Federal regulation of tobacco products and products that treat tobacco dependence: Are the playing fields level?

Food and Drug Law Journal

Volumn 53, Issue SUPPL., 1998, Pages 11-42

  Page, Joseph A ^a  

^a GEORGETOWN UNIVERSITY LAW CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CONFERENCE PAPER; FOOD AND DRUG ADMINISTRATION; LAW; MARKETING; PRESCRIPTION; SMOKING; SUBSTANCE ABUSE; TOBACCO INDUSTRY; UNITED STATES;

DRUG APPROVAL; ECONOMIC COMPETITION; HUMANS; JURISPRUDENCE; LEGISLATION, DRUG; PLANTS, TOXIC; PUBLIC HEALTH; SMOKING CESSATION; TOBACCO; TOBACCO INDUSTRY; TOBACCO USE DISORDER; TOBACCO, SMOKELESS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

NICOTIANA TABACUM;

EID: 0031873203     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (313)

1. See, e.g., Lanham Trademark Act, Pub. L. No. 79-480, § 43(a), 60 Stat. 427, 441 (1946), as amended by Pub. L. No. 102-542, § 3(c), 106 Stat. 3568 (1992) (codified at 15 U.S.C. § 1125(a)(1)(B) (1994)) (federal remedy for false advertising and product disparagement available to competitors). For a discussion of state laws dealing with unfair or deceptive practices, see generally Marshall A. Leaffer & Michael H. Lipson, Consumer Actions Against Unfair or Deceptive Practices: The Private Uses of Federal Trade Commission Jurisprudence, 48 GEO. WASH. L. REV. 521 (1980).
2. See, e.g., Lanham Trademark Act, Pub. L. No. 79-480, § 43(a), 60 Stat. 427, 441 (1946), as amended by Pub. L. No. 102-542, § 3(c), 106 Stat. 3568 (1992) (codified at 15 U.S.C. § 1125(a)(1)(B) (1994)) (federal remedy for false advertising and product disparagement available to competitors). For a discussion of state laws dealing with unfair or deceptive practices, see generally Marshall A. Leaffer & Michael H. Lipson, Consumer Actions Against Unfair or Deceptive Practices: The Private Uses of Federal Trade Commission Jurisprudence, 48 GEO. WASH. L. REV. 521 (1980).
3. The common law provides remedies for competitors injured by such wrongful practices as the interference with contractual relations. See W. PAGE KEETON ET AL., PROSSER AND KEETON ON THE LAW OF TORTS § 125, at 978 (5th ed. 1984). It also provides a remedy in tort for consumers and others injured by defective, unreasonably dangerous products. See id. § 98, at 692.
4. On deterrence and legal liability, see Gary T. Schwartz, Reality in the Economic Analysis of Tort Law: Does Tort Law Really Deter?, 42 UCLA L. REV. 377 (1994).
5. See, e.g., 26 U.S.C. §§ 5701 et seq. (1994) (tax on cigarettes).
6. See, e.g., 15 U.S.C. § 1337(a) (Surgeon General directed to report on health consequences of smoking).
7. See, e.g., 41 C.F.R. § 101-20.105-3(b) (1997) (prohibiting smoking in certain areas of federal buildings).
8. See, e.g., Orphan Drug Act, Pub. L. No. 97-414, 96 Stat. 2049 (1983) (codified as amended at 21 U.S.C. §§ 360aa et seq. (1994) (providing incentives for the development of drugs to treat diseases or conditions with small patient populations).
9. See, e.g., 23 U.S.C. § 153 (1994) (providing grants to states that require motorcycle helmets and seat belts in the front seats of vehicles).
10. For an example of direct statutory regulation, see the Refrigerator Safety Act, Pub. L. No. 84-930, 70 Stat. 953 (1956) (codified at 15 U.S.C. §§ 1211 et seq.) (illegal to manufacture refrigerators without device enabling them to be opened from the inside).
11. See, e.g., Consumer Product Safety Act, Pub. L. No. 92-573, 86 Stat. 1207 (1972) (codified as amended at 15 U.S.C. §§ 2051-2081) (delegation of broad authority to the Consumer Product Safety Commission to regulate consumer products).
12. Some state statutes authorize the dissolution of a corporation that has engaged in repeated unfair trade practices. See, e.g., FLA. STAT. chs. 501.204(1), 501.207(3) (1993).
13. See, e.g., 15 U.S.C. § 2056(a)(1) (mandate under Consumer Product Safety Act that standards be set in terms of performance requirements).
14. Thus, motor vehicles are not regulated in the same way as mobile homes. Compare National Traffic and Motor Vehicle Safety Act of 1966, Pub. L. No. 89-563, 80 Stat. 718 (1966) (codified as amended at 15 U.S.C. § 1381ff (1988 & Supp. III 1991)), with National Mobile Home Construction and Safety Standards Act of 1974, Pub. L. No. 93-383, 88 Stat. 700 (1974) (codified at 42 U.S.C. §§ 5401 et seq. (1994)).
15. Thus, motor vehicles are not regulated in the same way as mobile homes. Compare National Traffic and Motor Vehicle Safety Act of 1966, Pub. L. No. 89-563, 80 Stat. 718 (1966) (codified as amended at 15 U.S.C. § 1381ff (1988 & Supp. III 1991)), with National Mobile Home Construction and Safety Standards Act of 1974, Pub. L. No. 93-383, 88 Stat. 700 (1974) (codified at 42 U.S.C. §§ 5401 et seq. (1994)).
16. For an excellent historical account of cigarette smoking, see RICHARD KLUGER, ASHES TO ASHES: AMERICA'S HUNDRED YEAR CIGARETTE WAR, THE PUBLIC HEALTH AND THE UNABASHED TRIUMPH OF PHILIP MORRIS (1996).
17. The type of government regulation affecting the tobacco industry, at least until recently, might be explained under public-choice theory, which views the political process through the lens of economic analysis, and legislation as a commodity to be bought and sold; legislative decisionmaking, under this theory, can lead to arbitrary and discriminatory results, often yields outcomes that favor private interest groups, and bestows economic gain beyond what the free market would produce. See William N. Eskridge, Jr., Politics Without Romance: Implications of Public Choice Theory for Statutory Interpretation, 74 VA. L. REV. 275, 283-95 (1988); see also Jonathan R. Macey, Promoting Public-Regarding Legislation Through Statutory Interpretation: An Interest Group Model, 86 COLUM. L. REV. 223, 227-33 (1986); see generally ANTHONY DOWNS, AN ECONOMIC THEORY OF DEMOCRACY (1957); DENNIS MUELLER, PUBLIC CHOICE (1979).
18. The type of government regulation affecting the tobacco industry, at least until recently, might be explained under public-choice theory, which views the political process through the lens of economic analysis, and legislation as a commodity to be bought and sold; legislative decisionmaking, under this theory, can lead to arbitrary and discriminatory results, often yields outcomes that favor private interest groups, and bestows economic gain beyond what the free market would produce. See William N. Eskridge, Jr., Politics Without Romance: Implications of Public Choice Theory for Statutory Interpretation, 74 VA. L. REV. 275, 283-95 (1988); see also Jonathan R. Macey, Promoting Public-Regarding Legislation Through Statutory Interpretation: An Interest Group Model, 86 COLUM. L. REV. 223, 227-33 (1986); see generally ANTHONY DOWNS, AN ECONOMIC THEORY OF DEMOCRACY (1957); DENNIS MUELLER, PUBLIC CHOICE (1979).
19. The type of government regulation affecting the tobacco industry, at least until recently, might be explained under public-choice theory, which views the political process through the lens of economic analysis, and legislation as a commodity to be bought and sold; legislative decisionmaking, under this theory, can lead to arbitrary and discriminatory results, often yields outcomes that favor private interest groups, and bestows economic gain beyond what the free market would produce. See William N. Eskridge, Jr., Politics Without Romance: Implications of Public Choice Theory for Statutory Interpretation, 74 VA. L. REV. 275, 283-95 (1988); see also Jonathan R. Macey, Promoting Public-Regarding Legislation Through Statutory Interpretation: An Interest Group Model, 86 COLUM. L. REV. 223, 227-33 (1986); see generally ANTHONY DOWNS, AN ECONOMIC THEORY OF DEMOCRACY (1957); DENNIS MUELLER, PUBLIC CHOICE (1979).
20. The type of government regulation affecting the tobacco industry, at least until recently, might be explained under public-choice theory, which views the political process through the lens of economic analysis, and legislation as a commodity to be bought and sold; legislative decisionmaking, under this theory, can lead to arbitrary and discriminatory results, often yields outcomes that favor private interest groups, and bestows economic gain beyond what the free market would produce. See William N. Eskridge, Jr., Politics Without Romance: Implications of Public Choice Theory for Statutory Interpretation, 74 VA. L. REV. 275, 283-95 (1988); see also Jonathan R. Macey, Promoting Public-Regarding Legislation Through Statutory Interpretation: An Interest Group Model, 86 COLUM. L. REV. 223, 227-33 (1986); see generally ANTHONY DOWNS, AN ECONOMIC THEORY OF DEMOCRACY (1957); DENNIS MUELLER, PUBLIC CHOICE (1979).
21. Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended 21 U.S.C. §§ 301 et seq.).
22. See Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539 (1976).
23. See Nutrition Labeling and Education Act of 1990, Pub. L. No. 101-535, 104 Stat. 2353 (1990), as
24. See generally part III infra. The most notable exception has been in the federal regulation of labeling and advertising cigarettes. See Federal Cigarette Labeling and Advertising Act, Pub. L. No. 89-92, 79 Stat. 283 (1965), replaced by Public Health Cigarette Smoking Act, Pub. L. No. 91-222, 84 Stat 87 (1970) (codified as amended at 15 U.S.C. §§ 1331-1341), discussed infra at part III (B) (4). For a useful account of the history of the 1965 Act, see A. LEE FRITSCHLER, SMOKING AND POLITICS: POLICYMAKING AND THE FEDERAL BUREAUCRACY (1969). Cigarette manufacturers also have enjoyed a remarkable degree of success avoiding civil liability at the hands of consumers claiming injury from the use of the products. See Robert L. Rabin, Institutional and Historical Perspectives on Tobacco Tort Liability, in SMOKING POLICY: LAW, POLITICS, AND CULTURE ch. 6 (R. Rabin & S. Sugarman eds. 1993); Gary T. Schwartz, Tobacco Liability in the Courts, id. ch. 7. For contrasting views on the desirability of holding the tobacco industry liable in tort for smoking-related harm, compare Donald W. Garner, Cigarette Dependency and Civil Liability of Cigarette Manufacturers: A Modest Proposal, 53 S. CAL. L. REV. 1423 (1980), with Gregory P. Taxin, Tobacco Industry Liability for Cigarette-Related Injuries: "Smokers. Give It Up!," 16 J. PROD. & TOXIC LIAB. 221 (1994).
25. See generally part III infra. The most notable exception has been in the federal regulation of labeling and advertising cigarettes. See Federal Cigarette Labeling and Advertising Act, Pub. L. No. 89-92, 79 Stat. 283 (1965), replaced by Public Health Cigarette Smoking Act, Pub. L. No. 91-222, 84 Stat 87 (1970) (codified as amended at 15 U.S.C. §§ 1331-1341), discussed infra at part III (B) (4). For a useful account of the history of the 1965 Act, see A. LEE FRITSCHLER, SMOKING AND POLITICS: POLICYMAKING AND THE FEDERAL BUREAUCRACY (1969). Cigarette manufacturers also have enjoyed a remarkable degree of success avoiding civil liability at the hands of consumers claiming injury from the use of the products. See Robert L. Rabin, Institutional and Historical Perspectives on Tobacco Tort Liability, in SMOKING POLICY: LAW, POLITICS, AND CULTURE ch. 6 (R. Rabin & S. Sugarman eds. 1993); Gary T. Schwartz, Tobacco Liability in the Courts, id. ch. 7. For contrasting views on the desirability of holding the tobacco industry liable in tort for smoking-related harm, compare Donald W. Garner, Cigarette Dependency and Civil Liability of Cigarette Manufacturers: A Modest Proposal, 53 S. CAL. L. REV. 1423 (1980), with Gregory P. Taxin, Tobacco Industry Liability for Cigarette-Related Injuries: "Smokers. Give It Up!," 16 J. PROD. & TOXIC LIAB. 221 (1994).
26. See generally part III infra. The most notable exception has been in the federal regulation of labeling and advertising cigarettes. See Federal Cigarette Labeling and Advertising Act, Pub. L. No. 89-92, 79 Stat. 283 (1965), replaced by Public Health Cigarette Smoking Act, Pub. L. No. 91-222, 84 Stat 87 (1970) (codified as amended at 15 U.S.C. §§ 1331-1341), discussed infra at part III (B) (4). For a useful account of the history of the 1965 Act, see A. LEE FRITSCHLER, SMOKING AND POLITICS: POLICYMAKING AND THE FEDERAL BUREAUCRACY (1969). Cigarette manufacturers also have enjoyed a remarkable degree of success avoiding civil liability at the hands of consumers claiming injury from the use of the products. See Robert L. Rabin, Institutional and Historical Perspectives on Tobacco Tort Liability, in SMOKING POLICY: LAW, POLITICS, AND CULTURE ch. 6 (R. Rabin & S. Sugarman eds. 1993); Gary T. Schwartz, Tobacco Liability in the Courts, id. ch. 7. For contrasting views on the desirability of holding the tobacco industry liable in tort for smoking-related harm, compare Donald W. Garner, Cigarette Dependency and Civil Liability of Cigarette Manufacturers: A Modest Proposal, 53 S. CAL. L. REV. 1423 (1980), with Gregory P. Taxin, Tobacco Industry Liability for Cigarette-Related Injuries: "Smokers. Give It Up!," 16 J. PROD. & TOXIC LIAB. 221 (1994).
27. See generally part III infra. The most notable exception has been in the federal regulation of labeling and advertising cigarettes. See Federal Cigarette Labeling and Advertising Act, Pub. L. No. 89-92, 79 Stat. 283 (1965), replaced by Public Health Cigarette Smoking Act, Pub. L. No. 91-222, 84 Stat 87 (1970) (codified as amended at 15 U.S.C. §§ 1331-1341), discussed infra at part III (B) (4). For a useful account of the history of the 1965 Act, see A. LEE FRITSCHLER, SMOKING AND POLITICS: POLICYMAKING AND THE FEDERAL BUREAUCRACY (1969). Cigarette manufacturers also have enjoyed a remarkable degree of success avoiding civil liability at the hands of consumers claiming injury from the use of the products. See Robert L. Rabin, Institutional and Historical Perspectives on Tobacco Tort Liability, in SMOKING POLICY: LAW, POLITICS, AND CULTURE ch. 6 (R. Rabin & S. Sugarman eds. 1993); Gary T. Schwartz, Tobacco Liability in the Courts, id. ch. 7. For contrasting views on the desirability of holding the tobacco industry liable in tort for smoking-related harm, compare Donald W. Garner, Cigarette Dependency and Civil Liability of Cigarette Manufacturers: A Modest Proposal, 53 S. CAL. L. REV. 1423 (1980), with Gregory P. Taxin, Tobacco Industry Liability for Cigarette-Related Injuries: "Smokers. Give It Up!," 16 J. PROD. & TOXIC LIAB. 221 (1994).
28. See generally part III infra. The most notable exception has been in the federal regulation of labeling and advertising cigarettes. See Federal Cigarette Labeling and Advertising Act, Pub. L. No. 89-92, 79 Stat. 283 (1965), replaced by Public Health Cigarette Smoking Act, Pub. L. No. 91-222, 84 Stat 87 (1970) (codified as amended at 15 U.S.C. §§ 1331-1341), discussed infra at part III (B) (4). For a useful account of the history of the 1965 Act, see A. LEE FRITSCHLER, SMOKING AND POLITICS: POLICYMAKING AND THE FEDERAL BUREAUCRACY (1969). Cigarette manufacturers also have enjoyed a remarkable degree of success avoiding civil liability at the hands of consumers claiming injury from the use of the products. See Robert L. Rabin, Institutional and Historical Perspectives on Tobacco Tort Liability, in SMOKING POLICY: LAW, POLITICS, AND CULTURE ch. 6 (R. Rabin & S. Sugarman eds. 1993); Gary T. Schwartz, Tobacco Liability in the Courts, id. ch. 7. For contrasting views on the desirability of holding the tobacco industry liable in tort for smoking-related harm, compare Donald W. Garner, Cigarette Dependency and Civil Liability of Cigarette Manufacturers: A Modest Proposal, 53 S. CAL. L. REV. 1423 (1980), with Gregory P. Taxin, Tobacco Industry Liability for Cigarette-Related Injuries: "Smokers. Give It Up!," 16 J. PROD. & TOXIC LIAB. 221 (1994).
29. See generally part III infra. The most notable exception has been in the federal regulation of labeling and advertising cigarettes. See Federal Cigarette Labeling and Advertising Act, Pub. L. No. 89-92, 79 Stat. 283 (1965), replaced by Public Health Cigarette Smoking Act, Pub. L. No. 91-222, 84 Stat 87 (1970) (codified as amended at 15 U.S.C. §§ 1331-1341), discussed infra at part III (B) (4). For a useful account of the history of the 1965 Act, see A. LEE FRITSCHLER, SMOKING AND POLITICS: POLICYMAKING AND THE FEDERAL BUREAUCRACY (1969). Cigarette manufacturers also have enjoyed a remarkable degree of success avoiding civil liability at the hands of consumers claiming injury from the use of the products. See Robert L. Rabin, Institutional and Historical Perspectives on Tobacco Tort Liability, in SMOKING POLICY: LAW, POLITICS, AND CULTURE ch. 6 (R. Rabin & S. Sugarman eds. 1993); Gary T. Schwartz, Tobacco Liability in the Courts, id. ch. 7. For contrasting views on the desirability of holding the tobacco industry liable in tort for smoking-related harm, compare Donald W. Garner, Cigarette Dependency and Civil Liability of Cigarette Manufacturers: A Modest Proposal, 53 S. CAL. L. REV. 1423 (1980), with Gregory P. Taxin, Tobacco Industry Liability for Cigarette-Related Injuries: "Smokers. Give It Up!," 16 J. PROD. & TOXIC LIAB. 221 (1994).
