BEHAVIORAL SCIENCES AND MENTAL DISORDERS, INST. OF MED., THE DEVELOPMENT OF MEDICATIONS FOR THE TREATMENT OF OPIATE AND COCAINE ADDICTIONS: ISSUES FOR THE GOVERNMENT AND PRIVATE SECTOR (Carolyn E. Fulco, Catharyn T. Liverman & Laurence E. Early eds. 1995); COMMITTEE ON OPPORTUNITIES IN DRUG ABUSE RESEARCH, DIV. OF NEUROSCIENCE AND BEHAVIORAL HEALTH, INST. OF MED., PATHWAYS OF ADDICTION: OPPORTUNITIES IN DRUG ABUSE RESEARCH (1996); COMMITTEE TO IDENTIFY STRATEGIES TO RAISE THE PROFILE OF SUBSTANCE ABUSE AND ALCOHOLISM RESEARCH, DIV. OF NEUROSCIENCE AND BEHAVIORAL HEALTH, DIV. OF HEALTH PROMOTION AND DISEASE PREVENTION, INST. OF MED., DISPELLING THE MYTHS ABOUT ADDICTION: STRATEGIES TO INCREASE UNDERSTANDING AND STRENGTHEN RESEARCH (1997).
124. The Institute of Medicine recently conducted three extensive reviews of the importance of biomedical research to provide the foundation for treatment development for drug dependence disorders. These reviews provide a wealth of observations that should be considered in ensuring that treatment development can advance as expeditiously as possible. COMMITTEE TO STUDY MEDICATION DEV. AND RESEARCH, NAT'L INST. OF DRUG ABUSE, DIV. OF BEHAVIORAL SCIENCES AND MENTAL DISORDERS, INST. OF MED., THE DEVELOPMENT OF MEDICATIONS FOR THE TREATMENT OF OPIATE AND COCAINE ADDICTIONS: ISSUES FOR THE GOVERNMENT AND PRIVATE SECTOR (Carolyn E. Fulco, Catharyn T. Liverman & Laurence E. Early eds. 1995); COMMITTEE ON OPPORTUNITIES IN DRUG ABUSE RESEARCH, DIV. OF NEUROSCIENCE AND BEHAVIORAL HEALTH, INST. OF MED., PATHWAYS OF ADDICTION: OPPORTUNITIES IN DRUG ABUSE RESEARCH (1996); COMMITTEE TO IDENTIFY STRATEGIES TO RAISE THE PROFILE OF SUBSTANCE ABUSE AND ALCOHOLISM RESEARCH, DIV. OF NEUROSCIENCE AND BEHAVIORAL HEALTH, DIV. OF HEALTH PROMOTION AND DISEASE PREVENTION, INST. OF MED., DISPELLING THE MYTHS ABOUT ADDICTION: STRATEGIES TO INCREASE UNDERSTANDING AND STRENGTHEN RESEARCH (1997).
125. U.S. DEP'T OF HEALTH AND HUMAN SERVS., NATIONAL INST. ON DRUG ABUSE, DRUG ABUSE AND DRUG ABUSE RESEARCH: THE THIRD TRIENNIAL REPORT TO CONGRESS (1991).
126. Jed E. Rose, Joseph E. Herskovi, Yvonne Trilling & Murray E. Jarvik, Transdermal Nicotine Reduces Cigarette Craving and Nicotine Preference, 38 CLINICAL PHARMACOLOGY & THERAPEUTICS 450 (1985); Jed E. Rose, Murray E. Jarvik & K.D. Rose, Transdermal Administration of Nicotine, 13 DRUG & ALCOHOL DEPENDENCE 209 (1984).
127. Jed E. Rose, Joseph E. Herskovi, Yvonne Trilling & Murray E. Jarvik, Transdermal Nicotine Reduces Cigarette Craving and Nicotine Preference, 38 CLINICAL PHARMACOLOGY & THERAPEUTICS 450 (1985); Jed E. Rose, Murray E. Jarvik & K.D. Rose, Transdermal Administration of Nicotine, 13 DRUG & ALCOHOL DEPENDENCE 209 (1984).
128. Nancy Kaufman, From Tobacco Mythology to Science: Will Policy Research Ever Guide Practice? 6 (Supp. 2) TOBACCO CONTROL S3 (1997) (delineating many of the research challenges as well as specific approaches that could be taken).
129. See infra note 100.
130. This table is original and the information was provided by various pharmaceutical companies or found in the general press.
131. The application was submitted originally in 1981 along with the NDA for two-milligram Nicorette gum, but was later withdrawn by the company because FDA believed that the four-milligram dose was not needed and could further delay approval of the two-milligram gum.
132. Food and Drug Administration Modernization Act of 1997, Pub. L. No. 105-115, § 112, 111 Stat. at 2309 (codified at 21 U.S.C. § 356); Page, supra note 13.
