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What is INTERVALS about?

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Tob Control ; 14 : Nicotine Tob Res ; 14 : Nicotine and nonnicotine factors in cigarette addiction. Abrams, D et al. Statement from specialists in nicotine science and public health policy. For any smoke-free alternative to be successful in swiftly reducing harm compared with continued smoking, it has to fulfil two criteria: it must be scientifically substantiated as significantly less harmful than cigarettes; and, it should be satisfying for current smokers so that they completely switch.

The Harm reduction equation presented at the E-cigarette summit by Clive Bates. Leading tobacco policy experts acknowledge that successful harm reduction depends on smoker acceptance of alternative products. Royal College of Physicians of London, Basis for comparison in our assessment framework.

PMI has a range of RRPs in various stages of development, scientific assessment and commercialization.

Providing a Science Base for the Evaluation of Tobacco Products

The IOM determined that regulation of all tobacco products was needed to implement a strategy for harm reduction, but it did not attempt to provide a framework for comprehensively assessing tobacco products. Its report stopped short of identifying studies to be incorporated into a product assessment or indicating how such studies would be identified, used, and interpreted.

SACTob also noted that claims of reduced exposure or reduced harm should be supported by adequate scientific data provided by the manufacturer and independently verified by an appropriate government agency prior to permitting the claim. A point of note is TobReg's conclusion that research and testing should be interactive and iterative and should include analysis of a product's physical characteristics, chemistry, toxicology, and behavioral use patterns.

However, Hatsukami, et al.

Assessing the harmfulness - Tobacco in Australia

The tobacco industry also has been developing frameworks to study PREPs. LSRO's proposed framework was divided into three phases: testing, comparative risk assessment, and decision-making. The framework drew heavily on pre-clinical laboratory studies in vitro and in vivo and human clinical studies, with specific recommendations for biomarkers and biological effects assessments to be utilized. Proposing a weight of evidence approach, the framework also recommended laboratory studies before proceeding to human studies.

It also emphasized that increased toxicological effects should lead to the re-design or abandonment of a product design change, and that risk comparisons should focus on lung cancer, chronic obstructive pulmonary disease, and cardiovascular disease, at minimum. Importantly, the weight given to epidemiological and behavioral studies in LRSO's reports was slight, and any consideration of consumer perception, abuse liability, or untoward effects in general was placed in post-market considerations, implying that these factors would not be considered as part of the pre-market evaluation or used to assess a health claim of a PREP.

It should be noted that the BATCO framework, as presented, did not address important issues such as downstream effects eg, re-uptake, initiation, and reduced cessation and gave little importance to the role of consumer reactions to and perceptions of PREPs. Importantly, these industry-sponsored frameworks focus almost exclusively on exposure reduction claims surrounding the introduction of PREPs, and do not offer comprehensive approaches for evaluating tobacco products. For example, the tobacco industry-sponsored frameworks fail to address how consumers may perceive and use these products, and how the availability of these new products might ultimately impact overall tobacco use patterns and population health.

Account Options

Thus, they do not adequately consider new or modified product usage patterns within the context of how all available tobacco products are used, which is an essential requirement for evaluating the population-level risk of PREPs. The aim of the project was to develop a framework for the comprehensive evaluation of tobacco products, and to identify research and infrastructure gaps critical to future regulatory science needs.

Through a two-year iterative process, experts representing diverse scientific disciplines considered various approaches to comprehensive product evaluation. Two central principles were used to guide the approach: 1 that the introduction or modification of tobacco products must not increase harm eg, by elevating disease risk, increasing initiation, or delaying smoking cessation and instead must reduce harm at the population level, and 2 that tobacco manufacturers' health-related or exposure-related claims about tobacco products must be verifiable and lead to a reduction in harm at the population level.

After a draft framework was developed by subset of TobPRAC members, independent scientists and public health experts evaluated the proposed assessment framework during a two-day workshop. Following revisions based upon the recommendations, additional written comments were solicited from other experts and a final consensus document was developed. These deliberations were conducted to help guide regulation of tobacco products by government entities such as the FDA. However, this process was conducted independent of any specific regulatory process or entity. The following objectives were established to guide development of the tobacco product assessment framework:.

The follow section presents the framework developed by TobPRAC and also discusses the relationship between the framework and FDA tobacco regulatory actions to date. Figure 2 provides an overview of the framework for tobacco product assessment. The framework consists of four phases, each of which includes specific assessment strategies that can provide an empirical basis for demonstrating the risk a given tobacco product.

The four phases are: 1 pre-market evaluation; 2 pre-claims evaluation; 3 post-market activities; and 4 monitoring and re-evaluation. The second phase, pre-claims evaluation, is relevant only if health-related or reduced exposure claims are anticipated. The Conceptual Framework proposed in this report comprises four components. Each component includes an overall goal and a list of the specific types of data needed to evaluate whether the goal for that phase has been met.

Additional detail and figures for each component, contexts and pitfalls can be found in the full report as supplemental material. Each phase of the process has a Product Evaluation Goal PEG that defines the core purpose of the phase, or the key research question to be addressed Table 2.

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These SEAs identify specific types of data to be collected and analyzed. All SEAs within a particular phase are required if one is to conclude that the goal for that phase has been met. The framework requires consideration of the heterogeneity among individuals and population subgroups eg, different use, perception, and harm by race, sex, age, smoking history, metabolic capacity, genetics, and health status. This is particularly critical if a new product appeals to or is marketed specifically towards a population subgroup.

This first phase occurs before a new product is introduced onto the market, and it is applied to all new products, whether or not they make exposure- or health-related claims. Although all SEAs are required to inform the PEG, an initial assessment of laboratory study results would be required before testing in human subjects. If laboratory results identified any worsening of overall toxicant exposure in comparison to the reference products, human testing would be not be required at this point since product marketing would be prohibited.

If the process continued to human testing, the data collected on human use patterns would then inform the operational parameters of additional laboratory testing. For example, smoking machine puff profiles could be recalibrated to better mimic actual smoking behavior.

The scope and amount of human testing would depend on the novelty of the product. A battery of chemical and toxicological tests would be employed to ensure the safety of the test subjects; human testing would be halted if increases in overall toxicant exposure in comparison to the reference product were identified.

Human studies are the sine qua non for understanding tobacco-related disease risk, including addiction risk, at the individual level. Pre-clinical laboratory studies eg, smoke constituent analyses, and in vitro and in vivo toxicology assessments are useful for screening the potential impact of product design changes and ensuring that there are no obvious unintended consequences. However, no new product should be permitted to enter the market without at least some human testing, because only such studies can directly assess the impact of the product's use.

Even human studies, though, have limitations. Most notably, because of the long latency period of many of the illnesses caused by tobacco use, the risk profile of a new tobacco product cannot be fully known for decades. In principle it would be possible to use intermediate biomarkers of disease risk as proxy measures to predict risk reduction. With respect to addiction, abuse liability and comparisons of addiction risk across products can be evaluated in human laboratory studies according to standardized methods.

For example, guidance from the FDA Center for Drug Evaluation and Research CDER outlines methods that have been used to assess many nicotine products and other drugs across various routes of administration. Such design features can be evaluated by extension of the methods described by CDER in its guidance for assessing abuse deterrence and, conversely, abuse and addiction risk in diverse opioid formulations.