FDA -- Looking at 2009 Federal Legislation &

                        the related 2000 U.S. Supreme Court Decision

EXCERPTS from The Virginian-Pilot, March 22, 2000, FDA's control of tobacco snuffed, Paul Clancy and Ledyard King.

"I think it is a little light at the end of the tunnel,'' said David Jones, a tobacco farmer from Bracey, Va., near South Hill.

Although the Food and Drug Administration repeatedly said it sought only to regulate cigarettes and not ban them, a Philip Morris spokesman said the industry feared that anti-smoking groups would have tried to force the government to impose such a prohibition.

That would have devastating economic effects not just on farmers but thousands of cigarette manufacturing plant employees in Richmond, Brendan McCormick, a spokesman for the New York-based company, said Tuesday.

Such a move would also abruptly end multibillion-dollar settlements the industry has entered into with states over health care costs incurred from smoking, he said.

Not everyone in Virginia is happy with the Supreme Court's decision, which likely will throw the responsibility for regulating teen-age smoking back to Congress.

Anne Morrow Donley, an anti-smoking advocate in Richmond, said the court's ruling has left the regulation of an addictive substance up to a Congress whose leaders are beholden to the free-spending tobacco lobby and whose members do not appear interested in protecting the health of their constituents.

"If we're going to say that as a government we're going to look out for the welfare and well-being of the people, then we must say that tobacco must be regulated as a drug,'' said Donley, who co-founded Group to Alleviate Smoking in Public, GASP, 15 years ago.

"This is agreeing with the tobacco companies that it's OK to continue with business as usual and sell an addictive drug that kills,'' she said of the ruling.

EXCERPTS from Reuters, March 21, 2000, writer James Vicini, "High Court Rules FDA Lacks Power Over Tobacco", James Vicini.

 The decision was a major victory for the tobacco industry, which has been hit with a number of civil lawsuits seeking huge damages for smoking-related illnesses.

 The ruling initially sent the stock prices of tobacco companies sharply higher on Wall Street, although most of the gains disappeared by the time the market closed.

 The ruling sends the battle over cigarette regulation back to Congress. Immediately after the decision, Clinton urged congressional leaders to get tobacco legislation approved.

 Some lawmakers plan to introduce legislation to explicitly give the FDA authority over tobacco, although it seems unlikely the Republican-controlled Congress will approve such a major initiative before the November elections.

Seizing on a key election-year issue for Democrats, Vice President Al Gore said, ``Tobacco is one of  the most addictive substances known to man and should be regulated as a drug.''

Gore, who is likely to face Republican George W. Bush in the presidential race, said, ``It is time for the  Republican Congress and George Bush to show their  independence from Big Tobacco and do the right thing by passing  legislation.''

 Justice Sandra Day O'Connor said in the court's majority opinion that the case involved one of the most troubling public health problems facing the nation -- thousands of premature deaths that occur each year from tobacco use.

 O'Connor said the FDA had ``amply demonstrated'' that tobacco use, especially among children and adolescents, posed perhaps the single most significant threat to public health in the United States.

 ``No matter how important, conspicuous and controversial the issue and regardless of how likely the public is to hold the executive branch politically accountable, an administrative agency's power to regulate in the public interest must always be grounded in a valid grant of authority from Congress,'' she wrote.

 O'Connor was joined in the majority by cigarette smokers  William Rehnquist, the chief justice, and Antonin Scalia, former cigar smoker Clarence Thomas, and nonsmoker Anthony  Kennedy. They represent the court's most conservative members.

 Dissenting were justices Stephen Breyer, John Paul Stevens, Ruth Bader Ginsburg and David Souter, all nonsmokers and the court's most liberal members.

 Taking the unusual step of reading his dissent from the bench,  Breyer said he would have ruled that the law gives the FDA the power to regulate tobacco.

 ``The upshot is that the court today holds that a regulatory statute aimed at unsafe drugs and devices does not authorize regulation of a drug (nicotine) and a device (a cigarette) that the court itself finds unsafe,'' Breyer said.

 He noted that ``tobacco products kill more people in this country every year than ... AIDS, car accidents, alcohol, homicides,  illegal drugs, suicides and fires, combined.''

EXCERPTS from Associated Press, March 21, 2000, "Court: FDA Can't Regulate Tobacco", Laurie Asseo.

 Writing for the four, [Justice] Breyer said the federal Food, Drug and Cosmetic Act allows the FDA to regulate tobacco. ``Far more than most, this particular drug and device risks the life-threatening harms that administrative regulation seeks to rectify,'' he added.

 Breyer said he did not believe the law would require a ban on cigarettes.

 He also said the fact that only 2.5 percent of smokers manage to quit each year ``illustrates a certain reality - the reality that the  nicotine in cigarettes creates a powerful physiological addiction  flowing from chemically induced changes in the brain.''

Updated 24 April 2009