Thank you for regulating: Why philip morris's embrace of FDA regulation helps the company but harms the agency

Administrative Law Review

Volumn 61, Issue 1, 2009, Pages 197-233

  Barker, Kevin Gauntt ^a  

^a AMERICAN UNIVERSITY   (United States)

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EID: 68049146087     PISSN: 00018368     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (289)

1. Philip Morris and other major tobacco companies filed suit in 1997 against the Food and Drug Administration (FDA), claiming that the agency lacked jurisdiction to regulate tobacco products because cigarette manufacturers did not attach therapeutic-benefit claims to their products. The federal district court ruled in FDA's favor, but the Fourth Circuit reversed. The Supreme Court granted certiorari and affirmed the Fourth Circuit decision.
2. See FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 129-31, 161 (2000) (holding that Congress had not given FDA the authority to regulate tobacco products).
3. Patricia A. McDaniel & R.E. Malone, Understanding Philip Morris's Pursuit of U.S. Government Regulation of Tobacco, 14 TOBACCO CONTROL 193, 193 (2005) (asserting that Philip Morris has been "aggressively pursuing" FDA regulation since 2000)
4. see also Legacy Tobacco Documents Library, Privileged & Confidential Annual Meeting 2000- Draft Litigation Points 3 (Feb. 23, 2000) [hereinafter Legacy Tobacco Documents Library], http://legacy.library.ucsf.edu/tid/pxg77a00/ pdf (tobacco industry insider memo stating that, although the industry had opposed past FDA regulatory efforts because the agency had treated tobacco like a "medical product," it supported "sensible regulation" that, inter alia, respected adult consumers' right to smoke and guided the industry toward the development of "less risky" products). Soon after the internal decision, the company publicly declared its position.
5. See Barry Meier, Executive Says Philip Morris Is Open to Some Regulation, N.Y. TIMES, Feb. 29, 2000, at A12 (reporting that Philip Morris is open to "some" government regulation).
6. Samuel Loewenberg, Smoke Screen: Why Is Philip Morris Supporting FDA Regulation of Cigarettes?, SLATE, July 25, 2002, http://www.slate.com/id/ 2068476/ (A veteran tobacco lobbyist for a competitor of Philip Morris stated, "They are impenetrable to me. Their strategy is impenetrable, their positions are impenetrable &mellip; I find their positions to be nuts."). One journalist wrote a lengthy magazine article devoted to figuring out why Philip Morris supported regulation, exploring whether a measure could benefit both Philip Morris and the general public. Joe Nocera, If It's Good for Philip Morris, Can It Also Be Good for Public Health?, N.Y. TIMES MAG., June 18, 2006, available at http://www.nytimes.com/2006/06/18/magazine/ 18tobacco.html.
7. See, e.g., Loewenberg, supra note 3 (reporting that the American Lung Association chief lobbyist, Paul Billings, was initially "cynical," but now believes the company has legitimately altered its policy aims).
8. A longtime tobacco health expert remarked that H.R. 1108 could be renamed the "Marlboro Protection Act."
9. See The Need for FDA Regulation of Tobacco: Examining S. 625, To Protect the Public Health by Providing the FDA with Certain Authority to Regulate Tobacco Products: Hearing on H.R. 1108 Before the S. Comm. on Health, Educ, Labor, and Pensions, 110th Cong. 57 (2007) [hereinafter Senate Hearing] (statement of Alan Blum, M.D., Director, University of Alabama Center for the Study of Tobacco and Society).
10. H.R. 1108, 110th Cong, (as introduced in the House of Representatives, Feb. 15, 2007).
11. See generally C. STEPHEN REDHEAD & VANESSA BURROWS, CONG. RESEARCH SERV., FDA REGULATION OF TOBACCO PRODUCTS: A POLICY AND LEGAL ANALYSIS (2007), available at http://www.nationalaglawcenter.org/assets/crs/RL32619.pdf (detailing the litany of tobacco-industry regulation bills proposed since 2000).
12. The 110th Congress's H.R. 1108 was simply a reintroduction of bills introduced in previous Congresses
13. the legislation was first introduced in the 108th Congress. REDHEAD & BURROWS, supra note 6, summary. Further, the FDA tobacco bills that have been introduced since the 107th Congress-and gained legislative momentum-have been either identical or very similar in content to each other and H.R. 1108. Id. at 19-20. Even though a future bill may well be a carbon copy of H.R. 1108, bills are assigned a different number if reintroduced in a different session of Congress.
14. See GOVTRACK.US, http://www.govtrack.us/congress/bill.xpd?bill=hl 10-1108 (last visited Feb. 20, 2009) (explaining that congressional members often reintroduce old legislation, which is renumbered for the new congressional session).
15. Nineteenth-century railroad executives, for example, were instrumental in Congress's passage of legislation authorizing federal regulation of the industry.
16. See generally GABRIEL KOLKO, RAILROADS AND REGULATION: 1877-1916 (1965). Contemporary examples of the big-business push for regulation include the Alliance of Automobile Manufacturers' advocacy of government-raised fuel efficiency standards and the Mortgage Bankers Association's advocacy of federal control over predatory lending.
17. See Eric Lipton & Gardiner Harris, In Turnaround, Industries
18. Seek U.S. Regulations, NYTlMES.COM, Sept. 16, 2007, http://www.nytimes. com/2007/09/16/washington/16regulate.html (observing the phenomenon of the push for regulation by "some of the nation's biggest industries" and expounding the self-interests dictating this advocacy).
19. See RICHARD D. STONE, THE INTERSTATE COMMERCE COMMISSION AND THE RAILROAD INDUSTRY: A HISTORY OF REGULATORY POLICY 4 (1991) (noting that united Populist farmers led the initial push to regulate railroads).
20. See KOLKO, supra note 8, at 17-20 (revealing that after many failed attempts at "self-regulation," industry executives increasingly favored federal regulation).
21. See id. at 232-33 (characterizing railroad executives as preempting the public's demand for action by hiding behind railroad-friendly federal regulation and as "relying on the [Interstate Commerce] Commission [(ICC)] as a means of attaining their own ends").
22. See id. at 44 (concluding that while the ICC bill was "conservative," the public saw it as "radical").
23. For the full procedural history of the challenges to FDA regulation of tobacco products
24. see Coyne Beahm, Inc. v. FDA, 966 F. Supp. 1374 (M.D.N.C. 1997), Brown & Williamson Tobacco Corp. v. FDA, 153 F.3d 155 (4th Cir. 1998), and FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000).
25. For example, a 2000 draft of the bill eliminated federal preemption of potential state tort claim damages, which was one of Philip Morris's "requirements" for supporting FDA regulation. John Scruggs, Philip Morris's chief lobbyist at the time, manifested his stiff opposition to such a provision. In reporting to his Philip Morris colleagues, Scruggs said, "I took the opportunity to 'fall on my sword' and made it very clear [to congressional staff members] that we would do everything in our power to kill this bill and any other bill that contained] such a provision." McDaniel & Malone, supra note 2, at 194-95.
26. As two congressional analysts note, "H.R. 1108 ⋯ represents an attempt to balance the competing interests of Philip Morris and leading anti-tobacco groups." REDHEAD & BURROWS, supra note 6, at 20. Philip Morris has intensely lobbied Congress concerning FDA regulation for years, and some of the compromises in H.R. 1108 might have been drafted by the industry. Id. at 194. Representatives from Philip Morris in the past have "worked with legislators, meeting with staff to explain [Philip Morris]'s views, helping to write legislation, and lobbying on behalf of [FDA regulatory] legislation [Philip Morris] supported." Id. at 195. When Republicans proved difficult to win over because of their ideological opposition to increased government regulation, Philip Morris representatives used polls showing that suburban swing voters-whose support was key to maintaining a Republican majority in Congress-favored FDA regulation of tobacco. Philip Morris even tried to hide its support for two early FDA regulation bills-publicly criticizing the legislation while privately rallying support-in order to "avoid the impression that it was dictating terms to Congress." Id. at 194-95.
