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Abstract
Background The tobacco industry (TI) uses several strategies to attract new consumers, including using additives in tobacco products, which makes tobacco especially attractive to youth. Based on scientific evidence and the principles of the WHO Framework Convention on Tobacco Control, the Brazilian Health Regulatory Agency (ANVISA, for the name in Portuguese), published the Collegiate Board Resolution (RDC, for the name in Portuguese) 14/2012 in 2012, prohibiting the addition of substances that enhance the flavour and taste of tobacco products in order to make them more attractive. In response, the TI used various strategies to prevent RDC 14/2012 from entering into force. At the time, the Brazilian additive ban was the most comprehensive in the world as it included a ban on menthol.
Objectives This paper analyses the arguments and strategies used by the TI to prevent the implementation of the additives ban.
Methods Review of published articles, reports, legislation and legislative activity, internal TI documents, media stories and other documents to describe TI’s reaction to the ban.
Results The results show that the TI used some well-known strategies to delay or cancel the entering into force of the resolution. For example, the TI attempted political interference, used litigation and commissioned studies with findings that questioned the resolution’s rationale. The TI strategies used in Brazil are similar to those used at the global level to oppose other tobacco control measures.
Conclusions TI successfully delayed the most comprehensive additive ban in the world using its usual tactics, despite the fact that none of the arguments presented by the TI had an acceptable scientific basis or evidence.
- tobacco industry
- tobacco product additives
- tobacco flavours
- smoking prevention
- who framework convention on tobacco control (fctc)
Statistics from Altmetric.com
- tobacco industry
- tobacco product additives
- tobacco flavours
- smoking prevention
- who framework convention on tobacco control (fctc)
Introduction
Tobacco use is the leading cause of preventable death and disease in the world.1 Efforts to address this global epidemic need to include strategies to ensure that young people do not become addicted to tobacco products. Evidence shows that the younger the person starts smoking, the sooner he or she becomes a regular smoker, and the harder it is for them to quit.2 3 Even smoking chocolate cigarettes in childhood correlates with smoking in adulthood.4 5
Estimates indicate that, globally, 82 000 to 99 000 children start smoking every day.6–8 In Brazil, data indicate (2013–2014) that 18.5% of adolescents between 12 and 17 years of age have tried cigarettes in their lifetime.9 The national Special Tobacco Survey (PETab) conducted by the Brazilian Ministry of Health showed that 17.2% of the population aged 15 years or older used tobacco products in 2008.10 Other surveys showed that the majority of smokers in Brazil started to smoke before they were 20 years of age.10 11
The tobacco industry (TI) uses a variety of strategies to attract new smokers, maintain dependency and prevent tobacco control regulations.1 12 13 These strategies lead to reduced cessation and target young people to start, as the industry needs to replace smokers who stop smoking or die.14–16 Among the strategies used by the TI to maintain addiction and profits, cigarette engineering is perhaps one of the most ingenious. Modern cigarettes are the result of innumerable technological developments where all aspects of their composition are controlled and built to, among other characteristics, optimise the delivery of nicotine to the smoker, facilitate the initiation of new smokers, make the product more palatable and less irritating, mask environmental tobacco smoke and reduce production costs.17–23
One of the technologies used by the TI is the use of additives. The TI’s own internal documents point to additives as an important technology for expanding its markets.16 17 19 23–28 The use of additives in tobacco products facilitates tobacco use, enhances the effects of nicotine and allows the TI to use false claims of properties associated with health and well-being.27 29–32
Data from the TI33 show that flavourings are added to cigarettes to improve their flavour and aroma.34 Additionally, TI documents show that these additives are also used to reduce airway irritation caused by smoke.23 33–35 The TI recognises that irritation caused by smoke, unpleasant taste, astringency, dry mouth and other unpleasant tobacco characteristics are effective barriers to the initiation and perpetuation of smoking,16 this the TI considered additives pivotal to market success.
Aware of the TI’s reasons to use additives, ANVISA, the Brazilian agency empowered, by legislation, to regulate tobacco products, considered the evidence on additives and its public health harms and published a resolution, RDC 14/2012, in 2012, which inter alia prohibited the use of additives that altered the flavour and taste of tobacco products to make them more attractive.36
This paper reviews the TI’s strategies in response to the resolution and analyses the TI’s arguments to prevent it from going into effect.
Methods
This retrospective, qualitative analysis was conducted from January 2016 to June 2018. We conducted a literature review using the PubMed (MEDLINE), using the terms tobacco+additives and cigarettes+additives (heat not burn tobacco, JUUL and electronic cigarettes were not included). Tobacco+additive returned 147 papers. We selected papers published in English, Spanish or Portuguese and scanned them to determine relevance to this study, resulting in 56 papers included. Using the same criteria, and excluding the repeated papers, the search using cigarette+additive resulted an additional 14 papers for a total of 70 papers published from 1990 to 2018.
We searched SCIELO using the same strategy. The term tobacco+additives returned a total of eight papers. After excluding duplicates, one additional paper was found. The term cigarette+additives returned no new papers.
Additional systematic searches of internal TI documents were conducted using the Truth Tobacco Industry Documents library (TTID),37 using the snowball searches38 and combining qualitative content analysis with iterative strategies described for searching TTID.39 We tried to identify additional documents on the TI strategies to stop the additives ban. No strategies were found that had not been previously described.
We searched the internet, including websites hosted by TI or its allies, websites of organisations that support tobacco control policies, federal government websites, the regional newspapers from south (the main tobacco producer region in the country) and the largest newspapers in Brazil, to identify additional sources of information related to the additive ban and the TI’s response to it. Legislative activity was monitored through the websites of the House of Representatives and the Federal Senate, as well as internet search engines.40 41
Information regarding the public consultation process on the ban, lawsuits and other information related to the resolution was obtained through a request to ANVISA under the auspices of the Access to Information Law.42
To ensure data reliability and reproducibility, information from all data sources, including the TI documents, has been triangulated with scientific papers, government reports, Framework Convention on Tobacco Control (FCTC) documents or other official document from governments or international organisations.
The findings are presented using the taxonomy on TI interference described in the article by Ulucanlar et al.43
Results
The process of banning additives in Brazil started as part of Brazil’s engagement with the FCTC Working Group on articles 9 (Regulation of the contents of tobacco products) and 10 (Regulation of tobacco product disclosures) in 2010. Shortly after the fourth Conference of the Parties (COP4) of the FCTC (COP4) in 2010, ANVISA took procedural steps to call a public consultation on a proposed resolution to ban additives.44 After the resolutions was issued, the TI continued its attacks, through litigation (see figure 1 for a timeline of events).
Timeline of process of additive ban and TI strategies in Brazil. COP, Conference of the Parties; TI, tobacco industry; WG, working group.
We did not identify any TI strategy that had not been previously described. The following TI’s strategies were used to interfere with the implementation of additive ban: litigation,45 46 mechanisms to prevent regulations,47 front groups,48 use of bad science,49 lobby,47 50 51 allegations about the increase of illicit trade,52 fake news and false arguments.47 50 51 53
TI and COP 4
The discussion on the regulation of additives in Brazil began before ANVISA called for a public consultation on the topic.
In November 2010, at COP4, the TI (and related groups), noting that restrictions on using additives in tobacco products was part of the discussions on the development of guidelines for the implementation of articles 9 and 10 of the FCTC, moved to prevent the adoption of such restrictions, mostly through the International Tobacco Growers Association (ITGA), a TI lobbying tool.54 55 In Brazil, ITGA’s opposition effort56 was represented by the Brazilian Association of Tobacco Growers (AFUBRA).48 Brazilian farmers, backed by the TI, demonstrated at the door of COP4,57 and congressmen linked to the TI’s interests exerted political pressure to change the members of the Brazilian delegation to COP4.53 58 At the time, news reports surfaced alleging that a civil servant, who was a member of the Brazilian delegation, was providing information to the TI directly from COP4.59 60 The Brazilian Government initiated an administrative process to investigate this allegation, but found that the statute of limitation was reached and there were no known consequences from the investigation.61
The main argument used by the TI to prevent the adoption of the guidelines was that the prohibition of additives would make the production of burley-type tobacco unfeasible. The TI claimed that as burley require the addition of sugars to become palatable, a ban would lead to the loss of income for thousands of workers. Further, the TI claimed that there was no scientific evidence to support an additives ban.54 62 63
Despite the TI pressure, FCTC Parties at COP four decided, by consensus, to adopt the recommendation to restrict the use of additives in tobacco products.64 65
Using Ulucanlar’s taxonomy43 to TI’s response, the discursive strategies of unanticipated costs to economy and society and intended public health benefits were the strategies identified The instrumental strategies were the use of coalition management, information management and direct involvement and influence in policy (table 1).
