Tobacco in the Colonies What was the role of tobacco in the colonial period? How was smoking viewed by most people in the 1950s? What happened in 1964? Why is it so hard to quit smoking? Federal Cigarette Labeling and Advertising Act - 1965/1969 Required hazard labeling on cigarettes Banned cigarette advertising in electronic medial regulated by the FCC Why not ban it everywhere? Prevented state additional requirements Which requirements were they worried about? What happened in torts in 1965? What about non-tort concerns? Public Health Impact of Tobacco #1 preventable cause of illness #1 problem is heart disease 6 out of 7 smokers do not live to get lung cancer Emphysema is the big lung issue - nasty way to live, then you die Slow progress in limiting smoking May have plateaued after the tobacco settlement In Defense of Tobacco Limits retirement Saves Medicare and Social Security Great for private pension plans as well Tobacco will reduce life-time health care costs if you smoke enough Ideally you will also eat a lot of burgers Improves job opportunities for young, cheaper workers Politics of FDA Chairman Kessler was appointed by Bush I Liked publicity Wanted to keep his job when Clinton can into office Banned silicone breast implants - just to be safe Made 4.5 billion for trial lawyers and got to keep his job FDA v. Brown & Williamson Tobacco Corp. The FDA decided to regulate tobacco What was the politics? What had it said about tobacco regulation over the past 50 years? FDA Authority Anything sold in interstate commerce with the intent to affect the structure or function of the body is a drug Drugs must be proven safe and effective FDA Regulation of Tobacco Does it fit within the definition of a drug? What would be the effect of applying the safe and effective test to tobacco? Does this create a regulatory paradox? How is it different from chemotherapy? Statutory Provisions The Act prohibits "[t]he introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adultered or misbranded." 21 U. S. C. §331(a) §352(j) deems a drug or device misbranded "[i]f it is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof." Tobacco Labeling Second, a drug or device is misbranded under the Act "[u]nless its labeling bears ... adequate directions for use ... in such manner and form, as are necessary for the protection of users," except where such directions are "not necessary for the protection of the public health." §352(f)(1). Is it possible to label tobacco so it can be used safely? Chevron - Step One Does tobacco fall under the statute? Is it specifically named? Is it specifically prohibited? Why is there a question of ambiguity in what the statute means? Doesn't tobacco affect the body? Chevron – Step Two What was congressional intent? What is the evidence that congress did not intend for the FDA to regulation tobacco? Alternative regulatory schemes and agencies? Renewed and expanded the FDA Act without addressing tobacco United States Supreme Court Opinion The majority (Scalia) said this was evidence that Congress did not intend for the FDA to regulate tobacco, and that such intent trumped Chevron Minority (Breyer) said just look at the law Politics trumps principle Lorillard Tobacco Company v. Reilly, 533 U.S. 525 (2001) What is MA trying to do? Types of Preemption Explicit Implicit How is the United States Supreme Court's preemption analysis similar to a Chevron analysis? Preemption Language Congress unequivocally precludes the requirement of any additional statements on cigarette packages beyond those provided in §1333. 15 U. S. C. §1334(a). Congress further precludes States or localities from imposing any requirement or prohibition based on smoking and health with respect to the advertising and promotion of cigarettes. §1334(b). What did Congress Intend with the Cigarette Labeling Act? What was MA's defense against preemption? What did the court find was the congressional intent? The context in which Congress crafted the current pre-emption provision leads us to conclude that Congress prohibited state cigarette advertising regulations motivated by concerns about smoking and health. Justice Steven's Irony Justice Stevens finds it ironic that we conclude that "federal law precludes States and localities from protecting children from dangerous products within 1,000 feet of a school," in light of our prior conclusion that the "Federal Government lacks the constitutional authority to impose a similarly-motivated ban" in United States v. Lopez, 514 U. S. 549 (1995). Why is this case different? What could the state do? Smokeless Tobacco and Cigars Are these covered by the Act? Why? What does the court see as the limitation on state regulation of their advertising? What is the state's justification for limiting advertising near schools? Why was 1000 feet too far? Actions v. Speech Could the state ban the sale of tobacco to minors? Can it ban the use unattended sales such as vending machines? Can it ban tobacco sales entirely? Why is this different from bans on advertising? Could Congress preempt state bans on tobacco sales? What Should We Do About Tobacco Use? What is the public interest? What are the individual liberties issues? Are the other substances people want to use that we ban? Is tobacco different in any physiological, as opposed to political sense? How well do the other bans work? What are the unintended consequences? What About Obesity?