Dataset Information

Bridging: Accelerating Regulatory Acceptance of Reduced-Risk Tobacco and Nicotine Products.

ABSTRACT:

Introduction

The number and variety of alternative tobacco and nicotine products that can potentially provide reduced-risk choices for cigarette smokers who switch completely to such products instead of continued smoking have grown substantially in the past decade. Innovation and choice are likely to improve the prospects of smokers making the switch, but this provides challenges to regulators and manufacturers to ensure that changes to regulations and products promote and do not hinder contributions to tobacco harm reduction.

Aims and methods

This paper looks at where bridging data sets for tobacco heating products, closed system vaping products, and oral nicotine products might enable innovation while protecting the interests of consumers.

Results

We review product data from chemical studies and a toxicological study showing how bridging can be applied and consider what product development changes might allow bridging from existing datasets or trigger the need for new ones.

Conclusions

Bridging across specific product ranges can increase the speed of innovation, foster competition, and limit the burden of assessment for regulators while maintaining product safety and quality.

Implications

Bridging partial data sets is an established practice within other industries, that aims to improve efficiency with regulatory approvals, accepts natural product variation, and supports product innovation. We review product data from chemical studies and a toxicological study showing how bridging can be applied and consider what product development changes might allow bridging from existing datasets or trigger the need for new ones. This in turn can increase the speed of innovation, foster competition, and limit the burden of assessment for regulators while maintaining product safety and quality.

SUBMITTER: Gaca M

PROVIDER: S-EPMC9356683 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

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Publications

Bridging: Accelerating Regulatory Acceptance of Reduced-Risk Tobacco and Nicotine Products.

Gaca Marianna M Williamson Justine J Digard Helena H Adams Louise L Hawkridge Lauren L Proctor Christopher C

Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco 20220801 9

<h4>Introduction</h4>The number and variety of alternative tobacco and nicotine products that can potentially provide reduced-risk choices for cigarette smokers who switch completely to such products instead of continued smoking have grown substantially in the past decade. Innovation and choice are likely to improve the prospects of smokers making the switch, but this provides challenges to regulators and manufacturers to ensure that changes to regulations and products promote and do not hinder ...[more]

PMID: 35171296

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Project description:IntroductionCigarette smoking remains the leading preventable cause of death in the United States. Recent efforts have explored the potential health and policy benefits of reducing nicotine, an addictive component, in combustible cigarettes. To date, an experimental, prospective analysis directly comparing the effects of varying regulatory environments on purchases of multiple products has yet to be conducted. The present study compared real purchasing of conventional cigarettes, reduced-nicotine cigarettes, and a variety of other nicotine and tobacco products across a range of regulatory environments.MethodsParticipants were assigned to one of five groups, each associated with a different nicotine level (mg of nicotine to g of tobacco) in SPECTRUM investigational cigarettes (15.8, 5.2, 2.4, 1.3, and 0.4 mg/g). Across sessions, participants made real purchases for nicotine/tobacco products in an Experimental Tobacco Marketplace. Each session corresponded with a distinct regulatory environment wherein different nicotine/tobacco products were available for purchase.ResultsOur results suggest that the primary drivers of cigarette and nicotine purchasing are regulatory environment and the presence/absence of alternative nicotine and tobacco products. Perhaps surprisingly, nicotine level does not appear to be such a driver of purchasing behavior under these experimental conditions. Investigational cigarette purchasing is lowest when other preferred combustible products are available and highest when investigational cigarettes are the only combustible product available for purchase.ConclusionsIf a reduced-nicotine policy is implemented, great care should be taken in determining and making available less-harmful nicotine/tobacco products as the availability of preferred combustible products may result in undesirable levels of purchasing.ImplicationsThis is the first experimental study investigating different potential regulatory effects related to a reduced-nicotine policy by examining purchasing across a range of nicotine/tobacco products. Our results suggest the presence of affordable, highly preferred combustible products is likely to maintain tobacco purchasing at undesirable levels. To promote switching to less-harmful products, affordable alternate nicotine and tobacco products should be readily available. Finally, our results suggest that the availability of noncigarette products, not cigarette nicotine level, will most likely affect purchasing of reduced-nicotine cigarettes.