133. Reginald V. Fant, Wallace B. Pickworth & Jack E. Henningfield, The Addictive Effects of Nicotine Are Related to the Speed of Delivery, in 10 NICOTINE AS A THERAPEUTIC AGENT, IMMUNITY AND ENVIRONMENT 53 (1997). The safety of nicotine has been studied extensively and reviewed recently, leading to the general conclusion that relative to tobacco products, pure nicotine medications are remarkably safe. For example, one concern regarding nicotine medications was their potential adverse effects in patients with active cardiac disease. Two recent studies have confirmed that the risks of nicotine transdermal patch to such patients are not only substantially lower than that posed by continued cigarette smoking but may be minimal at doses recommended for smoking cessation. One study focused on the effects of transdermal nicotine and placebo in 584 cardiac patients. Anne M. Joseph, Suzanne M. Norman, Linda H. Ferry, Allan V. Prochazka, Eric C. Westman, Bonnie G. Steele, Scott E. Sherman, Minot Cleveland, David O. Antonnucio, Neial Hartman & Paul G. McGovern, The Safety of Transdermal Nicotine as an Aid to Smoking Cessation in Patients with Cardiac Disease, 335 NEW ENG. J. MED. 1792 (1996). The main outcome was increased smoking cessation in people wearing the active patches. Cardiovascular events and other side effects did not differ across the groups despite the fact that some people smoked while wearing active patches. A second study examined the effects of nicotine transdermal patches on coronary perfusion capacity in patients with compromised cardiovascular function. John J. Mahmarian, Lemuel A. Moye, George A. Nasser, Sherif F. Nagueh, Marilyn F. Bloom, Neal L. Benowitz, Mario S. Verani, William G. Byrd & Craig M. Pratt, Nicotine Patch Therapy in Smoking Cessation Reduces the Extent of Exercise-Induced Myocardial Ischemia, 30 J. AM. C. CARDIOLOGY 125 (1997). An exercise thallium test using the single-photon emission computed tomography method to assess changes in myocardial perfusion deficit revealed that substitution of transdermal patch delivered nicotine for cigarette smoking decreased magnitude of the perfusion deficit. These studies support the conclusions that use of nicotine transdermal systems place patients at substantially lower risk cardiovascular events than cigarette smoking, and that judicious use of the patches to enable smoking cessation in persons with coronary artery disease may be appropriate to consider on an individual basis. Neal L. Benowitz, Nicotine Replacement Therapy: What Has Been Accomplished - Can We Do Better?, 45 DRUGS 157 (1993); Henningfield, Nicotine Medications, supra note 31, at 1201.
134. Reginald V. Fant, Wallace B. Pickworth & Jack E. Henningfield, The Addictive Effects of Nicotine Are Related to the Speed of Delivery, in 10 NICOTINE AS A THERAPEUTIC AGENT, IMMUNITY AND ENVIRONMENT 53 (1997). The safety of nicotine has been studied extensively and reviewed recently, leading to the general conclusion that relative to tobacco products, pure nicotine medications are remarkably safe. For example, one concern regarding nicotine medications was their potential adverse effects in patients with active cardiac disease. Two recent studies have confirmed that the risks of nicotine transdermal patch to such patients are not only substantially lower than that posed by continued cigarette smoking but may be minimal at doses recommended for smoking cessation. One study focused on the effects of transdermal nicotine and placebo in 584 cardiac patients. Anne M. Joseph, Suzanne M. Norman, Linda H. Ferry, Allan V. Prochazka, Eric C. Westman, Bonnie G. Steele, Scott E. Sherman, Minot Cleveland, David O. Antonnucio, Neial Hartman & Paul G. McGovern, The Safety of Transdermal Nicotine as an Aid to Smoking Cessation in Patients with Cardiac Disease, 335 NEW ENG. J. MED. 1792 (1996). The main outcome was increased smoking cessation in people wearing the active patches. Cardiovascular events and other side effects did not differ across the groups despite the fact that some people smoked while wearing active patches. A second study examined the effects of nicotine transdermal patches on coronary perfusion capacity in patients with compromised cardiovascular function. John J. Mahmarian, Lemuel A. Moye, George A. Nasser, Sherif F. Nagueh, Marilyn F. Bloom, Neal L. Benowitz, Mario S. Verani, William G. Byrd & Craig M. Pratt, Nicotine Patch Therapy in Smoking Cessation Reduces the Extent of Exercise-Induced Myocardial Ischemia, 30 J. AM. C. CARDIOLOGY 125 (1997). An exercise thallium test using the single-photon emission computed tomography method to assess changes in myocardial perfusion deficit revealed that substitution of transdermal patch delivered nicotine for cigarette smoking decreased magnitude of the perfusion deficit. These studies support the conclusions that use of nicotine transdermal systems place patients at substantially lower risk cardiovascular events than cigarette smoking, and that judicious use of the patches to enable smoking cessation in persons with coronary artery disease may be appropriate to consider on an individual basis. Neal L. Benowitz, Nicotine Replacement Therapy: What Has Been Accomplished - Can We Do Better?, 45 DRUGS 157 (1993); Henningfield, Nicotine Medications, supra note 31, at 1201.
135. Reginald V. Fant, Wallace B. Pickworth & Jack E. Henningfield, The Addictive Effects of Nicotine Are Related to the Speed of Delivery, in 10 NICOTINE AS A THERAPEUTIC AGENT, IMMUNITY AND ENVIRONMENT 53 (1997). The safety of nicotine has been studied extensively and reviewed recently, leading to the general conclusion that relative to tobacco products, pure nicotine medications are remarkably safe. For example, one concern regarding nicotine medications was their potential adverse effects in patients with active cardiac disease. Two recent studies have confirmed that the risks of nicotine transdermal patch to such patients are not only substantially lower than that posed by continued cigarette smoking but may be minimal at doses recommended for smoking cessation. One study focused on the effects of transdermal nicotine and placebo in 584 cardiac patients. Anne M. Joseph, Suzanne M. Norman, Linda H. Ferry, Allan V. Prochazka, Eric C. Westman, Bonnie G. Steele, Scott E. Sherman, Minot Cleveland, David O. Antonnucio, Neial Hartman & Paul G. McGovern, The Safety of Transdermal Nicotine as an Aid to Smoking Cessation in Patients with Cardiac Disease, 335 NEW ENG. J. MED. 1792 (1996). The main outcome was increased smoking cessation in people wearing the active patches. Cardiovascular events and other side effects did not differ across the groups despite the fact that some people smoked while wearing active patches. A second study examined the effects of nicotine transdermal patches on coronary perfusion capacity in patients with compromised cardiovascular function. John J. Mahmarian, Lemuel A. Moye, George A. Nasser, Sherif F. Nagueh, Marilyn F. Bloom, Neal L. Benowitz, Mario S. Verani, William G. Byrd & Craig M. Pratt, Nicotine Patch Therapy in Smoking Cessation Reduces the Extent of Exercise-Induced Myocardial Ischemia, 30 J. AM. C. CARDIOLOGY 125 (1997). An exercise thallium test using the single-photon emission computed tomography method to assess changes in myocardial perfusion deficit revealed that substitution of transdermal patch delivered nicotine for cigarette smoking decreased magnitude of the perfusion deficit. These studies support the conclusions that use of nicotine transdermal systems place patients at substantially lower risk cardiovascular events than cigarette smoking, and that judicious use of the patches to enable smoking cessation in persons with coronary artery disease may be appropriate to consider on an individual basis. Neal L. Benowitz, Nicotine Replacement Therapy: What Has Been Accomplished - Can We Do Better?, 45 DRUGS 157 (1993); Henningfield, Nicotine Medications, supra note 31, at 1201.
136. Reginald V. Fant, Wallace B. Pickworth & Jack E. Henningfield, The Addictive Effects of Nicotine Are Related to the Speed of Delivery, in 10 NICOTINE AS A THERAPEUTIC AGENT, IMMUNITY AND ENVIRONMENT 53 (1997). The safety of nicotine has been studied extensively and reviewed recently, leading to the general conclusion that relative to tobacco products, pure nicotine medications are remarkably safe. For example, one concern regarding nicotine medications was their potential adverse effects in patients with active cardiac disease. Two recent studies have confirmed that the risks of nicotine transdermal patch to such patients are not only substantially lower than that posed by continued cigarette smoking but may be minimal at doses recommended for smoking cessation. One study focused on the effects of transdermal nicotine and placebo in 584 cardiac patients. Anne M. Joseph, Suzanne M. Norman, Linda H. Ferry, Allan V. Prochazka, Eric C. Westman, Bonnie G. Steele, Scott E. Sherman, Minot Cleveland, David O. Antonnucio, Neial Hartman & Paul G. McGovern, The Safety of Transdermal Nicotine as an Aid to Smoking Cessation in Patients with Cardiac Disease, 335 NEW ENG. J. MED. 1792 (1996). The main outcome was increased smoking cessation in people wearing the active patches. Cardiovascular events and other side effects did not differ across the groups despite the fact that some people smoked while wearing active patches. A second study examined the
137. Reginald V. Fant, Wallace B. Pickworth & Jack E. Henningfield, The Addictive Effects of Nicotine Are Related to the Speed of Delivery, in 10 NICOTINE AS A THERAPEUTIC AGENT, IMMUNITY AND ENVIRONMENT 53 (1997). The safety of nicotine has been studied extensively and reviewed recently, leading to the general conclusion that relative to tobacco products, pure nicotine medications are remarkably safe. For example, one concern regarding nicotine medications was their potential adverse effects in patients with active cardiac disease. Two recent studies have confirmed that the risks of nicotine transdermal patch to such patients are not only substantially lower than that posed by continued cigarette smoking but may be minimal at doses recommended for smoking cessation. One study focused on the effects of transdermal nicotine and placebo in 584 cardiac patients. Anne M. Joseph, Suzanne M. Norman, Linda H. Ferry, Allan V. Prochazka, Eric C. Westman, Bonnie G. Steele, Scott E. Sherman, Minot Cleveland, David O. Antonnucio, Neial Hartman & Paul G. McGovern, The Safety of Transdermal Nicotine as an Aid to Smoking Cessation in Patients with Cardiac Disease, 335 NEW ENG. J. MED. 1792 (1996). The main outcome was increased smoking cessation in people wearing the active patches. Cardiovascular events and other side effects did not differ across the groups despite the fact that some people smoked while wearing active patches. A second study examined the effects of nicotine transdermal patches on coronary perfusion capacity in patients with compromised cardiovascular function. John J. Mahmarian, Lemuel A. Moye, George A. Nasser, Sherif F. Nagueh, Marilyn F. Bloom, Neal L. Benowitz, Mario S. Verani, William G. Byrd & Craig M. Pratt, Nicotine Patch Therapy in Smoking Cessation Reduces the Extent of Exercise-Induced Myocardial Ischemia, 30 J. AM. C. CARDIOLOGY 125 (1997). An exercise thallium test using the single-photon emission computed tomography method to assess changes in myocardial perfusion deficit revealed that substitution of transdermal patch delivered nicotine for cigarette smoking decreased magnitude of the perfusion deficit. These studies support the conclusions that use of nicotine transdermal systems place patients at substantially lower risk cardiovascular events than cigarette smoking, and that judicious use of the patches to enable smoking cessation in persons with coronary artery disease may be appropriate to consider on an individual basis. Neal L. Benowitz, Nicotine Replacement Therapy: What Has Been Accomplished - Can We Do Better?, 45 DRUGS 157 (1993); Henningfield, Nicotine Medications, supra note 31, at 1201.
