Clearing the Smoke Assessing the Science Base for Tobacco Harm Reduction (2001) / Chapter Skim
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7 Implementation of a Science-Based Policy of Harm Reduction
7 Implementation of a Science-Based Policy of Harm Reduction
Pages 201-230
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From page 201... ...
This is why many public health leaders believe that what has come to be called "harm reduction" must be included as a subsidiary component of a comprehensive public health policy toward tobacco. Some public health officials oppose the adoption of harm reduction strategies because of concerns that promoting this approach will not, over the long term, prove to be beneficial to public health or to the individual tobacco users who might otherwise have quit (Ferrence et al., 2000; Warner et al., 1997~.
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From page 202... ...
Nonetheless, despite advances in understanding tobacco toxicology and the pathophysiology and epidemiology of tobacco-related diseases, little is known about the health effects of using products that reduce exposure to one or more tobacco toxicants or about the public health consequences of promoting tobacco-related products or pharmaceutical products as potential reduced-exposure products (PREPs)
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From page 203... ...
To improve the science base for a harm reduction strategy for tobacco products and to protect public health, the committee's scientific findings and conclusions must be translated into a comprehensive policy framework that includes the following elements: · a substantial and sustained research program to address the critical unresolved questions that are susceptible to scientific resolution, as identified in this report; · a strong surveillance program that will serve both as an "early warning system" for identifying problems associated with PREPs and as an epidemiological tool for evaluating long-term health consequences; a well-designed program of public health education (including media campaigns) to help people understand that preventing the
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From page 204... ...
Modified tobacco products with exposure reduction claims currently fall into a twilight zone of regulatory uncertainty. Previous reports of the Institute of Medicine (IOM, 1994,1998)
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From page 205... ...
conventional tobacco products and modified products that are marketed without claims of reduced exposure to tobacco toxicants or reduced risk of disease; 2. modified tobacco products or tobacco-like products, whether tobacco containing or not, that are marketed with such claims; and 3.
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From page 206... ...
would be required to receive from the regulatory agency prior approval of the claim based on scientific evidence presented by the manufacturer that the claim is not false or misleading; products for which risk reduction claims are made would be subject to postmarketing epidemiological studies. · New brands and modifications of conventional tobacco products without health claims would be permitted to enter the market without prior regulatory approval if they are certified to present "no greater risk" than products already on the market.
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From page 207... ...
Summary of Regulatory Principles A science-based regulatory framework for implementing tobacco harm reduction should conform to the following 11 principles: 1. Manufacturers of tobacco products, whether conventional or modified, should be required to obtain quantitative analytical data on the ingredients of each of their products and to disclose such information to the regulatory agency.
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From page 208... ...
In the absence of any claim of reduced exposure or reduced risk, manufacturers of tobacco products should be permitted to market new products or modify existing products without prior approval of the regulatory agency after informing the agency of the composition of the product and certifying that the product could not reasonably be expected to increase the risk of cancer, heart disease, pulmonary disease, adverse reproductive effects, or other adverse health effects, compared to similar conventional tobacco 7.
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From page 209... ...
11. Exposure reduction and risk reduction claims for drugs and devices that are supported by appropriate scientific and clinical evidence should be allowed by the FDA.
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From page 210... ...
DHHS, 2000~. Principle 2: Yield Assessment All tobacco products should be assessed for yields of nicotine and other tobacco toxicants according to a method that reflects actual circumstances of human consumption; when necessary to support claims, human exposure to various constituents of tobacco smoke should be assessed using appropriate biomarkers.
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From page 211... ...
he regulatory agency, as its first step, should develop a sound methodology for ascertaining the actual yields of nicotine, tar, or any other constituents of tobacco products, based on human consumption. Human exposure to some constituents of tobacco smoke can be assessed by use of biochemical markers of exposure to those constituents, although at present this methodology is technically difficult and still imprecise; however, it is likely that better exposure measures will be developed in the future.
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From page 212... ...
Principle 3: Toxicity Testing Manufacturers of all PREPs should be required to conduct appropriate toxicological testing in preclinical laboratory and animal models and appropriate clinical testing in humans to support the health-related claims associated with each product and to disclose the methods and results of such testing to the regulatory agency. Under the regulatory arrangements recommended by the committee, tobacco manufacturers would have to obtain appropriate toxicological data from the scientific literature or conduct toxicological testing in connection with any new product or modification of an existing product (1)
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From page 213... ...
Under this approach, manufacturers would be permitted to market products with claims of reduced exposure or reduced risk (compared with whatever benchmark product is stated in the labeling) as long as the claim is approved on the basis of appropriate scientific data by the regulatory agency before marketing and, where judged necessary for risk reduction claims, appropriate plans for postmarketing surveillance are also approved.
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From page 214... ...
The committee judges that exposure reduction and risk reduction claims for tobacco-related PREPs should be treated as analogous to "effectiveness" claims for drugs and devices. lust like drug claims, they are intended to assure consumers of a potential health benefit if the product is used as directed, and just like drug claims, they should be presented accurately and supported by appropriate scientific data.
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From page 215... ...
Products that increase exposure to one or more tobacco toxicants while reducing exposure to others will present a complex challenge to the regulatory agency. At a minimum, approved claims of reduced exposure should be accompanied by warning statements regarding any increased exposure.
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From page 216... ...
From this perspective, adequate regulatory authority to promote accurate public understanding of the health effects of tobacco-related PREPs is perhaps the single most important feature of effective regulation. The burden of proving any claim of reduced exposure or reduced risk should rest on the manufacturer.
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From page 217... ...
In the judgment of the committee, a harm reduction strategy using tobacco-related PREPs cannot be implemented successfully unless consumers are fully informed through accurate labeling and advertising about the health consequences of using all types of tobacco products and about the substantial gaps in scientific knowledge. The committee finds no justification for continuing the current situation in which pharmaceutical products intended to aid smoking cessationthe desired public health goal must be labeled and promoted truthfully under a "not false or misleading" standard, while tobacco products claiming to reduce exposure or risk at best a partial and uncertain step toward disease reduction can be promoted under generic consumer deception laws, with the burden of proof on the FTC to police violations after the fact.
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From page 218... ...
less hazardous than smoking the conventional product. How the complex of claims and caveats associated with PREPs can best be articulated in labeling is one of the major challenges facing the regulatory agency.
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From page 219... ...
· The agency should also consider requiring that labels for PREPs that make exposure reduction claims disclose that the reduction in exposure depends upon the user not compensating for the reduction by increasing use or by inhaling more deeply. Consideration should also be given to a disclosure that the health benefits of the product's exposure reduction have not yet been established in scientifically recognized tests or ongoing studies.
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From page 220... ...
Although these are questions that will have to be addressed by the regulatory agency in due course, the committee itself is disinclined to permit claims that the product "may" or "might" reduce the risk of disease (or that "growing evidence suggests that the risk is reduced") unless, as judged by the regulatory agency after review of data by an independent scientific advisory committee, the degree of exposure reduction is likely to result in a meaningful decrease in tobacco-related morbidity or mortality that can be measured in subsequent epidemiological studies.
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From page 221... ...
. Given that considerable time will be needed to enact appropriate legislation, to staff a new regulatory agency, and to bring whole classes of products into a new regulatory system, a number of modified tobacco products with risk-reduction claims may enter the marketplace in coming years without regulatory review, assuming they are positioned not to fall under the drug or device laws.
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From page 222... ...
, for all PREPs. Principle 7: "No Increased Risk" Threshold for All Tobacco Products In the absence of any claim of reduced exposure or reduced risk, manufacturers of tobacco products should be permitted to market new products or modify existing products without prior approval of the regulatory agency after informing the agency of the composition of the product and upon certifying that the product could not reasonably be expected to increase the risk of cancer, heart disease, pulmonary disease, adverse reproductive effects, or other adverse health effects, compared to similar conventional tobacco products, as judged on the basis of the most current toxicological and epidemiological information.
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From page 223... ...
The committee considered whether premarket approval by the regulatory agency should be required for modifications and new brands of conventional tobacco products without claims of reduced exposure or reduced risk, and rejected this approach in favor of premarket notification and certification by the manufacturer. Although some product modifications may be undertaken to improve taste or other features linked to consumer satisfaction, future innovation in the tobacco market in this
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From page 224... ...
This review should be conducted by independent panels of experts reporting to the regulatory agency, with the objective of identifying those ingredients that add no significant toxicity to tobacco products and therefore can be considered safe in the context of this use. Sufficient knowledge of the toxicity of many of the constituents and ingredients of tobacco products may already be available (see Chapter 10)
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From page 225... ...
The committee notes that the review of food additives has been conducted without public disclosure of trade secrets, such as the composition of spices and flavoring agents, and believes that this principle should be respected in any review of the ingredients added to tobacco products. Principle 9: Performance Standards The regulatory agency should be empowered to set performance standards (e.g., maximum levels of toxicants; definitions of terms such as "low tar")
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From page 226... ...
The agency should also have the authority to remove from the market ingredients or products that do not meet the test of no increased risk; to prohibit claims that are not supported by adequate scientific data; to seize products that are improperly labeled; to act promptly against advertising campaigns and promotional materials that are false or misleading; and to require corrective action. Principle 11: Regulation of Drugs and Devices Exposure reduction and risk reduction claims for drugs that are supported by appropriate scientific and clinical evidence should be allowed by the FDA.
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From page 227... ...
While the committee again emphasizes that cessation of smoking is the desired goal for all smokers, it also concludes that drugs with exposure reduction and risk reduction claims, if properly regulated and proved efficacious, have a place among the treatment modalities that should be available to current smokers. The committee judges, for example, that statements such as "helps recruitment into treatment clinics" or "reduces the use of cigarettes without compensation" are appropriate indications if supported by adequate data from clinical trials.
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From page 228... ...
SUMMARY In this chapter, the committee has addressed key elements of a regulatory framework for implementing the scientific and policy recommendations made in the body of the report. In the committee's judgment, harm reduction is a feasible and justifiable public health policy but only if it is implemented carefully to achieve the following objectives: · manufacturers have the necessary incentive to develop and market products that reduce exposure to tobacco toxicants and that have a reasonable prospect of reducing the risk of tobacco-related disease;
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From page 229... ...
It is proposed as an essential component of a package of public policy initiatives (including research, education, and surveillance) that this committee believes is necessary to realize whatever benefit tobacco or pharmaceutical product innovation can offer in reducing the nation's burden of tobacco-related illness and death.
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From page 230... ...
1998. Federal regulation of tobacco products and products that treat tobacco dependence: are the playing fields level?
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