>Sender: >To: >X-Original-Message-ID: <05c901bf3d1f$272d3d60$9acf69cf@pacbell.net> >From: "Peter McWilliams" >Subject: Supreme Ban? >Date: Thu, 2 Dec 1999 15:44:19 -0800 >X-Mozilla-Status: 8001 >X-Mozilla-Status2: 00000000 > > >Here are two front-page stories from the two Times about the Supreme Court >hearing on FDA controling nicotine. > >Whatever the outcome, it will be favorable to drug reform. If cigarettes are >not banned, how can the FDA continue to ban marijuana? And there'll be a >Supreme Court ruling behind it. > >Enjoy, > >Peter > > > > >LA Times > >High Court Wary of Classifying Tobacco as Drug > > >By DAVID G. SAVAGE, Times Staff Writer > > > > > > WASHINGTON--The Clinton administration's plan to regulate cigarettes as >legal drugs received a surprisingly hostile hearing before the Supreme Court >on Wednesday. > In skeptical questioning, most of the justices suggested that federal >health regulators overreached three years ago when they claimed power over >cigarettes and smokeless tobacco. > The prospect of federal control has alarmed the already beleaguered >tobacco industry, which believes that such regulation would threaten its >very survival. > Under a policy adopted in 1996 by the Food and Drug Administration, >regulators could have ordered the industry to reduce or eliminate nicotine >from cigarettes. Tobacco industry lawyers have feared that such control >eventually would result in the prohibition of cigarettes. > However, those possibilities appeared to fade quickly during >Wednesday's argument. > The Supreme Court justices, looking closely at the Food, Drug and >Cosmetic Act of 1938, said that they did not see how cigarettes could be >classified in the same category as medicines. > "It just doesn't fit," Justice Sandra Day O'Connor exclaimed, >describing her reaction to calling a cigarette a drug. > Under the 1938 law, federal regulators can oversee drugs that are sold >to prevent diseases or cure illnesses, she said. But, she added, "it strains >credibility" to say that Congress meant to include cigarettes under this >rubric, since tobacco products are not sold as medicine. > And if cigarettes were covered by the law, they would "have to be >banned," O'Connor said, since their risks to health clearly outweigh their >benefits. > She noted that FDA lawyers had defined their authority so broadly as to >cover anything that is intended by its maker to have an effect on the body. > "Could the FDA regulate horror movies?" O'Connor wondered, since such >films are designed "to get the adrenaline pumping." > No one has seriously suggested anything of the sort, replied U.S. >Solicitor Gen. Seth Waxman, representing the administration. > "Well, 30 years ago, no one suggested the government could regulate >cigarettes," interjected Chief Justice William H. Rehnquist, a regular >smoker. > The skepticism from O'Connor and Rehnquist was echoed in questions from >Justice Antonin Scalia, the court's other steady smoker, as well as from >those who might have been seen as more friendly to the anti-tobacco >arguments, including Justices David H. Souter and Anthony M. Kennedy. > Only Justices Stephen G. Breyer and John Paul Stevens strongly defended >the Clinton administration's stand. > With control over cigarettes, FDA officials had hoped to ban most >tobacco advertising, including sports promotions. They also intended to >forbid the sale of cigarettes through vending machines. Retailers would be >required to ask for photo identifications before selling cigarettes to >anyone younger than 27. > Those proposed rules have been stalled pending the outcome of the court >battle. > Last year, the U.S. Court of Appeals in Richmond, Va., struck down the >FDA's claim of authority over tobacco products, and most of the justices >sounded Wednesday as though they will uphold that ruling. > If they do, the issue would move back to Congress. But the >Republican-controlled Congress recently has shown no enthusiasm for bringing >tobacco under the FDA's control. > However, anti-tobacco forces have been winning on other fronts. In a >series of legal settlements with the states, the major tobacco firms have >agreed to pay $246 billion to cover smoking-related health costs. > The Justice Department has brought a similar federal lawsuit against >the tobacco firms, and several class-action suits are pending in state >courts. > In 1995, then-FDA Commissioner David A. Kessler said newly discovered >evidence--industry documents--showed that tobacco industry officials had >known for decades that nicotine is addictive and that the amount of nicotine >in cigarettes can be manipulated. > Tobacco use "is the largest cause of preventable death in the United >States," the FDA added. Each year, more than 400,000 Americans die from >smoking-related illnesses. > This new evidence, combined with the enormous health consequences of >smoking, justifies a sharp change in federal policy, the administration >said. > The justices were unswayed. What's new about this, Scalia asked, since >the health dangers of cigarettes have been documented for decades. > Certainly in 1964, when the surgeon general first