WASHINGTONIn its review of the proposed tobacco settlement, the American Cancer Society (ACS) recommended a number of changes it considers essential.
The American Cancer Society supports the right settlement, but this is not that settlement, said ACS chairman George Dessart. There are major elements of the current settlement proposal that will require substantial revisions for the agreement to succeed in its more important potential benefit to public healthreducing tobacco use and therefore tobacco-caused disease and death.
ACS officials outlined their objections to the settlement at a press briefing, and painted parts of it as illusionary. The much-mentioned settlement figure of $368.5 billion to be paid by the tobacco industry over 25 years, for example, overstates the real value of the amount to be paid, said physician-economist
Jeffrey E. Harris, MD, PhD, of the Massachusetts Institute of Technology, who assisted with the ACS analysis. Much of the settlement would be tax deductible, resulting in a loss of revenue for the federal government.
The Societys concerns range from limitations on the authority of the FDA to regulate nicotine(Drug information on nicotine) and the federal preemption of state and local tobacco control regulations, to the need to ensure full disclosure of tobacco industry records and to regulate all tobacco additives.
ACS president Myles P. Cunningham, MD, said the Society would not back any agreement that did not give the FDA unfettered authority to regulate tobacco products or that failed to provide provisions that would ensure significant decreases in the number of young cigarette smokers.
However, he and others at the briefing expressed confidence that an acceptable agreement will be enacted. We are at a time when [elected officials] dont want to have to say, I carry water for the tobacco industry, said John Seffrin, PhD, ACS chief executive officer.
A Unified Stand
The ACS undertook its detailed review after the tobacco industry and the Attorneys General of 40 states announced their proposed accord, which would require Congress to enact specific pieces of legislation to bring the pact to fruition. The proposal quickly drew criticism from the Clinton Administration, and the reaction of health groups has ranged from total rejection to partial acceptance.
Dr. Seffrin said that ACS officials had met twice with other major antismoking groups and planned additional meetings to hammer out a more unified stand on the proposed settlement. The public wants a settlement, and were here to help them get it, Dr. Cunningham said.
The societys major objections include:
1. Industry payments: The $368.5 billion payment required from the tobacco companies appears too small to significantly reduce youth smoking, ACS said. It would force a 41 cents a pack increase in the price of cigarettes in the first year of the agreement, which would grow to 62 cents in the fifth year and remain there.
ACS suggested a much steeper price increase is needed to discourage youngsters from smoking. It backs raising the federal tobacco excise tax to $2 a pack from the current 24 cents a pack. We know that a $2 increase will save 2.3 million lives, Mr. Dessart said.
2. FDA regulation: The settlement imposes too many restrictions and procedural hurdles on the agency, ACS argued. The settlement should give FDA the authority to regulate cigars and pipe tobacco and to develop performance standards designed to reduce or eliminate any tobacco constituents, including nicotine.
A final settlement should delete requirements that the FDA must demonstrate that forcing modifications to tobacco products, such as removing nicotine, will not result in significant smuggling. It also should eliminate the heightened standard of proof written into the agreement and allow traditional administrative law to apply.
Under the proposed pact, it could be years and years before the FDA could take action on a matter of public health, said Stephen E. Lawton, JD, a member of the Washington law firm of Hogan and Hartson.
Mr. Lawton noted that a US District Court judge has ruled that the FDA does not have the power to regulate tobacco advertising. Congress could, however, craft a constitutionally acceptable law so that the FDA could govern tobacco company advertising and promotions, he said. To have that authority and to exercise that authority is critical to any tobacco control policy, he added.
3. Preemption: States and localities should be authorized to enact laws that are more stringent than federal tobacco control laws, the ACS said.
4. Industry disclosure: Tobacco companies should be required to provide the FDA all their documents relevant to public health, safety, and the development of less hazardous tobacco products, including those records involving research and marketing. The public now wants the truth and to see those documents, Dr. Cunningham said.
5. Underage tobacco use: ACS complained that no economic incentives exist to ensure that the industry meets the agreements look-back provisions that set specific targets for reducing underage tobacco use. Youth cigarette smoking is supposed to be reduced 30% in the fifth year, 50% in the seventh, and 60% in the 10th. Smokeless tobacco use is supposed to drop by 25% in year 5, 35% in year 7, and 45% in year 10.
ACS urged that reduction requirements be required for all tobacco products, including cigars and pipe tobacco, and that legislation raise the smokeless tobacco reduction targets to the same levels as cigarettes.
Over the past 10 years, the increase in use of smokeless products among teenage boys has outpaced that of cigarettes, the Society argued. It also recommended a surcharge on each company and on each brand that failed to achieve the smoking reduction levels.
6. Regulation of nontobacco ingredients: The ACS supports the settlement provision that tobacco companies provide FDA a list of all the nontobacco ingredients they use. However, it also makes the following recommendations:
- Ingredients must include all additives and other substances derived from tobacco, plus nontobacco ingredients.
- The FDA should be given the authority to establish standards to assess tobacco safety.
- Congress should pass legislation making clear that safety assessments must include an evaluation of ingredients used in combination with each other, as well as the fact that ingredients are altered through burning.
- The FDA should receive the authority and the resources to establish an appropriate means of measuring risk and of determining the reduced risk of any so-called safer cigarettes that may be developed.