27. See Regarding "H.R. 1108, Family Smoking Prevention and Tobacco Control Act": Hearing Before the Subcomm. on Health of the H. Comm. on Energy and Commerce, 110th Cong. 7 (2007) (submission of Alan Blum, M.D., Director, The University of Alabama Center for the Study of Tobacco and Society), available at http://energycommerce.house.gov/cmte-mtgs/110-he-hrg. 100307.HR-1108.Tobacco.shtml (follow Alan Blum, M.D. hyperlink) (declaring that "[t]his bill is a godsend for Philip Morris").
28. See H.R. 1108, 110th Cong, (as introduced in the House of Representatives, Feb. 15,2007).
29. See id. § 907(a) (establishing general tobacco product standards).
30. Id. § 907(d)(3)(AMB).
31. H.R. 1108 and the tobacco industry use modified rather than reduced. Since modified risk must mean either reduced or increased risk (and the bill certainly does not contemplate increased-risk cigarettes), this is a semantical distinction that is potentially confusing for the reader. Accordingly, I will use reduced rather than modified. H.R. 1108 concedes this point in the bill's definitions. Id. § 911(b)(1).
32. Id. §911(0)
33. Id. I 911(g)(2).
34. Id. § 906(d)(1).
35. Id. § 907(a)(1)(A). A cottage industry of criticism has developed around the bill's exemption of menthol from an otherwise exhaustive list of banned flavorings. Studies have suggested (but have not proved) that menthol may increase incidents of disease and makes quitting more difficult. Additionally, African-American smokers overwhelmingly choose menthol cigarettes.
36. See Stephanie Saul, Cigarette Bill Treats Menthol with Leniency, N.Y. TIMES, May 13, 2008, at A15, available at http://www.nytimes.com/2008/05/13/ business/13menthol.html.
37. H.R. 1108 § 906(d)(3)(A)(ii). If the buying age were raised to nineteen, then almost no high-school students could purchase cigarettes
38. A tobacco researcher explains that it is generally understood that raising the permissible buying age is important for "getting cigarettes out of high schools." Senate Hearing, supra note 5, at 158 (prepared statement of Anne Landman, Tobacco Document Research and Consulting).
39. Compare Senate Hearing, supra note 5, at 163 (prepared statement of Michael Siegel, M.D., M.P.H., Professor, Social and Behavioral Sciences Department, Boston University School of Public Health) ("The one thing you will never hear the supporters of this legislation do is estimate the number of lives they think this legislation will save. All they can do is talk about 'countless' lives being saved. And they are quite correct. The lives are countless. You cannot count them because they do not exist."), and Statement of FDA Commissioner Andrew C. von Eschenbach, M.D., Oct. 3, 2007, http://www.fda.gov/ola/2007/tobaccol00307.html (warning that H.R. 1108 might cause the public to believe that cigarettes are safe and may encourage smoking), with Senate Hearing, supra note 5, at 105 (letter from David A. Kessler, M.D., former FDA Commissioner) (endorsing H.R. 1108 without discussing specific provisions and stating that it "is a strong bill and would significantly advance the public health").
40. FDA currently faces accusations of industry capture. For example, a 2007 Institute of Medicine report criticized FDA's focus on the speed of drug approval (which favors the pharmaceutical industry), finding that FDA was not concerned enough with drug safety (which protects the public).
41. See BOARD ON POPULATION HEALTH AND PUBLIC HEALTH PRACTICE, THE FUTURE OF DRUG SAFETY: PROMOTING AND PROTECTING THE HEALTH OF THE PUBLIC 97-98 (2007), available at http://books.nap.edu/openbook.php?record-id=11750&page=97 (describing the undesirable effects of the Prescription Drug User Fee Act on FDA).
42. Commissioner von Eschenbach writes, Were H.R. 1108 enacted, FDA would need to create an entirely new "tobacco center" to implement the detailed program created by the bill. By far, the most important and daunting challenge would be to develop the expertise necessary to carry out the functions called for by this bill. FDA does not have expertise regarding customarily marketed tobacco products and, therefore, would have to establish an entirely new program and hire new experts. Creating the appropriate organizational structure and hiring experts in the field of tobacco control and related sciences and other experts needed to staff the program at every level is considerably more challenging than simply filling identified vacancies in an existing program. Von Eschenbach, supra note 26.
43. See generally Peter Barton Hurt, The State of Science at the Food and Drug Administration, 60 ADMIN. L. REV. 431 (2008) (detailing how FDA is currently scientifically and structurally overwhelmed).
44. See McDaniel & Malone, supra note 2, at 197 (positing that Philip Morris views FDA regulation as a means to improve the company's "unfavorable" public image).
45. Industry capture describes both authorizing legislation that favors big business (addressed in this Comment) and the favorable implementation of regulation. For a technical, theoretical discussion of both phenomena
46. see BARRY M. MITNICK, THE POLITICAL ECONOMY OF REGULATION: CREATING, DESIGNING, AND REMOVING REGULATORY FORMS 206-42 (1980).
47. See generally H.R. 1108, 110th Cong. § 907 (as introduced in the House of Representatives, Feb. 15, 2007) (stating the tobacco-product standards)
48. id. §912 (establishing the judicial review provision).
49. See generally id. § 911 (regulating "modified risk tobacco products").
50. See KOLKO, supra note 8, at 6 (arguing, in the context of the railroad industry, that scholars have refiexively concluded that industry opposes regulation).
51. See id. at 2 (explaining that many historians imagined a federal government "redirect[ing] the balance of economic power on behalf of the public").
52. See GEORGE J. STIGLER, The Theory of Economic Regulation, in THE CITIZEN AND THE STATE 114 (1975) (claiming that as a rule, industry acquires the regulation which then chiefly benefits the industry).
53. See STONE, supra note 9, at 6 (describing the creation of ICC to over
54. see the Act to Regulate Commerce).
55. Id. at 3-4.
56. Id. at 6.
57. See KOLKO, supra note 8, at 6 (describing this historical depiction and noting the role the railroad industry played in the movement for federal regulation). Kolko's thesis that railroads were instrumental in achieving regulation and that the ICC in turn benefitted the industry, while controversial and provocative when published, has gained critical acceptance.
58. See, e.g., George W. Hilton, 77ie Consistency of the Interstate Commerce Act, 9 J.L. & ECON. 87, 105 (1966) (praising Kolko's work)
59. see also George J. Stigler, The Theory of Economic Regulation, 2 BELL J. ECON. & MGMT. Sci. 3, 17 (1971) ('"So many economists &mellip; have denounced the ICC for its pro-railroad policies that this has become a cliche' of the literature.")
60. cf. STONE, supra note 9, at 5-6 ("There is some indication that Kolko may be correct in that some, if not all, of the railroads thought that regulation would be beneficial to them in controlling competition by eliminating rate differences among railroads.").
61. KOLKO, supra note 8, at 3.
62. See id. at 232 (asserting that the industry's push was a means of preempting less-friendly regulation and describing federal regulation as a "safe shield")
63. see also STONE, supra note 9, at 5 ("[F]ederal regulation of the railroads was in the offing, as many groups in the country were pushing for it.").
64. See Hilton, supra note 39, at 87 (explaining that ICC's formation was in response to "widespread dissatisfaction" with the railroad industry).
