This document presents research questions relevant to Articles 9 and 10 of the FCTC. It differs slightly from a number of other articles on research directions in this area in that it is not a comprehensive review of the evidence (e.g., Scientific Committee on Emerging and New Identified Health Risks [SCENIHR], 2010), as detailed in the research questions it identified [cf. Hecht (2011)], is much broader in scope than carcinogens and other toxins (e.g., WHO, 2007; Hecht, 2011), and is not formulated as part of the broader harm reduction agenda (Zeller, Hatsukami and the Strategic Dialogue on Tobacco Harm Reduction Group, 2010). This document has a slightly different focus, as it covers research needed in the early stages of implementing effective product regulation under Article 9 of the FCTC and also examines research on optimizing disclosure needed to support and evaluate Article 10 regulation. It starts from the Conference of the Parties (COP) sub-guidelines for these two articles (www.who.int/fctc/protocol/guidelines/adopted/article_9and10/en/ Index.html) and focuses on what we consider to be the limited amount of research that could facilitate rapid action, and covers the scope of regulatory opportunities ranging from attractiveness to addiction to carcinogenicity/toxicity. In the 1960s and 1970s, public health advocates and some health officials focused their attention on the possibility of reducing the harmfulness of cigarettes. These efforts were based on a logic that seemed reasonable at the time. Wynder and Graham (1950) and Doll and Hill (1950) showed a dose-response relationship between cigarette smoking and disease. Wynder, Graham and Croninger (1953) showed a dose-response relationship between tobacco tar applied to mouse skin and tumor response, so it was logical to think that reducing the number of tar particles applied to the lungs would reduce the potential for disease. While this view is relatively simple and limited to numbers, no one believed that the tobacco industry would reduce the tar measured in a way that had nothing to do with actual human exposure and could have increased the risk of disease. The World Health Organization Framework Convention on Tobacco Control (FCTC) is a treaty adopted by the 56th World Health Assembly in Geneva, Switzerland, on 21 May 2003.  This was the first World Health Organization treaty adopted under Article 19 of the WHO Constitution.
 The Treaty entered into force on 27 February 2005.  It has been signed by 168 countries and is legally binding in 181 countries that have ratified it.  There are currently 15 UN member states that are not parties to the Treaty (nine that have not signed the Treaty and six of them have signed but not ratified it).  N.G. wrote this article under contract number HHSN261 201100185P from the National Cancer Institute. R.B. has no conflicts. This document is part of a series of articles designed to outline research questions relevant to the successful implementation of the various provisions of the Framework Convention on Tobacco Control (FCTC). This paper focuses on issues related to Articles 9 and 10 of the FCTC. This paper focuses on the most important research for most countries, rather than what is desirable in countries with high research capacity. While Article 9 deals with the testing and measurement of the content and emissions of tobacco products and their regulation, Article 10 deals with the disclosure of information on these ingredients and emissions to government authorities and the public. Due to the close relationship between these two articles, the guidelines for their implementation have been brought together in a single set of directives.
In Japan, ultra-nicotine cigarette brands with ventilation holes on cigarette filters have been widely marketed to smokers. The use of these brands of cigarettes leads to compensatory smoking. Brands of menthol cigarettes that have a refreshing and anesthetic effect are also sold. In 2013, smokeless tobacco products similar to Swedish snus, the sale of which is banned in the European Union with the exception of Sweden, were placed on the Japanese market. These tobacco products have “toxicity”, have a “ventilation filter”, are “attractive” and promote “addiction”. Tobacco smoke and smokeless tobacco are classified by the International Agency for Research on Cancer (IARC) in “Group 1: Carcinogenic to humans”. Articles 9 and 10 of the World Health Organization Framework Convention on Tobacco Control (WHO FCTC) regulate the content of tobacco products and the disclosure of tobacco products. The implementation of some other articles has progressed gradually in Japan. However, Articles 9 and 10 are out of time. Japanese governmental authorities are urged to implement articles 9 and 10 without delay. It should be noted that there are more chemicals of concern. A recently published consolidated list identified 98 chemicals of concern.
This highlights the challenge of making tobacco smoke less toxic, as much of it is produced by partial pyrolysis. There is only one research question that applies to any substance known to be hazardous in all brands. It`s “How far can we go?” This is the central research question here. In some cases, it can be addressed, at least in part, by disclosing exposure to toxins from existing products. We believe that with the relatively small number of issues that need to be clarified before regulation can take place, and much of this requires being informed by current science, enough is known to start regulating. The most important properties of nicotine in tobacco (Hoffmann & Hoffmann, 2010; Wayne & Carpenter, 2010), which affect the addictive potential and thus the “solution”, are as follows: The industry has been able to manipulate sensory qualities in the design of its products for individual brands. One goal is to target specific sub-populations with brands designed to overcome barriers to use related to the taste of the product. For example, adolescents and women have been approached in this way (Carpenter, Wayne, & Connolly, 2005; Carpenter, Wayne, Pauly, Koh, & Connolly, 2005). The research questions we focus on are those that are needed to support the early stages of regulation.
In the course of regulation, new and more difficult research questions will undoubtedly arise. An analysis of what is reasonably easy to know can be formulated around the tobacco production process. The following highlights the aspects in which sufficient standardization and centralization of decisions exist or can exist to clearly influence the final products. Based on our current understanding of the factors influencing tobacco toxicity and/or consumer appeal, the following aspects of the tobacco production and manufacturing process may be useful to regulators: Definition of disclosure: Section 10 requires disclosure of ingredients and emissions to government agencies and disclosure of toxic levels and emissions to the public. The FCTC 2030 project aims to support Parties to the WHO FCLAT Convention eligible for Official Development Assistance (ODA) to achieve the SDGs by advancing the implementation of the Convention.