Regulation of Ingredients

Many countries regulate tobacco product ingredients. Over 50 countries require tobacco manufacturers to report the ingredients used in their products to regulators. These countries include all of the European Union countries, Brazil, Mexico, Ukraine, Turkey, Israel and Thailand. Several countries, including Germany, the United Kingdom and France, also regulate the ingredients that are permitted for use in tobacco products.

The scientific basis for tobacco product ingredient regulation has not been widely addressed. Today there are no internationally accepted scientific test methods for assessing tobacco product ingredients. To address this, the Framework Convention on Tobacco Control’s Conference of Parties has established a Working Group to elaborate guidelines for the testing and measuring of the contents and emissions of tobacco products and to propose a scientific basis of tobacco product regulation. The Working Group stated in 2007 that this “is an emerging field” and “more work [is needed] to develop a better understanding of these issues.” [1] 

Tobacco control advocates and public health organizations such as the World Health Organization (WHO) have claimed that ingredients increase the toxicity and addictiveness of cigarettes. However, WHO has also stated that cigarettes without ingredients (e.g., no-additive brands) have “never been demonstrated to be less dangerous or addictive than…cigarettes” with ingredients. Public health groups have also argued that ingredients are detrimental to public health because they make cigarettes more palatable or attractive. Some public health advocates have called for a ban on ingredients solely to reduce tobacco product attractiveness. In 2010, the European Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) concluded that there is no evidence that ingredients increase the addictiveness of tobacco products and found that it is very difficult to identify the role of individual additives in enhancing the tobacco products' "attractiveness". The Committee also stated that “additives do not appear to be increasing the use of tobacco products overall. The incidence of smoking is stable or in decline in most EU member states.”

Our View

We support laws that require manufacturers to report all of the ingredients used in their tobacco products to regulators and the public. The ingredients information we have reported to many countries is available to the public on this website.

Regulations should protect manufacturers’ disclosures of by-brand ingredient formulas. Public disclosure of that information would cause serious damage, benefiting a manufacturer’s competitors and helping criminal organizations that manufacture counterfeit cigarettes. The public health objectives of ingredients reporting can be met without requiring manufacturers to disclose exact by-brand formulas. Nevertheless, where adequate assurances of trade secrets can be provided, we support laws requiring disclosure of by-brand formulas to regulators.

We also believe that regulations should be developed to assess ingredients for use in tobacco products. Test methods should be developed based on objective scientific standards, using existing toxicological testing standards and assays recognized by bodies such as the OECD, WHO and the German Standardization Organization DIN [2]

The guiding principle for ingredient assessment should be to determine whether ingredients significantly increase the inherent toxicity of the tobacco smoke. In 2001 the U.S. Institute of Medicine External reference (IOM) stated that cigarette ingredients should be reviewed “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.” To our knowledge, objective tests do not exist that can measure whether smoke from a cigarette with an ingredient or ingredients is more addictive than smoke from a cigarette without an ingredient or ingredients.

Based on both epidemiological observations (comparing countries where most cigarettes have flavor ingredients with countries where most cigarettes do not have flavor ingredients) and our extensive toxicological testing, we believe that the ingredients we use do not increase the inherent toxicity of tobacco smoke. Based on the same epidemiological observations, we believe that the ingredients we use do not increase the inherent addictiveness of tobacco smoke. As WHO and other public health advocates have said, there is no science today that establishes that cigarette brands with ingredients are more toxic or addictive than cigarette brands without ingredients. 

We strongly disagree that ingredients should be banned to reduce and ultimately eliminate the palatability or attractiveness of tobacco products. Regulations should not force manufacturers to market products that consumers do not want and take away from adult smokers the ability to buy the products they find appealing. The “make it taste bad” approach to ingredients regulation is also flawed because it ignores the evidence that strongly suggests that an ingredients ban will not result in less smoking.

Today millions of smokers in countries including China, the United Kingdom, South Africa, Canada and Australia smoke cigarettes that do not contain flavor ingredients (Virginia-style cigarettes). To these millions of smokers, ingredients do not make brands “more attractive” or “more palatable.” Banning ingredients will have little or no impact on the brands smoked in these countries. 

However, an ingredients ban will impact the majority of brands in the United States, Germany, France, Italy, Russia, Brazil, Mexico, Japan and many other countries. Smokers in these countries will lose the ability to purchase and smoke the brands they prefer, for no reason other than WHO and others have decided that their brands are “too appealing.” But there are no data that even remotely suggest that smokers in these countries will stop or reduce smoking because they can only buy cigarettes without ingredients. It is more likely that they will smoke cigarettes without ingredients, just as smokers in China, the United Kingdom, South Africa and Canada do today. 

The so-called public health benefit of an ingredients ban is thus wholly speculative. At this point, the only clear beneficiaries of an ingredients ban are the manufacturers of cigarette brands without flavor ingredients – and the clear losers are manufacturers of brands that use flavor ingredients and the consumers who prefer those brands.

A ban on blended cigarettes is also likely to result in an increase in illicit trade and in the volume of cross-border sales, two phenomena that are already significant in many countries around the world. If consumers prefer traditional blended cigarettes over other styles, they will purchase their preferred product abroad, over the Internet, or on the illicit market. Historically this gives rise to trafficking in cigarettes by gangs or organized crime networks, resulting in increased criminal activity in local communities. It also results in a loss of government revenue with no comparable reduction in consumption, because legitimate product is often just substituted with contraband.

 

[1] Conference of the Parties to the WHO Framework Convention on Tobacco Control, Second Session, Elaboration of guidelines for implementation of the Convention (decision FCTC/COP1(15)), Article 9: Product regulation (2007)

[2] DIN (2004) The Toxicological Evaluation of Additives for Tobacco Products - A Guide, 1st Edition, Technical Report 133. Deutsches Institut für Normung. Berlin: Beuth Verlag GmbH.

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