TPSAC Menthol Report Answers the Scientific Questions, But Doesn't Tip Committee's Hand, Demonstrating this is About Policy and Politics, Not Science

Six draft chapters of the FDA Tobacco Products Scientific Advisory Committee (TPSAC) menthol report are now available. These chapters are the following:

• CHAPTER 1: OVERVIEW: WHAT THIS REPORT IS ABOUT and CHAPTER 2: TPSAC’S APPROACH TO ITS CHARGE
  
• CHAPTER 3: THE PHYSIOLOGICAL EFFECTS OF MENTHOL CIGARETTES
• CHAPTER 4: PATTERNS OF MENTHOL CIGARETTE SMOKING
  
• CHAPTER 5: MARKETING AND CONSUMER PERCEPTION
  
• CHAPTER 7: EFFECTS OF MENTHOL ON THE DISEASE RISKS OF SMOKING

These chapters answer all of the key scientific issues that the Committee was asked to consider. Briefly, the report concludes the following:

• There is no evidence that menthol cigarettes are any more hazardous than other cigarettes in terms of their health effects.
• Menthol does contribute to the smoking initiation process by masking the harsh taste of tobacco.
• Menthol cigarettes are disproportionately popular among African American smokers.
• Menthol cigarettes are marketed disproportionately to African Americans.
• The marketing messages convey that menthol cigarettes may be safer.
• Menthol cigarettes may increase the difficulty of quitting.
• The marketing of menthol cigarettes, in combination with its effects, make the product appealing, lead to a perception of relative safety compared to other cigarettes, and make the product more appealing, especially among the African American population.

Based on these findings, it is completely impossible to know what the Committee's recommendations will be. They could recommend a ban on menthol cigarettes, regulation of menthol levels, regulation of menthol cigarette marketing, or further study. Any of these options could be consistent with the scientific findings of the report.

The Rest of the Story

That one can read essentially the full report and have no idea what the Committee will recommend demonstrates a point I have been making for some time: that the menthol issue is not a scientific one, but purely a political and policy one. In other words, science cannot determine what the nation's approach to menthol cigarettes should be. Only policy criteria and politics can make that determination. Thus, the Committee has essentially wasted a year of time and a huge amount of resources. Nothing new came out of the report. This is all information we have known for some time. The Committee could have made its recommendations a year ago, as none of these scientific findings add anything new that was necessary to contribute to a policy decision.

Put in other words, the decision about whether or not to ban menthol cigarettes is not one that flows logically from any particular scientific finding regarding menthol. What it flows from is simply two things:

1. The policy criteria that one decides to use to judge whether a cigarette flavoring should be banned; and

2. Politics.

Essentially, there are two criteria that TPSAC could use to make a decision regarding menthol:

A. A cigarette flavoring should be banned if it increases the toxicity of the product.

B. A cigarette flavoring should be banned if it contributes to increased smoking initiation or decreased smoking cessation by making smoking more appealing.

Under criterion A, menthol should not be banned because there is no evidence that menthol cigarettes are any more toxic than other cigarettes. This is something we knew a year ago before the Committee began its research and deliberations.

Under criterion B, menthol should be banned because obviously it increases the appeal of the product. The cigarette companies would not use this additive if it didn't increase the appeal of the product. That is the case with every additive. This is something we knew a year ago before the Committee began its research and deliberations.

You see, nothing happened in the past year that contributed toward the Committee's decision. What it needs to do is figure out what is the appropriate criterion to use in making a policy decision regarding menthol. This is an issue of policy, not science. Nothing that is in the report contributes towards that decision. The decision is separate from the science. You have to decide what policy criteria to use, and that doesn't have any relationship to the scientific issues. It could have been done a year ago, and no report was necessary to come to such a decision.

This is very different from an issue where the science actually dictates the decision. For example, if the FDA were deciding whether or not to approve a new drug, we could read the advisory committee's report and we would immediately know whether the committee would recommend to approve or disapprove the drug. The answer to the question would flow logically out of the conclusions in the report.

The same thing is true of an FDA panel considering whether to take a particular drug off the market. The answer flows from the scientific analysis.

The menthol issue is completely different. No clear answer flows from this scientific analysis. At the end of the day, it comes down to: What criteria are you going to use to decide the appropriate regulatory approach to menthol as a cigarette flavoring or additive? The answer to that question in no way flows from scientific information. It flows from policy judgment. Or, at worst, from political considerations.

So I find myself in the absurd situation of having no better idea (literally zero percent improvement in confidence) of what TPSAC will recommend after having read six chapters of its report than before the committee even started considering the issue.

The Committee could still recommend a ban on menthol cigarettes, regulation of menthol levels, regulation of menthol cigarette marketing, or further study. None of these policy approaches flows directly from the report's analysis of the scientific issues. It is a completely separate and different decision.