30. See generally part III infra. The most notable exception has been in the federal regulation of labeling and advertising cigarettes. See Federal Cigarette Labeling and Advertising Act, Pub. L. No. 89-92, 79 Stat. 283 (1965), replaced by Public Health Cigarette Smoking Act, Pub. L. No. 91-222, 84 Stat 87 (1970) (codified as amended at 15 U.S.C. §§ 1331-1341), discussed infra at part III (B) (4). For a useful account of the history of the 1965 Act, see A. LEE FRITSCHLER, SMOKING AND POLITICS: POLICYMAKING AND THE FEDERAL BUREAUCRACY (1969). Cigarette manufacturers also have enjoyed a remarkable degree of success avoiding civil liability at the hands of consumers claiming injury from the use of the products. See Robert L. Rabin, Institutional and Historical Perspectives on Tobacco Tort Liability, in SMOKING POLICY: LAW, POLITICS, AND CULTURE ch. 6 (R. Rabin & S. Sugarman eds. 1993); Gary T. Schwartz, Tobacco Liability in the Courts, id. ch. 7. For contrasting views on the desirability of holding the tobacco industry liable in tort for smoking-related harm, compare Donald W. Garner, Cigarette Dependency and Civil Liability of Cigarette Manufacturers: A Modest Proposal, 53 S. CAL. L. REV. 1423 (1980), with Gregory P. Taxin, Tobacco Industry Liability for Cigarette-Related Injuries: "Smokers. Give It Up!," 16 J. PROD. & TOXIC LIAB. 221 (1994).
31. See infra part III (C). The days of the industry's immunity from civil liability also may be numbered. For accounts of recent litigation that has begun to breach the wall of immunity, see CARRICK MOLLENKAMP ET AL., THE PEOPLE v. BIC TOBACCO: HOW THE STATES TOOK ON THE CIGARETTE GIANTS (1998); PETER PRINGLE, CORNERED: BIG TOBACCO AT THE BAR OF JUSTICE (1998).
32. See infra part III (C). The days of the industry's immunity from civil liability also may be numbered. For accounts of recent litigation that has begun to breach the wall of immunity, see CARRICK MOLLENKAMP ET AL., THE PEOPLE v. BIC TOBACCO: HOW THE STATES TOOK ON THE CIGARETTE GIANTS (1998); PETER PRINGLE, CORNERED: BIG TOBACCO AT THE BAR OF JUSTICE (1998).
33. Indeed, the development of a reduced-risk cigarette by Company C might have significant product-liability implications for Company A. It might present plaintiffs seeking damages from Company A for smoking-related harm the opportunity to develop proof that Company A's product was defective because at the time of its marketing there was a feasible, reasonably safe alternative design for cigarettes, and if such a design had been adopted, plaintiff would not have suffered harm. See RESTATEMENT OF TORTS: PRODUCTS LIABILITY § 2(b) (Proposed Final Draft Apr. 1, 1997). amended by Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-417, 108 Stat. 4325 (1994).
34. Indeed, the development of a reduced-risk cigarette by Company C might have significant product-liability implications for Company A. It might present plaintiffs seeking damages from Company A for smoking-related harm the opportunity to develop proof that Company A's product was defective because at the time of its marketing there was a feasible, reasonably safe alternative design for cigarettes, and if such a design had been adopted, plaintiff would not have suffered harm. See RESTATEMENT OF TORTS: PRODUCTS LIABILITY § 2(b) (Proposed Final Draft Apr. 1, 1997). amended by Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-417, 108 Stat. 4325 (1994).
35. See U.S. DEP'T OF HEALTH & HUMAN SERVS., REDUCING THE HEALTH CONSEQUENCES OF SMOKING - 25 YEARS OF PROGRESS: A REPORT OF THE SURGEON GENERAL 428 (1989).
36. See U.S. DEP'T OF HEALTH & HUMAN SERVS., THE HEALTH CONSEQUENCES OF SMOKING - NICOTINE ADDICTION: A REPORT OF THE SURGEON GENERAL 471 (1988).
37. See id. at 471-79; see also Tamara Nordenberg, Which Nicotine Replacement Product Appeals to You?, FDA CONSUMER, Nov.-Dec. 1997, at 22, 23. For a more detailed discussion of tobacco-dependence treatment medications, see Jack E. Henningfield, Tobacco-Dependence Medications: Public Health and Regulatory Issues, 53 FOOD & DRUG L.J. 75 (Supp. 1998).
38. See id. at 471-79; see also Tamara Nordenberg, Which Nicotine Replacement Product Appeals to You?, FDA CONSUMER, Nov.-Dec. 1997, at 22, 23. For a more detailed discussion of tobacco-dependence treatment medications, see Jack E. Henningfield, Tobacco-Dependence Medications: Public Health and Regulatory Issues, 53 FOOD & DRUG L.J. 75 (Supp. 1998).
39. See id. at 88.
40. See Nordenberg, supra note 24, at 22.
41. See Tamara Nordenberg, It's Quitting Time: Smokers Need Not Rely on Willpower Alone, FDA CONSUMER, Nov.-Dec. 1997, at 19, 21.
42. See Nordenberg, supra note 24, at 22, 23.
43. They include a cigarette-cessation tablet and a gum containing six homeopathic medicines. See Cigarrest, About the Formula (visited May 1, 1998) 〈http://www.cigarrest.com/formula.htm〉.
44. One device is a receptacle for a pack of cigarettes. It generates, by a process of squeezing, tiny holes in the filters of each cigarette. The holes are designed to let air mix with the smoke from the cigarette, and produce a cooling effect that is claimed to condense and trap nicotine and other toxins. See Why Phaseout Works (visited May 1, 1998) 〈http://members.aol.com/freshairii/works2.html〉. Another is an artificial cigarette with a cartridge that releases a flavor simulating the sensation of inhaling from a cigarette. It is meant to replicate smoking by occupying the hands of the consumer and releasing a mint-like flavor into the mouth and lungs. See E-Z Quit Smokeless Artificial Cigarette System (visited May 1, 1998) 〈http:// www.quitsmoking.com/ezquit.htm〉.
45. One device is a receptacle for a pack of cigarettes. It generates, by a process of squeezing, tiny holes in the filters of each cigarette. The holes are designed to let air mix with the smoke from the cigarette, and produce a cooling effect that is claimed to condense and trap nicotine and other toxins. See Why Phaseout Works (visited May 1, 1998) 〈http://members.aol.com/freshairii/works2.html〉. Another is an artificial cigarette with a cartridge that releases a flavor simulating the sensation of inhaling from a cigarette. It is meant to replicate smoking by occupying the hands of the consumer and releasing a mint-like flavor into the mouth and lungs. See E-Z Quit Smokeless Artificial Cigarette System (visited May 1, 1998) 〈http:// www.quitsmoking.com/ezquit.htm〉.
46. See Henningfield, supra note 24, at 90; see also Metacalm -S, The Natural Way to Become Smoke Free (visited May 1, 1998) 〈http://www.metabolic.com/metas.htm〉 (information about dietary supplement intended to help smokers manage the nervousness and craving that accompany nicotine withdrawal, and to provide vitamins, minerals, amino acids, and herbs that help body normalize metabolic pathways affected by smoking).
47. See generally THE HEALTH CONSEQUENCES OF SMOKING - NICOTINE ADDICTION, supra note 23; see also Henningfield, supra note 24, at 80.
48. See Analysis Regarding Food and Drug Administration's Jurisdiction Over Nicotine-Containing Cigarettes and Smokeless Tobacco, 60 Fed. Reg. 41,453, 41,786 (Aug. 11, 1995).
49. See 21 U.S.C. § 321(g)(1)(B) ("[t]he term 'drug' means . . . articles intended for use in the . . . cure, mitigation, [or] treatment of disease in man . . .").
50. See 60 Fed. Reg. at 41,468.
51. See 21 U.S.C. § 321(g)(1)(C) ("[t]he term 'drug' means . . . articles . . . intended to affect . . . any function of the body of man . . . "). A third definitional alternative, being listed in one of several named pharmaceutical compendia (id. § 321 (g)(1)(A)), might also apply. For a discussion of the difficulties that might arise from the use of this subsection, see infra notes 178-80 and accompanying text.
52. See Pub. L. No. 100-607, § 503(a), 102 Stat. 3048, 3121 (1988) (codified as amended at 21 U.S.C. § 393) (establishing authority of Commissioner of Food and Drugs over the administration of the Act). FDA has authority to promulgate regulations for the efficient enforcement of the FDCA. 21 U.S.C. § 371(a). These regulations, under certain circumstances, may carry the force of law. See National Nutritional Foods Ass'n v. Weinberger, 512 F.2d 688 (2d Cir. 1975).
53. See 21 U.S.C. § 331(a). For specifics on what constitutes the adulteration of a drug, see id. § 351.
54. See id. § 331 (a). For specifics on what constitutes the misbranding of a drug, see id. § 352.
55. See id. § 331(f).
56. See Heckler v. Chaney, 470 U.S. 821, 831 (1985) ("an agency's decision not to prosecute or enforce, whether through civil or criminal process, is a decision generally committed to an agency's absolute discretion").