warned Americans of >the hazards of smoking, ordinary Americans--as well as the FDA--knew of the >dangers, Rehnquist said. > Maybe so, Waxman said, but the leaders of the major tobacco companies >testified under oath just a few years ago that they believed cigarettes were >not addictive. > "No one believed them," Scalia responded. > The sharp tone of the questioning came as a surprise. During the 1980s, >when the Ronald Reagan administration's policies were being attacked in the >courts by liberal interest groups, the Supreme Court ruled that judges >should defer to the decisions of executive agencies. > Waxman relied on that doctrine Wednesday, but without much success. > Instead, the justices questioned him on where the government's >anti-tobacco policy would lead. > How could cigarettes be kept on the market, they asked, if they are >deemed to be drugs? > Waxman said that the agency would have to weigh the risks and would >conclude, at least for now, that prohibition would be a mistake. > But the question seemed to confirm the justices in their view that >cigarettes were not meant to be regulated as drugs by the FDA. > A ruling in the case (FDA vs. Brown & Williamson Tobacco, 98-1152) is >expected in several months. > >New York Times: > >Justices Skeptical of U.S. Claim on Cigarettes > >---------------------------------------------------------------------------- >---- >Related Articles >Church-State Issue Returns to High Court (Dec. 2, 1999) >Issue in Depth: Supreme Court Guide >Forum > >Join a Discussion on Issues Before the Supreme Court >---------------------------------------------------------------------------- >---- > >By LINDA GREENHOUSE >ASHINGTON -- The Clinton Administration faced a notably skeptical Supreme >Court Wednesday as it tried to convince the justices that the Food and Drug >Administration has jurisdiction over tobacco and the authority to regulate >cigarettes as "drug delivery devices." > >The crowded courtroom became, for an intense hour, the current battleground >in the tobacco wars that have swept through Congress and presidential >politics. But the familiar policy arguments took second place to a prolonged >dissection of food and drug law. > > > >Solicitor General Seth P. Waxman labored to demonstrate that the regulations >the F.D.A. > >issued in 1996, which were struck down last year by a federal appeals court, >fit comfortably within the agency's core public health mission. The >regulations placed restrictions on cigarette sales and advertising aimed at >those under the age of 18. > >Richard M. Cooper, a former general counsel of the Food and Drug >Administration, now representing the five cigarette makers that challenged >the regulations, said the agency's action was "lawless" in the absence of an >explicit Congressional grant of authority. > >Justice Sandra Day O'Connor, who observed several times that regulating >smoking "just doesn't fit" within the agency's statutory authority, asked >Waxman whether under his theory the agency could regulate horror movies >"because so many people go to them to get scared and get their adrenaline >pumping." > >When the solicitor general replied that "no one is suggesting" that the Food >and Drug Administration regulate movies, guns and the like, Chief Justice >William H. Rehnquist interrupted to observe that "30 years ago, no one >suggested" that the agency had authority over cigarettes. > >A significant hurdle for the administration was the fact that for nearly its >entire history, from its establishment under the Federal Food, Drug and >Cosmetic Act of 1938 until the mid-1990's, the agency said it had no >authority to regulate smoking. > >Waxman's position is that the agency changed its mind in the face of new and >"overwhelming evidence" that nicotine is addictive and that cigarette >manufacturers "knew this and were engineering their products to deliver the >precise dose of nicotine that consumers need to obtain its effects." > >The Food, Drug and Cosmetic Act defines a drug as a substance, other than >food, "intended to affect the structure or any function of the body." So >evidence not only of nicotine's properties but of the manufacturers' intent >to exploit those effects was crucial to the agency's late-day reevaluation, >Waxman said. > >But his point, although he made it repeatedly, appeared lost on the >justices. "Wasn't it clear in 1938, even much earlier," that smoking was >harmful, Justice Antonin Scalia wanted to know. Even in the early 1900's, >there was a movement among the states to ban smoking, he said. "Why wasn't >the Surgeon General's report fully enough?" Justice Scalia added, referring >to the 1964 study that documented the health effects of smoking. > >Another major hurdle for the administration appeared to be the F.D.A.'s >choice to regulate smoking rather than ban it. For a drug or medical device >to be marketed with the agency's approval, it must be proven "safe" and >"effective," with the health benefits for those who use it outweighing any >risks. > >The industry has argued that in light of that regulatory structure and of >the agency's determination that cigarettes are not safe, it must ban them if >it has jurisdiction over them at all, a step with such drastic economic and >social policy implications that the agency must be able to point to explicit >Congressional authorization to exercise such power. > >This was essentially the conclusion of the United States Court of Appeals >for the Fourth Circuit, in Richmond, which ruled against the agency's >jurisdiction in a 2-to-1 decision in August 1998. > >Waxman said today that while the agency might eventually decide to ban >cigarettes, it had decided that a better approach for now was to try to keep >those under the age of 18 from starting to smoke while not interfering with >older smokers, "a majority of whom are addicted." The agency had concluded >that than letting people in that group keep smoking was safer for them than >a total ban, he said. > >Justice O'Connor was unpersuaded. "It strains credibility to say that these >products can be safe," she said, adding: "I just don't understand how >someone can stand here and say that." If the agency had jurisdiction, it >would have no choice but to impose a ban, she said, "but we've certainly >operated for a long time with the understanding that this wasn't covered." > >Perhaps the most devastating response to the solicitor general's >presentation came from Justice David H. Souter, who offered Waxman a lengthy >summary of the arguments. Justice Souter said the solicitor general had "in >large part answered" many of the technical legal issues in the case but that >"the global problem" still remained of whether Congress had given the agency >the power it now claimed. > >"It does not seem to me reasonable at this point for the government to >assert jurisdiction," Justice Souter said. > >By the time Cooper, representing the industry, began his half-hour at the >podium, his work appeared largely accomplished. But not in all respects. He >apparently failed to convince Justice Stephen G. Breyer with his assertion >that the agency could only establish a manufacturer's "intent" by pointing >to specific health claims made for a product. Since no such claims are made >for cigarettes, there is no basis for F.D.A. regulation, Cooper said. > >"The unusual thing here is that we have a product that everyone knows what >it is," Justice Breyer said. "Why do you need a claim? Is the statute >supposed to stop the F.D.A. from looking at the real world?" At another >point, Justice Breyer said: "Smokers are no longer able to kid themselves >about this -- that nicotine satisfies a craving caused by chemical >addiction." That was the effect on the body that fit the definition of a >drug, Justice Breyer suggested. > >A colloquy with Justice Ruth Bader Ginsburg served as a platform for >Cooper's arguments about the limits of the agency's jurisdiction. Justice >Ginsburg asked whether heroin, if it were lawful, could be regulated by the >Food and Drug Administration. > >"If it doesn't purport to have a health benefit, it couldn't be regulated by >the F.D.A.," Cooper said. > >Justice Ginsburg asked, "Even if the product was harmful to health?" > >Cooper, offering as an example household cleaning products that are >dangerous when swallowed, said, "There are thousands of products that are >harmful to health" that fall outside the agency's jurisdiction. > > >Justice Ginsburg rejected that example, asking for one in which "the core >use is putting it into the body." > >The agency has no jurisdiction over "street drugs," Cooper replied. > >What about marijuana for which health benefits are claimed, Justice John >Paul Stevens asked. > >"Oh yes," Cooper said, with such claims, the agency could assert >jurisdiction. > >In rebuttal, Waxman said that limiting the agency's jurisdiction to products >with explicit health claims would "revolutionize" food and drug law and >create a huge regulatory loophole. > >The regulations at issue in the case, Food and Drug Administration v. Brown >and Williamson Tobacco Corporation, No. 98-1152, are based on the agency's >conclusion that people who reach the age of 18 without smoking are unlikely >to start. The regulations prohibit the sale of cigarettes or smokeless >tobacco to those under 18 and require retailers to check the identification >of those under age 27. > >The regulations at issue also included restrictions on advertising, which >Judge William L. Osteen Sr. of Federal District Court in Greensboro, N.C., >found in an earlier phase of the case to fall outside the agency's statutory >authority. The Fourth Circuit consequently did not rule on the advertising >restrictions, but if the Supreme Court rules in favor of the agency's >jurisdiction, the tobacco industry has indicated it will challenge those >restrictions on the grounds of free-speech. > >In addition to Brown and Williamson, the other plaintiffs in the case are >Philip Morris Inc. the Lorillard Tobacco Company, the United States Tobacco >Company, and the National Association of Convenience Stores. > > > > >================================================================ > >This message is sent to you because you are subscribed to > the mailing list . >To unsubscribe, E-mail to: