InDepth 12B Regulation to disclose or reduce harm from tobacco products

Last updated: August 2016 

Suggested citation: Greenhalgh, EM, & Scollo, MM InDepth 12B: Regulation to disclose or reduce harm from tobacco products. In Greenhalgh, EM, Scollo, MM and Winstanley, MH [editors]. Tobacco in Australia: Facts and issues. Melbourne: Cancer Council Victoria; 2023. Available from:


Note: This section is currently under review

For smokers who are unable or unwilling to quit, reducing the health risks of tobacco products themselves has been proposed as a pragmatic option. Modification of the cigarette so that the inhaled smoke is less carcinogenic, toxic, and inflammatory might represent a major opportunity for harm reduction.1 This approach was first proposed in the 1970s with, for example, the suggestion of low-tar medium-nicotine cigarettes as a strategy for ‘safer smoking’.2 Some public health experts assert that the regulation of potentially reduced exposure products is necessary and feasible, and should be part of comprehensive public health policy toward tobacco. They argue that effective regulation would allow a better understanding of the toxicology and health effects of products, as well as ongoing monitoring of individual and public health risks. Regulation could also ensure that labelling and advertising of products accurately convey risk, or levels of certainty about risks from consumption, allowing more informed choices by consumers and potential reduction of harm. Regulation could also foster clear and consistent policies regarding scientific testing, labelling, and advertising of products.3 Researchers recently suggested that lung cancer risks from smoking may be increasing in the US due to changes in the design of cigarettes since the 1950s, and proposed that regulatory control over cigarette design may therefore reduce health risks from smoking.4,5

In 2003, WHO convened a formal Study Group on Tobacco Product Regulation (TobReg) to examine the scientific basis for regulation. Its 2007 report recommended establishing levels for selected smoke toxicants per milligram of nicotine, as well as banning the importation or sale of products with yields above these levels. Toxicants were chosen based on animal and human toxicity data, hazard indices, variability of the toxicants across brands, the potential for the toxicant to be lowered, inclusion of constituents from both particulate and gas phases of smoke and from different chemical classes in cigarette smoke.6 The TobReg group has suggested that the upper limit for these toxicants should be set at the median level of products presently on the market based on existing data, with regular reviews of these levels.7

The WHO and Scientific Advisory Committee on Tobacco Regulation developed a statement of principles to guide the evaluation of new or modified tobacco products, and concluded that: 

  1. Existing scientific evidence is not sufficient to assess the differences in health risk potential between newly engineered tobacco products and existing products for composition, exposure, toxicity, or harm. 
  2. Regulatory oversight of cigarette and cigarette-like products should include examination of at least five separate aspects of the new products: physical chemical characteristics of the tobacco and tobacco smoke, uptake of toxicants (both by smokers and by non-smokers), toxicity, addiction potential, and disease risk.
  3. Regulatory oversight of smokeless tobacco products should also include examination of at least five separate aspects of the new products: physical chemical characteristics of the product and its constituents, uptake of toxicants, toxicity, addiction potential, and disease risk.
  4. Claims of reduced exposure or reduced harm should be supported by adequate scientific data provided by the manufacturer who intends to make the claim.
  5. Each type of claim requires a substantive body of evidence; an independent regulatory body capable of examining the claims should determine whether the claims are valid.
  6. No claim should be permitted for any tobacco product unless found to be valid by an independent regulatory body on the basis of adequate scientific data submitted by the manufacturer.
  7. Regulatory oversight, including post-market surveillance, is necessary to assess and monitor changes in newly modified tobacco products.
  8. Demonstration of reductions in smoke emissions or reduced uptake of toxicants alone is not sufficient to support claims or implications of reduced toxicity or harm.
  9. Claims of reductions in smoke emissions or reduced uptake of toxicants need to be examined in post market surveillance to determine what smokers and non-smokers actually understand from those messages.
  10. Evidence supporting a reduction in carcinogenicity must be interpreted in light of the potential effects of the changes in the product on the other major diseases caused by cigarette smoking.8

Although establishing regulations is a slow and complex process, supporters of tobacco product regulation have contended that swift action is needed in the face of a massive epidemic of tobacco-related disease, and to reduce harm to young people taking up smoking. They argued that mandating and widely publicising TobReg’s recommendations would be sufficient, and countries that do not manufacture cigarettes could ban the importation of products that fail to meet the standards. The tobacco industry would be responsible for testing products and providing data, with spot checks that are funded by tobacco taxes ensuring the accuracy of such data. Although international standards would be ideal, given the difficulty of this goal, it is likely that national legislation will be the starting point with the hope that it spreads to other countries. They suggested that countries such as Australia, New Zealand, and Singapore, which have total advertising and promotion bans, might be ideal, as such countries could prohibit any attempts the tobacco industry would likely make at marketing the regulated cigarettes as ‘safer’.7

In the meantime, Australia became a Party to the WHO Framework Convention on Tobacco Control (FCTC) on February 27, 2005. The FCTC aims to regulate some of the causes of the tobacco epidemic, including trade liberalisation and direct foreign investment, illicit trade, and tobacco advertising, promotion and sponsorship beyond national borders. The FCTC recognises the need for tobacco product regulation, and under Articles 9 and 10, parties will be developing systems to regulate the contents, design and emissions of products and to require reporting on the same from manufacturers.9 Partial implementation guidelines have been adopted for Articles 9 and 10, with further guidelines for the testing, measuring, and regulation of tobacco smoke constituents to be elaborated on in a step-by-step process.10 A number of jurisdictions, including the EU, Brazil, South Africa, and Egypt, have implemented limits on tar and nicotine emissions. Other countries requiring regular reporting of tar and nicotine emissions and ingredients include Canada, US, and Hong Kong.11

For a detailed discussion of the current state of the construction and labelling of Australian cigarettes, see Sections 12.8 and 12.9

12B.1 FDA regulation

In 2009, US President Barack Obama signed into law the Family Smoking Prevention and Tobacco Control Act (FSPTCA) granting the US Food and Drug Administration authority to regulate the manufacture, distribution, and marketing of tobacco products. The FSPTCA aims to provide basic consumer protections and to promote public health and safety from the harmful effects of tobacco products.12

Among its many provisions, the Act established requirements for tobacco product ingredient submissions. Section 904(a)(1) of the Act requires each tobacco product manufacturer or importer to submit a listing of all ingredients, including tobacco, substances, compounds, and additives that are added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product by brand and by quantity in each brand and sub-brand. For tobacco products on the market as of June 22, 2009, the list of ingredients had to be submitted by December 22, 2009. For tobacco products not on the market as of June 22, 2009, section 904(c)(1) requires that the list of ingredients be submitted at least 90 days prior to delivery for introduction into interstate commerce. The act also requires submission of information whenever any additive, or the quantity of any additive, is changed.13 In March 2012, the FDA issued draft guidance on reporting harmful and potentially harmful constituents in tobacco products and tobacco smoke constituents in tobacco products, with the criteria that they are a carcinogen, toxicant, or addictive. The FDA intends to publically display the list of constituents by brand and by quantity in each brand and sub-brand, in a format ‘‘that is understandable and not misleading to a lay person.’’14

The Act also prohibits tobacco companies from making reduced harm claims such as ‘light,’ ‘low,’ or ‘mild,’ without filing an application for a modified risk tobacco product and obtaining an order to market as such, and bans cigarettes with characterising flavours (such as fruit, candy, and clove), except menthol and tobacco.13 Effective August 8th 2016, the FDA extended its regulatory authority to all tobacco products, including e-cigarettes, cigars, and hookah and pipe tobacco. These products are therefore now subject to each of the above requirements.15

A national survey in the US in 2014–15 examined perceptions of tobacco constituents and FDA regulation. Over one-quarter of adults, and over one-third of smokers, reported having looked for information about tobacco constituents in cigarette smoke; however, the vast majority had little awareness of the actual constituents. More than half of respondents indicated that they would like relevant information to be available on cigarette packs, while just over one-quarter preferred to access that information online. Two-thirds felt that the FDA can effectively regulate tobacco products.16  

12B.2 EU regulation

In 2001, the European Union (EU) established maximum yield limits for cigarettes for tar (10mg), nicotine (1mg) and carbon monoxide (10mg).17 In April 2014, the EU adopted a revision of the Tobacco Products Directive (TPD), which regulates the manufacture, presentation, and sale of tobacco products, and aims to homogenise approaches to tobacco regulation across the 28 EU member states. The revision states that the maximum emission limits remain valid, and also highlights that it could be necessary and appropriate at a later date to reduce the emission levels for tar, nicotine and carbon monoxide, or to establish maximum levels for other emissions from tobacco products, taking into consideration their toxicity or addictiveness.18

The TPD has also specified minimum rules and regulations regarding:  