Discursive and instrumental strategies used by the tobacco industry to try to stop additive ban in Brazil, based on Ulucanlar et al 43
TI and public consultation to discuss the additives ban
After COP4, on 29 November 2010, ANVISA published a public consultation, CP112/2010, making available for comments a draft update of Resolution 46/200166 and a proposed prohibition of additives.67 The consultation lasted from November 2010 to March 2011, the longest public consultation process of ANVISA’s entire history to date (the usual public consultation duration at the time was 30 days).68 The draft text banned the addition to tobacco products of all substances used to alter flavour, aroma, colour or suggest any therapeutic/beneficial association with tobacco products, including all sugars except starch. Exceptions were also applied to components that were considered essential for manufacturing or did not enhance the attractiveness of tobacco products, such as adhesives and pigments to make the cork colour pattern in filters.67 The TI and its allies reacted to the public consultation on several fronts, using arguments similar to those used to interfere with the Partial Guidelines for Implementation of articles 9 and 10 of the FCTC at COP4.54
Contributions to the public consultation were sent electronically, by post and hand-delivered.69 ANVISA considered as actual contributions those that objectively brought arguments against or in favour of the proposed draft. Contributions that simply stated that they were against or in favour of the text69 were counted but not addressed. Additionally, statements that omitted the participant’s name, address, position (in favour or against) or lacked a reference to the public consultation were disqualified.69 Of the 127 905 documents received, only 10 were, in effect, a contribution. (To date, this public consultation remains the one with the highest number of comments received by ANVISA.) While in itself this was not a concern, a story by newspaper Folha de São Paulo 50 suggested that such a large number of comments aimed to delay the process of analysis of public comments and, consequently, the release and implementation of the proposed resolution. Analysis of documents obtained through access of information law69 revealed that:
The TI printed its own form for submitting contributions, containing filling instructions, to protest against the proposed regulation. Two thousand of these forms were blank when delivered.
Thousands of forms were mailed from Rio de Janeiro, according to the postmark, however the addresses on the forms were from other states.
Five hundred forms were sent without any identification and only contained a statement against the proposed draft.
In some cases, ANVISA contacted the signatory to seek clarification on the comment submitted, and was told by the supposed signatory that they had never participated in the process.
In one case, the person indicated that they were at an event, was requested to sign the public comment form, but indicated that he was led to believe that the form was some type of survey research.
Some of the addresses submitted on the forms were non-existent.
These finding indicate that these comments, and the massive participation in the public consultation, were likely coordinated by TI as a strategy to delay the conclusion of the process.
In 2010, a bill was proposed in congress (PDL 3034/2010)70 to stop the results of the Public Consultation 112/2010, claiming that the proposed resolution usurped the mandate of the national congress. (In 2012, this legislative proposal was modified to counteract the effects of the actual resolution, RDC 14/2012.) According to public references, the bill proponent had received campaign donations from Alliance One (R$100 000) and five cars from Souza Cruz (British and American Tobacco in Brazil) to donate to charities.60 71–73 As of March 2019, this bill proposal is listed as archived .70
Another legislative proposal, in 2011 (PL 2901/2011)74 aimed to amend Tobacco Control Law 9294/199675 of 15 July 1996, by banning additives except for menthol and tobacco flavours. The justification used in PL 2901/2011 was the same as that used by the TI, that the prohibition of additives would prevent the production of burley-type tobacco, while preserving the use of menthol and tobacco-flavouring additives. The proposed bill would also remove ANVISA’s authority to regulate additives. In 2015, this bill proposal was removed by its author.74
At the municipal level, the Municipal Councils of Paraíso-RS, Santa Cruz do Sul-RS, Cruz das Almas-BA, Mato Leitão-RS, São Miguel do Oeste-SC and Canguçu-RS,76–81 requested the cancellation of the call for public comments. The City Council of Rio Pardo-RS also submitted a request to ANVISA for the revocation of articles 9 and 10 of the FCTC.82 At the state level, the states of Rio Grande do Sul, Santa Catarina and Paraná83–85 sent declarations opposing CP112/2010. These municipalities, and states, are the largest tobacco growing regions in Brazil.
Additional opposition to the Public Consultation CP112/2010 came from Congressional Agriculture Committee86 which made a motion to repudiate the consultation. Additionally, ANVISA received a request for clarification from the Cabinet of the President (Civil House)87 and a request for cancellation from a Charter88 of the Tobacco Production Chain Sectoral Chamber (part of the Ministry of Agriculture, Livestock and Supply). ANVISA also received a joint letter from a congressman and a Senator, copying the Minister of Health, requesting the cancellation of the public consultation. According to public references, this congressman received contributions from TI to his campaign.71 89 We were unable to determine if the Senator has received financial or other contributions from TI.
After the public consultation ended, a public hearing on the additives ban was scheduled for October 2011 at the National Cancer Institute (INCa). The hearing was suspended following a preliminary court injunction from the Federal Court of Rio Grande do Sul, filed by the Interstate Tobacco Industry Union (SINDITABACO).45 The injunction alleged that INCa’s space would be insufficient to accommodate those interested in participating in the public hearing. Two months later, a public hearing was held at a sports centre in Brasília (capacity 24 000 people), with approximately 100 people participating.
In 2011, the Getúlio Vargas Foundation (FGV for the name in Portuguese) published a study,49 funded by TI and groups linked to the TI90 (according to the publication—SINDITABACO—Interstate Tobacco Industry Union, FETAG—Federation of Agricultural Workers in Rio Grande do Sul; FETAESC—Federation of Agricultural Workers of the State of Santa Catarina; STIFA—Union of Workers in the Tobacco and Food Industries of Santa Cruz do Sul and Region; CNTUR—National Confederation of Tourism; ABRASEL—Brazilian Association of Bars and Restaurants), concluding that the prohibition of additives would bring no public health benefits while it would negatively affect the production of burley-type tobacco and increase illicit trade.49 FGV is a respectable and traditional research institute and university, which until the publication of this study had never positioned itself contrary to public health policies, especially tobacco control. In fact, in the past, it has contributed to research and data supporting tobacco control policies.
The FGV report had no scientific merit, as it misrepresented references used in its analysis, used references from authors with conflicts of interest and concluded that the resolution would stimulate the illicit trade without any justification.91 In addition, the report did not provide any information of authorship; thus, it is impossible to verify possible conflicts of interest or the credentials of those who wrote it, a pivotal concern given previous research showing TI’s use of junk science as a strategy to oppose tobacco control policies. The FGV report was analysed by Lencucha and Pontes,92 and the authors concluded: “FGV document either drew from unreliable sources (ie, those directly or indirectly supported by the tobacco industry) or misrepresented information presented in credible sources.”
The discursive and instrumental strategies used during the public comments’ process are detailed in table 1.
TI and the ANVISA’s resolution banning additives—RDC 14/2012
Despite all the pressure to cancel it, the public comments process was finalised, and resolution RDC14/2012 was published on 15 March 2012.36 It prohibited the use of substances with flavouring or aromatising properties that could impart, intensify, modify or enhance flavour or aroma of all tobacco products. The group of prohibited substances included adjuvants of technology for aromatisation and flavouring agents; additives with nutritional properties, such as amino acids and vitamins; additives associated with alleged stimulating or invigorating properties (eg, guarana and caffeine); pigments; fruit and other vegetables; sweeteners or any substance capable of giving sweet aroma or flavour, other than sugars; seasonings, herbs and spices or any substance that may give aroma or flavour of spices and herbs; ameliorants; and ammonia and all its compounds and derivatives.
The resolution included a few exceptions allowing the use of some humectants, sugars and some other components considered essential to the manufacture of cigarettes. The resolution also allowed the use of certain additives, provided that they were not used to change the taste of cigarettes (and other tobacco products), and that TI could offer a justification for their use. In the case of sugars, ANVISA was sensitive to TI's economic arguments. Sugars are known to be used to improve the organoleptic aspects of tobacco smoke, in addition to being suspected of potentiating the effects of nicotine.35 93–95 However, the resolution allowed sugar to be added, although only to the extent necessary to replace the naturally occurring loss of sugar during the curing process.
After the publication of the resolution, the TI continued to pressure ANVISA to review its position and to allow the use of additives. In July 2012, the TI requested ANVISA’s Board of Directors to create an exception and allow the industry to use 146 additives, among them menthol. The TI argued that these were necessary to maintain the original flavour of the tobacco, lost during the curing and manufacturing process, and that they would occur naturally in tobacco.52 96 97 ANVISA’s technical staff opposed this exception.52 96 97 ANVISA’s Board of Directors decided to temporarily allow the use of 121 of the 146 additives, during which time a working group (WG) of experts would evaluate the possibility of permanently creating an exception for these 121 additives.98 In August 2014, the WG99 published its final report.100 It corroborated the opinion of the technical staff of ANVISA, reinforcing the importance of prohibiting the use of all flavouring substances in tobacco products, and recommending the full implementation of RDC 14/2012.28 100 The WG report also recommended the ban of sugars. After the WG’s report, ANVISA’s Board of Directors revoked the Normative Instruction that had temporarily allowed the use of 121 additives in tobacco products.99
In 2012, under pressure from the TI, the Brazilian Government removed four members from the Brazilian delegation (from ANVISA and INCA) that were attending the fifth Conference of the Parties (COP5) of the FCTC in Seoul, South Korea. These delegates had less than 12 hours’ notice to return to Brazil.101 102 At the same time, according the non-governmental organisation (NGO) ACTBr, a Brazilian delegation member, despite the scientific literature to the contrary, advocated TI friendly positions during COP5.101–104 The NGO accused part of the Brazilian delegation of working in line with TI’s interests and providing false information to the press.102
In September 2013, a Federal Supreme Court injunction suspended the ban on tobacco product additives. The court filing by Brazil’s National Confederation of Industries did not question any technical aspects of the resolution. It questioned, instead, the competence of ANVISA to regulate tobacco products’ additives. In March 2018, the Supreme Court found in favour of ANVISA.46 However, the decision did not preempt cases filed in lower courts halting the implementation. These cases are being judged one by one and, as of March 2019, there are 18 court cases pending and the resolution remains without implementation. According ANVISA, TI more than doubled the number of flavoured cigarettes in the Brazilian market between 2008 and 2018 (23 brands in 2008 to 58 brands in 2018).105
The discursive strategies and instrumental strategies are listed in table 1.
