WASHINGTON--The Marlboro Man's long-anticipated final ride into the sunset will likely be delayed, as the proposed tobacco settlement that would ban his image appears to be headed for a long and heated debate.
The provision in the settlement banning the use of humans and cartoons in cigarette advertising may be noncon-troversial, but numerous other elements of the settlement are receiving close scrutiny and criticism from medical and public policy groups--a prologue to the contentious debate the agreement will likely face in Congress.
The proposed settlement was negotiated by the tobacco industry, seven attorneys general representing the 40 states that have sued the tobacco companies for reimbursement of Medicare funds spent on treatment of tobacco-related diseases, and a group of plaintiff's lawyers. The sole public health group involved in the negotiations was the Campaign for Tobacco-Free Kids.
The agreement requires the tobacco industry to make concessions on advertising, labeling, and smoking in public places, and to pay $368.5 billion in the next 25 years to compensate the states for medical care of smokers, finance anti-smoking programs, and pay for health care of uninsured children. In return, the tobacco companies would get protection from class action lawsuits and limits on punitive damages from individual suits.
Although medical groups are supportive of the document's general goal of reducing tobacco consumption, experts interviewed by Oncology News International expressed major concerns about many of the provisions.
Two important sticking points are the restraints the settlement would place on the FDA's ability to regulate nicotine(Drug information on nicotine) in cigarettes and the inadequacy of the penalties for failing to meet goals in reducing underage tobacco use.
'Paralyzes the FDA'
"The agreement virtually paralyzes the FDA from regulating nicotine in cigarettes," said John F. Banzhaf III, executive director of Action on Smoking and Health (ASH), a national nonprofit legal action and educational organization fighting for the rights of nonsmokers. Mr. Banzhaf led the successful campaign to ban cigarette commercials on television and to limit smoking in public places, restaurants, and airplanes.
The FDA currently has the right to regulate nicotine as a drug and cigarettes as a nicotine delivery system. A federal court decision last spring that upheld this right is being appealed by the tobacco companies. Under the settlement, the FDA could immediately reduce nicotine levels and could ban nicotine from cigarettes in 12 years, but with several significant, if not prohibitive, restrictions.
The FDA would have to prove that the action--lowering nicotine levels or banning nicotine--would lead to measurable improvements in health, would be technologically feasible, and would not create a substantial market for "contraband or other tobacco products that do not meet the product safety standard," in other words, a black market.
The FDA's decision would then be reviewed by Congress, and the tobacco industry would have the right to judicial review of any such action, a legal process that could take years.
Pennies per Pack?
Critics of the agreement also think that the financial penalties would not be enough to curb the industry. Although $368.5 billion sounds like a tidy sum, even divvied up over 25 years, critics speculate that the most of the money could be raised by increasing cigarette prices. Furthermore, most of the sum would be tax deductible as a business expense.
As part of the settlement, the tobacco industry would have to take steps to dissuade underage smoking, and if it does not decrease by 60% in 10 years, the industry would be fined $80 million for each percentage point short of the goal, with a cap of $2 billion annually.
Critics say, however, that this penalty would amount to only a few pennies per cigarette pack. In addition, the agreement contains a loophole that would allow the companies up to a 75% abatement of the penalty if they could prove to the FDA that they had complied in good faith with the provisions of the settlement.
"The deal is basically a settlement for a few cents on the dollar, most of which will be paid by the public and by smokers themselves," Mr. Banzhaf said.
Lowell Schnipper, MD, of Beth Israel Hospital, Boston, and chair of ASCO's public issues committee, also considers the penalties too modest in light of the industry's enormous profits. He said in an interview that the document is really a first draft and any legislation that comes out of Congress could be quite different.
Nothing to Stop Overseas Sales
Mr. Banzhaf noted that "there are no provisions in the settlement whatsoever to protect 95% of smokers, that is, those who are outside of the United States."
Dr. Schnipper echoed this concern: "The agreement made no attempt to address the issue of the export of tobacco products to countries outside the United States, which to us at ASCO is a significant omission."
In a separate interview, Ernst Wynder, MD, executive director of the American Health Foundation, also said that a more global viewpoint on tobacco control is needed and that any settlement should benefit not just US children but all the world's children. Dr. Wynder, with Evarts Graham, wrote the landmark paper linking lung cancer and tobacco.
Action on Smoking and Health, the organization headed by Mr. Banzhaf, is one of some two dozen medical and health advocacy groups sitting on a panel that is reviewing the agreement for Congress and the White House.
The Koop-Kessler panel, named after its co-chairs, C. Everett Koop, MD, former US Surgeon general, and David Kessler, MD, former director of the FDA, does not appear to be in a mood to compromise on these issues. Dr. Koop has called the plan as it stands "absolutely unacceptable."