57. FDA recommends enforcement, but it is the U.S. Department of Justice that makes the ultimate decision whether to go ahead with the proceeding. See Developments in the Law: The Federal Food, Drug, and Cosmetic Act, 67 HARV. L. REV. 632, 683-84 (1954); Twelfth Survey of White Collar Crime: Federal Food and Drug Act Violations, 34 AM. CRIM. L. REV. 645, 656 (1997).
58. FDA recommends enforcement, but it is the U.S. Department of Justice that makes the ultimate decision whether to go ahead with the proceeding. See Developments in the Law: The Federal Food, Drug, and Cosmetic Act, 67 HARV. L. REV. 632, 683-84 (1954); Twelfth Survey of White Collar Crime: Federal Food and Drug Act Violations, 34 AM. CRIM. L. REV. 645, 656 (1997).
59. See 21 U.S.C. § 334.
60. See id. § 332.
61. See id. § 333. For a good summary of the most recent developments in the use of the Act's criminal sanctions, see Federal Food and Drug Act Violations, supra note 42, at 660-62.
62. See I. Scott Bass, Enforcement Powers of the Food and Drug Administration: Foods, Dietary Supplements, and Cosmetics, in 1 FUNDAMENTALS OF LAW AND REGULATION: AN IN-DEPTH LOOK AT FOODS, VETERINARY MEDICINES, AND COSMETICS 55, 70-72 (R. Brady, R. Cooper & R. Silverman eds. 1997) [hereinafter 1 FUNDAMENTALS].
63. See 21 U.S.C. § 375.
64. See id. § 360(b) (providing that new producers of drugs must provide FDA with their names and addresses).
65. A product falling into the latter category might be called "not a new drug" or an "old drug." Today a drug not considered a new drug would be subject to regulation under the Over-the-Counter Drug Review and would be called an over-the-counter drug. See part (II) (B) (8) infra. 50 21 U.S.C. § 321(p)(1). A second category of new drugs includes drugs whose safety and efficacy has been recognized as a result of investigations, but which have not been used to a material extent or for a material time under the conditions prescribed, recommended, or suggested in the labeling. Id. § 321(p)(2).
66. See 21 C.F.R. § 312.2(b)(3) (1997).
67. See Weinberger v. Bentex Pharmaceutical, Inc., 412 U.S. 645 (1973); Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609 (1973).
68. See 21 U.S.C. § 331 (d).
69. The relevant statutory provision is found at 21 U.S.C. § 355, which sets out in detail the procedures that must be followed and the standards that must be applied before a new drug may be marketed legally. On new drug development generally, see U.S. FOOD & DRUG ADMIN., FROM TEST-TUBE TO PATIENT: NEW DRUG DEVELOPMENT IN THE UNITED STATES - AN FDA CONSUMER SPECIAL REPORT (2d ed. Jan. 1995).
70. See J.A. DiMasi, New Drug Development: Cost, Risk & Complexity, 29 DRUG INFO. J. 375 (1995).
71. See Sam Kazman, Deadly Overcaution: FDA's Drug-Approval Process 1 J. REG. & SOC. COSTS 35 (1990). For an FDA Deputy Commissioner's defense of his agency's record on new drug approvals, see William B. Schultz, We're Not Dragging Our Feet on New Drugs, WASH. POST, Apr. 13, 1995, at A31.
72. See Sam Kazman, Deadly Overcaution: FDA's Drug-Approval Process 1 J. REG. & SOC. COSTS 35 (1990). For an FDA Deputy Commissioner's defense of his agency's record on new drug approvals, see William B. Schultz, We're Not Dragging Our Feet on New Drugs, WASH. POST, Apr. 13, 1995, at A31.
73. See 21 C.F.R. § 312.2(b)(3).
74. See id. § 312.23(a)(8).
75. See id. pt. 56. If the sponsor plans to conduct clinical trials in an institution, such as a hospital, she must also obtain the approval of the institutional review board within the institution. See Geoffrey M. Levitt, James N. Czaban & Andrea S. Paterson, Human Drug Regulation, in 2 FUNDAMENTALS OF LAW AND REGULATION: AN IN-DEPTH LOOK AT THERAPEUTIC PRODUCTS 159, 165 (D. Adams, R. Cooper & J. Kahan eds. 1997) [hereinafter 2 FUNDAMENTALS].
76. See 21 C.F.R. § 312.40.
77. See id. § 312.21.
78. See 21 U.S.C. § 355(b); 21 C.F.R. § 314.50.
79. See PETER BARTON HUTT & RICHARD A. MERRILL, FOOD AND DRUG LAW: CASES AND MATERIALS 519 (2d ed. 1991) (citing Report of the Subcomm. on Science, Research, and Technology of the House Comm. on Science and Technology, 96th Cong., 2d Sess. (1980)).
80. See Prescription Drug User Fee Act of 1992, Pub. L. No. 102-571, 106 Stat 4491 (codified at 21 U.S.C. §§ 379g-379h). These fee requirements were scheduled to expire in October 1997. Id. § 105, 106 Stat. at 4498. They were renewed under the FDA Modernization Act of 1997. Pub. L. No. 105-115, § 103, 111 Stat. 2296, 2299-2304 (1997).
81. See Prescription Drug User Fee Act of 1992, Pub. L. No. 102-571, 106 Stat 4491 (codified at 21 U.S.C. §§ 379g-379h). These fee requirements were scheduled to expire in October 1997. Id. § 105, 106 Stat. at 4498. They were renewed under the FDA Modernization Act of 1997. Pub. L. No. 105-115, § 103, 111 Stat. 2296, 2299-2304 (1997).
82. See 21 U.S.C. § 355(c)(1).
83. See David A. Kessler, Remarks by the Commissioner of Food and Drugs, 52 FOOD & DRUG L.J. 1 (1997); GENERAL ACCOUNTING OFFICE, FDA DRUG APPROVAL: REVIEW TIME HAS DECREASED IN RECENT YEARS (Oct. 1995).
84. See David A. Kessler, Remarks by the Commissioner of Food and Drugs, 52 FOOD & DRUG L.J. 1 (1997); GENERAL ACCOUNTING OFFICE, FDA DRUG APPROVAL: REVIEW TIME HAS DECREASED IN RECENT YEARS (Oct. 1995).
85. See 21 U.S.C. § 355(d).
86. See id.
87. See HUTT & MERRILL, supra note 63, at 522-24 (citing Hearings Before a Subcomm. of the House Comm. on Government Operations, 88th Cong., 2d Sess. (1964)).
88. 21 U.S.C § 355(d)(5).
89. In a regulation assessing, inter alia, the effectiveness of nonprescription smoking-deterrent medications, FDA took the position that the smoking status of subjects taking the product on a trial basis should be evaluated at the end of four months to determine efficacy. See Smoking Deterrent Products for Over-the-Counter Human Use, 58 Fed. Reg. 31,236, 31,238 (June 1, 1993).
90. See Henningfield, supra note 24, at 86. Moreover, the agency has rejected smoking reduction as a criterion for assessing the efficacy of nonprescription drugs. See infra note 108 and accompanying text.
91. A legal ground the agency might assert for disapproval is that "based on a fair evaluation of all material facts, [the proposed] labeling is false or misleading." 21 U.S.C. § 355(d)(7). FDA would have to ground such an assertion on the conviction that any indication other than smoking cessation would be of no real benefit to tobacco users, and, therefore, that labeling a drug for this use would deceive consumers.
92. Id. § 355(d)(7).
93. See Statement Regarding the Demonstrations of Effectiveness of Human Drug Products and Devices, 60 Fed. Reg. 39,180, 39,181 (Aug. 1, 1995).
94. Pub. L. No. 105-115, § 115, 111 Stat. at 2313 (codified at 21 U.S.C. § 355(d)).
95. See 21 U.S.C. § 355(d). This means that, in effect, FDA prescribes the information that must appear on the labeling of a "new drug." See Richard A. Merrill, Compensation for Prescription Drug Injuries, 59 VA. L. REV. 1, 11 (1973).
96. See generally Mary M. Dunbar, Shaking Up the Status Quo: How AIDS Activists Have Challenged Drug Development and Approval Procedures, 46 FOOD DRUG COSM. L.J. 673 (1991).
97. See Ronald Podraza, The FDA's Response to AIDS, 48 FOOD & DRUG L.J. 351, 359, 367 (1993). For a cautionary commentary on FDA's policy toward AIDS treatment, see Matthew C. Lovell, Second Thoughts: Do the FDA's Responses to a Fatal Drug Trial and the AIDS Activist Community's Doubts About Early Access to Drugs Hint at a Shift in Basic FDA Policy?, 51 FOOD & DRUG L.J. 273 (1996).
98. See Ronald Podraza, The FDA's Response to AIDS, 48 FOOD & DRUG L.J. 351, 359, 367 (1993). For a cautionary commentary on FDA's policy toward AIDS treatment, see Matthew C. Lovell, Second Thoughts: Do the FDA's Responses to a Fatal Drug Trial and the AIDS Activist Community's Doubts About Early Access to Drugs Hint at a Shift in Basic FDA Policy?, 51 FOOD & DRUG L.J. 273 (1996).
99. See New Drug, Antibiotic, and Biological Drug Product Regulations: Accelerated Approval, 57 Fed. Reg. 58,942 (Dec. 11, 1992).
100. Pub. L. No. 105-115, § 112, 111 Stat. at 2309 (codified at 21 U.S.C. § 356). The terms "serious or life-threatening" would seem to encompass grave conditions, such as nicotine addiction, that do not have an immediate adverse effect but can lead to deadly consequences over the long term.
101. Id. (codified at 21 U.S.C. § 356(b)(1)).
102. See 21 U.S.C. § 355(e).
103. See id. § 355(k).
104. 21 C.F.R. § 314.80.
105. See Pub. L. No. 105-115, § 112(a), 111 Stat. at 2309 (codified at 21 U.S.C. § 356(b)(2)(A)).
106. See Levitt, Czaban & Paterson, supra note 59, at 176-78.
107. See 21 C.F.R. § 314.54.
108. See American Pharmaceutical Ass'n v. Weinberger, 377 F. Supp. 824 (D.D.C. 1974), aff'd, 530 F.2d 1054 (D.C. Cir. 1976) (per curiam). 90 FDA, however, may approve NDAs for new drugs on which manufacturers have placed voluntary controls on distribution. See HUTT & MERRILL, supra note 63, at 635.
109. Pub. L. No. 91-513, 84 Stat. 1236 (1970) (codified at 21 U.S.C. §§ 801 et seq.).
110. The criteria for listing are spelled out in 21 U.S.C. § 811.
111. See id. § 353(b)(4) (FDCA § 503(b)(4)).
112. See id. § 353(b)(1)(A) (FDCA § 503(b)(1)(A)).
113. See id. § 353(b)(1)(C) (FDCA § 503(b)(1)(C)).
114. See id. § 353(b)(1)(B) (FDCA § 503 (b)(1)(B)).
115. For discussion of so-called "OTC switches," see Peter Barton Hutt, Framework for Future Decisions on Transferring Drugs from Prescription to Nonprescription Status, 37 FOOD DRUG COSM. L.J. 427 (1982); Kaplan et al., Over-the-Counter Drugs, in 2 FUNDAMENTALS, supra note 59, at 233, 238-41.
116. For discussion of so-called "OTC switches," see Peter Barton Hutt, Framework for Future Decisions on Transferring Drugs from Prescription to Nonprescription Status, 37 FOOD DRUG COSM. L.J. 427 (1982); Kaplan et al., Over-the-Counter Drugs, in 2 FUNDAMENTALS, supra note 59, at 233, 238-41.
117. See supra note 28 and accompanying text.
118. Pub. L. No. 87-781, 76 Stat. 780 (1962).
119. 21 U.S.C. § 321(p) (FDCA § 201(p)).
120. Id. § 355(d) (FDCA § 505(d)).
121. Pub. L. No. 87-781, § 107(c), 76 Stat. at 788. For a concise summary of these provisions, see Note, Drug Efficacy and the 1962 Drug Amendments, 60 GEO. L.J. 185, 195 (1971).
122. At this time, FDA estimated that between 100,000 and 500,000 separate OTC products were on the market. See FDA Formally Proposes Extensive Review of Non-Prescription Drugs' Effectiveness, WALL ST. J., Jan. 5, 1972, at 4.
123. See 37 Fed. Reg. 85 (Jan. 5, 1972).
124. For general descriptions of the OTC Review, see Charles C. Ames & Steven C. McCracken, Framing Regulatory Standards to Avoid Formal Adjudication: The FDA As a Case Study, 64 CAL. L. REV. 14 (1976); Note, FDA's Over-the-Counter Drug Review: Expeditious Enforcement by Rulemaking, 11 MICH. J.L. REFORM 142 (1977).
125. For general descriptions of the OTC Review, see Charles C. Ames & Steven C. McCracken, Framing Regulatory Standards to Avoid Formal Adjudication: The FDA As a Case Study, 64 CAL. L. REV. 14 (1976); Note, FDA's Over-the-Counter Drug Review: Expeditious Enforcement by Rulemaking, 11 MICH. J.L. REFORM 142 (1977).
126. See Smoking Deterrent Drug Products for Over-the-Counter Human Use: Tentative Final Monograph, 50 Fed. Reg. 27,552 (July 3, 1985).
127. See Smoking Deterrence Drug Products for Over-the-Counter Human Use, 58 Fed. Reg. 31,236 (June 1, 1993).
128. See id. at 31,238.
129. 21 U.S.C. § 321(m) (FDCA § 201(m)).
130. For a long illustrative list, see 21 C.F.R. § 202.1(1)(2).
131. See Jeffrey N. Gibbs & Judith E. Beach, Adulteration and Misbranding of Drugs, in 2 FUNDAMENTALS, supra note 59, at 205, 215.
132. See generally David A. Kessler, Regulating the Prescribing of Human Drugs for Nonapproved Uses under the Food, Drug, and Cosmetic Act, 15 HARV. J. LEGIS. 693 (1978); see also William L. Christopher, Off-Label Drug Prescriptions: Filling the Regulatory Vacuum, 48 FOOD & DRUG L.J. 247 (1993).
133. See generally David A. Kessler, Regulating the Prescribing of Human Drugs for Nonapproved Uses under the Food, Drug, and Cosmetic Act, 15 HARV. J. LEGIS. 693 (1978); see also William L. Christopher, Off-Label Drug Prescriptions: Filling the Regulatory Vacuum, 48 FOOD & DRUG L.J. 247 (1993).
134. See Pub. L. No. 105-115, § 401, 111 Stat. at 2356 (codified at 21 U.S.C. §§ 360aaa-aaa-5).
135. See Richard B. Ruge, Regulation of Prescription Drug Advertising: Medical Progress and Private Enterprise, 32 LAW & CONTEMP. PROBS. 650 (1967).
136. 21 U.S.C. § 352(n) (FDCA § 502(n)).
137. 21 C.F.R. § 202.1.
138. See Tamara Nordenberg, Direct to You: TV Drug Ads That Make Sense, FDA CONSUMER, Jan.-Feb. 1998, at 7, 8.
139. See FOOD & DRUG ADMIN., POLICY STATEMENT: VOLUNTARY MORATORIUM ON DIRECT-TO-CONSUMER ADVERTISING (1983).
140. See Direct-to-Consumer Advertising of Prescription Drugs; Withdrawal of Moratorium, 50 Fed. Reg. 36,677 (Sept 9, 1995).
141. See generally FOOD & DRUG ADMIN., DIV. OF DRUG MARKETING, ADVERTISING AND COMMUNICATION, CURRENT ISSUES AND PROCEDURES (1994).
142. See Nordenberg, supra note 117, at 9; Samuel Goldreich, Mystery Medication: FDA Rules Lead to Ads Without Name of Product, WASH. TIMES, July 3, 1997, at B7.
143. See Draft Guidance for Industry: Consumer-Directed Broadcast Advertisements, 62 Fed Reg. 43,171 (Aug. 12, 1997). Adequate provision might constitute furnishing an "800" number, an e-mail address, or the address of a Website on the Internet where consumers might obtain complete information about the product Television advertisements already have begun to promote the sale of one of the prescription-only medications approved for the treatment of nicotine dependence, buproprion hydrochloride.
144. See Wheeler-Lea Amendments, Pub. L. No. 75-447, 52 Stat 111 (1938) (codified at 15 U.S.C. §§ 41, 44, 45, 52-58).
145. See Pub. L. No. 87-781, 76 Stat. at 780.
146. 15 U.S.C. § 45(a)(1).
147. Id. §§ 52, 55. Section 55 specifically states that the failure to reveal material facts might amount to false advertising.
148. FTC Policy Statement Regarding Advertising Substantiation Program, 49 Fed. Reg. 30,999, 31,000 (Aug. 2, 1984).
149. See 16 C.F.R. §§ 2.31-2.34.
150. See, e.g., In re Warner-Lambert Co., 86 F.T.C. 1398 (1975), modified and enforced, 562 F.2d 749 (D.C. Cir. 1977), cert. denied, 435 U.S. 950 (1978); In re Continental Baking Co., 83 F.T.C. 865, modified, 83 F.T.C. 105 (1973), enforced and modified in part, 532 F.2d 207 (2d Cir. 1976), modified, 90 F.T.C. 181 (1977).
151. See Caswell O. Hobbs, Advertising for Therapeutic Products, in 2 FUNDAMENTALS, supra note 59, at 359, 379-82; Teresa M. Schwartz, The Need for Coordinated Regulation Among Federal Agencies, 43 GEO. WASH. L. REV. 1031, 1041-52 (1975) (FTC-FDA liaison).
152. See Caswell O. Hobbs, Advertising for Therapeutic Products, in 2 FUNDAMENTALS, supra note 59, at 359, 379-82; Teresa M. Schwartz, The Need for Coordinated Regulation Among Federal Agencies, 43 GEO. WASH. L. REV. 1031, 1041-52 (1975) (FTC-FDA liaison).
153. See 6 THE NEW ENCYCLOPEDIA BRITANNICA 24 (15th ed. 1997).
154. 21 U.S.C. § 321(g)(1)(A) (FDCA § 201(g)(1)(A)).
155. See Mesery v. United States, 447 F. Supp. 548 (D. Nev. 1977).
156. See Kaplan et al., supra note 97, at 242-45.
157. 21 U.S.C. § 321(h) (FDCA § 201 (h)). Such a device would qualify as treating a disease or affecting a bodily function for the same reasons that a substance intended to serve the same purposes would qualify as a drug. See part II (B) (1) supra. 136 Pub. L. No. 94-295, 90 Stat. 539 (1976) (as amended by Safe Medical Devices Act of 1990, Pub. L. No. 101-629, 104 Stat. 4511; Medical Device Amendments of 1992, Pub. L. No. 102-300, 106 Stat. 238; and FDA Modernization Act of 1997, Pub. L. No. 105-115, 111 Stat. at 2296.
158. 21 U.S.C. § 321(h) (FDCA § 201 (h)). Such a device would qualify as treating a disease or affecting a bodily function for the same reasons that a substance intended to serve the same purposes would qualify as a drug. See part II (B) (1) supra. 136 Pub. L. No. 94-295, 90 Stat. 539 (1976) (as amended by Safe Medical Devices Act of 1990, Pub. L. No. 101-629, 104 Stat. 4511; Medical Device Amendments of 1992, Pub. L. No. 102-300, 106 Stat. 238; and FDA Modernization Act of 1997, Pub. L. No. 105-115, 111 Stat. at 2296.
159. 21 U.S.C. § 360c(a)(1)(A) (FDCA § 513(a)(1)(A)). The Act provides that Class I status is justified when general controls are adequate to provide reasonable assurances of safety and efficacy, or, if not, the device is not intended for a use that would have substantial importance in preventing impairment of human health and does not carry with it an unreasonable risk of illness or injury. Id.
160. Id. § 360c(a)(1)(B) (FDCA § 513(a)(1)(B)). The Act indicates that Class II status will rest on a finding that general controls are insufficient to provide reasonable assurances of the safety and efficacy of the device. Id.
161. Id. § 360c(a)(1)(C) (FDCA § 513(a)(1)(C)). The statutory standard for a Class III device is that neither general nor special controls would be adequate to provide reasonable assurances of safety and efficacy, and the device is intended for a use that would have substantial importance in preventing the impairment of human health, or it created a potential undue risk of injury or illness. Id. 140 Id. § 360i (FDCA § 519).
162. Id. § 360(k) (FDCA §510(k)).
163. Id. § 360d (FDCA § 514).
164. Id. § 360e (FDCA ¶515).
165. See Howard M. Holstein & Edward C. Wilson, Developments in Medical Device Regulation, in 2 FUNDAMENTALS 257, 265-67.
166. See part III (C) (4) infra for a more detailed discussion of these tools.
167. See 21 U.S.C. § 321(f) (FDCA § 201(f)).
168. See id. § 321(ff) (FDCA § 201(fl)).
169. Id. § 321(g)(1)(B) (FDCA § 201(g)(1)(B)).
170. Id. § 321(g)(1) (FDCA § 201(g)(1)).
171. Id. § 343(r)(6)(A) (FDCA § 403(r)(6)(A)). On the statutory evolution of this section, see William R. Pendergast, Dietary Supplements, in 1 FUNDAMENTALS, supra note 46, at 257, 271-73, 261-62. FDA recently has proposed regulations that define more specifically the criteria the agency will use to identify disease-related claims. See Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body, 63 Fed. Reg. 23,624, 23,626-28 (Apr. 29, 1998).
172. Id. § 343(r)(6)(A) (FDCA § 403(r)(6)(A)). On the statutory evolution of this section, see William R. Pendergast, Dietary Supplements, in 1 FUNDAMENTALS, supra note 46, at 257, 271-73, 261-62. FDA recently has proposed regulations that define more specifically the criteria the agency will use to identify disease-related claims. See Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body, 63 Fed. Reg. 23,624, 23,626-28 (Apr. 29, 1998).
173. 21 U.S.C. § 343(r)(6)(C) (FDCA § 403(r)(6)(c)).
174. Id. § 343(r)(6) (FDCA § 403(r)(6)).
175. See supra notes 32-34 and accompanying text.
176. 21 U.S.C. § 343(r)(6)(A) (FDCA § 403(r)(6)(A)).
177. Id. § 343(r)(6)(B) (FDCA § 403(r)(6)(B)).
178. Id. § 343(r)(6) (FDCA § 403(r)(6)).
179. These laws are summarized and discussed in Susan H. Carchman, Should the FDA Regulate Nicotine-Containing Cigarettes? Has the Agency Established a Legal Basis, and If Not, Should Congress Grant It?, 51 FOOD & DRUG L.J. 85, 90-93 (1996).
180. See Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, 61 Fed. Reg. 44,396 (Aug. 28, 1996).
181. A U.S. District Court has upheld the agency's regulations. See Coyne Beahm, Inc. v. U.S. Food & Drug Admin., 958 F. Supp. 1060 (M.D.N.C. 1997). Its decision is under appeal to the U.S. Court of Appeals for the Fifth Circuit, which recently has scheduled the case for reargument. See Suein L. Hwang & Ann Davis, Tobacco Firms' Hopes in Lawsuit Are Dashed by Reargument Order, WALL ST. J., Apr. 20, 1998, at B11. For articles discussing the legal validity of the FDA regulations, see Open Forum, 51 FOOD & DRUG L.J. 471-500 (1996). See also Lars Noah & Barbara A. Noah, Nicotine Withdrawal: Assessing the FDA's Effort to Regulate Tobacco Products, 48 ALA. L. REV. 1 (1996) (arguing regulations invalid); James T. O'Reilly, Tobacco and the Regulatory Earthquake: Why the FDA Will Prevail After the Smoke Clears, 24 No. KY. L. REV. 509 (1997) (arguing regulations valid).
182. A U.S. District Court has upheld the agency's regulations. See Coyne Beahm, Inc. v. U.S. Food & Drug Admin., 958 F. Supp. 1060 (M.D.N.C. 1997). Its decision is under appeal to the U.S. Court of Appeals for the Fifth Circuit, which recently has scheduled the case for reargument. See Suein L. Hwang & Ann Davis, Tobacco Firms' Hopes in Lawsuit Are Dashed by Reargument Order, WALL ST. J., Apr. 20, 1998, at B11. For articles discussing the legal validity of the FDA regulations, see Open Forum, 51 FOOD & DRUG L.J. 471-500 (1996). See also Lars Noah & Barbara A. Noah, Nicotine Withdrawal: Assessing the FDA's Effort to Regulate Tobacco Products, 48 ALA. L. REV. 1 (1996) (arguing regulations invalid); James T. O'Reilly, Tobacco and the Regulatory Earthquake: Why the FDA Will Prevail After the Smoke Clears, 24 No. KY. L. REV. 509 (1997) (arguing regulations valid).
183. A U.S. District Court has upheld the agency's regulations. See Coyne Beahm, Inc. v. U.S. Food & Drug Admin., 958 F. Supp. 1060 (M.D.N.C. 1997). Its decision is under appeal to the U.S. Court of Appeals for the Fifth Circuit, which recently has scheduled the case for reargument. See Suein L. Hwang & Ann Davis, Tobacco Firms' Hopes in Lawsuit Are Dashed by Reargument Order, WALL ST. J., Apr. 20, 1998, at B11. For articles discussing the legal validity of the FDA regulations, see Open Forum, 51 FOOD & DRUG L.J. 471-500 (1996). See also Lars Noah & Barbara A. Noah, Nicotine Withdrawal: Assessing the FDA's Effort to Regulate Tobacco Products, 48 ALA. L. REV. 1 (1996) (arguing regulations invalid); James T. O'Reilly, Tobacco and the Regulatory Earthquake: Why the FDA Will Prevail After the Smoke Clears, 24 No. KY. L. REV. 509 (1997) (arguing regulations valid).
184. A U.S. District Court has upheld the agency's regulations. See Coyne Beahm, Inc. v. U.S. Food & Drug Admin., 958 F. Supp. 1060 (M.D.N.C. 1997). Its decision is under appeal to the U.S. Court of Appeals for the Fifth Circuit, which recently has scheduled the case for reargument. See Suein L. Hwang & Ann Davis, Tobacco Firms' Hopes in Lawsuit Are Dashed by Reargument Order, WALL ST. J., Apr. 20, 1998, at B11. For articles discussing the legal validity of the FDA regulations, see Open Forum, 51 FOOD & DRUG L.J. 471-500 (1996). See also Lars Noah & Barbara A. Noah, Nicotine Withdrawal: Assessing the FDA's Effort to Regulate Tobacco Products, 48 ALA. L. REV. 1 (1996) (arguing regulations invalid); James T. O'Reilly, Tobacco and the Regulatory Earthquake: Why the FDA Will Prevail After the Smoke Clears, 24 No. KY. L. REV. 509 (1997) (arguing regulations valid).
185. See, e.g., S. 1415, 105th Cong., 2d Sess. (1998); S. 1889, 105th Cong., 2d Sess. (1998); S. 1648, 105th Cong., 2d Sess. (1998); S. 1530, 105th Cong., 1st Sess. (1997). The Senate failed to pass S. 1415; on a motion to close off debate, the bill failed to attract the requisite number (60) of votes. See 144 CONG. REC. S6479 (daily ed. June 17, 1998).