138. For a discussion of criteria and issues concerning the use of terms such as "light," "low," and "lowest," and regulations regarding the use of these terms in the FDA's final rules on food labeling, see U.S. DEP'T OF HEALTH AND HUMAN SERVS., FOOD AND DRUG ADMTN., 21 C.F.R. pt. 1, et. seq.; Food Labeling; General Provisions; Nutrition Labeling; Label Format; Nutrient content Claims; Health Claims; Ingredient Labeling; State and Local Requirements; and Exemptions; Final Rules, 58 Fed. Reg. 2302 (Jan. 6, 1993).
139. See Page, supra note 13.
140. This omission may date back to the relative lack of concern of many clinicians and regulators in the early 1980s (prior to documentation of the debilitating effects of nicotine withdrawal for many people), and concern that such an indication might promote use of the products to prevent degradation of mental functioning during periods that a person could not smoke. It was argued that this scenario would reduce the pressure to quit tobacco use forever. While well intentioned, this position is grounded more in philosophy and theory than data, and does not recognize the possibility that such use also may represent a first step toward quitting and that many people may require long-term use of medications (currently discouraged by labeling) to sustain tobacco abstinence.
141. Symptom-specific indications also have been considered. Such indications, for example, can be targeted toward alleviating a specific symptoms such as the reduction of cravings, or the alleviation of anxiety or depression associated with nicotine withdrawal. Moreover, different delivery systems may lend themselves to different indications. For example, the transdermal patch might be more effective for withdrawal suppression than a nasal spray or a vapor-type product. On the other hand, for symptomatic relief, the patch may prove to be less useful in patients who already have been detoxified and do not wish to become physically dependent again. Nicotine gum might prove to be a better option for this population.
142. See Leslie M. Schuh & Jack E. Henningfield, Nicotine Replacement Treatment and Public Health Interventions: Towards a Marriage of Two Approaches, in TOBACCO AND HEALTH (Karen Slama ed. 1995) (discussion of how cessation treatment may be often taken as an ends in itself instead of as one means to a greater end, namely reduction of death and disease).
143. GEORGE E. WOODY, LAURA F. MCNICHOLAS, FRANK J. VOCCI, JR., JACK E. HENNINGFIELD & STAFF OF THE PILOT DRUG EVALUATION UNIT OF THE FOOD AND DRUG ADMIN., GUIDELINES FOR THE DEVELOPMENT AND EVALUATION OF DRUGS FOR THE TREATMENT OF PSYCHOACTIVE SUBSTANCE USE DISORDERS (1994).
144. This table is modified from a table in NEW DEVELOPMENTS IN NICOTINE DELIVERY SYSTEMS, supra note 41, at 26.
145. AVRAM GOLDSTEIN, ADDICTION: FROM BIOLOGY TO DRUG POLICY 235 (1994).
146. Draft manuscript given by Avram Goldstein, M.D., to Jack E. Henningfield (Aug. 3, 1997)(on file with author).
147. GOLDSTEIN, supra note 110, at 115.
148. Warner et al., supra note 49, at 1087. See also HEALTH EDUCATION AUTHORITY (U.K.), REGULATING NICOTINE DELIVERY SYSTEMS: HARM REDUCTION AND THE PREVENTION OF SMOKING-RELATED DISEASE (1997) (summary of a meeting held in November 1996 at the Health Education Authority, London, United Kingdom); UN ROUNDTABLE REPORT, supra note 12.