  • Health warnings. Combined graphic and text health warnings must cover 65% of the front, back and top of pack 
  • Ingredients. Mandatory reporting on ingredients is now required for all tobacco products through a standardised electronic format 
  • Flavourings. Flavourings in cigarettes and RYO tobacco products that give the product a ‘characterising’ flavour other than tobacco are banned (e.g. candy, alcohol, vanilla, fruit, spice, herbs), including menthol from 2020
  • Snus. Remains illegal in all Member States except Sweden
  • Packaging. Cigarette packs are to be a cuboid shape and contain at least 20 cigarettes per pack, with no promotional or misleading messages 
  • Cross-border sales. Cross border distance sales will not be banned at EU-level, but member states may choose to ban such sales
  • E-cigarettes. E-cigarettes will be regulated as consumer products if containing 20mg/mL or less of nicotine unless the manufacturer chooses to make therapeutic claims, in which case they will be required to seek a medicinal licence
  • Illicit trade. An EU-wide tracking and tracing system for the legal supply chain will be introduced. 

The introduction of this directive was fiercely opposed by the tobacco industry, which spent enormous amounts of time and money attempting to delay and amend the TPD. In particular, the proposed introduction of plain packaging, an ingredients ban, and a point-of-sale display ban faced high levels of resistance. Philip Morris International alone employed more than 160 lobbyists, and spent millions trying to subvert the TPD.19 Though ultimately it was successfully adopted, these attempts by the tobacco industry resulted in delays to implementation and some weakening (e.g., two provisions were removed: plain packaging and a retail display ban).20

Relevant news and research

For recent news items and research on this topic, click here. ( Last updated May 2024)



1. Gray N. Tobacco control: reflections on our mistakes and those who made them. Current Oncology Reports, 2012; 14(6):475–9. Available from:

2. Russell M. Low-tar medium-nicotine cigarettes: a new approach to safer smoking. British Medical Journal, 1976; 1(6023):1430–33. Available from:

3. Stratton K, Padma S, Wallace R, and Bondurant S. Clearing the smoke: assessing the science base for tobacco harm reduction. Institute of Medicine, 2001. Available from: .

4. US Department of Health and Human Services. The health consequences of smoking - 50 years of progress. Atlanta, GA: US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2014. Available from: .

5. Burns D, Anderson C, and Gray N. Has the lung cancer risk from smoking increased over the last fifty years? Cancer Causes & Control, 2011; 22(3):389–97. Available from:

6. Burns DM, Dybing E, Gray N, Hecht S, Anderson C, et al. Mandated lowering of toxicants in cigarette smoke: a description of the World Health Organization TobReg proposal. Tobacco Control, 2008; 17(2):132–41. Available from:

7. Gray N. Regulation of consumer products: the bizarre case of strawberry jam and cigarettes. Respirology, 2008; 13(6):761–3. Available from:

8. World Health Organization and Scientific Advisory Committee on Tobacco Regulation (SACTob). Statement of principles guiding the evaluation of new, or modified tobacco products. Geneva: WHO, 2003. Available from: .

9. WHO Framework Convention on Tobacco Control. New York: United Nations, 2003. Available from: .

10. WHO Framework Convention on Tobacco Control Conference of the Parties. Partial guidelines for implementation of Articles 9 and 10 of the WHO Framework Convention on Tobacco Control. FCTC/COP3(7). 2010. Available from:

11. O'Connor RJ and Hurley PJ. Existing technologies to reduce specific toxicant emissions in cigarette smoke. Tobacco Control, 2008; 17(suppl. 1):i39–48. Available from: 

12. Campaign for Tobacco-Free Kids. FDA regulation of tobacco products: a common sense law to protect kids and save lives, 2010. Available from: .

13. Family Smoking Prevention and Tobacco Control Act. No. 111-31 2009. Available from: .

14. US Food and Drug Administration (FDA). Harmful and potentially harmful constituents in tobacco products and tobacco smoke; established list 2012. Available from:

15. US Food and Drug Administration (FDA). FDA's new regulations for e-cigarettes, cigars, and all other tobacco products. 2016. Available from:

16. Boynton MH, Agans RP, Bowling JM, Brewer NT, Sutfin EL, et al. Understanding how perceptions of tobacco constituents and the FDA relate to effective and credible tobacco risk messaging: A national phone survey of US adults, 2014-2015. BMC Public Health, 2016; 16(1):516. Available from:

17. European Commission. Tobacco products directive 2001/37/ec. 2001. Available from:

18. EU Tobacco Products Directive (2014/40/EU). 2014. Available from:

19. Peeters S, Costa H, Stuckler D, McKee M, and Gilmore AB. The revision of the 2014 European tobacco products directive: An analysis of the tobacco industry's attempts to ‘break the health silo’. Tobacco Control, 2015. Available from:

20. Tobacco Tactics. EU tobacco products directive revision, 2015. Available from: