• Tobacco industry
• Harm Reduction
• Public policy

Because of the extensive evidence that tobacco companies have worked systematically to subvert the scientific process, and the long history of the tobacco industry’s manipulation of science and rhetoric around its products,1 in a paper published in 2009 we proposed criteria and other considerations to assess possible funding models for research that include financial support from the tobacco industry.2 The eight specific criteria were: transparency and independence; competitive funding process; ownership of data and freedom to publish; independent research agenda; transparent, effective and independent governance structure; protection against conflict of interest; minimal industry public relations (PR) gains that counteract public health; and feasibility.

Subsequently, the Foundation for a Smoke-Free World (FSFW) was launched in 2017, fully funded by Philip Morris International (PMI) ‘to reduce harm and deaths from smoking worldwide’.3 The president and chief executive officer (CEO) of the FSFW at the time claimed that the Foundation met all the criteria we had proposed in that 2009 paper.4 Two of us who were in a position to comment publicly published a letter where we disagreed, noting FSFW’s lack of independence from its industry sponsor, potential for conflicts of interest and clear PR gains for its industry sponsor.5

As of 29 September 2023, FSFW now operates under an updated ‘Final Grant Agreement and Termination of Second Amended and Restated Pledge Agreement’, and on 12 October 2023, a new FSFW president and CEO (henceforth CEO) was announced. According to the Foundation’s current website, its three areas of focus are health and science research, agricultural diversification and industry transformation.6 The Agreement’s ‘Definition of Charitable Purpose’ that describes the purpose and focus of the FSFW includes terms such as ‘alternatives to cigarettes and other combustible products’, ‘field of tobacco harm reduction’ and ‘reduced risk products’.7 Transnational tobacco companies have co-opted the public health term harm reduction as an ‘opportunistic tactical adaptation to policy change’,8 focusing on the use of industry products rather than on the many other ways (such as smoke-free public places) that have been proven to reduce smoking and its concomitant harms. Further, so-called harm reduction has been a major component of tobacco companies’ ‘transformation’ narratives which, on analysis, are being used as a calculated strategy to delay implementation of proven tobacco control policies.9 10

Given the vast sums that PMI gave as its parting charitable gift (US$140 million in total between the final grant and termination payment), FSFW can continue its activities for several years with this tobacco industry funding. In a 27 November 2023 Reuters article, the new CEO was quoted as saying, ‘Any skepticism around our independence can be laid to rest.’11 As we discuss, this claim remains to be fully evaluated, and we have seen no explicit comments from either the new CEO or the Foundation about the other criteria laid out in 2009. Thus, it remains important to review the organisation’s credibility according to those criteria.

The purposes of this paper are to: (1) remind the tobacco control community that the criteria exist; (2) alert the tobacco control community and researchers of information needed and questions that might be asked of FSFW to help form judgements about this new iteration of FSFW; and (3) put the FSFW on notice that they need to address each of these criteria and speak publicly about their plans regarding the specific issues raised in the 2009 paper.

Unfortunately, conducting a thorough assessment using our 2009 paper is not possible because critical details related to FSFW governance, decision-making and process have not been announced. While conclusions about any new direction at FSFW are premature, we provide the following as a guide for those interested in the issues raised by our paper. As we said in the conclusion to the original paper, we welcome further analysis and discussion among the tobacco control community about the criteria—whether any should be added, deleted or refined.

1. Transparency and independence: The extent of the transparency for evaluating and selecting projects for FSFW funding is unclear at this time, nor is there clarity regarding whether there will be independent review by experts who are not tobacco industry employees or contractors. As indicated in the 2009 paper, priorities must be determined through a strategic planning process involving a wide range of non-industry stakeholders. Further, full disclosure of the funding source—that is, indicating PMI’s funding of FSFW—must be provided in each and every publication, presentation and other work products. Full disclosure of FSFW as a funding source, including the fact that FSFW was fully funded by PMI, did not occur consistently by previous FSFW grantees.12 In order to meet this criterion fully, FSFW must institute, monitor and enforce a policy requiring that grantees disclose the source of funding as well as the origin of the funds (PMI).

2. Competitive funding process: Currently, there is a lack of clarity regarding the extent to which the process for supporting FSFW-funded projects will be competitive, with evaluation by industry-independent experts who have appropriate expertise relevant to the tobacco/nicotine-related science being proposed.

3. Ownership of data and freedom to publish: We expect that the FSFW will continue to provide grants that, once awarded, will place no restrictions on investigators’ freedom to publish their findings.

4. Independent research agenda: At this time, given the recent announcements by FSFW, we would expect that the research agenda of the Foundation under the new CEO will be set independently of the tobacco industry and other partners who may have a conflict of interest that could influence the outcome. But the question remains whether the programme of research and other awards will benefit the tobacco company sponsor directly or indirectly. Even if the tobacco industry has no further direct control over the research agenda, they have set the FSFW and its grantees in a specific direction through the last 6 years of activity and a new CEO has been chosen whose vision and values align with continuing along a trajectory of an industry-preferred understanding of harm reduction with a sole focus on industry products.