186. In 1604 James I, King of England, railed against the smoking of tobacco as "harmful to the brain, dangerous to the lung." See KLUGER, supra note 14, at 15.
187. See id. at 108-10.
188. Pub. L. No. 59-384, 34 Stat. 768 (1906).
189. 21 U.S.C. § 321(f) (FDCA §201(f)) ("[t]he term 'food' means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article").
190. See supra part II (B) (1).
191. 21 U.S.C. § 321(I) (FDCA § 201(I)) ("[t]he term 'cosmetic' means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles, except that such term shall not include soap").
192. Id. § 321(h) (FDCA § 201(h)) (covering instruments, apparatus, and contrivances intended for uses such as would qualify an article as a "drug" under 21 U.S.C. §§ 321(g)(2), (3)).
193. Id. § 321(g)(1)(B) (FDCA § 201(g)(1)(B)).
194. Id. § 321(g)(1)(C) (FDCA § 201(g)(1)(C)).
195. See 1 JAMES T. O'REILLY, FOOD AND DRUG ADMINISTRATION § 13.03 (1979).
196. It is ironic that Jean Nicot, the Frenchman for whom nicotine was named, helped popularize the smoking of tobacco in the mid-sixteenth century by extolling its curative powers. See FRITCHLER, supra note 19, at 5-6; KLUGER, supra note 14, at 9.
197. See United States v. 46 Cartons More or Less, Containing Fairfax Cigarettes, 113 F. Supp. 336 (D.N.J. 1953).
198. See United States v. 354 Bulk Cartons Trim Reducing-Aid Cigarettes, 178 F. Supp. 847 (D.N.J. 1959).
199. See Federal Trade Comm'n v. Liggett & Myers Tobacco Co., 108 F. Supp. 573 (S.D.N.Y. 1952), aff'd, 203 F.2d 955 (2d Cir. 1953).
200. See, e.g., Hearings on S. 1454 Before the Consumer Subcomm. of the Sen. Comm. on Commerce, 92d Cong., 2d Sess. 239 (1972) (statement of Commissioner of Food and Drugs).
201. 655 F.2d 236 (D.C. Cir. 1980).
202. In other words, a manufacturer, knowing that almost every consumer of his product was using it in a certain way, could be considered to intend such a use if he continued to market the product with knowledge of the way it was being used.
203. 21 U.S.C. § 321(g)(1)(a) (FDCA § 201(g)(1)(a)).
204. See 1 USP DISPENSING INFORMATION, DRUG INFORMATION FOR THE HEALTH CARE
205. United States v. An Article of Drug . . . Ova II, 414 F. Supp. 660 (D.N.J. 1975), aff'd without opinion, 535 F.2d 1248 (3d Cir. 1976). The court went on to make a not-altogether persuasive attempt to salvage some permissible meaning out of § 321(g)(1)(A). The shakiness of this prong of the "drug" definition probably persuaded FDA not to rely on it, even as an alternative ground, when the agency finally decided to regulate nicotine as a drug. See infra part III (C) (2).
206. On the Consumer Product Safety Act, see generally MICHAEL R. LEMOV, CONSUMER PRODUCT SAFETY COMMISSSION (1983); WILLIAM KIMBLE, FEDERAL CONSUMER PRODUCT SAFETY ACT (1975).
207. On the Consumer Product Safety Act, see generally MICHAEL R. LEMOV, CONSUMER PRODUCT SAFETY COMMISSSION (1983); WILLIAM KIMBLE, FEDERAL CONSUMER PRODUCT SAFETY ACT (1975).
208. On the Consumer Product Safety Act, see generally MICHAEL R. LEMOV, CONSUMER PRODUCT SAFETY COMMISSSION (1983); WILLIAM KIMBLE, FEDERAL CONSUMER PRODUCT SAFETY ACT (1975).
209. Pub. L. No. 92-573, 86 Stat. 1207, 1208 (1972) (codified at 15 U.S.C. § 2052(a)(1)(B)).
210. Pub. L. No. 86-613, 74 Stat. 372 (1960) (codified at 15 U.S.C. § 1261(f)(2)).
211. Consumer Product Safety Improvements Act, Pub. L. No. 94-284, 90 Stat. 503 (1976).
212. 21 U.S.C. § 802(6). This creates an interesting anomaly. Despite the recognized addictiveness of cigarettes, they are exempted from regulation under the Controlled Substances Act; a tobacco-dependence treatment medication containing nicotine, however, conceivably might be regulated under the Act. See supra part II (B) (7) (b).
213. See, e.g., Fair Packaging and Labeling Act, Pub. L. No. 89-755, 80 Stat. 1296, 1301 (1966) (codified at 15 U.S.C. § 1459(a)(1)) (tobacco products excluded from coverage).
214. 15 U.S.C. § 45(a)(1).
215. In 1931, the U.S. Supreme Court held that FTC could take action against false advertising only if it adversely affected competition. FTC v, Raladam, 283 U.S. 643, 649 (1931). The Wheeler-Lea Amendments subsequently made it clear that the Commission could protect the consuming public against deceptive advertisements. See Pub. L. No. 75-447, 52 Stat. at 111.
216. 15 U.S.C. § 55(b)-(e).
217. Id. §§ 321(f), (g)(1), (h), (i) (FDCA §§ 201(f), (g)(1), (h), (i)).
218. See KLUGER, supra note 14, at 130.
219. See DEP'T OF HEALTH, EDUC., & WELFARE, PUBLIC HEALTH SERV., SMOKING AND HEALTH REPORT OF THE ADVISORY COMMITTEE TO THE SURGEON GENERAL OF THE PUBLIC HEALTH SERVICE (Pub. No. 1103) (1964).
220. See 29 Fed. Reg. 530 (Jan. 22, 1964).
221. Pub. L. No. 89-72, 79 Stat. 282 (1965) (codified as amended at 15 U.S.C. §§ 1331-1341).
222. 15 U.S.C. § 1331.
223. Id. § 1333(a).
224. Id. § 1334.
225. Id. § 1337(a).
226. Id. § 1337(b).
227. See Elizabeth Brenner Drew, The Quiet Victory of the Cigarette Lobby: How It Found the Best Filter Yet - Congress, ATLANTIC MONTHLY, Sept. 1965, at 76.
228. Pub. L. No. 91-222, 84 Stat. 87 (1970) (codified at 15 U.S.C. §§ 1331-1340). This statute pre-empted an initiative of the Federal Communications Commission, which first required broadcasters to give equal time for antismoking commercials and then proposed to ban all television advertising for tobacco products. See KLUGER, supra note 14, at 303-08, 327-28. The ban on television advertising also would put an end to the broadcast industry's need to provide time for antismoking advertisements, which apparently were having some effect on smokers. See Robert A. Kegan & David Vogel, The Politics of Smoking Regulation: Canada. France, and the United States, in SMOKING POLICY: LAW, POLITICS, AND CULTURE, supra note 19, at 22, 35.
229. Little Cigar Act of 1973, Pub. L. No. 93-109, 87 Stat. 352 (1973).
230. Pub. L. No. 99-252, 100 Stat. 30 (1986) (codified at 15 U.S.C. §§ 4401-4408).
231. The story is told in PHILIP J. HILTS, SMOKE SCREEN: THE TRUTH BEHIND THE TOBACCO INDUSTRY COVER-UP ch. 4 (1996); see also KLUGER, supra note 14, at 740-47. For an explanation by the FDA officials involved, see David A. Kessler et al., The Food and Drug Administration's Regulation of Tobacco Products, 335 NEW ENG. J. MED. 988 (1996).
232. The story is told in PHILIP J. HILTS, SMOKE SCREEN: THE TRUTH BEHIND THE TOBACCO INDUSTRY COVER-UP ch. 4 (1996); see also KLUGER, supra note 14, at 740-47. For an explanation by the FDA officials involved, see David A. Kessler et al., The Food and Drug Administration's Regulation of Tobacco Products, 335 NEW ENG. J. MED. 988 (1996).
233. See Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, 61 Fed. Reg. 44,396 (Aug. 28, 1996).
234. 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, 44,664-45,204 (Aug. 28, 1996).
235. See id. at 45,205-18.
236. See 61 Fed. Reg. at 44,616-18.
237. See id. at 44,617.
238. See 61 Fed. Reg. at 44,631-32.
239. See id. at 44,632-48.
240. See id. at 44,650-53.
241. 21 U.S.C. § 321 (p) (FDCA § 201(p)).
242. See 61 Fed. Reg. at 44,404. FDA insisted, however that it "could have used its drug authorities to implement similar types of controls on cigarettes and smokeless tobacco as it is imposing under the somewhat more flexible device authorities." Id. 213 On FDA's authority to regulate medical devices, see generally Howard M. Holstein & Edward C. Wilson, Developments in Medical Device Regulation, in 2 FUNDAMENTALS, supra note 59, at 257.
243. See 61 Fed. Reg. at 44,404. FDA insisted, however that it "could have used its drug authorities to implement similar types of controls on cigarettes and smokeless tobacco as it is imposing under the somewhat more flexible device authorities." Id. 213 On FDA's authority to regulate medical devices, see generally Howard M. Holstein & Edward C. Wilson, Developments in Medical Device Regulation, in 2 FUNDAMENTALS, supra note 59, at 257.
244. 21 U.S.C. § 321(h) (FDCA § 201(h)).
245. FDA established the requisite intent by using the same evidence and reasoning employed to support the conclusion that nicotine is a drug. See supra part II (B) (1).
246. 21 U.S.C. § 321(h) (FDCA § 201(h)).
247. 61 Fed. Reg. at 44,649-50.
248. See 21 U.S.C. § 353(g)(1) (FDCA § 503(g)(1)); see also Nancy L. Buc & Kate C. Beardsley, Combination Products and Other Jurisdictional Conundrums, in 2 FUNDAMENTALS, supra note 59, at 251.
249. 61 Fed. Reg. at 44,649-50.
250. See supra part II (B) (7) (c).
251. 21 U.S.C. § 360j(e)(1) (FDCA § 520(e)(1)).
252. Id. § 360j(e)(1)(B) (FDCA § 520(e)(1)(B)).
253. 61 Fed. Reg. at 44,426-62, 44,465-538.
254. Id. at 44,462-65.
255. 21 U.S.C. § 352(a) (FDCA § 502(a)).
256. 61 Fed. Reg. at 44,617.
257. Id. Authority for this requirement stems from 21 U.S.C. § 360j(e)(2), which provides that the label of a restricted device describe restrictions that have been placed on the device under 21 U.S.C. § 360j(1). The latter section provided FDA with a legal basis for placing restrictions on the distribution of cigarettes and smokeless tobacco products. See supra part III (C) (4).
258. Coyne Beahm, Inc., 958 F. Supp. at 1060.
259. The court relied on Chevron, U.S.A., Inc. v. Natural Resources Defense Council, 467 U.S. 837 (1984), which held that where a statute is silent or ambiguous with respect to a particular issue, an interpretation by the agency charged with administering the statute must be upheld if it is based on a permissible construction of the statutory language.
260. 21 C.F.R. §§ 201.128, 801.4.
261. The internal documents might have some relevance to the finding of foreseeability, because if a manufacturer intends for a product to be used in a certain way, he surely could anticipate it would be used in that way.
262. 21 U.S.C. § 360j(e)(1) (FDCA § 520(e)(1)).
263. Id. § 360j(e)(1)(B) (FDCA § 520(e)(1)(B)).
264. See id. § 352(q)-(r) (FDCA § 502(q)-(r)).
265. For arguments that a ban on content-based restrictions on tobacco advertising would be unconstitutional, see Martin H. Redish, Tobacco Advertising and the First Amendment, 81 IOWA L. REV. 589 (1996);
266. see also Daniel Helberg, Butt Out: An Analysis of the FDA's Proposed Restrictions on Cigarette Advertising Under the Commercial-Speech Doctrine, 29 LOY. L.A. L. REV. 1219 (1996) (student note criticizing FDA's attempt to restrict advertising of cigarettes). For defenses of FDA's proposed restrictions on advertising,
267. see Allison M. Zieve, The FDA's Regulation of Tobacco Products, 51 FOOD & DRUG L.J. 495, 498-99 (1996);
268. Lawrence O. Gostin, Peter S. Arno & Allan M. Brandt, Free Speech Smokescreen, WASH. POST, Mar. 3, 1997, at A23.
269. For FDA's explanation why it focused on the protection of minors, see 61 Fed. Reg. at 44,398-99.
270. See id. at 44,404.
271. 21 U.S.C. § 351 (FDCA § 501).
272. Id. § 352 (FDCA § 502).
273. E.g., id. § 352(s) (FDCA § 502(s)) (device misbranded if it is subject to a performance standard that requires specific labeling and it fails to bear such labeling).
274. Id. § 3601 (FDCA § 519).
275. Id. § 360(k) (FDCA § 510(k)).
276. For a discussion of these burdens, see supra part II (C).
277. Cf. James T. O'Reilly, A Consistent Ethic of Safety Regulation: The Case for Improving Regulation of Tobacco Products, 3 ADMIN. L.J. 215, 234-35 (1989) (resource drain as reason why FDA has hesitated to do battle with powerful tobacco industry).
278. 21 U.S.C. § 360c(a)(1)(B) (FDCA § 513(a)(1)(B)).
279. See id. § 360d (FDCA § 514).
280. Cf. 15 U.S.C. § 2056(a)(1) (standards promulgated under the Consumer Product Safety Act are to be "expressed in terms of performance requirements").
281. See H. REP. No. 94-853, 94th Cong., 2d Sess. 26 (1976). A design standard dictates how a desired result must be achieved.
282. S. REP. No. 94-33, 94th Cong., 1st Sess. 11 (1975).
283. See H. REP. No. 94-1090, 94th Cong., 2d Sess. (1976).
284. 21 U.S.C. § 360d(a)(2)(B)(i) (FDCA § 514(a)(2)(B)(i)).
285. For example, FDA first would need to secure the recommendation of an expert panel. Id. § 360c(b) (FDCA § 513(b)).
286. The procedures are detailed in 21 U.S.C. § 360(d) (FDCA § 513(d)). One commentator has described the procedures as "a procedural maze." Robert B. Leflar, Public Accountability and Medical Device Regulation, 2 HARV. J.L. & TECH. 1, 25 (1989). For a diagram of the standard-setting process, see id. at 26.
287. See Holstein & Wilson, supra note 144, at 295.
288. See id. at 273-84; Leflar, supra note 255, at 9-24.
289. See 21 U.S.C. § 360c(b) (FDCA § 513(b)).
290. See id. § 360e(b) (FDCA § 515(b)).
291. See id. § 360e(c) (FDCA § 515(c)).
292. See id. § 360e(d)(2)(A)-(B) (FDCA § 515(d)(2)(A)-(B)).
293. See supra notes 213-14 and accompanying text.
294. FDA Dkt. No. 98-P-0031 (Jan. 15, 1998).
295. Id. at 27-28.
296. For a description, see KLUGER, supra note 14, at ch. 6; John Slade, Tobacco Product Regulation: Context and Issues, 53 FOOD & DRUG L.J. 43 (Supp. 1998).
297. For a description of some of these products, see Slade, supra note 265, at 56.
298. See HILTS, supra note 204, at 109; Carchman, supra note 157, at 98.
299. See supra part III (C) (2).
300. See supra part III (C) (5).
301. See supra part II (B)(1).
302. See supra part III (C) (3).
303. See supra part IV (B).
304. In the 1950s, food labeling began to bear implied health-related claims to the effect that a particular product was low in fat or cholesterol. When FDA doubted the truth of the assertion, the agency took the position that such claims rendered the food misbranded. See Peter B. Hutt, Government Regulation of Health Claims in Food Labeling and Advertising, 41 FOOD DRUG COSM. L.J. 3, 27-34 (1986). FDA, however, could not take the same approach toward "low-tar-and-low-nicotine" cigarettes without first establishing jurisdiction over the products.
305. For a discussion of how foreseeability might establish intended use, see supra part III (C) (5).
306. For a discussion of tobacco-dependence treatment medications as new drugs, see supra part II (B) (3).
307. For a discussion of the new drug approval process, see supra part II (B) (4).
308. For a discussion of the difficulties that might arise from a decision to set performance standards, see supra part II (A) (7).
309. For elaboration of this point, see Henningfield, supra note 24, at 92.
310. See Kenneth E. Warner, John Slade & David T. Sweanor, The Emerging Market for Long-Term Nicotine Maintenance, 278 JAMA 1087, 1089 (1997).
311. Some of the bills that have been introduced in Congress to effectuate the settlement are cited in note 160, supra. See also S. REP. No. 105-180, 105th Cong., 2d Sess. (1998) (report on S. 1415). On a motion to close off debate, S. 1415 failed to attract the requisite number (60) of votes. See 144 CONG. REC. S6479 (daily ed. June 17, 1998). For a provocative criticism of the proposed settlement, see Jon D. Hanson & Kyle D. Logue, The Costs of Cigarettes: The Economic Case for Ex Post Incentive-Based Regulation, 107 YALE L.J. 1163 (1998).
312. Some of the bills that have been introduced in Congress to effectuate the settlement are cited in note 160, supra. See also S. REP. No. 105-180, 105th Cong., 2d Sess. (1998) (report on S. 1415). On a motion to close off debate, S. 1415 failed to attract the requisite number (60) of votes. See 144 CONG. REC. S6479 (daily ed. June 17, 1998). For a provocative criticism of the proposed settlement, see Jon D. Hanson & Kyle D. Logue, The Costs of Cigarettes: The Economic Case for Ex Post Incentive-Based Regulation, 107 YALE L.J. 1163 (1998).
313. Some of the bills that have been introduced in Congress to effectuate the settlement are cited in note 160, supra. See also S. REP. No. 105-180, 105th Cong., 2d Sess. (1998) (report on S. 1415). On a motion to close off debate, S. 1415 failed to attract the requisite number (60) of votes. See 144 CONG. REC. S6479 (daily ed. June 17, 1998). For a provocative criticism of the proposed settlement, see Jon D. Hanson & Kyle D. Logue, The Costs of Cigarettes: The Economic Case for Ex Post Incentive-Based Regulation, 107 YALE L.J. 1163 (1998).