The Scope of Preemption under the 2009 Family Smoking Prevention and Tobacco Control Act

Sam F. Halabi Although the Patient Protection and Affordable Care Act and the Dodd-Frank Wall Street Reform and Consumer Protection Act overshadow it, the first major law signed by President Barack Obama in his first term, the 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), competes with both health insurance and financial reform laws in terms of the human and economic cost it aimed to reduce: annually tobacco consumption kills over 400,000 Americans, sickens and injures more than 8 million and causes over $100 billion in economic loss. Previous legislative and regulatory efforts to curb the public health burden imposed by tobacco faltered against the industry’s strong ties in Congress, strategies that emphasized ineffective self-regulatory measures, and the U.S. Supreme Court’s decision in FDA v. Brown and Williamson Tobacco Corp., which rejected the Clinton Administration’s effort to assert FDA authority over tobacco products absent an explicit Congressional mandate to do so. Litigation had succeeded, however, as states’ attorneys general and private litigants slowly but steadily eroded the industry’s invulnerability in the courts, resulting in the Master Settlement Agreement with 46 states and as yet uncertain tort and statutory consumer protection liabilities that may run into the billions of dollars. Like the Affordable Care Act and Dodd-Frank that followed, the Tobacco Control Act included benefits for the target industry. There are at least two such benefits for tobacco firms in the law. First, the law raises costly barriers to entry for new participants in the tobacco sector, many of which would not have been constrained by the terms that applied to the major manufacturers voluntarily as part of the Master Settlement Agreement, nor without the law, the significant fees now imposed on the tobacco industry to fund FDA oversight. Second, Section 916 of the law provides an explicit, statutory preemption provision that, while ambiguous in important respects explored in this article, gives preemptive effect to certain tobacco products subjected to FDA premarket review.4 At issue in that preemption provision is the law’s authorization for “modified risk tobacco products” (MRTPs) and associated branding and labeling which, as the public health rationale goes, help current tobacco users consume products with less nicotine or fewer toxic contaminants and therefore reduce their risk of disease or death.5 Authorized under Section 911 of the Tobacco Control Act, these products include but are not limited to, “low-carcinogen cigarettes, devices that heat tobacco to release nicotine, smokeless tobacco, and novel nicotine products.” There is considerable controversy within the public health community as to the justification for giving legal sanction to MRTPs. While some public health organizations have called reduced risk of tobacco-related disease through “reducing exposure to tobacco toxicants . . . feasible” deceptive tactics used by the tobacco industry revolved around spurious claims about reduced risk especially the use of “light”, “ultra-light”, “low”, “mild” and associated color schemes to falsely communicate the possibility of less harm or even safety of tobacco products. In his comment to the FDA on Section 911, prominent public health scholar Stanton Glantz warned that “modified risk products have a strong potential for simply being the latest chapter in [tobacco companies’] fraud.” This article is the first to analyze the heretofore unanswered question: what is the scope of constitutional preemption when Section 911 (modified risk tobacco products) and Section 916 (preemption of state law) are read together against the broader background of U.S. Supreme Court precedent that will shape that inquiry? The Tobacco Control Act’s preemption provision implicates at least two relevant U.S. Supreme Court precedents on the scope of Article VI preemption for FDA-approved products as well as one decision specific to tobacco labeling: Wyeth v. Levine, Riegel v. Medtronic, Inc. and Altria v. Good. While the U.S. Supreme Court’s decision in Wyeth v. Levine concluded that a clear statement from Congress is necessary to preempt state law causes of action for certain pharmaceuticals, its decision in Riegel v. Medtronic suggests that an elaborate FDA approval process with an express preemption clause may suffice to demonstrate complete preemption in the medical device context. Indeed, Section 916’s preemption provision closely tracks the preemption provision at issue in Riegel (and other statutory schemes) but the law adds a section, a “rule of construction”, explicitly protecting causes of action based in state product liability law. That “rule of construction” adds an important lens to the statutory interpretation that will determine how extensively, if at all, Congress sought to displace state law regulating modified risk tobacco products. There is scant guidance from the legislative history on the scope of the law’s preemption provision. In the courts, Altria v. Good is the Court’s last statement on preemption of state law causes of action in the tobacco product labeling context and includes important insights into how Section 916 will be construed against modified risk claims. FDA is now considering the first modified risk tobacco product produced by Swedish Match, a firm participating in a joint venture with Philip Morris International, making the question of (and answer to) preemption all the more relevant. At stake in answering the preemption question correctly is how the tobacco industry may use Section 911 to continue historical practices with FDA’s approval and the public health implications of doing so. Tobacco consumers will inevitably use state law causes of action to allege that the content of tobacco manufacturers’ modified risk claims are misleading, that modified risk claims extend use of non-modified risk claim products, and that modified risk tobacco products are used to shape risk perception across other product lines. More broadly, construction of the preemption provision in the MRTP context will influence the relationship between the 2009 Tobacco Control Act and state law as FDA and federal courts shape the law’s implementation. The article concludes that Section 916’s preemption provision preserves rather than prevents product liability lawsuits to regulate tobacco firms’ behavior with respect to MRTPs and, relatedly, tobacco product branding and labeling. One of the most effective ways of policing industry use of modified-risk tobacco labeling is product liability claims based on state common law which explains the presence of the statute’s “rule of construction related to product liability.” State tort law causes of action create remedies for tobacco consumers deceived or misled by proposed labeling that nevertheless survives FDA premarket review, consistent with Congress’s intent for FDA regulation to work alongside state law in providing “ongoing oversight” of the tobacco industry. Part II of this article provides a brief history of tobacco industry practices with respect to reduced-risk claims as well as the regulatory regimes that followed, particularly the Federal Cigarette Labeling and Advertising Act. Part II situates the Tobacco Control Act’s Section 911 premarket review and post-market surveillance processes within this broader history. Part III sets forth the Tobacco Control Act’s Section 916 provision for preserving state regulatory authority over tobacco products excluding exceptions found in Section 916(a)(2)(A). This Part analyzes the statutory text, prefatory Congressional findings, and legislative history to identify and detail the extent of Section 916(a)(2)(A)’s preemptive scope. Given the law’s revolution in Congressional perspective on the role of state law as well as the statute’s purpose and Congressional findings, the most plausible conclusion is that Congress intended to preserve state product liability suits as an additional layer of oversight of MRTP labels and branding. Using Swedish Match’s 2014 modified risk tobacco product application for snus smokeless tobacco as well as other industry documents detailing the intended effect of snus on individual consumers, Part IV demonstrates that the relationship between FDA premarket review of MRTPs and the Tobacco Control Act’s preference for complementary state law is indistinguishable from the conclusion reached in Wyeth v. Levine.  State product liability and related tort claims against MRTPs are therefore not preempted by the law.  Part V provides a brief conclusion.

Read More (FDLI Members Only)
Subscribe

 

2017-05-15T23:34:29-04:00