   Furthermore, how the programmatic priorities of the Foundation will be set is uncertain. This uncertainty extends to the role of any external advisors who recommend that the Foundation pursue other tobacco control efforts that are not directly related to harm reduction. Are the harm reduction priorities established in the various legal documents released by the Foundation locked in stone? If so, these documents call into question the independence of the research and programmatic priorities of the Foundation. These are issues that should have been addressed by the Foundation and its new CEO prior to the recent announcement of the change in leadership.

5. Governance: We understand that the current FSFW board members report no affiliation with the tobacco industry broadly defined, and, moving forward, all board members should be respected senior leaders recognised for their integrity, science and/or relevant public policy expertise. To our knowledge, there has been no change in the FSFW board members following the new Agreement and the appointment of the new CEO. However, given there may be limitations on the kind of research that can be funded (as discussed above), this may influence the composition of the Board, possibly only attracting, and appointing, people who are more likely to be aligned with a tobacco industry conception of harm reduction.

6. Protection against conflict of interest: We have not seen a written conflict of interest policy with a clear statement of which relationships are prohibited along with mechanisms for enforcement of a stated conflict of interest policy.

7. Industry PR gains that counteract public health: The updated Agreement indicates that no further payments will be made to the FSFW and that ‘employees and agents shall make all decisions with respect to the utilization of Grant Funds for the Charitable Purpose on its own, free from the control, instructions, or influence, from or by Grantor or any of its affiliates, employees or agents’. This appears to be revised text that does not materially change what had been in an earlier document. However, historically, the FSFW has advocated for tobacco industry involvement in science and policymaking13 and has arguably functioned as a PR arm of the tobacco industry.14 This Final Agreement does nothing to stop that from continuing. In addition, the Agreement does not make explicit whether decisions other than those regarding the use of funds are also to be made fully independent of the Grantor or its affiliates, employees or agents.

8. Feasibility: This funding model is in place (and thus feasible).

We indicated in the 2009 paper that structure, implementation and oversight are critical aspects of having an acceptable funding model involving tobacco industry funds. We recommended, for example, that there be periodic oversight by an external group made up of people with the required tobacco-related expertise and who are demonstrably free of tobacco industry influence/funding. This periodic oversight is necessary to ensure that the funds are spent on independent, high-quality and relevant work and that the integrity of the structure and implementation continue to meet the criteria as well as other accepted benchmarks. We have not been able to find any report on the FSFW website that describes the Foundation’s oversight practices.

We note that the updated Agreement indicates that PMI will not provide any further payments to the Foundation, which may be seen by some to remove the Foundation’s financial dependence on the tobacco company moving forward. However, perspectives on this issue may differ. On the one hand, the fact that FSFW no longer has a formal relationship with and continued financial reliance on a tobacco industry sponsor suggests that its decision-making and governance now could be free of industry influence. On the other hand, the fact that PMI has paid FSFW an additional US$140 million has some concerned that the Foundation’s actions moving forward remain aligned with PMI’s interests. Further, it is possible that if FSFW did not act in accordance with the Agreement, including vis-à-vis the scope of allowable research, FSFW might need to reimburse funds not spent in accordance with the Agreement. In the absence of explicit details regarding scope, governance and decision-making going forward, these latter concerns remain reason for caution.

We also noted in the 2009 paper that we evaluated the models under the assumption that a broad range of tobacco control research would be undertaken with the funds and wrote ‘it may well be that the type of research conducted would be relevant to the acceptability of the different models’. For now, what work the Foundation will do is a significant unknown. This uncertainty, which we outlined in the discussion of criterion 4 above, needs to be addressed immediately so that there is a clear understanding of the actual degree of independence that now exists to establish priorities.

In a speech at the Food and Drug Law Institute on 26 October 2023, the CEO stated that FSFW would not be seeking or accepting any future tobacco industry funding.15 On 4 December 2023, the CEO issued a statement that the organisation would accept no funding from the tobacco or non-medicinal nicotine industry.16 While these statements address a critical issue related to funding sources, we have not heard yet from the FSFW CEO about how the Foundation will go about determining priorities for its work. It is also unclear what the nature of the input will be from any outside advisors enlisted by the new CEO regarding the establishment of programmatic priorities. Given the concerns that the field has expressed about the FSFW under the new CEO,11 17 18 the new leadership would have benefited from taking more time prior to making its recent announcements to work through the important details related to governance, decision-making and process. Overall, the hiring of a new CEO and PMI’s withdrawal, while potential signs of progress, by themselves are insufficient to assess properly the criteria and other considerations in the 2009 paper. For these reasons, conducting a thorough application of our 2009 paper to today’s FSFW remains impossible.