149. Warner et al., supra note 49, at 1087. See also HEALTH EDUCATION AUTHORITY (U.K.), REGULATING NICOTINE DELIVERY SYSTEMS: HARM REDUCTION AND THE PREVENTION OF SMOKING-RELATED DISEASE (1997) (summary of a meeting held in November 1996 at the Health Education Authority, London, United Kingdom); UN ROUNDTABLE REPORT, supra note 12.
150. See Shiffman et al., supra note 29.
151. Giovino et al., supra note 4, at S8.
152. Lynn T. Kozlowski, N.Y. Mehta & Christine T. Sweeny, Filter Ventilation Levels in Selected U.S. Cigarettes. 1997, 279 JAMA 424 (1998).
153. Food and Drug Admin., Drug Abuse Advisory Comm., Meeting No. 23 (July 14, 1992).
154. Michael J. Thun, Cathy A. Lally, John T. Flannery, Eugenia E. Calle, W. Dana Flanders & Clark W. Heath Jr., Cigarette Smoking and Changes in the Histopathology of Lung Cancer, 89 J. NATIONAL CANCER INSTITUTE 1580 (1997); Dietrich Hoffmann & Ilse Hoffmann, The Changing Cigarette, 1950-1995, 50 J. TOXICOLOGY & ENVTL. HEALTH 307 (1997).
155. Michael J. Thun, Cathy A. Lally, John T. Flannery, Eugenia E. Calle, W. Dana Flanders & Clark W. Heath Jr., Cigarette Smoking and Changes in the Histopathology of Lung Cancer, 89 J. NATIONAL CANCER INSTITUTE 1580 (1997); Dietrich Hoffmann & Ilse Hoffmann, The Changing Cigarette, 1950-1995, 50 J. TOXICOLOGY & ENVTL. HEALTH 307 (1997).
156. See Shiffman et al., supra note 29.
157. AMERICAN PSYCHIATRIC ASS'N: DSM-IV, supra note 46, at 244-47.
158. American Psychiatric Ass'n, supra note 40, at 3-5.
159. Henningfield, Nicotine Medications, supra note 31, at 1197-198.
160. As discussed in a report by the National Cancer Policy Board, efforts to reduce exposure (including the reduction of environmental smoke in nonsmokers) is a potentially important way (along with prevention and cessation) to reduce the tobacco-attributable death toll. The problem with the tobacco industry's reduced delivery cigarettes is that they did not actually lead to reduced exposure in cigarette smokers. NATIONAL CANCER POLICY BD., INSTITUTE OF MED. AND COMM'N ON LIFE SCIENCES, NATIONAL RESEARCH COUNCIL, TAKING ACTION TO REDUCE TOBACCO USE (1998).
161. NATIONAL INST. OF HEALTH, supra note 24; Burns, supra note 28; Jimenez-Ruiz et al., supra note 21; Shiffman et al., supra note 29.
162. Jimenez-Ruiz et al., supra note 21; Neal L. Benowitz, Shoshana Zevin & Peyton Jacob III, Dose-relates Suppression of Nicotine Intake from Ad Libitum Cigarette Smoking by Transdermal Nicotine, Paper presented at the Fourth Annual Meeting of the Society for Research on Nicotine and Tobacco, New Orleans, LA (Mar. 27-28, 1998); Karl Olov 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, Paper presented at the Fourth Annual Meeting of the Society for Research on Nicotine and Tobacco, New Orleans, LA (Mar. 27-28, 1998).
163. Jimenez-Ruiz et al., supra note 21; Neal L. Benowitz, Shoshana Zevin & Peyton Jacob III, Dose-relates Suppression of Nicotine Intake from Ad Libitum Cigarette Smoking by Transdermal Nicotine, Paper presented at the Fourth Annual Meeting of the Society for Research on Nicotine and Tobacco, New Orleans, LA (Mar. 27-28, 1998); Karl Olov 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, Paper presented at the Fourth Annual Meeting of the Society for Research on Nicotine and Tobacco, New Orleans, LA (Mar. 27-28, 1998).
164. NATIONAL INST. HEALTH, NATIONAL CANCER INST., THE FTC CIGARETTE TEST METHOD FOR DETERMINING TAR, NICOTINE, AND CARBON MONOXIDE YIELDS OF U.S. CIGARETTES: REPORT OF THE NCI EXPERT COMMTTTEE (Smoking and Tobacco Control Monograph 7) (1996);
165. Jack E. Henningfield, Lynn T. Kozlowski & Neal L. Benowitz, A Proposal to Develop Meaningful Labeling for Cigarettes, 272 JAMA 312 (1994).
166. Hoffmann & Hoffmann, supra note 118; Thun et al., supra note 118.
167. Burton et al., supra note 11.
168. Id. at 870.
169. Shiffman et al., supra note 11
170. Id. at 308.
171. Warner et al., supra note 49, at 1089.
172. GROWING UP TOBACCO FREE: PREVENTING NICOTINE ADDICTION IN CHILDREN AND YOUTHS (B.S. Lynch & R.J. Bonnie eds. 1994); U.S. DEP'T OF HEALTH AND HUMAN SERVS., PREVENTING TOBACCO USE AMONG YOUNG PEOPLE: A REPORT OF THE SURGEON GENERAL (1994); U.S. DEP'T OF HEALTH AND HUMAN SERVS., TOBACCO USE AMONG U.S. RACIAL/ETHNIC MINORITY GROUPS - AFRICAN AMERICANS, AMERICAN INDIANS AND ALASKA NATIVES, ASIAN AMERICANS AND PACIFIC ISLANDERS, HISPANICS: A REPORT OF THE SURGEON GENERAL (1998).
173. GROWING UP TOBACCO FREE: PREVENTING NICOTINE ADDICTION IN CHILDREN AND YOUTHS (B.S. Lynch & R.J. Bonnie eds. 1994); U.S. DEP'T OF HEALTH AND HUMAN SERVS., PREVENTING TOBACCO USE AMONG YOUNG PEOPLE: A REPORT OF THE SURGEON GENERAL (1994); U.S. DEP'T OF HEALTH AND HUMAN SERVS., TOBACCO USE AMONG U.S. RACIAL/ETHNIC MINORITY GROUPS - AFRICAN AMERICANS, AMERICAN INDIANS AND ALASKA NATIVES, ASIAN AMERICANS AND PACIFIC ISLANDERS, HISPANICS: A REPORT OF THE SURGEON GENERAL (1998).
174. GROWING UP TOBACCO FREE: PREVENTING NICOTINE ADDICTION IN CHILDREN AND YOUTHS (B.S. Lynch & R.J. Bonnie eds. 1994); U.S. DEP'T OF HEALTH AND HUMAN SERVS., PREVENTING TOBACCO USE AMONG YOUNG PEOPLE: A REPORT OF THE SURGEON GENERAL (1994); U.S. DEP'T OF HEALTH AND HUMAN SERVS., TOBACCO USE AMONG U.S. RACIAL/ETHNIC MINORITY GROUPS - AFRICAN AMERICANS, AMERICAN INDIANS AND ALASKA NATIVES, ASIAN AMERICANS AND PACIFIC ISLANDERS, HISPANICS: A REPORT OF THE SURGEON GENERAL (1998).
175. Burton et al., supra note 11; Shiffman et al., supra note 11.
176. See Jack E. Henningfield & Rosemary Nemeth-Coslett, Nicotine Dependence: Interface Between Tobacco and Tobacco-Related Disease, 93 CHEST 38S (1988) (discussion of pharmaceutical and health issues concerning these products); Analysis Regarding Food and Drug Administration's Jurisdiction Over Nicotine Containing Cigarettes and Smokeless Tobacco, 60 Fed. Reg. 41,453 (Aug. 11, 1995); 61 Fed. Reg. at 44,396.
177. See Jack E. Henningfield & Rosemary Nemeth-Coslett, Nicotine Dependence: Interface Between Tobacco and Tobacco-Related Disease, 93 CHEST 38S (1988) (discussion of pharmaceutical and health issues concerning these products); Analysis Regarding Food and Drug Administration's Jurisdiction Over Nicotine Containing Cigarettes and Smokeless Tobacco, 60 Fed. Reg. 41,453 (Aug. 11, 1995); 61 Fed. Reg. at 44,396.
178. See Jack E. Henningfield & Rosemary Nemeth-Coslett, Nicotine Dependence: Interface Between Tobacco and Tobacco-Related Disease, 93 CHEST 38S (1988) (discussion of pharmaceutical and health issues concerning these products); Analysis Regarding Food and Drug Administration's Jurisdiction Over Nicotine Containing Cigarettes and Smokeless Tobacco, 60 Fed. Reg. 41,453 (Aug. 11, 1995); 61 Fed. Reg. at 44,396.
179. See NATIONAL CLEARINGHOUSE ON TOBACCO AND HEALTH, SELECTED EXCERPTS FROM IMPERIAL TOBACCO LIMITED INTERNAL DOCUMENTS 54 (1992).
180. Id. at 55.
181. Id. at 48.
182. Id.
183. David T. Sweanor, Regulation of Tobacco and Nicotine, 28 TOBACCO EPIDEMIC 247 (1997).
184. CENTER FOR THE ADVANCEMENT OF HEALTH, supra note 79; AHCPR Smoking Cessation Guideline: Its Goals and Impact, 6 (Supp. 1) TOBACCO CONTROL S1-S106 (1997).
185. C. Everett Koop, Don't Forget the Smokers, WASH. POST, Mar. 8, 1998, at C7.
186. David A. Kessler, Sharon L. Natanblut, Judith P. Wilkenfeld, Catherine C. Lorraine, S.L. Mary, I.B.G. Bernstein & Larry J. Thompson, Nicotine Addiction: A Pediatric Disease, 130 J. PEDIATRICS 518 (1997).
187. This approach is advocated by Warner et al., supra note 50.
188. Neal L. Benowitz & Jack E. Henningfield, Establishing a Nicotine Threshold for Addiction, 331 NEW ENG. J. MED. 123 (1994).