65. Railroads tried many times to self-organize and establish rules to protect their collective interests, including attempts to collude on prices and to pool incomes in order to defuse price wars. Id. at 87-90. Since each attempt failed, executives increasingly believed that only the federal government could structure the industry in a manner that was not self-defeating.
66. See KOLKO, supra note 8, at 10-11, 14, 18-19 (describing failed pooling efforts which led the industry to turn to the government for "salvation").
67. See KOLKO, supra note 8, at 15, 37 (describing the industry's hope of limiting harmful regulation, while leading the public to think much had been accomplished)
68. cf THOM HARTMANN, UNEQUAL PROTECTION: THE RISE OF CORPORATE DOMINANCE AND THE THEFT OF HUMAN RIGHTS 161-62 (2002) (quoting disenchanted Reagan-era regulators as saying that the supreme industry feat would be to attain new regulation that is perceived as meaningful, but in fact applied by a captive agency).
69. KOLKO, supra note 8, at 37 (quoting railroad president Charles Adams, Jr., "In the hands of the right men, any bill would produce the desired results").
70. Compare Sarah Smith, America's Most Admired Corporations, FORTUNE, Jan. 29, 1990, at 58 (ranking Philip Morris as the second most admired corporation), with Edward A. Robinson, America's Most Admired Companies, FORTUNE, Mar. 3, 1997, at 68 (dropping Philip Morris to 147th on that year's list).
71. See, e.g., Oversight Hearing on Tobacco Products, Before the Subcomm. on Health and the Env't of the H. Comm. on Energy and Commerce, 103d Cong. 66, 68 (1994), available at http://tobaccodocuments.org/pm/2031195199-5455.html (William Campbell, then-president of Philip Morris USA, stated in response to the question of whether cigarette smoking caused lung cancer, "We don't know what causes cancer right now." Jim Johnston, then-Chairman and CEO of R.J. Reynolds, stated in response to the same question, "It may."). In the same hearing, six major tobacco companies' executives denied that nicotine was addictive. Id. at 78-79. A Philip Morris spokesman concedes that such miscalculations were largely responsible for the public's increasingly negative appraisal of Big Tobacco. For a candid discussion of industry mistakes
72. see Steven C. Parrish, Bridging the Divide: A Shared Interest in a Coherent National Tobacco Policy, 3 YALE J. HEALTH POL'YL. & ETHICS 109,109-12 (2002).
73. The suit settled in 1997 for more than $3 billion. Tobacco Industry Settles Mississippi Lawsuit: Florida Also Makes Settlement Offer, CNN.COM, July 3, 1997, http://www.cnn.com/US/9707/03/tobacco/index.html. For a behind-the-scenes look at the lawsuit
74. see Peter J. Boyer, The Bribe: How the Mississippi Lawyer Who Brought Down Big Tobacco Overstepped, NEW YORKER, May 19, 2008, at 44, available at http://www.newyorker.com/reporting/2008/05/19/080519fa-fact-boyer.
75. See David A. Kessler et al., The Food and Drug Administration's Regulation of Tobacco Products, 335 NEWENG. J. MED. 988, 988-89 (1996) (justifying FDA's regulatory appeared in February assumption under this theory)
76. see also PETER BARTON HUTT, RICHARD A. MERRILL & LEWIS A. GROSSMAN, FOOD AND DRUG LAW 80 (3d ed. 2007) (affirming that documents released in 1990s litigation suggested the industry's intentional manipulation of nicotine to "satisfy" customers' addictions).
77. See generally Alison Frankel, After the Smoke Cleared: The Inside Story of Big Tobacco's $206 Billion Settlement, AM. LAW., Jan.-Feb. 1999, at 48 (describing the agreement between states that had not previously reached settlement agreements with the tobacco companies). The Master Settlement Agreement (MSA), initially assumed to be a windfall for public health, has padded state coffers more than it has curbed smoking rates.
78. See Senate Hearing, supra note 5, at 80 (testimony of Alan Blum, M.D.) (claiming that state officials "squandered" MSA money)
79. see also McDaniel & Malone, supra note 2, at 198 (arguing that the MSA created "perverse incentives" for states, since state income from the MSA depends on continued tobacco sales).
80. See FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 120, 161 (2000) (rejecting FDA authority to regulate tobacco products in light of the Federal Food, Drug, and Cosmetic Act (FDCA) and other tobacco-specific legislation).
81. Id. at 161.
82. See supra note 46 and accompanying text (tracking Phillip Morris's declining reputation).
83. See John A. Byrne, Philip Morris: Inside America's Most Reviled Company, BUSINESSWEEK.COM, NOV. 29, 1999, http://www.businessweek.com/1999/99-48/ b3657003.htm (noting that the company's stock value fell $83.2 billion in 1998-1999 alone).
84. See McDaniel & Malone, supra note 2, at 194 (noting that
85. seeking regulation was part of a larger plan to be viewed as a "normal" and "legitimate" corporation to assure "continued success").
86. See id. (describing the name change as an "[ijmage enhancement").
87. Although required by the MSA, antismoking efforts have boosted Philip Morris's corporate reputation.
88. See Senate Hearing, supra note 5, at 87-88 (testimony of Alan Blum, M.D.) (relating that Philip Morris has attracted college talent because students believe the company helps people quit smoking).
89. See Parrish, supra note 47, at 114 (indicating that Philip Morris adopted a policy to clarify these effects of cigarette smoking).
90. The first evidence of the company's support for regulation 2000, Legacy Tobacco Documents Library, supra note 2, while FDA v. Brown & Williamson Tobacco Corp. was decided on March 21,2000. 529 U.S. 120,120 (2000).
91. KOLKO, supra note 8, at 238.
92. See Saul, supra note 24 (suggesting that Philip Morris's lobbying efforts as an industry leader could derail FDA regulatory legislation).
93. See supra notes 42-43 and accompanying text.
94. Compare supra note 1, and supra note 13 and accompanying text (describing Philip Morris's prior lawsuits arguing against regulation), with Meier, supra note 2, at A12 (revealing Philip Morris's February 2000 shift in policy).
95. For an extended discussion on Philip Morris's vision of an improved industry atmosphere under FDA regulation
96. see generally McDaniel & Malone, supra note 2.
97. Based on financial performance alone, Altria Group stock is undervalued, Nocera, supra note 3, but amateur investors balk at buying stock in what they term an "evil" industry. E.A. Smith & R.E. Malone, Thinking the "Unthinkable": Why Philip Morris Considered Quitting, 12 TOBACCO CONTROL 208, -209 (2003), available at http://repositories.cdlib.org/cgi/ viewcontent.cgi?article=3232&context=postprints.
98. See, e.g., H.R. 1108, 110th Cong. § 917(a)(2) (as introduced in the House of Representatives, Feb. 15, 2007) (preempting certain state and local requirements with limited exceptions).
99. Philip Morris has advanced the prospect of "avoiding litigation" as a business benefit of FDA regulation. McDaniel & Malone, supra note 2, at 194.
100. See also Senate Hearing, supra note 5, at 59 (prepared statement of Alan Blum, M.D.) (claiming the bill removes the risk of fraud litigation).
101. See Senate Hearing, supra note 5, at 58 (prepared statement of Alan Blum, M.D.) (arguing that federal funds would be better invested in a mass antismoking campaign than in FDA regulation).
102. When a company
103. seeks regulation, one of the benefits it invariably pursues is restricting market entry. STIGLER, supra note 35, at 118. Tighter operational standards, easily handled by Philip Morris, would make it difficult for new competitors to break into the market.
104. See Meier, supra note 2, at A12 (quoting an anti-tobacco advocate as commenting that Philip Morris might be trying to foreclose more severe government action).