Project description:Background and objectivesFlavored non-tobacco oral nicotine products (eg, nicotine pouches and nontherapeutic nicotine gum, lozenges, tablets, gummies), are increasingly marketed in the United States. Prevalence of non-tobacco oral nicotine product use among adolescents is unknown.MethodsWe calculated prevalence of ever and past 6-month use of nicotine pouches, other non-tobacco oral nicotine products (ie, gum, lozenges, tablets, and/or gummies), e-cigarettes, cigarettes, hookah or waterpipe, cigars, cigarillos, and snus among high school students in Southern California between September and December 2021. Generalized linear mixed models tested associations of sociodemographic factors and tobacco-product use with use of any non-tobacco oral nicotine product.ResultsAmong the sample (n = 3516), prevalence was highest for e-cigarettes (ever: 9.6%, past 6-month: 5.5%), followed by non-tobacco oral nicotine products (ever: 3.4%, past 6-month: 1.7%), and <1% for other products. Ever users of combustible tobacco (adjusted odds ratio [aOR] = 77.6; 95% confidence interval [CI] = 39.7-152) and ever users of noncombustible tobacco (aOR = 40.4; 95% CI= 24.3-67.0) had higher odds of ever using non-tobacco oral nicotine products, compared to never users of combustible and noncombustible tobacco. Use of any non-tobacco oral nicotine product was greater for Hispanic (versus all other races/ethnicities except Asian, aOR = 2.58; 95% CI = 1.36-4.87), sexual minority (versus heterosexual, aOR=1.63; 95% CI = 1.03-2.57), gender minority (versus male, aOR = 2.83; 95% CI = 1.29-6.19), and female (versus male, aOR=1.92, 95% CI = 1.20-3.06) participants.ConclusionsNon-tobacco oral nicotine products were the second most prevalent nicotine product used by adolescents. They were disproportionately used by certain racial or ethnic, sexual, or gender minority groups, and those with a history of nicotine use. Adolescent non-tobacco oral nicotine product use surveillance should be a public health priority.

Project description:Cigarette smoking causes major preventable diseases, morbidity, and mortality worldwide. Smoking cessation and prevention of smoking initiation are the preferred means for reducing these risks. Less harmful tobacco products, termed modified-risk tobacco products (MRTP), are being developed as a potential alternative for current adult smokers who would otherwise continue smoking. According to a regulatory framework issued by the US Food and Drug Administration, a manufacturer must provide comprehensive scientific evidence that the product significantly reduces harm and the risk of tobacco-related diseases, in order to obtain marketing authorization for a new MRTP. For new tobacco products similar to an already approved predicate product, the FDA has foreseen a simplified procedure for assessing "substantial equivalence". In this article, we present a use case that bridges the nonclinical evidence from previous studies demonstrating the relatively reduced harm potential of two heat-not-burn products based on different tobacco heating principles. The nonclinical evidence was collected along a "causal chain of events leading to disease" (CELSD) to systematically follow the consequences of reduced exposure to toxicants (relative to cigarette smoke) through increasing levels of biological complexity up to disease manifestation in animal models of human disease. This approach leverages the principles of systems biology and toxicology as a basis for further extrapolation to human studies. The experimental results demonstrate a similarly reduced impact of both products on apical and molecular endpoints, no novel effects not seen with cigarette smoke exposure, and an effect of switching from cigarettes to either MRTP that is comparable to that of complete smoking cessation. Ideally, a subset of representative assays from the presented sequence along the CELSD could be sufficient for predicting similarity or substantial equivalence in the nonclinical impact of novel products; this would require further validation, for which the present use case could serve as a starting point.

Dataset Information

Bridging: Accelerating Regulatory Acceptance of Reduced-Risk Tobacco and Nicotine Products.

Introduction

Aims and methods

Results

Conclusions

Implications

Publications

Bridging: Accelerating Regulatory Acceptance of Reduced-Risk Tobacco and Nicotine Products.

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