189. Fant et al., supra note 102, at 53-61.
190. See, e.g., Jed E. Rose, Nicotine Addiction and Treatment, 47 ANNUAL REV. MED. 493 (1996).
191. Slade & Henningfield, supra note 16.
192. Id.
193. For a discussion of congressionally developed regulatory provisions, see S. REP. No. 105-85, pt. 5, at 31-46 (testimony of Jack E. Henningfield, Ph.D. (Feb. 24, 1998); letter from Jack E. Henningfield to Sen. James M. Jeffords, Chair, Sen. Labor and Human Resources Comm. (Mar. 6, 1998)).
194. 27 C.F.R. § 270.11; 61 Fed. Reg. at 44,616.
195. 61 Fed. Reg. at 44,616.
196. See supra note 150.
197. Slade & Henningfield, supra note 16.
198. See S. 1415, 105th Cong., 2d Sess. (1998) (introduced by Sen. John McCain, R-AZ) [hereinafter McCain Bill]; S. 1648, 105th Cong., 2d Sess. (1998) (introduced by Sen. James M. Jeffords, R-VT) [hereinafter Jeffords Bill]; S. 1638, ["The Healthy Kids Act"], 105th Cong., 2d Sess. (1998) (introduced by Sen. Kent Conrad, D-ND) [hereinafter Conrad Bill].
199. National Tobacco-Free Kids Organization, Campaign for Tobacco-Free Kids, Proposed Settlement (June 20, 1997) (visited July 2, 1998) 〈http://www.tobaccofreekids.org/html/settlement_document.html〉.
200. Jeffords Bill, supra note 155.
201. Id.
202. Slade & Henningfield, supra note 16.
203. Henningfield, supra note 150.
204. Jeffords Bill, supra note 155; Henningfield, supra note 150.
205. See Slade & Henningfield, supra note 16; petition from American Lung Ass'n, American Ass'n for Respiratory Care, American Med. Women's Ass'n, American Pub. Health Ass'n, Americans for Nonsmokers Rights, Tobacco Prods. Liab. Project & Interreligious Coalition on Smoking OR Health, to Food and Drug Admin. (Jan. 15, 1998) [hereinafter ALA Petition].
206. McCain Bill & Conrad Bill, supra note 155.
207. See supra text accompanying notes 58-74.
208. CENTER FOR THE ADVANCEMENT OF HEALTH, supra note 82; U.S. DEP'T OF HEALTH AND HUMAN SERVS., supra note 19.
209. NATIONAL INST. OF HEALTH, NATIONAL CANCER INST., CIGARS: HEALTH EFFECTS AND TRENDS (Smoking and Tobacco Control Monograph 9) (1998).
210. Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301 et seq.).
211. Conrad Bill, supra note 155.
212. See Page, supra note 13.
213. 61 Fed. Reg. 44,396.
214. PETO ET. AL, supra note 1.
215. Neal L. Benowitz, Peyton Jacob III, John Slade & Lisa Yu, Nicotine Content of the Eclipse Nicotine Delivery Device, 87 AM. J. PUB. HEALTH 1865 (1997) (letter to the editor).
216. Proposed Rule, 62 Fed. Reg. at 43,899. See also COLLEGE ON PROBLEMS OF DRUG DEPENDENCE, COMMENT, supra note 88.
217. Proposed Rule, 62 Fed. Reg. at 43,899. See also COLLEGE ON PROBLEMS OF DRUG DEPENDENCE, COMMENT, supra note 88.
218. E.g., Jack E. Henningfield, Tula Michaelides & Steve Sussman, Developing Treatment for Nicotine-Addicted Youth: Issues and Challenges, J. CHILD & ADOLESCENT SUBSTANCE ABUSE (manuscript under review).
219. Slade & Henningfield, supra note 16.
220. See Page, supra note 13.
221. Jeffrey Taylor, House GOP Rejects Tobacco Proposal: Move Prompts Democrats To Charge Republicans Aren't Serious About Bill, WALL ST. J., Apr. 30, 1998, at A3. C. Everett Koop has warned against overly limiting attention to youth smoking to the virtual exclusion of attention to the legitimate need of adult smokers. See Koop, supra note 142, at C7. 178 See, e.g., Jeffrey Taylor, Big Tobacco's Lawyers Get a Jump in Congress, WALL ST. J., July 10, 1997, at A16; McCain and Hollings Introduce Tobacco Legislation, ScarcNet News, Nov. 6, 1997; Jeffrey Taylor, House GOP Rejects Tobacco Proposal; Move Prompts Democrats to Charge Republicans Aren't Serious About Bill, WALL ST. J., Apr. 30, 1998, at A3; John McCain, Conservative Agenda Lies in Ashes, WALL ST. J., June 24, 1998, at A18 (letter to the editor).
