Tobacco packaging and labeling policies in the WHO African Region: Progress 15 years after adoption of the WHO Framework Convention on Tobacco Control Article 11 Implementation Guidelines.

INTRODUCTION: Article 11 of the World Health Organization's Framework Convention on Tobacco Control (WHO FCTC) requires Parties to adopt and implement effective tobacco packaging and labeling policies to communicate health risks and reduce tobacco consumption. The goal of this study was to assess adoption of these policies in the WHO African Region (AFRO). METHODS: We reviewed tobacco packaging and labeling policies adopted in AFRO from the Campaign for Tobacco-Free Kids' Tobacco Control Laws database (w w w.tobaccocontrollaws.org). We assessed these policies based on WHO FCTC Article 11 and its Implementation Guidelines examining three sub-policy areas (health warning labels [HWLs], descriptive constituents and emissions information, and misleading packaging and labeling). We developed a scoring system to rank AFRO countries individually and by World Bank's income-level groups and documented the progress during 1985-2023. RESULTS: Forty (of 47) AFRO countries adopted national laws, of which a majority adopted large rotating pictorial HWLs and banned misleading descriptors; only Cote d'Ivoire and Mauritius adopted standardized packaging. The higher a country is in the World Bank's income-level group, the stronger their packaging and labeling policies are. This observation was not present in the sub-policy area of HWLs. Prior to approving the WHO FCTC Article 11 Implementation Guidelines, only 23 countries adopted text-only HWLs whereas 26 countries adopted pictorial HWLs after the approval. CONCLUSION: Several AFRO countries have adopted tobacco packaging and labeling policies that align with the WHO FCTC Article 11 Implementation Guidelines. More efforts could be directed toward the low-income group and disseminating standardized packaging throughout AFRO. IMPLICATIONS: In the WHO African Region (AFRO), the number of tobacco users is increasing, highlighting the need for tobacco packaging and labeling policies aligned with WHO FCTC Article 11 and its Implementation Guidelines as these are proven tobacco control strategies. This study provides a country-level and income-level group ranking of tobacco packaging and labeling policies and documents the evolution of health warning labels adopted in AFRO. It also identifies regional and income-level group successes and gaps in tobacco product packaging and labeling policies and provides recommendations to further align with WHO FCTC Article 11 and its Implementation Guidelines.

Adopting a WHO Framework Convention on Tobacco Control-Based Tobacco Control Law in Ethiopia: Sustained Transnational Health Advocacy and Multi-Sectoral Institutionalized Support.

OBJECTIVE: The objective of this study was to document how Ethiopia adopted a WHO Framework Convention on Tobacco Control (FCTC)-based tobacco control law. METHODS: We analyzed publicly available documents, including news media articles, advocacy reports, and government documents. We triangulated these findings by interviewing nine key stakeholders. Data were analyzed to construct a historical and thematic narrative and analyzed through a retrospective policy analysis. RESULTS: Local and international health advocacy efforts helped introduce and support WHO FCTC-based legislation by (1) educating policymakers about the WHO FCTC, (2) providing legal assistance in drafting legislation, (3) generating local data to counter industry claims, and (4) producing media advocacy to expose industry activity. Health advocates worked closely with government officials to create a multi-sectoral tobacco committee to institutionalize efforts and insulate tobacco companies from the policymaking process. Japan Tobacco International bought majority shares of the government-owned tobacco company and attempted to participate in the process, using standard industry tactics to undermine legislative efforts. However, with health advocacy assistance, government officials were able to reject these attempts and adopt a WHO FCTC-based law in 2019 that included 100% smoke-free indoor places, a comprehensive ban on tobacco advertising, and large pictorial health warning labels, among other provisions. CONCLUSION: Sustained local health advocacy efforts supported by international technical and financial assistance can help establish WHO FCTC-based tobacco control laws. Applying a standardized multi-sectoral approach can establish coordinating mechanisms to further institutionalize the WHO FCTC as a legal tool to build support with other government sectors and insulate the tobacco industry from the policymaking process.

United States Food and Drug Administration's authorization of reduced exposure claims for IQOS®: implications for regulation in Latin America.

Philip Morris International has used the July 7, 2020 United States Food and Drug Administration's (US FDA) modified risk tobacco product order for IQOS®, which authorized certain reduced exposure marketing claims, as a corporate strategy to promote and normalize its heated tobacco products in Latin America. The modified risk tobacco product orders are based on the US's unique regulatory system that is not, and should not be, replicated anywhere else in the world. Philip Morris International's global public relations campaign largely ignored the FDA's rejection of reduced risk claims for IQOS and other key FDA findings that are important for policy-makers, regulators, and consumers - including tobacco users and Philip Morris International's customers - to understand the risks associated with the product. In Latin America in particular, Philip Morris International has used media outlets to promote this misleading information to the public. This company has also used the FDA ruling to lobby regulators in Latin America to relax regulations on IQOS in the region. As tobacco companies rapidly introduce new tobacco products in low- and middle-income countries, public health advocates and Parties to the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) should take measures to prevent the promotion of misleading statements about heated tobacco products, including IQOS. As Latin American countries are at different stages in their regulation of heated tobacco products, governments should adhere to their WHO FCTC obligations and the recommendations of the Conference of the Parties by entirely prohibiting the sale of heated tobacco products or strictly applying to heated tobacco products all the relevant tobacco demand-reduction policies based on the WHO FCTC (making sure to capture both heated cigarettes and heating devices).

Philip Morris International ha empleado el dictamen que la Administración de Alimentos y Medicamentos (FDA) de Estados Unidos emitió el 7 de julio del 2020 sobre IQOS como producto de tabaco de riesgo modificado ­que la autorizó a usar ciertas declaraciones relativas a una exposición reducida al comercializar el producto­ como estrategia corporativa para promover y normalizar sus productos de tabaco calentado en América Latina. Los dictámenes sobre productos de tabaco de riesgo modificado se fundamentan en el sistema regulatorio único de Estados Unidos, que no se replica ni debería ser replicado en ningún otro lugar del mundo. La campaña mundial de relaciones públicas de Philip Morris International omitió en gran medida que la FDA rechazó los argumentos de que IQOS implica un riesgo reducido y otros hallazgos clave de la FDA que son importantes para que los responsables de las políticas, los reguladores y los consumidores, incluidos los consumidores de tabaco y los clientes de Philip Morris International, comprendan los riesgos asociados con el producto. En América Latina en particular, Philip Morris International ha utilizado los medios de comunicación para difundir esta información engañosa. Esta compañía también ha utilizado el fallo de la FDA para presionar a los reguladores en América Latina con el objetivo de que flexibilicen las regulaciones sobre IQOS en la Región. A medida que las compañías tabacaleras introducen con celeridad nuevos productos de tabaco en países de ingresos bajos y medianos, los defensores de la salud pública y los Estados Parte del Convenio Marco para el Control del Tabaco de la Organización Mundial de la Salud (CMCT de la OMS) deben tomar medidas para evitar la difusión de declaraciones engañosas sobre los productos de tabaco calentado, como IQOS. Dado que los países latinoamericanos se encuentran en diferentes etapas en la regulación de los productos de tabaco calentado, los gobiernos deben cumplir con sus obligaciones estipuladas en el CMCT de la OMS y las recomendaciones de la Conferencia de las Partes mediante la prohibición total de la venta de productos de tabaco calentado o la aplicación estricta a los productos de tabaco calentado de todas las políticas pertinentes sobre la reducción de la demanda de tabaco basadas en el CMCT de la OMS (y asegurarse de abarcar tanto los cigarrillos calentados como los dispositivos de calentamiento).

A Philip Morris International utilizou a decisão de 7 de julho de 2020 da Administração de Alimentos e Fármacos dos Estados Unidos (United States Food and Drug Administration, FDA), que caracterizou o IQOS como produto de tabaco com risco modificado e que permitiu o uso de determinadas alegações de exposição reduzida no marketing do produto, como estratégia corporativa para promover e normalizar seus produtos de tabaco aquecido na América Latina. As decisões relativas aos produtos de tabaco com risco modificado se baseiam no singular sistema regulatório dos EUA, que não é e não deve ser reproduzido em nenhum outro lugar do mundo. A campanha global de relações públicas da Philip Morris International ignorou em grande parte a rejeição da FDA às afirmações de risco reduzido do IQOS e outros achados fundamentais da FDA, que são informações importantes para formuladores de políticas, órgãos regulamentadores e consumidores ­ incluindo usuários de tabaco e clientes da Philip Morris International ­ entenderem os riscos associados ao produto. A Philip Morris International tem usado a mídia para veicular essa informação enganosa ao público, principalmente na América Latina. A empresa também usou a decisão da FDA para pressionar órgãos regulamentadores na América Latina a flexibilizarem a regulamentação do IQOS na região. Conforme as empresas de tabaco introduzem rapidamente novos produtos em países de baixa e média renda, os ativistas de saúde pública e as Partes da Convenção-Quadro para Controle do Tabaco (CQCT) da Organização Mundial da Saúde (OMS) devem tomar providências para prevenir a promoção de alegações enganosas sobre produtos de tabaco aquecido, incluindo o IQOS. Como os países da América Latina estão em diferentes estágios da regulamentação de produtos de tabaco aquecido, os governos devem cumprir suas obrigações com a CQCT da OMS e seguir as recomendações da Conferência das Partes, proibindo totalmente a venda de produtos de tabaco aquecido ou aplicando rigorosamente aos produtos de tabaco aquecido todas as políticas relevantes de redução da demanda por tabaco, com base na CQCT da OMS (certificando-se de abranger tanto os cigarros aquecidos quanto os dispositivos de aquecimento).

United States Food and Drug Administration’s authorization of reduced exposure claims for IQOS®: implications for regulation in Latin America

[ABSTRACT]. Philip Morris International has used the July 7, 2020 United States Food and Drug Administration’s (US FDA) modified risk tobacco product order for IQOS®, which authorized certain reduced exposure marketing claims, as a corporate strategy to promote and normalize its heated tobacco products in Latin America. The modified risk tobacco product orders are based on the US’s unique regulatory system that is not, and should not be, replicated anywhere else in the world. Philip Morris International’s global public relations campaign largely ignored the FDA’s rejection of reduced risk claims for IQOS and other key FDA findings that are important for policy-makers, regulators, and consumers – including tobacco users and Philip Morris International’s customers – to understand the risks associated with the product. In Latin America in particular, Philip Morris International has used media outlets to promote this misleading information to the public. This company has also used the FDA ruling to lobby regulators in Latin America to relax regulations on IQOS in the region. As tobacco companies rapidly introduce new tobacco products in low- and middle-income countries, public health advocates and Parties to the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) should take measures to prevent the promotion of misleading statements about heated tobacco products, including IQOS. As Latin American countries are at different stages in their regulation of heated tobacco products, governments should adhere to their WHO FCTC obligations and the recommendations of the Conference of the Parties by entirely prohibiting the sale of heated tobacco products or strictly applying to heated tobacco products all the relevant tobacco demand-reduction policies based on the WHO FCTC (making sure to capture both heated cigarettes and heating devices).

[RESUMEN]. Philip Morris International ha empleado el dictamen que la Administración de Alimentos y Medicamentos (FDA) de Estados Unidos emitió el 7 de julio del 2020 sobre IQOS como producto de tabaco de riesgo modificado —que la autorizó a usar ciertas declaraciones relativas a una exposición reducida al comercializar el producto— como estrategia corporativa para promover y normalizar sus productos de tabaco calentado en América Latina. Los dictámenes sobre productos de tabaco de riesgo modificado se fundamentan en el sistema regulatorio único de Estados Unidos, que no se replica ni debería ser replicado en ningún otro lugar del mundo. La campaña mundial de relaciones públicas de Philip Morris International omitió en gran medida que la FDA rechazó los argumentos de que IQOS implica un riesgo reducido y otros hallazgos clave de la FDA que son importantes para que los responsables de las políticas, los reguladores y los consumidores, incluidos los consumidores de tabaco y los clientes de Philip Morris International, comprendan los riesgos asociados con el producto. En América Latina en particular, Philip Morris International ha utilizado los medios de comunicación para difundir esta información engañosa. Esta compañía también ha utilizado el fallo de la FDA para presionar a los reguladores en América Latina con el objetivo de que flexibilicen las regulaciones sobre IQOS en la Región. A medida que las compañías tabacaleras introducen con celeridad nuevos productos de tabaco en países de ingresos bajos y medianos, los defensores de la salud pública y los Estados Parte del Convenio Marco para el Control del Tabaco de la Organización Mundial de la Salud (CMCT de la OMS) deben tomar medidas para evitar la difusión de declaraciones engañosas sobre los productos de tabaco calentado, como IQOS. Dado que los países latinoamericanos se encuentran en diferentes etapas en la regulación de los productos de tabaco calentado, los gobiernos deben cumplir con sus obligaciones estipuladas en el CMCT de la OMS y las recomendaciones de la Conferencia de las Partes mediante la prohibición total de la venta de productos de tabaco calentado o la aplicación estricta a los productos de tabaco calentado de todas las políticas pertinentes sobre la reducción de la demanda de tabaco basadas en el CMCT de la OMS (y asegurarse de abarcar tanto los cigarrillos calentados como los dispositivos de calentamiento).

[RESUMO]. A Philip Morris International utilizou a decisão de 7 de julho de 2020 da Administração de Alimentos e Fármacos dos Estados Unidos (United States Food and Drug Administration, FDA), que caracterizou o IQOS como produto de tabaco com risco modificado e que permitiu o uso de determinadas alegações de exposição reduzida no marketing do produto, como estratégia corporativa para promover e normalizar seus produtos de tabaco aquecido na América Latina. As decisões relativas aos produtos de tabaco com risco modificado se baseiam no singular sistema regulatório dos EUA, que não é e não deve ser reproduzido em nenhum outro lugar do mundo. A campanha global de relações públicas da Philip Morris International ignorou em grande parte a rejeição da FDA às afirmações de risco reduzido do IQOS e outros achados fundamentais da FDA, que são informações importantes para formuladores de políticas, órgãos regulamentadores e consumidores – incluindo usuários de tabaco e clientes da Philip Morris International – entenderem os riscos associados ao produto. A Philip Morris International tem usado a mídia para veicular essa informação enganosa ao público, principalmente na América Latina. A empresa também usou a decisão da FDA para pressionar órgãos regulamentadores na América Latina a flexibilizarem a regulamentação do IQOS na região. Conforme as empresas de tabaco introduzem rapidamente novos produtos em países de baixa e média renda, os ativistas de saúde pública e as Partes da Convenção-Quadro para Controle do Tabaco (CQCT) da Organização Mundial da Saúde (OMS) devem tomar providências para prevenir a promoção de alegações enganosas sobre produtos de tabaco aquecido, incluindo o IQOS. Como os países da América Latina estão em diferentes estágios da regulamentação de produtos de tabaco aquecido, os governos devem cumprir suas obrigações com a CQCT da OMS e seguir as recomendações da Conferência das Partes, proibindo totalmente a venda de produtos de tabaco aquecido ou aplicando rigorosamente aos produtos de tabaco aquecido todas as políticas relevantes de redução da demanda por tabaco, com base na CQCT da OMS (certificando-se de abranger tanto os cigarros aquecidos quanto os dispositivos de aquecimento).

United States Food and Drug Administration's authorization of reduced exposure claims for IQOS®: implications for regulation in Latin America / Autorización de la Administración de Alimentos y Medicamentos de Estados Unidos de declaraciones sobre exposición reducida respecto de IQOS: implicaciones para la regulación en América Latina / Autorização pela Administração de Alimentos e Fármacos dos Estados Unidos de alegações de exposição reduzida para os produtos IQOS: implicações para a regulamentação na América Latina

ABSTRACT Philip Morris International has used the July 7, 2020 United States Food and Drug Administration's (US FDA) modified risk tobacco product order for IQOS®, which authorized certain reduced exposure marketing claims, as a corporate strategy to promote and normalize its heated tobacco products in Latin America. The modified risk tobacco product orders are based on the US's unique regulatory system that is not, and should not be, replicated anywhere else in the world. Philip Morris International's global public relations campaign largely ignored the FDA's rejection of reduced risk claims for IQOS and other key FDA findings that are important for policy-makers, regulators, and consumers - including tobacco users and Philip Morris International's customers - to understand the risks associated with the product. In Latin America in particular, Philip Morris International has used media outlets to promote this misleading information to the public. This company has also used the FDA ruling to lobby regulators in Latin America to relax regulations on IQOS in the region. As tobacco companies rapidly introduce new tobacco products in low- and middle-income countries, public health advocates and Parties to the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) should take measures to prevent the promotion of misleading statements about heated tobacco products, including IQOS. As Latin American countries are at different stages in their regulation of heated tobacco products, governments should adhere to their WHO FCTC obligations and the recommendations of the Conference of the Parties by entirely prohibiting the sale of heated tobacco products or strictly applying to heated tobacco products all the relevant tobacco demand-reduction policies based on the WHO FCTC (making sure to capture both heated cigarettes and heating devices).

RESUMEN Philip Morris International ha empleado el dictamen que la Administración de Alimentos y Medicamentos (FDA) de Estados Unidos emitió el 7 de julio del 2020 sobre IQOS como producto de tabaco de riesgo modificado —que la autorizó a usar ciertas declaraciones relativas a una exposición reducida al comercializar el producto— como estrategia corporativa para promover y normalizar sus productos de tabaco calentado en América Latina. Los dictámenes sobre productos de tabaco de riesgo modificado se fundamentan en el sistema regulatorio único de Estados Unidos, que no se replica ni debería ser replicado en ningún otro lugar del mundo. La campaña mundial de relaciones públicas de Philip Morris International omitió en gran medida que la FDA rechazó los argumentos de que IQOS implica un riesgo reducido y otros hallazgos clave de la FDA que son importantes para que los responsables de las políticas, los reguladores y los consumidores, incluidos los consumidores de tabaco y los clientes de Philip Morris International, comprendan los riesgos asociados con el producto. En América Latina en particular, Philip Morris International ha utilizado los medios de comunicación para difundir esta información engañosa. Esta compañía también ha utilizado el fallo de la FDA para presionar a los reguladores en América Latina con el objetivo de que flexibilicen las regulaciones sobre IQOS en la Región. A medida que las compañías tabacaleras introducen con celeridad nuevos productos de tabaco en países de ingresos bajos y medianos, los defensores de la salud pública y los Estados Parte del Convenio Marco para el Control del Tabaco de la Organización Mundial de la Salud (CMCT de la OMS) deben tomar medidas para evitar la difusión de declaraciones engañosas sobre los productos de tabaco calentado, como IQOS. Dado que los países latinoamericanos se encuentran en diferentes etapas en la regulación de los productos de tabaco calentado, los gobiernos deben cumplir con sus obligaciones estipuladas en el CMCT de la OMS y las recomendaciones de la Conferencia de las Partes mediante la prohibición total de la venta de productos de tabaco calentado o la aplicación estricta a los productos de tabaco calentado de todas las políticas pertinentes sobre la reducción de la demanda de tabaco basadas en el CMCT de la OMS (y asegurarse de abarcar tanto los cigarrillos calentados como los dispositivos de calentamiento).

RESUMO A Philip Morris International utilizou a decisão de 7 de julho de 2020 da Administração de Alimentos e Fármacos dos Estados Unidos (United States Food and Drug Administration, FDA), que caracterizou o IQOS como produto de tabaco com risco modificado e que permitiu o uso de determinadas alegações de exposição reduzida no marketing do produto, como estratégia corporativa para promover e normalizar seus produtos de tabaco aquecido na América Latina. As decisões relativas aos produtos de tabaco com risco modificado se baseiam no singular sistema regulatório dos EUA, que não é e não deve ser reproduzido em nenhum outro lugar do mundo. A campanha global de relações públicas da Philip Morris International ignorou em grande parte a rejeição da FDA às afirmações de risco reduzido do IQOS e outros achados fundamentais da FDA, que são informações importantes para formuladores de políticas, órgãos regulamentadores e consumidores - incluindo usuários de tabaco e clientes da Philip Morris International - entenderem os riscos associados ao produto. A Philip Morris International tem usado a mídia para veicular essa informação enganosa ao público, principalmente na América Latina. A empresa também usou a decisão da FDA para pressionar órgãos regulamentadores na América Latina a flexibilizarem a regulamentação do IQOS na região. Conforme as empresas de tabaco introduzem rapidamente novos produtos em países de baixa e média renda, os ativistas de saúde pública e as Partes da Convenção-Quadro para Controle do Tabaco (CQCT) da Organização Mundial da Saúde (OMS) devem tomar providências para prevenir a promoção de alegações enganosas sobre produtos de tabaco aquecido, incluindo o IQOS. Como os países da América Latina estão em diferentes estágios da regulamentação de produtos de tabaco aquecido, os governos devem cumprir suas obrigações com a CQCT da OMS e seguir as recomendações da Conferência das Partes, proibindo totalmente a venda de produtos de tabaco aquecido ou aplicando rigorosamente aos produtos de tabaco aquecido todas as políticas relevantes de redução da demanda por tabaco, com base na CQCT da OMS (certificando-se de abranger tanto os cigarros aquecidos quanto os dispositivos de aquecimento).

Transparency as a remedy against racketeering: preventing and restraining fraud by exposing Big Tobacco's dirty secrets.

The 1990s state litigation that resulted in the tobacco industry's initial document disclosure obligations fully expired in 2010. These obligations have been extended and enhanced until 2021 through a federal lawsuit against the tobacco industry over violations of the Racketeer Influenced Corrupt Organizations Act (RICO). In this special communication, we summarise and explain the new legal framework and enhanced document disclosure obligations of the major US tobacco companies. We describe the events leading up to these new requirements, including the tobacco companies' failed attempt to close the Minnesota Tobacco Document Depository, the release of 100 000 documents onto the companies' document websites discovered to have been publicly available at the Minnesota Tobacco Document Depository but not online, and the addition of over 2300 documents to those websites, which are also now publicly available at Minnesota after being secured for years in a separate, non-public storage room at the Minnesota Tobacco Document Depository. We also detail the document indexing enhancements and redesign of the University of California, San Francisco's Legacy Tobacco Documents Library website, made possible by the RICO litigation, and which is anticipated to be released in September 2014. Last, we highlight the public health community's continued opportunity to expose the US tobacco industry's efforts to undermine public health through these new search enhancements and improved document accessibility and due to the continuously growing document collection until at least 2021.

Tracking the relevance of the WHO Framework Convention on Tobacco Control in legislation and litigation through the online resource, Tobacco Control Laws.

The WHO Framework Convention on Tobacco Control is increasingly referenced and incorporated into the objectives, definitions and provisions of domestic legislation worldwide. It is also relied upon by courts in interpreting and upholding strong tobacco control measures challenged by the tobacco industry. In this special communication, we describe these trends and explore the important new online resource-Tobacco Control Laws (http://www.tobaccocontrollaws.org)--that has been used to track them.

Legislating tolerance: Spain's national public smoking law.

While Spain's national tobacco control legislation prohibits smoking in many indoor public places, the law provides for an exception to the prohibition of smoking by allowing separate seating sections and ventilation options in certain public places such as bars and restaurants, hotels and airports. Accordingly, Spain's law is not aligned with Article 8 Guidelines of the World Health Organization's Framework Convention on Tobacco Control, which requires parties to ensure universal protection against secondhand smoke exposure in all enclosed public places, workplaces and on all means of public transport. Spain's law is currently being promoted by the tobacco companies in other countries as a model for smoke-free legislation. In order to prevent weakening of smoke-free laws in other countries through industry-supported exceptions, we investigated the tactics used by the tobacco companies before the implementation of the new law and assessed the consequences of these actions in the hospitality sector. Internal tobacco industry documents made public through US litigation settlements dating back to the 1980s were searched in 2008-9. Documents show that tobacco companies sought to protect hospitality venues from smoking restrictions by promoting separate seating for smokers and ineffective ventilation technologies, supporting an unenforceable voluntary agreement between the Madrid local government and the hospitality industry, influencing ventilation standards setting and manipulating Spanish media. The Spanish National Assembly should adopt comprehensive smoke-free legislation that does not accommodate the interests of the tobacco industry. In doing so, Spain's smoke-free public places law would be better aligned with the Framework Convention on Tobacco Control.

Open doorway to truth: legacy of the Minnesota tobacco trial.

More than a decade has passed since the conclusion of the Minnesota tobacco trial and the signing of the Master Settlement Agreement (MSA) by 46 US State Attorneys General and the US tobacco industry. The Minnesota settlement exposed the tobacco industry's long history of deceptive marketing, advertising, and research and ultimately forced the industry to change its business practices. The provisions for public document disclosure that were included in the Minnesota settlement and the MSA have resulted in the release of approximately 70 million pages of documents and nearly 20,000 other media materials. No comparable dynamic, voluminous, and contemporaneous document archive exists. Only a few single events in the history of public health have had as dramatic an effect on tobacco control as the public release of the tobacco industry's previously secret internal documents. This review highlights the genesis of the release of these documents, the history of the document depositories created by the Minnesota settlement, the scientific and policy output based on the documents, and the use of the documents in furthering global public health strategies.

"Efforts to Reprioritise the Agenda" in China: British American Tobacco's Efforts to Influence Public Policy on Secondhand Smoke in China.

BACKGROUND: Each year, 540 million Chinese are exposed to secondhand smoke (SHS), resulting in more than 100,000 deaths. Smoke-free policies have been demonstrated to decrease overall cigarette consumption, encourage smokers to quit, and protect the health of nonsmokers. However, restrictions on smoking in China remain limited and ineffective. Internal tobacco industry documents show that transnational tobacco companies (TTCs) have pursued a multifaceted strategy for undermining the adoption of restrictions on smoking in many countries. METHODS AND FINDINGS: To understand company activities in China related to SHS, we analyzed British American Tobacco's (BAT's) internal corporate documents produced in response to litigation against the major cigarette manufacturers to understand company activities in China related to SHS. BAT has carried out an extensive strategy to undermine the health policy agenda on SHS in China by attempting to divert public attention from SHS issues towards liver disease prevention, pushing the so-called "resocialisation of smoking" accommodation principles, and providing "training" for industry, public officials, and the media based on BAT's corporate agenda that SHS is an insignificant contributor to the larger issue of air pollution. CONCLUSIONS: The public health community in China should be aware of the tactics previously used by TTCs, including efforts by the tobacco industry to co-opt prominent Chinese benevolent organizations, when seeking to enact stronger restrictions on smoking in public places.

Waking a sleeping giant: the tobacco industry's response to the polonium-210 issue.

The major tobacco manufacturers discovered that polonium was part of tobacco and tobacco smoke more than 40 years ago and attempted, but failed, to remove this radioactive substance from their products. Internal tobacco industry documents reveal that the companies suppressed publication of their own internal research to avoid heightening the public's awareness of radioactivity in cigarettes. Tobacco companies continue to minimize their knowledge about polonium-210 in cigarettes in smoking and health litigation. Cigarette packs should carry a radiation-exposure warning label.

Movie moguls: British American Tobacco's covert strategy to promote cigarettes in Eastern Europe.

BACKGROUND: Though the cigarette companies have long publicly denied paying for product placement in films, the documentary evidence from the 1950s-1980s overwhelmingly suggests otherwise. METHODS: Approximately 800,000 pages of previously secret internal corporate British American Tobacco Company documents were reviewed at the Minnesota Tobacco Document Depository from March 2003 through May 2005. Documents were also searched online at the various tobacco document collections between February 2004 and November 2004. RESULTS: A small collection of internal corporate documents from British American Tobacco show that in the late 1990s the company evaluated investing in a movie destined for Eastern Europe. By being an investor, BAT could influence the alteration of the movie script to promote BAT's brands, thus providing marketing opportunities without a clear violation of movie product placement restrictions. CONCLUSION: Future protocols to the WHO Framework Convention on Tobacco Control should seek to curtail more than just payment for tobacco product placement. More restrictive provisions will be needed to hinder creative strategies by the tobacco industry to continue tobacco promotion and trademark diversification through movies.

Playing hide-and-seek with the tobacco industry.

Despite many peer-reviewed works that draw on tobacco industry documents that have now been made public, questions remain about how complete a picture has emerged. We present a conceptual framework that identifies and evaluates tobacco industry efforts to conceal information. Widespread document destruction like that in recent litigation in Australia is just one of more than a dozen tobacco industry efforts to prevent access, or at least timely access, to documents. Industry efforts range from small, locally employed initiatives to company-wide tactics. Some efforts, such as using "oral only" procedures, scrambling telephone lines, or involving lawyers in scientific projects, are preemptive. Others seek to deal with already existing documents by invoking bogus claims of legal privilege, stipulating "read then destroy" for memos, and rewriting problematic memos. That evidence of concealment has, in fact, been found in tobacco company archives attests to the futility of attempting to control the flow of millions of pieces of paper among tens of thousands of employees. However, researchers have yet to reveal the full story: We know of the industry's failures in concealing information, but not its successes. The industry's objective is not destruction of information per se, but prevention of public disclosure of that information. Exposing the tobacco industry's many approaches to concealment provides greater insight into companies' intentions and potential means for stripping away that concealment.

Turning free speech into corporate speech: Philip Morris' efforts to influence U.S. and European journalists regarding the U.S. EPA report on secondhand smoke.

BACKGROUND: Previously secret internal tobacco company documents show that the tobacco industry launched an extensive multifaceted effort to influence the scientific debate about the harmful effects of secondhand smoke. Integral to the industry's campaign was an effort to derail the Environmental Protection Agency's (EPA) risk assessment on environmental tobacco smoke (ETS) by recruiting a network of journalists to generate news articles supporting the industry's position and pushing its public relations messages regarding the ETS issue. METHODS: Searches of previously secret internal tobacco industry records were conducted online and at the Minnesota Tobacco Document Depository. In addition, searches on the World Wide Web were conducted for each National Journalism Center alumnus. Lexis-Nexis was used to locate news stories written by the journalists cited in this paper. RESULTS: Philip Morris turned to its public relations firm Burson Marsteller to "build considerable reasonable doubt em leader particularly among consumers" about the "scientific weaknesses" of the EPA report. A Washington, DC, media and political consultant Richard Hines was a key player in carrying out Burson Marsteller's media recommendations of "EPA bashing" for Philip Morris. In March 1993, Philip Morris' vice president of corporate affairs policy and administration reported to Steve Parrish, vice president and general counsel of Philip Morris, that their consultant was "responsible for a number of articles that have appeared in em leader major news publications regarding EPA and ETS." In addition to placing favorable stories in the press through its consultant, Philip Morris sought to expand its journalist network by financially supporting a U.S. school of journalism; the National Journalism Center (NJC). Philip Morris gleaned "about 15 years worth of journalists at print and visual media throughout the country em leader to get across [its] side of the story" resulting in "numerous pieces consistent with our point of view." The company planned to "design innovative strategies to communicate [its] position on ETS through education programs targeting policy makers and the media" via the NJC. Finally, journalists associated with think tanks that were financially supported by Philip Morris wrote numerous articles critical of the EPA. CONCLUSIONS: This is the first report, from the tobacco industry's own documents, to show the extent to which the tobacco industry has gone to influence the print media on the issue of the health effects of secondhand smoke. Unfortunately, what we report here is that even journalists can fall victim to well-orchestrated and presented public relations efforts regardless of their scientific validity. It is not clear how various professional media organizations oversee the ethical conduct of their members. Certainly, on the topic of the health effects of secondhand smoke, more scrutiny is warranted from these organizations for articles written by their members lest the public be misinformed and thus ill served.

A cigarette manufacturer and a managed care company collaborate to censor health information targeted at employees.

A review of internal tobacco company documents showed that the tobacco company Philip Morris and the insurance company CIGNA collaborated to censor accurate information on the harm of smoking and on environmental tobacco smoke exposure from CIGNA health newsletters sent to employees of Philip Morris and its affiliates. From 1996 to 1998, 5 of the 8 CIGNA newsletters discussed in the internal tobacco documents were censored.We recommend that accrediting bodies mandate that health plans not censor employee-directed health information at the request of employers.

Big tobacco is watching: British American Tobacco's surveillance and information concealment at the Guildford depository.

The 1998 State of Minnesota legal settlement with the tobacco industry required British American Tobacco (BAT) to provide public access to the 8 million pages housed in its document depository located near Guildford, UK, and to any company documents sent to the Minnesota depository. While the Minnesota depository is managed by an independent third party, BAT's Guildford depository is run by the company itself. Starkly different from the Minnesota depository, at the Guildford depository it is extraordinarily more difficult to access, search, and obtain requested documents. BAT's approach to running the Guildford depository, in our view, amounts to concealing what is supposed to be public information. Newly produced BAT documents from subsequent litigation, dating from 1996 to 2001 disclose the company's efforts to gather intelligence on visitors and their work. We believe that BAT has acted to make access to information more difficult by delaying document production requested by public visitors and refusing to supply requested documents in an electronic format despite, in the company's own words, the establishment of "big time imaging" capabilities at the Guildford depository. During testimony in 2000, then BAT Chairman, Martin Broughton stated to the UK House of Commons Health Select Committee that the scanning and subsequent placement of the Guildford collection online "would be an extreme effort for absolutely no purpose whatsoever", stating that "there is no indication to me that serious researchers are showing any interest in the papers em leader ". New documents show that not only did the company recognise the importance of research undertaken by visitors, but also invested substantial resources and undertook numerous scanning projects during that time. The vulnerability of this important resource is demonstrated by the decreased number of files listed on the electronic database and the inadvertent deletion of an audio tape housed at the depository. With regard to intelligence gathering, BAT's law firm reported to BAT on the daily activities of depository visitors. Despite assurances to the contrary, these depository visitor reports show that BAT apparently tracked the database searches of a visitor. The company also tracked the physical movement of visitors and, in at least one instance, observed and noted the personal mobile phone use of a visitor. These activities raise ethical issues about BAT and/or its solicitors observing the work of lawyers and researchers representing health and government bodies. Given this new evidence, we assert that BAT is incapable of operating its depository in the spirit of the Minnesota settlement and should, therefore, be divorced from its operation. Accordingly, we recommend that the company provide its entire document collection electronically to interested parties thus allowing greater access to the public-health community as has been done in the USA.

The tobacco industry's political efforts to derail the EPA report on ETS.

Previously secret tobacco industry documents detailed a multifaceted approach of political strategies aimed to derail the 1993 Environmental Protection Agency (EPA) risk assessment on environmental tobacco smoke (ETS). These pervasive strategies included the following: (1) lobbying the first Bush Administration to approve an executive order that would impose new risk assessment standards for federal agencies, thus delaying the release of the EPA report; (2) having the first Bush Administration transfer jurisdiction over ETS from the EPA to Occupational Safety and Health Administration (OSHA), thus obviating the need for the release of the EPA report; and (3) applying enormous political pressure directly by alleging improper procedure and policy at EPA. Although some of the attempted strategies failed, the political pressure from Congressman Thomas Bliley (R-VA) was a success. This is the first report showing how a single member of Congress in conjunction with his staff, tobacco industry attorneys, and executives worked very aggressively to do the tobacco industry's bidding. These tactics successfully delayed the EPA risk assessment and placed a cloud over its validity that was not fully vindicated until December 2002 when the U.S. 4th Circuit Court of Appeals overturned the tobacco industry's suit against the EPA. The documents show that the industry will expend whatever effort is necessary to protect itself from public health policy that would adversely affect consumption of cigarettes and, therefore, profit.