105. See McDaniel & Malone, supra note 2, at 194 (explaining that Philip Morris regarded regulation as "inevitable" and thought it "better to act now [under a Republican-controlled Congress] than to risk more onerous regulations" under any future Democrat-controlled Congress).
106. See Stuart Elliott, Uncle Sam Is No Match for the Marlboro Man, N. Y. TIMES, Aug. 27, 1995, §3, at 11, available at http://query.nytimes.com/ gst/fullpage.html?res=990CEFDE163AF934A1575BC0A9639582 60 (describing Marlboro's former branding, developed in the 1950s, which incorporated the Latin phrase for "I came, I saw, I conquered," attributed to Julius Caesar).
107. See KOLKO, supra note 8, at 41 (quoting 1880s railroad expert William P. Shinn months before the ICC's passage as saying, "The leading railroad companies &mellip; are now almost without an exception in [favor of the ICC]").
108. See Stephanie Saul, Reynolds Ads Say Tobacco Oversight Is Burden F.D.A. Doesn't Need, N.Y. TIMES, Apr. 2, 2008, at C7, available at http://wvw.nytimes. com/2008/04/02siness/media/02reynolds.html (reporting that Reynolds opposes the bill)
109. see also Statement from Lorillard Tobacco on FDA-Tobacco Regulation Legislation (Apr. 3, 2008) [hereinafter Lorillard Statement], http://www.reuters.com/article/pressRelease/idUS209594+03-Apr-2008+PRN20080403 (explaining that while Lorillard supports "reasonable federal regulation of the tobacco industry," it opposes H.R. 1108 because the bill has "fundamental problems").
110. See Saul, supra note 74 (indicating that tighter advertising restrictions could make it harder for Reynolds to market its Camel cigarettes)
111. see also Lorillard Statement, supra note 74 (asserting that H.R. 1108 would provide a "competitive advantage to [Lorillard's] larger rivals").
112. See Saul, supra note 74 (indicating "the bill could benefit Philip Morris over its smaller competitors" by "imposing tighter restrictions on advertising").
113. Id.
114. See Ugur Yucelt & Erdener Kaynak, A Study of Measuring Influence of Advertising and Forecasting Cigarette Sales, 5 MANAGERIAL & DECISION ECON. 213, 217 (1984) (finding evidence that "increased spending on advertising&mellip; increases cigarette consumption").
115. See generally MASTER SETTLEMENT AGREEMENT, available at http://www.naag.oig/backpages/naag/tobacco/msa/msa-pd&1109185724-1032468605- cigmsa.pdf.
116. See Lorillard Tobacco Co. v. Reilly, 533 U.S. 525, 589-90 (2001) (holding that state bans on point-of-sale advertising violated the First Amendment).
117. H.R. 1108, 110th Cong. § 906(d) (as introduced in the House of Representatives, Feb. 15, 2007).
118. See Senate Hearing, supra note 5, at 157 (prepared statement of Anne Landman) (noting that Philip Morris had MSA drafts prepared in 1991 "in anticipation" of cigarette advertising legislation).
119. KOLKO, supra note 8, at 6.
120. Even with the anti-tobacco lobby's support, several recent FDA tobacco bills have failed in Congress.
121. See REDHEAD & BURROWS, supra note 6, at 13, 19-20 (describing failed bills and attributing some of the failures to lack of support from both the industry and the public-health community).
122. See Statement by Matthew Myers, former President, Campaign for Tobacco-Free Kids, Rep. Davis' Sham FDA Bill Protects the Tobacco Industry, Not the Public Health, June 14, 2001, http://www.tobaccofreekids.org/Script/ DisplayPressRelease.php3?Display=368 (naming Philip Morris as "the main proponent of sham FDA legislation").
123. Philip Morris USA Government Affairs, FDA & Tobacco (2008) [hereinafter 2008 Philip Morris Policy Statement], http://www.philipmorrisusa. com/en/cms/Responsibility/Government-Relations/Legislative-Issues/pdfs/ fda-and-tobacco.pdf.aspx.
124. See Meier, supra note 2 (stating Philip Morris's February 2000 policy stance).
125. See, e.g., Senate Hearing, supra note 5, at 33 (statement of Jack E. Henningfield, Ph.D., Vice President, Research and Health Policy, Pinney and Associates, Bethesda, MD and Professor of Behavioral Biology at Johns Hopkins University School of Medicine, Baltimore, MD) (asserting that regulation is necessary because FDA authority could lead to less harmful, less addictive tobacco products and could reduce deception)
126. see id. at 72-73 (testimony of Matthew L. Myers, former President, Campaign for Tobacco-Free Kids) (defending H.R. 1108's merits).
127. See Senate Hearing, supra note 5, at 127, 157-58, 162, for examples of public-health figures who have issued statements opposing H.R. 1108.
128. E.g., H.R. 1108, 110th Cong. §§ 907(a), 911(0 (as introduced in the House of Representatives, Feb. 15,2007)
129. see infra Part II.A (discussing H.R. 1108's compromises).
130. See, e.g., Senate Hearing, supra note 5, at 11 (statement of Matthew L. Myers) (claiming the bill might save millions of lives).
131. Parrish, supra note 47, at 110.
132. See FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 129-31, 161 (2000) (holding that Congress had not given FDA the authority to regulate tobacco products).
133. See REDHEAD & BURROWS, supra note 6, at 5-6 (noting that FDA planned to use its drug-device regulatory formula to promulgate tobacco rules).
134. See von Eschenbach, supra note 26 (describing the dire health effects, including a litany of diseases, caused by tobacco use).
135. When the Kessler-led FDA undertook regulation, it altered its usual methods, claiming it could regulate cigarettes as "devices" without violating FDA's statutory dictate to ban unsafe drugs. HUTT, MERRILL & GROSSMAN, supra note 49, at 80.
136. Senate Hearing, supra note 5, at 1 (opening statement of Sen. Ted Kennedy, Chairman, S. Comm. on Health, Education, Labor, and Pensions).
137. See also Centers for Disease Control and Prevention, Smoking and Tobacco Use, http://www.cdc.gov/tobacco/data-statistics/fact-sheets/fast-facts/index.htm ("In the United States, cigarette smoking is responsible for about&mellip; 438,000 deaths per year.").
138. See Brown & Williamson, 529 U.S. at 121 (citing an FDA declaration-before the agency's assumption of regulatory control in 1996-that if the agency regulated cigarettes, it would have to remove them from the market because "it would be impossible to prove they were safe for their intended use")
139. cf. Cheryl Healton, Keynote Speech on the Application of Harm Reduction to Other Public Health Problems: What Is Similar or Different About the Issue of Tobacco?, 11 J. HEALTH CARE L. & POL'Y 93, 97 (2008) (asserting that if tobacco were a new product, it would never make it to the market).
140. H.R. 1108, 110th Cong. § 907(a) (as introduced in the House of Representatives, Feb. 15,2007).
141. See id. § 912(a) ("[A]ny person adversely affected by such regulation or denial may file a petition for judicial review of such regulation or denial&mellip;").
142. See Lars Noah, The Little Agency That Could (Act with Indifference to Constitutional and Statutory Strictures), 93 CORNELL L. REV. 901, 904 (2008) (remarking that in order to circumvent the hassles of informal rulemaking, where judicial challenges typically arise before rules go into effect, FDA has increasingly resorted to "nonbinding guidelines").
143. See James T. O'Reilly, Losing Deference in the FDA's Second Century: Judicial Review, Politics, and a Diminished Legacy of Expertise, 93 CORNELL L. REV. 939, 940, 973-76 (2008) (arguing that executive branch mismanagement led to the decrease in deference to FDA)
144. Cf. David C. Vladeck, The FDA and Deference Lost: A Self-inflicted Wound or the Product of a Wounded Agency? A Response to Professor O'Reilly, 93 CORNELL L. REV. 981, 983 (2008) (agreeing that FDA has lost deference, but blaming the loss on FDA's lack of scientific expertise, underfunding, and overmandating)
145. HUTT, MERRILL & GROSSMAN, supra note 49, at 1556 (remarking that while historically FDA successfully fended off litigation, its success has recently declined).
146. See, e.g., supra notes 1, 13 and accompanying text (describing Philip Morris's litigation history)
147. Arnold & Porter LLP, Light Cigarette Class Action Litigation, http://www.arnoldporter.com/experience.cfm?action=view&id=845&owner= practice (last visited July 20, 2008) (listing the firm's successful litigation efforts on behalf of Philip Morris). In addition to Philip Morris's propensity to sue, FDA has generally faced more litigation in recent years. O'Reilly, supra note 102, at 942.
148. H.R. 1108 § 907(a)(3).
149. Such a standard would undoubtedly warrant Chevron deference.
150. See Chevron U.S.A. Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 843 (1984) (holding that if an enabling statute is ambiguous, courts should defer to the agency's statutory construction so long as it is reasonable). One administrative law scholar elaborates: "The key to Chevron is that, when a statute contains either an ambiguity that the Court cannot decipher using its arsenal of interpretive devices, or a 'gap' in the statutory scheme, Congress is signaling its intent that the agency, rather than the Court, should supply the missing meaning." John S. Kane, Refining Chevron-Restoring Judicial Review to Protect Religious Refugees, 60 ADMIN. L. REV. 513,530 (2008) (emphasis added).
151. H.R. 1108 § 907(a)(3). The Federal Food, Drug, and Cosmetic Act (FDCA) requires that valid performance standards for drugs and devices contain "provisions to provide reasonable assurance of [a product's] safe and effective performance" and "where necessary to provide reasonable assurance of [a product's] safe and effective performance, include ⋯ provisions respecting the construction, components, ingredients, and properties [of the product.]" 21 U.S.C. § 360d(a)(2) (2006). In other words, current food and drug law demands that Congress provide specificities for evaluating a product. Although it is arguable whether H.R. 1108's tobacco-product-standard directives follow logically from the FDCA's performance-standard guidelines, such a contention ignores the uniqueness of FDA's regulation of tobacco, given cigarettes' inherent dangerousness.
152. See von Eschenbach, supra note 26 ("Tobacco products &mellip; are intrinsically injurious to health."). Since there is no way to reasonably assure that a cigarette is "safe," the FDCA's performance-standard provisions are outmoded
153. different requirements should be used for tobacco, and the traditional performance-standard provisions should be abandoned.
154. H.R. 1108 § 907(a)(3).
155. Id. § 907(b)(1)(E).
156. See Vladeck, supra note 102, at 983 (claiming that courts' "declining deference" to FDA decisions is not just the result of "ill-considered, politically motivated decisions" but also relates to eroding resources and increasing responsibilities).
157. See Cass R. Sunstein, In Defense of the Hard Look: Judicial Activism and Administrative Law, 7 HARV. J.L. & PUB. POL'Y 51, 53 (1984) (arguing that judicial review of agency action is a healthy practice which promotes the separation of powers). But
158. see Frank B. Cross, Shattering the Fragile Case for Judicial Review of Rulemaking, 85 VA. L. REV. 1243, 1244 (1999) (arguing that there is no valid justification for judicial review of agency rulemaking).
159. Some analysts argue that tobacco-product standards promulgated under H.R. 1108 would automatically cue Chevron deference. E.g., Christopher N. Banthin & Richard A. Daynard, Room for Two in Tobacco Control: Limits on the Preemptive Scope of the Proposed Legislation Granting FDA Oversight of Tobacco, 11 J. HEALTH CARE L. & POL'Y 57, 62 (2008). Such an assertion, however
160. seems predicated on the old FDA model, when the agency was the gold standard for regulatory bodies and courts rarely questioned its scientific bases. The modern FDA does not retain such a privilege, and the agency has lost many cases in the past decade that it would have won under a traditional deference review.
161. See O'Reilly, supra note 102, at 973-76 (cataloging examples of judicial decisions that do not defer to FDA).
162. H.R. 1108 § 907(a)(4)(A)(i).
163. One of the company's biggest fears is that cigarettes will be regulated to the point of unpalatability.
164. See Parrish, supra note 47, at 115 (noting that Philip Morris supports the removal of harmful components so long as cigarettes remain fit for adult consumption).
165. See H.R. 1108 § 912(a)(1) (stating that "any person adversely affected by such regulation or denial" may file for judicial review).
166. See, e.g., Senate Hearing, supra note 5, at 59 (prepared statement of Alan Blum, M.D.) (explaining that reducing nicotine levels would cause smokers to ingest more cigarettes to calm cravings). Experts disagree whether reducing nicotine levels would be desirable for the public health. This example merely demonstrates that if FDA did find the reduction to be desirable, its findings could be challenged more aggressively than if Congress gave the agency tobacco-product-standard guidelines that are more general.
167. See H.R. 1108 § 907(a)(3)(A)-(B) (directing FDA to consider the risks and benefits to the population as a whole, including current tobacco users).
168. Id. § 907(b)(1)(E).
169. See Senate Hearing, supra note 5, at 176 (memorandum of Joel L. Nitzkin, M.D., M.P.H., D.P.A., Chairman, American Association of Public Health Physicians Tobacco Control Task Force) ("This [contraband] provision stands as an open invitation to tobacco companies to assert in court that any proposed change in the composition of its tobacco products that change the taste, reduce the attraction to nicotine addicts or significantly increase the cost of manufacture could increase the demand for contraband.").
170. see Parrish, supra note 47, at 110 (admitting that Philip Morris
171. seeks regulation to make profits).
172. Indeed, given a tobacco product standard directive that invites litigation, FDA might not issue regulations at all or might issue industry-friendly rules. Senator Cobum's remarks are instructive: "The only problem with [assuming FDA will take on the industry] is the Bureaucrats' Law of Washington-never do what is right when you can do what is safe&mellip; The FDA is like a balloon. You push in one place, it goes out somewhere else." Senate Hearing, supra note 5, at 82 (testimony of Sen. Tom Cobum, Member, S. Comm. on Health, Education, Labor, and Pensions)
173. Cf. Lars Noah & Richard A. Merrill, Starting from Scratch?: Reinventing the Food Additive Approval Process, 78 B.U. L. REV. 329, 443 (1998) (asserting that FDA has escaped "unrealistic [congressional] directives" in the past).
174. Nocera, supra note 3.
175. H.R. 1108 §911(/)(1).
176. Id. § 911(g)(1)(A).
177. Id. § 911(g)(3)(A). The tobacco industry has a documented history of knowingly deceiving the public about health risks.
178. See United States v. Philip Morris USA, Inc., 449 F. Supp. 2d 1, 852 (D.D.C. 2006) (discussing Philip Morris's persistent attempts to deceive the public by concealing or distorting the health risks of cigarettes). Compare the current proposal with HARTMANN, supra note 44, at 162-63 (noting that 1990s legislation gave FDA authority to regulate genetically modified foods, yet problematically required the agency to rely on manufacturers' science).
179. See Senate Hearing, supra note 5, at 59 (statement of Alan Blum, M.D.) ("[S]moking prevalence is directly proportional to the degree of perceived harm from smoking⋯ .")
180. see also Andrew Steptoe et al., An International Comparison of Tobacco Smoking, Beliefs and Risk Awareness in University Students from 23 Countries, 97 ADDICTION 1561, 1569 (2002), available at http://www3.interscience.wiley.com/ cgi-bin/fulltext/118957918/PDFSTART (replicating past studies that had found a "robust association between smoking and beliefs in the importance of not smoking for health").
181. See Nocera, supra note 3 (observing Philip Morris's efforts to grow the company in a declining market through development of "reduced harm" tobacco products and noting a $350 million reduced-risk tobacco product research-and-design facility at company headquarters).
182. In United States v. Philip Morris USA, Inc., the court found that tobacco companies had engaged in a long-term conspiracy to conceal smoking's health risks, noting that the companies had "suppressed research [and] distorted the truth about low tar and light cigarettes." 449 F. Supp. 2d at 852.
183. Altria Group projects that cigarette sales will decline 3.5% this year. This projection, in addition to shareholders' complaints that the company was too focused on cigarettes, in part motivated Altria's recent $10.3 billion acquisition of United States Tobacco, Inc., the world's largest snuff manufacturer. Chris Burritt, Altria to Buy UST for $10.3 Billion, Gaining Skoal (Update2), BLOOMBERG.COM, Sept. 8, 2008, http://www.bloomberg.com/apps/ news?pid=20601103&sid=anOAnSGfaSQM.
184. See Thomas M. Anderson, Altria Versus Philip Morris International, KIPLINGER.COM, Apr. 18, 2008, http://www.kiplinger.com/columns/picks/archive/ 2008/pick0418.htm (noting a declining demand for tobacco in the United States, but increased demand in emerging nations).
185. See Parrish, supra note 47, at 114 (acknowledging the Philip Morris position that smoking causes lethal health problems).
186. In 1954, 40% of Americans said that smoking causes cancer. In 1969, the number was 70%. In the 1980s, 80% believed in the link. By 1999, 90% of Americans agreed that smoking causes cancer. David W. Moore, Americans Agree with Philip Morris: Smoking Is Harmful: But Public Blames Smokers More Than Tobacco Companies for Smoking-Related Health Problems, GALLUP NEWS SERVICE, Oct. 14, 1999, hrtp://www.gallup.com/poll/3538/Americans-Agree-Philip-Morris- Smoking-Harmful.aspx.
187. See Senate Hearing, supra note 5, at 59 (prepared statement of Alan Blum, M.D.) (noting that increasing perception of smoking's perils decreases consumption).
188. Id.
189. The prospect of litigation may incentivize bargained rulemaking by FDA that would be accepted by tobacco companies.
190. The prospect of litigation may incentivize bargained rulemaking by FDA that would be accepted by tobacco companies.
191. See von Eschenbach, supra note 26 (reciting H.R. 1108's "perverse incentive effects")
192. see also supra note 121 and accompanying text (describing FDA's response to industry and observing that FDA maneuvers around its conflicts).
193. See Anna Wilde Mathews & Vanessa O'Connell, Philip Morris Gears Up for FDA Regulation: Using Science, It Tries to Prove Its Products Can Be Lower-Risk, WALL ST. J., June 21, 2007, available at http://online.wsj.com/ article-email/SB118235450194442081-lMyQjAxMDE3ODIyMTMyNTE0Wj.html (noting that Philip Morris's reduced-risk investment is larger than that of its peers).
194. See H.R. 1108, 110th Cong. § 2(45) (as introduced in the House of Representatives, Feb. 15, 2007) (incorporating Federal Trade Commission's (FTC) mission to protect consumers and regulate competition).138. Implicit health claims, such as "light" and "low tar," have created litigation.
195. See, e.g., United States v. Philip Morris USA, Inc., 449 F. Supp. 2d 1, 852 (D.D.C. 2006) (holding Philip Morris liable for fraud for "distort[ing] the truth about low tar and light cigarettes")
196. Brown v. Brown & Williamson Tobacco Corp., 479 F.3d 383, 392-93 (5th Cir. 2007) (holding that state claims of consumer fraud relating to "light" cigarettes were preempted by FTC approval).
197. A recent Canadian study found that 79% of adults and 59% of youths believed that tobacco companies "rarely" or "never" told the truth. Bronwen J. Waller et al., Youth Attitudes Towards Tobacco Control: A Preliminary Assessment, 25 CHRONIC DISEASES CANADA 97, 98 tbl.l (2004), available at http://www.phac-aspc.gc.ca/publicat/ cdic-mcc/25-3/a-e.html. Perhaps illustrating this point, Philip Morris's latest attempt at marketing a "safer" cigarette has gone awry.
198. See Vanessa O'Connell, Altria Drops New Filter Cigarettes in Strategy Setback, WALL ST. J., June 23, 2008, at Bl (describing the failed attempt to sell the Marlboro Ultra Smooth, a cigarette with a "high- technology" filter).
199. H.R. 1108 §911(0(1).
200. See Associated Press, Philip Morris in Quest for Lower-Risk Tobacco Items, L.A. TIMES, Oct. 29, 2007, at C2 (reporting Citigroup analyst Bonnie Herzog's claim that Philip Morris's reduced-risk innovation, which would put the company at "the head of the pack," prompted Philip Morris to seek FDA regulation).
201. Some public-health advocates applaud the development of reduced-risk tobacco products and argue that the bill, with its long-term epidemiological science requirements, makes it difficult (or as one advocate terms it "actually impossible") for reduced-risk cigarettes to be approved, and thus will (problematically) allow only for approval of reduced-exposure products. Senate Hearing, supra note 5, at 59, 164 (prepared statements of Alan Blum, M.D. and Michael Siegel, M.D.). While these public-health figures favor the development of reduced-risk cigarettes, which would be proven to lower overall disease incidence, they do not take into account H.R. 1108's two-year deadline for issuing reduced-risk standards.
202. The research-and-design facility itself cost $350 million, a figure that does not include the collateral expenses of the reduced-risk operation, which encompasses the salaries of an estimated 500 scientists, engineers, and support staff. Michael Felberbaum, Philip Morris Opens New Research Center, USATODAY.COM, Oct. 29, 2007, http://www.usatoday.com/money/ economy/2007-10-28-3266642839-x.htm.
203. See Parrish, supra note 47, at 115 (declaring that FDA oversight is essential to guide manufacturers of reduced-risk and reduced-exposure products).
204. See McDaniel & Malone, supra note 2, at 194 (implying that consumers trust Philip Morris more after learning that the company supports FDA regulation
205. when consumers were informed that Philip Morris favors a federal regulatory regime, public disapproval of the company decreased from 50% to 35%).
206. See Anderson, supra note 130 (noting that tobacco use in the "developed world" has "waned for decades").
207. H.R. 1108,110th Cong. § 911(/)(1) (as introduced in the House of Representatives, Feb. 15,2007).
208. /c/. § 911(g)(1).
209. See Senate Hearing, supra note 5, at 56 (statement of Alan Blum, M.D.) (exhibiting Dr. Blum's skepticism of the bill)
210. see also id. at 164 (prepared statement of Michael Siegel, M.D.) (noting that the bill would "allow[] reduced exposure products to essentially be falsely marketed as reduced risk products (thus institutionalizing the very problem that the health organizations have expressed so much concern about)").
211. H.R. 1108 §911(g)(1)(A).
212. Id. §911(g)(2)(A)(ii).
213. See Senate Hearing, supra note 5, at 56 (statement of Alan Blum, M.D.) (explaining that H.R. 1108 has no mandate to eliminate cyanide gases from cigarettes).
214. Id.
215. Id. at 59 (statement of Alan Blum, M.D.)
216. see also Richard J. O'Connor et al., Smoker Awareness of and Beliefs About Supposedly Less-Harmful Tobacco Products, 29 AM. J. PREVENTATIVE MED. 85, 85, 89 (2005) (finding that 25% of smokers who could name a cigarette brand that claims to reduce exposure to cigarette-smoke constituents believed that the products were less harmful-a belief in conflict with scientific evidence).
217. Senate Hearing, supra note 5, at 56 (testimony of Alan Blum, M.D.).
218. See H.R. 1108 § 911(g)(1)(A) (allowing approval of modified risk products if the applicant can demonstrate that the product significantly reduces the harm and risk of tobacco-related disease).
219. See Senate Hearing, supra note 5, at 58-59 (prepared statement of Alan Blum, M.D.) (explaining that consumers would believe reduced-exposure cigarettes decrease the risks of getting disease).
220. See Hurt, supra note 28, at 431 (noting that the author is a member of FDA's Science Review Subcommittee)
221. id. at 432 (declaring that FDA is "an agency with expanded responsibilities, stagnant resources, and the consequent inability to implement or enforce its statutory mandates").
222. Senate Hearing, supra note 5, at 6 (opening statement of Sen. Enzi, Ranking Member, S. Comm. on Health, Education, Labor, and Pensions).
223. JOHN P. SWANN, HISTORY OF THE FDA, http://www.fda.gov/oc/history/ historyoffda/default.htm.
224. See Richard A. Merrill, The Architecture of Government Regulation of Medical Products, 82 VA. L. REV. 1753, 1767-68 (1996) (noting FDA's expanded duties, placing the agency in a gatekeeping position).
225. See Hurt, supra note 28, at 432 ("The FDA has become a paradigmatic example of the 'hollow government' syndrome-an agency with expanded responsibilities, stagnant resources, and the consequent inability to implement or enforce its statutory mandates.").
226. H.R. 1108, 110th Cong. § 920 (as introduced in the House of Representatives, Feb. 15, 2007).
227. See von Eschenbach, supra note 26 (indicating that the projected FDA appropriations for 2008-2010 will be insufficient to implement H.R. 1108's complex program).
228. One critic claims the system has worsened FDA's low public confidence numbers and "should be abandoned." For a discussion of the "Destructive Impact of User Fees,"
229. see Hurt, supra note 28, at 452-54.
230. Commissioner von Eschenbach writes, By far, the most important and daunting challenge would be to develop the expertise necessary to carry out tne functions called for by this bill. FDA does not have expertise regarding customarily marketed tobacco products and, therefore, would have to establish an entirely new program and hire new experts. Creating the appropriate organizational structure and hiring experts in the field of tobacco control and related sciences and other experts needed to staff the program at every level is considerably more challenging than simply filling identified vacancies in an existing program. Von Eschenbach, supra note 26.
231. See supra notes 1, 13 and accompanying text (discussing litigation between the tobacco industry and FDA)
232. See von Eschenbach, supra note 26 (reasoning that regulating under H.R. 1108 would undermine FDA's public-health role).
233. See Noah, supra note 101, at 923-24 (noting that the Administration's preference for minimal regulation caused an "about-face" in FDA philosophy).
234. FDA is overmandated, underfunded, and ill-performing. Hurt, supra note 28, at 432. The tobacco industry has successfully "outwitted" government regulatory efforts for decades. Senate Hearing, supra note 5, at 87 (statement of Alan Blum, M.D.). H.R. 1108 has crucial compromises that were most likely lobbied-for by the tobacco industry.
235. See supra notes 14-15 and accompanying text (describing Philip Morris's extensive lobbying efforts to promote legislation authorizing FDA regulation over the tobacco industry). Given such a confluence of undesirable circumstances, it is understandable that FDA does not want to regulate. Further, one legal scholar argues that FDA's recent spate of regulatory failures more likely resulted from "structural weaknesses and resource limitations" than from an antiregulatory political mindset. Vladeck, supra note 102, at 984
236. see also id. at 994-97 (describing FDA's regulatory failures). Thus, agency problems might transcend politics.
237. See, e.g., Senate Hearing, supra note 5, at 56-58 (statement and prepared statement of Alan Blum, M.D.) (noting the industry's history of making implicit, untrue lowered-risk claims)
238. cf. id. at 176 (memorandum of Joel L. Nitzkin, M.D.) (asserting that the proposed requirements under H.R. 1108 "strongly favor" Philip Morris, thus explaining its support of the bill).
239. See id. at 87 (testimony of Alan Blum, M.D.) ("[Philip Morris has] done wonders with any regulation. They have outwitted us.").
240. See Nocera, supra note 3 (relating Matthew Myers's opinion that FDA regulatory success may depend on Philip Morris's not obstructing meaningful rules).
241. See id. at 84-85 (testimony of Alan Blum, M.D.) (commenting on the absurdity of giving FDA authority over tobacco given the agency's recent failures). Compare Senate Hearing, supra note 5, at 176 (memorandum of Joel Nitzkin, M.D.) (noting that H.R. 1108 invites litigation), with id. at 32 (opening statement of Sen. Hatch) (expressing concern about giving the struggling agency more responsibilities with "maybe not enough finances to take care of it").
242. E.g., Vladeck, supra note 102, at 994-97.
243. FDA's critics already cry industry capture, pointing out, for example, that the agency relies on science from experts with relationships with prescription drug manufacturers. Cristina Rodriguez, The FDA Preamble: A Backdoor to Federalization of Prescription Warning Labels?, 41 J. MARSHALL L. REV. 161, 165 (2007).
244. See Hutt, supra note 28, at 442-43 (demonstrating that while FDA had a public-confidence rating of 80% in the 1970s, by 2006 it had slipped to 36%).
245. See Burritt, supra note 129 (describing Altria Group's marketing strategy)
246. see also McDaniel & Malone, supra note 2, at 197 (positing that the tobacco industry supports FDA regulation to boost its public image).
247. See Nocera, supra note 3 (Matthew Myers explained that the real test of Philip Morris's commitment to regulation would come only after regulation begins).
248. See Senate Hearing, supra note 5, at 14 (prepared statement of Matthew Myers) (claiming that the bill has the support of every major public-health organization).
249. 2008 Philip Morris Policy Statement, supra note 86, at 32.
250. see supra note 121 and accompanying text (demonstrating Sen. Coburn's doubt that the FDA bureaucracy will take aggressive action).
251. One FDA expert asserts the agency is at a "critical point in its history" and that the picture of FDA's future he gleans from recent assessments is "alarming." Vladeck, supra note 102, at 997,999.
252. See von Eschenbach, supra note 26 (noting that "the most important and daunting challenge" would be to develop FDA expertise to implement H.R. 1108).
253. See Senate Hearing, supra note 5, at 57 (statement of Alan Blum, M.D.) (detailing the tobacco industry's history of circumventing regulation and of consumer deception).
254. When the FTC tried (and failed) to impose restrictions on the industry after the Surgeon General's 1964 warning, it took "decades" for the agency to recover. PBS, Inside the Tobacco Deal, FRONTLINE ONLINE, http://www.pbs.org/wgbh/pages/frontline/shows/settlement/interviews/myers.html (interview with Matthew Myers) (last visited Oct. 14, 2008). A similar failure for FDA could make an already hostile regulatory atmosphere worse, portending a bleak future for the agency.
255. See supra note 102 and accompanying text (discussing increased judicial distrust of the agency).
256. Food & t)rug Administration, FDA's Mission Statement, http://www.fda.gov/opacom/morechoices/mission.html (last visited Oct. 14, 2008)
257. cf. HUTT, MERRILL & GROSSMAN, supra note 49, at 5 (declaring that FDA's perpetual assignment has been to ensure the products it regulates are safe).