222. Jeffrey Taylor, House GOP Rejects Tobacco Proposal: Move Prompts Democrats To Charge Republicans Aren't Serious About Bill, WALL ST. J., Apr. 30, 1998, at A3. C. Everett Koop has warned against overly limiting attention to youth smoking to the virtual exclusion of attention to the legitimate need of adult smokers. See Koop, supra note 142, at C7. 178 See, e.g., Jeffrey Taylor, Big Tobacco's Lawyers Get a Jump in Congress, WALL ST. J., July 10, 1997, at A16; McCain and Hollings Introduce Tobacco Legislation, ScarcNet News, Nov. 6, 1997; Jeffrey Taylor, House GOP Rejects Tobacco Proposal; Move Prompts Democrats to Charge Republicans Aren't Serious About Bill, WALL ST. J., Apr. 30, 1998, at A3; John McCain, Conservative Agenda Lies in Ashes, WALL ST. J., June 24, 1998, at A18 (letter to the editor).
223. Jeffrey Taylor, House GOP Rejects Tobacco Proposal: Move Prompts Democrats To Charge Republicans Aren't Serious About Bill, WALL ST. J., Apr. 30, 1998, at A3. C. Everett Koop has warned against overly limiting attention to youth smoking to the virtual exclusion of attention to the legitimate need of adult smokers. See Koop, supra note 142, at C7. 178 See, e.g., Jeffrey Taylor, Big Tobacco's Lawyers Get a Jump in Congress, WALL ST. J., July 10, 1997, at A16; McCain and Hollings Introduce Tobacco Legislation, ScarcNet News, Nov. 6, 1997; Jeffrey Taylor, House GOP Rejects Tobacco Proposal; Move Prompts Democrats to Charge Republicans Aren't Serious About Bill, WALL ST. J., Apr. 30, 1998, at A3; John McCain, Conservative Agenda Lies in Ashes, WALL ST. J., June 24, 1998, at A18 (letter to the editor).
224. Jeffrey Taylor, House GOP Rejects Tobacco Proposal: Move Prompts Democrats To Charge Republicans Aren't Serious About Bill, WALL ST. J., Apr. 30, 1998, at A3. C. Everett Koop has warned against overly limiting attention to youth smoking to the virtual exclusion of attention to the legitimate need of adult smokers. See Koop, supra note 142, at C7. 178 See, e.g., Jeffrey Taylor, Big Tobacco's Lawyers Get a Jump in Congress, WALL ST. J., July 10, 1997, at A16; McCain and Hollings Introduce Tobacco Legislation, ScarcNet News, Nov. 6, 1997; Jeffrey Taylor, House GOP Rejects Tobacco Proposal; Move Prompts Democrats to Charge Republicans Aren't Serious About Bill, WALL ST. J., Apr. 30, 1998, at A3; John McCain, Conservative Agenda Lies in Ashes, WALL ST. J., June 24, 1998, at A18 (letter to the editor).
225. Jeffrey Taylor, House GOP Rejects Tobacco Proposal: Move Prompts Democrats To Charge Republicans Aren't Serious About Bill, WALL ST. J., Apr. 30, 1998, at A3. C. Everett Koop has warned against overly limiting attention to youth smoking to the virtual exclusion of attention to the legitimate need of adult smokers. See Koop, supra note 142, at C7. 178 See, e.g., Jeffrey Taylor, Big Tobacco's Lawyers Get a Jump in Congress, WALL ST. J., July 10, 1997, at A16; McCain and Hollings Introduce Tobacco Legislation, ScarcNet News, Nov. 6, 1997; Jeffrey Taylor, House GOP Rejects Tobacco Proposal; Move Prompts Democrats to Charge Republicans Aren't Serious About Bill, WALL ST. J., Apr. 30, 1998, at A3; John McCain, Conservative Agenda Lies in Ashes, WALL ST. J., June 24, 1998, at A18 (letter to the editor).
226. See Page, supra note 13.
227. Slade & Henningfield, supra note 16.
228. HEALTH EDUCATION AUTHORITY (U.K.), supra note 113.
229. ALA Petition, supra note 162.
230. Food and Drug Admin., Center for Drug Evaluation and Research, Drug Abuse Advisory Committee meeting, chaired by Robert L. Balster (1983) and Meeting No. 27, Abuse Liability Assessment of Nicotine Nasal Spray (Aug. 1, 1994). See also 60 Fed. Reg. at 41,453; 61 Fed. Reg. at 44,396.
231. Food and Drug Admin., Center for Drug Evaluation and Research, Drug Abuse Advisory Committee meeting, chaired by Robert L. Balster (1983) and Meeting No. 27, Abuse Liability Assessment of Nicotine Nasal Spray (Aug. 1, 1994). See also 60 Fed. Reg. at 41,453; 61 Fed. Reg. at 44,396.
232. Food and Drug Admin., Center for Drug Evaluation and Research, Drug Abuse Advisory Committee meeting, chaired by Robert L. Balster (1983) and Meeting No. 27, Abuse Liability Assessment of Nicotine Nasal Spray (Aug. 1, 1994). See also 60 Fed. Reg. at 41,453; 61 Fed. Reg. at 44,396.
233. National Cancer Policy Bd., supra note 123; Committee to Study Medication Dev. and Research, supra note 94; 61 Fed. Reg. at 44,396.