TI key arguments to deter the additive ban
Table 2 lists the key arguments used by TI and its allies.27 29–32 63 106–114
The key arguments used by TI against the additive ban in Brazil
Discussion
The TI strategies used to interfere in the implementation of Brazil’s additive ban are the same described in the literature.115–128 We found no difference between the arguments used to deter new regulations worldwide and arguments used in Brazil, with adaptations to the Brazilian context. A similar pattern of strategies was found in the Canadian additive ban in 2009, the first additive regulation in the world.129 130
Casting doubt on the public health impact, misusing science, using public relations, funding political campaigns, lobbying, intimidating, using economic power and litigation, corruption, using front groups and establishing alliances are TI strategies that have been previously described.115 In Brazil, the TI used very similar strategies, suggesting a high degree of coordination and organisation of these actions globally. This is not surprising, since the TI in Brazil, as in many other countries, is mostly composed of few multinational companies.
The main arguments of the TI and its allies against the prohibition of additives had no scientific basis. The main reference used by the TI and its allies to indicate the negative impact of the RDC 14/2012 was the report produced by the FGV and financed by the TI.49 The TI claims about the impossibility to use burley tobacco and the economic damage to tobacco growers were not true, as TI can produce cigarettes with no additives. The use of front groups allegedly representing tobacco growers, has similarly been previously described.54 55 115
The litigation and the mechanisms to prevent regulation are also well described by previous research,115 121 125–128 131–133 as is the use of public consultation as a strategy to prevent, or at least delay, the regulation (in other areas of tobacco control policy), although the massive amount of submissions in Brazil is unique. It highlights the need for transparency and disclosure of conflicts in public’s participation in policy making.
Conclusion
The prohibition of additives in tobacco products is essential to contain the tobacco epidemic and its benefits to public health are unquestionable. Its rationale is largely supported by the scientific literature, internal TI documents and by the TI’s own statements during the Brazilian additive ban process. None of the arguments used by the TI was evidence-based.
Brazil was the first country in the world to prohibit all additives that change smell and taste (Canada’s ban has exceptions), even those ones that not direct impart a characteristic flavour, in all tobacco products. The case of Brazil is a lesson on how countries considering a comprehensive additive ban should prepare to face fierce opposition from the TI. Mechanisms used to guarantee transparency and stakeholders’ participation can be used by the TI to prevent new tobacco control regulations. Governments, therefore, be prepared to prevent TI from abusing the system and dedicate appropriate resources to respond. Governments must adopt mechanisms that prevent undue pressure in its public health policies. In addition, the judiciary should be encouraged to reflect on its important role in preserving the health of the population.
What this paper adds
What is already known on this subject
The tobacco industry uses a range of additives, including flavours, to make tobacco products more palatable, to increase nicotine absorption and to make products more attractive to population groups such as youth and certain minority groups.
What important gaps in knowledge exist on this topic
Very few countries have attempted to pass comprehensive bans on tobacco products’ additives, thus the tobacco industry’s range of responses to these policies have not yet been documented.
What this study adds
This is the first study to describe the tobacco industry’s reaction to an additive ban policy. The lessons from Brazil could assist countries considering additives ban to prepare for, and counter, the tobacco industry opposition.
Acknowledgments
The authors would like to thank ANVISA, FIOCRUZ and the Brazilian National Council for Scientific and Technological Development (CNPq, Conselho Nacional de Desenvolvimento Científico e Tecnológico).
References
Footnotes
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Disclaimer This paper represents solely and exclusively the opinion and thinking of the authors, based on the evidence available at the time. It does not represent ANVISA, FIOCRUZ, Ministry of Health and the Brazilian Government’s institutional views, policies or opinions.
Competing interests None declared.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.