258. See, e.g., United States v. Philip Morris USA, Inc., 449 F. Supp. 2d 1, 852 (D.D.C. 2006) (discussing Philip Morris's persistent attempts to deceive the public by concealing or distorting the health risks of cigarettes).
259. The Surgeon General issued the epochal warning in 1964 that smoking caused cancer and disease.
260. See Parrish, supra note 47, at 111 (regretting that the tobacco industry publicly denied the conclusion and describing the "reservoir of public anger" emanating from the denial).
261. Senate Hearing, supra note 5, at 58 (prepared statement of Alan Blum, M.D.).
262. Id.
263. H.R. 1108, 110th Cong. § 911(h)(5) (as introduced in the House of Representatives, Feb. 15,2007).
264. See Statement on the Science of Reduced Risk Tobacco Products Before the H. Comm. on Government Reform (2003) (statement of Scott J. Leischow, Ph.D., Chief, Dep't of Health & Human Services), available at http://www.hhs.gov/ asl/testify/t030603a.html (declaring that "all tobacco products are hazardous &mellip; there is no safe level of tobacco use").
265. See, e.g., Senate Hearing, supra note, at 59, 164 (listing health advocates' arguments that FDA should not be allowed to approve reduced-exposure products).
266. See H.R. 1108 § 911(g)(2)(A)(ii)-(iv) (permitting FDA approval of tobacco products without support from long-term epidemiological studies).
267. See von Eschenbach, supra note 26 (commenting that the bill makes the public-health-minded FDA regulate a product that causes disease even when "used as intended").
268. See Senate Hearing, supra note 5, at 159 (prepared statement of Anne Landman) (declaring "a healthy tobacco trade is antithetical to public health").
269. H.R. 1108 stipulates that FDA take into account "users and non-users" when approving reduced-risk products
270. namely, the proposal considers the probability that users would be less likely to quit smoking or that non-users would begin smoking. H.R. 1108 § 907(a)(3)(A)-(B). However, FDA decisions would be based in large part on tobacco-industry scientific data. Id. § 911(g)(3)(A). Furthermore, consumer perception of the products' dangerousness would not be measured until after approval in postmarket surveillance. Id. § 911(g)(2)(C)(ii).
271. See Senate Hearing, supra note 5, at 57 (statement of Alan Blum, M.D.) (opining that while currently only the tobacco companies commit consumer fraud, H.R. 1108 will necessarily implicate FDA in fraudulent behavior).
272. Rob Stein, House Votes to Let FDA Regulate Tobacco Industry, WASH. POST, July 31, 2008, at A2, available at http://www.washingtonpost.com/wp-dyn/content/ article/2008/07/30/AR2008073002674.html ("The White House has signaled that President Bush will veto the legislation if it is approved by the Senate, which may not have a veto-proof majority in support of it."). As illustrated by the vote margin, regulating tobacco is not a purely partisan issue. Persuading Republicans to support regulation that the party generally frowns upon has long been a goal of Philip Morris.
273. See McDaniel & Malone, supra note 2, at 194-95 (observing that over a recent ten-year period the company donated $8.1 million to Republicans and developed lobbying tactics designed to appeal to the party's members).
274. See Govtrack.us, H.R. 1108 (110th Cong.), http://www.govtrack.us/ congress/bill.xpd?bill=hl 10-1108 (explaining that the bill as H.R. 1108 is dead, but could be introduced in a future session of Congress under a different bill number).
275. See REDHEAD & BURROWS, supra note 6, summary (explaining that the Family Smoking Prevention and Tobacco Control Act was first introduced in the 108th Congress, and that the 110th Congress's H.R. 1108 was simply a reintroduction of that original bill). The FDA tobacco bills that have been introduced since the 107th Congress-and gained the support of both Philip Morris and the public-health community-have been either identical or very similar in content to each other and H.R. 1108. Id. at 19-20.
276. See id. at 20 (noting that H.R. 1108, introduced in February 2007 in a Democratic-majority House of Representatives, was "an attempt to balance the competing interests of Philip Morris and leading anti-tobacco groups"). Further, Philip Morris issued a policy statement that advocated FDA regulation as of April 2008. 2008 Philip Morris Policy Statement, supra note 86. By April 2008, the company must have appreciated the possibility of a Democratic Congress and Democratic President beginning in 2009, as Gallup polls from that month had Barack Obama and John McCain in a statistical dead heat.
277. See Lee Byron, Chris Barnes & Henry Corrigan-Gibbs, Presidential Polls Over Time, NYTIMES.COM, Nov. 2, 2008, http://elections.nytimes.com/2008/ president/whos-ahead/polling/index.html.
278. See Saul, supra note 24 (proffering that legislation requires Philip Morris's support).
279. See Parrish, supra note 47, at 114 (conceding that any regulation must still allow his company to make profits, as it is an obligation the company has to its shareholders).
280. Senator Coburn offers his H.R. 1108 assessment: "We're going to shuffle this [bill] over and in 10 years, we're going to be back here talking about the same thing because Marlboro will be Marlboro tomorrow." Senate Hearing, supra note 5, at 83.
281. See Healton, supra note 98, at 98 (lamenting that "[i]t is very difficult to have enlightened public policy if the majority of our state legislators and federal legislators &mellip; are receiving tobacco industry donations").
282. Current tobacco-control theory focuses less on regulating the composition of cigarettes and more on reducing the harm to second-hand smoke recipients and "denormalizing" cigarette smoking. Senate Hearing, supra note 5, at 158 (prepared statement of Anne Landman).
283. See Heather Knight, S.F. Pushes Legislation to Promote Good Health, SFGATE.COM, Aug. 4, 2008, http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2008/ 08/04/MNBG122T4F.DTL (noting that the money is spent on massive statewide advertising, increased cigarette taxes, and limits on permissible smoking areas)
284. Victoria Colliver, Employers Ponder Tough Tactics to Halt Smoking, SFGATE.COM, June 17, 2008, http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/ 2008/06/16/BUKGHA2VO.DTL&tsp=l (indicating that only Utah's smoking rate is lower than that of California).
285. See, e.g., Healton, supra note 98, at 94 (explaining that the national "truth®" mass-media advertising campaign was crucial in slashing youth smoking by 22% in its first two years).
286. See Senate Hearing, supra note 5, at 83 (testimony of Sen. Coburn) ("[Health advocates are] going to trust an agency to do what we don't have the courage to do as a Congress&mellip; We don't have the courage to do what is really necessary.").
287. See STEVEN P. CROLEY, REGULATION AND PUBLIC INTERESTS: THE POSSIBILITY OF GOOD REGULATORY GOVERNMENT 184, 186-87 (2008) (noting that during the 1995-1996 FDA notice-and-comment rulemaking period concerning tobacco regulation, the agency received "seven hundred thousand pieces of written commentary" and that the tobacco industry submitted a "single 'comment' objecting to [FDA's] proposed rule that consisted of some two thousand pages of written commentary and another forty-seven thousand pages of supporting documents").
288. See Noah, supra note 101, at 904 (noting that the hassles of informal rulemaking, including judicial review, have led FDA to resort to "nonbinding guidelines").
289. See von Eschenbach, supra note 26 ("Associating the Agency with the approval of these inherently dangerous products would undermine the Agency's mission" and regulating tobacco would require an "entirely new program" from the ground up.). By far, the most important and daunting challenge would be to develop the expertise necessary to carry out the functions called for by this bill. FDA does not have expertise regarding customarily marketed tobacco products and, therefore, would have to establish an entirely new program and hire new experts. Creating the appropriate organizational structure and hiring experts in the field of tobacco control and related sciences and other experts needed to staff the program at every level is considerably more challenging than simply filling identified vacancies in an existing program. Id.