Glantz Analysis Of How The Tobacco Deal Compares To Several Proposed Standards
ANALYSIS OF HOW THE TOBACCO DEAL COMPARES TO SEVERAL PROPOSED STANDARDS.
Brion Fox and Stanton Glantz
June 26, 1997
Introduction:
Prior to the publication of the proposed settlement deal, many commentators published benchmarks regarding the minimum standards any deal would need to contain in order to make it reasonable for consideration. We have performed a quick analysis of the proposed deal against the various standards and find that it does not meet the minimum required standards for any of the benchmarks. This is true despite the fact that many of the suggested benchmarks were subjected to heavy criticism that they were too lenient.
I. National Center for Tobacco Free Kids - Core Principles - Press Release
1) Regulatory authority: The FDA must have the authority to regulate the manufacture, sale, labeling, distribution, and marketing of tobacco products.
While the FDA maintains a certain amount of regulatory authority over tobacco products, it undeniably loses authority through increased regulatory burdens, a requirement that it cannot prohibit the cigarette in its "basic" form, and the inability to eliminate nicotine for more than twelve years. Does the deal meet this minimum standard: NO.
2) Minimum standard: The current FDA requirements governing youth access and tobacco marketing are essential minimum components of any public policy initiative. The agency's ability to augment these requirements should not be curtailed.
The deal seems to meet this standard. YES.
3) Victims' rights: The rights of victims of the tobacco industry to seek compensation for the injuries they have suffered should not be abridged and the tobacco industry should not be immunized from accountability for its wrongdoing.
The deal clearly limits the rights of individuals to sue by eliminating class actions lawsuits, eliminating punitive damages for past conduct, limiting the types of lawsuits that can be brought in the future, and placing annual caps on individual suits and annual caps aggregated over all tort suits. NO.
4) Public education and tobacco control: A well-funded, effective sustained public education and tobacco control campaign that is protected from political pressure is critical to reducing tobacco use.
Although the deal makes suggestions to Congress, there are no guarantees of funding, and the funding specifically targeted to tobacco control efforts appears to disappear after the eighth year. MAYBE.
5) Preemption: Congress should not preempt state or local laws that are stronger than federal laws, nor should the FDA be preempted from revising the form, content, and placement of the warnings on cigarette packs.
Because of the supremacy clause and restrictions as a result of states inability to burden interstate commerce, the deal will result in preemption. NO.
6) Public disclosure: The tobacco industry must disclose its research and studies about the effects of its products, including nicotine, on the human body and the marketing of tobacco to children.
The requirements in the deal relating to the release of tobacco industry documents are clumsy and burdensome. It is not clear whether these provisions will produce the documents as well as continuing the discovery process of the litigation, and it appears likely that the industry will be able to maintain its claims of privilege for many documents. NO.
In addition to these six principles, it is vital to recognize that there are other issues which are key components of any overall comprehensive tobacco control plan, including items such as increased tobacco taxes, protection of nonsmokers from environmental tobacco smoke, and the role of the American tobacco industry in international tobacco sales.
The deal will have little economic impact on the cigarette companies, but it will have some, which will probably be passed on to consumers as price increases. As for ETS, the deal creates a hospitality exception which is significantly expansive such that non-smokers will not be adequately protected from ETS. Furthermore, the deal abdicates any international responsibility. Overall on the other issues, NO.
II. George Annas, New England Journal of Medicine, January 23, 1997.
1. . . .no rationale for blanket immunity. . . .
Although no blanket immunity is given, the limitations placed on future lawsuits are so high, that they amount to de facto immunity from the point of view of the tobacco companies. NO.
2. . . .reducing smoking. . .
It is unclear what effect the deal will have on smoking rates, though there are no requirements or specific incentives to reduce overall smoking rates. PROBABLY NOT.
3. . . .making smoking itself less addictive and safer. . .
Although there are allowances for the FDA to regulate the content of cigarettes, as identified above this will prove difficult, and the FDA can never prohibit the "basic" form of cigarette. There are also no requirements for the development of safer technologies. NO.
4. . . .restrict the access of children to cigarettes and ban advertising aimed at them. . .
The deal makes a good faith effort to meet the youth access goals. (Although many are skeptical about the likely success of the suggested programs.) YES. The advertising restrictions are modest, not a ban. PARTIALLY.
5. . . .increasing taxes on cigarettes to fund anti-smoking advertising and smoking- cessation programs. . . .
See above, money is raised, it is unclear where the money will go. MAYBE.
6. . . .A truly global settlement must transcend U.S. boundaries, and a U.S. settlement should help set worldwide standards for tar and nicotine.
See above. NO.
III. Kluger, New York Times Magazine, April 7, 1996 (as quoted in Annas)
1. Congress would [grant blanket] . . . immunity to the tobacco companies against all pending and future product liability claims. . . .
See above. YES.
2. The FDA would be given regulatory oversight of the manufacture and packaging of cigarettes, including the power to set maximum levels for their hazardous ingredients.
See above. NO.
3. Health warning labels would be enlarged to occupy the entire back of all cigarette packs and would carry far more informative language.
The labeling requirements in the deal are not as strict as these. NO.
4. . . . .OSHA [Occupational Safety and Health Administration] regulations restricting smoking at most work places . . . and FDA [regulations regarding advertising would be properly implemented]. . . .
See above. PARTIALLY.
5. The federal cigarette tax would be double to 48 cents to pay for enforcing these new regulations. An additional 2-cents-a-pack levy would pay for an anti- smoking advertising campaign. . . .
The deal does increase taxes but would provide some money for enforcement and suggests some for an advertising campaign. See above. MAYBE.
IV. David Burns, et al., in an editorial in Tobacco Control
1. Acceptance by the tobacco manufacturers of the causal relationship between tobacco use and disease, and the addictive nature of nicotine;
There is no requirement that the tobacco companies make a public statement similar to the one made by Bennet Lebow in the Liggett deal. NO.
2. A total ban on tobacco advertising and promotion;
The deal does not ban all advertisement. NO.
3. FDA jurisdiction over tobacco products and their nicotine content, with the intent of removing nicotine as soon as acceptable nicotine substitution products are available;
The deal preserves nicotine and weakens the FDA authority. NO.
4. Reimbursement to the states for Medicaid and other state expenditure attributable to smoking, to the maximum extent feasible;
Burns et al. calculate the maximum amount the tobacco industries could afford in a given year to be approximately $38 billion. This deal would realize about $14 billion/year, not factoring in the lost tax revenue because the industry would be able to deduct their payments as a business expense. NO.
5. Funding for local, state and federal programmes and research in tobacco control;
See above. MAYBE.
6. Acceptance of legislation and regulations protecting the right of non-smokers to breathe air free of tobacco smoke;
See above. NO.
7. Funding for a large, national, media-led, anti-tobacco campaign; and
See above. MAYBE
8. Cessation assistance for addicted smokers.
This is suggested as a part of the allocation of money. YES.
IV. American Lung Association
1. No immunity should be provided the tobacco industry or tobacco industry executives. This includes no criminal immunity, no preemption of class actions or an individual's rights to sue in state/federal court and no caps on award settlements.
See above. NO.
2. No conditions should be made relative to the authority of the Food and Drug Administration to regulate tobacco products.
See above. NO.
V. An International Statement Circulated and Signed by Leading Tobacco Control Advocates Worldwide
1. Apply regulatory controls adopted as part of a settlement to all cigarettes manufactured in the United States, including those destined for export.
As stated above, the deal abdicates all international responsibility. NO.
2. Require the tobacco companies to agree to a code of conduct embodying the regulatory provisions contained in a U.S. settlement in areas such as marketing to children, advertising and marketing, labeling and performance requirements for reduction of new children smokers. The industry must immediately agree to end practices such as cigarette giveaways, television advertising, sports, music and other similar sponsorships and clothing giveaways. This code should be developed in consultation with the World Health Organization, the International Union Against Cancer and other international tobacco control advocates.
See above. NO.
3. Require the tobacco companies not to oppose efforts in other countries to adopt regulatory measures (for example, workplace restrictions on smoking and ingredient regulation) which are in line with World Health Organization recommendations.
See above. NO.
4. Assure that any immunities or limits on liability granted to the tobacco companies not apply to the companies' exports or activities or investments abroad. There should be no immunities or limits on liability or annual caps covering potential litigation in either U.S. or non-U.S. courts relating to the tobacco companies' exports or activities and investments abroad. There should be no immunity or limits on liability applied to enforcement in U.S. courts of foreign judgments against the tobacco companies.
See above. NO.
5. Ensure full public disclosure of the tobacco company documents now obtained by tobacco litigants and those sought by litigants but currently held by the tobacco companies under claim of attorney-client privilege.
See above. NO.
6. Require full public disclosure by the tobacco companies in every country of all political donations and political lobbying efforts.
See above. NO.
7. Entitle non-American victims to the same levels of compensation in U.S. courts as American victims, and ensure they maintain comparable legal remedies.
See above. NO.
8. Require the U.S. tobacco companies to offer to compensate foreign government health agencies, proportional to their market share (taking into account smuggled cigarettes) and reflecting the formula used to determine their payment to the states for Medicaid reimbursement.
See above. NO.
9. Require the tobacco companies to contribute $10 billion annually to the World Health Organization or other agreed upon international agencies for tobacco-control programs. This contribution would not preclude non-American demands for compensation for injuries caused by tobacco.
See above. NO.
10. Contain an explicit stipulation by the tobacco companies that they will not claim in any context that settlement terms concerning their overseas sales or operations preclude other governments in any way from adopting laws and regulations more restrictive than those adopted in the United States.
See above. NO.
11. Contain an explicit stipulation by the tobacco companies that they will not seek assistance from the U.S. Trade Representative, the U.S. Department of Commerce, U.S. embassies or other U.S. government agencies to resist or repeal other countries' tobacco control regulations and laws.
See above. NO.
12. Penalize companies shown to participate in or support international tobacco smuggling.
See above. NO.
13. Ensure that international tobacco control advocates be represented on a independent panel to determine the public health consequences of any final settlement. Apply regulatory controls adopted as part of a settlement
See above. NO.
Conclusion:
As can be seen from this quick analysis, which does not even address some of the weaker part of the agreement, the deal does not meet the weakest of the proposals outlined above. Also significant is how much the proposals differ from each other. One lesson that we can take from this, is that we still have not developed a consensus as to the appropriate public health response to a tobacco deal. That is, we know that this deal is inadequate, but it is nevertheless premature to consider any deal.
In our March 5, 1997 commentary in JAMA we bulleted 16 public policy issues for discussion prior to the development of any deal. Among the issues we raised were who should be a part of the settlement and how that deal should be constructed. We also requested an extensive discussion on the appropriate measure of damages to compensate for the harms to society, the real costs of forfeiting future litigation, the risks of including the FDA regulations in a settlement, the risks of singling out one industry for special treatment, the risks of preempting local solutions, the apparent conflict of interest between the attorneys prosecuting the lawsuits and the public health, and the costs of not fully releasing all tobacco industry documents.
We would echo those same sentiments again, because we fear that our suggestions fell on deaf ears the first time. Despite the ongoing discussions on the settlements, most of it has centered on what is supposedly being gained for the public health. Little of the discussion has focused on what the public health community forfeits in this deal, and not what it forfeits is significant. It is not too late to begin that discussion.
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