FDA Tobacco Panel is Asking All the Wrong Questions on Menthol, and Wasting Incredible Time and Resources - Michael Siegel

In an incredible display of wasted time and resources by a federal bureaucracy, the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) is asking all the wrong questions about menthol in its deliberations about whether menthol should be included in the federal ban on flavored cigarettes.

The background here is essential: The Congress enacted a ban on flavored cigarettes, but exempted menthol for purely political, not scientific reasons. As a last minute compromise to save the bill because the Congressional Black Caucus was threatening to withdraw support over the menthol exemption, the bill's supporters hastily stuck in a provision that would require the FDA to revisit the issue of menthol.

Surely, in light of this background, the relevant question before the TPSAC is whether or not the same justification that led to the ban on flavored cigarettes also applies to menthol. In other words, the question is whether or not there is a justification for an exemption for menthol cigarettes from the flavoring ban. To look at this issue from any other perspective is ignorant of the legislative history and of the reason why the FDA was asked to look at menthol in the first place.

The specific reason why the FDA was asked to look at menthol was that the Black Congressional Caucus had questioned the justification for exempting menthol from the flavoring ban. I believe, therefore, that the FDA ought to look at the issue from that precise perspective. Does the reasoning which supports a ban on flavored cigarettes also support a ban on menthol cigarettes?

To look at the issue from any other perspective is, I believe, inappropriate.

So let's examine the reasoning that was used to support the ban on flavored cigarettes. The following 5 points are critical:

1. The ban on flavored cigarettes was not supported by a contention that flavored cigarettes are more harmful than other cigarettes.

There is no evidence that flavored cigarettes are any more harmful than other cigarettes and I am not aware of any anti-smoking group or policy maker that has made such an assertion. The relative harm of flavored cigarettes simply did not enter the picture and is not part of the reasoning for the ban on flavored cigarettes.

2. The ban on flavored cigarettes was not supported by a contention that flavored cigarettes are more addictive, or more difficult to quit smoking, than other cigarettes.

There is no evidence that flavored cigarettes are any more addictive or harder to quit smoking than other cigarettes and I am not aware of any anti-smoking group or policy maker that has made such an assertion. The relative addictive potential of flavored cigarettes simply did not enter the picture and is not part of the reasoning for the ban on flavored cigarettes.

3. The ban on flavored cigarettes was not supported by a claim that youth are more likely to smoke these products.

There is strong evidence that the opposite is true: youth are far less likely to smoke flavored cigarettes than the non-flavored cigarettes on the market: Marlboros, Camels, and Newports. Between 2007 and 2010, the market share for flavored cigarettes among youth was dismally small, and no flavored cigarette brand manufactured by any Big Tobacco company was used by youths.

4. The ban on flavored cigarettes was not supported by a claim that flavored cigarettes are targeted specifically to youth.

There is no evidence that, since 2007, any tobacco companies have been targeting their marketing of flavored cigarettes toward youth. In fact, the few flavored cigarette brands on the market during this most recent time period appeared to be marketing toward adult smokers. On the basis of marketing patterns, it is the non-flavored cigarettes which would have been the primary concerns, not the few flavored ones.

5. The one and only one consideration which supported the ban on flavored cigarettes was that these flavorings enhance the taste and therefore the appeal of these products, especially to youth.

This, in fact, is the sole factual (or "scientific") support offered for the ban on flavored cigarettes. By adding flavors like chocolate, strawberry, coconut, or pineapple to their cigarettes, manufacturers will make their products taste better and therefore be more appealing to consumers, especially youth who are probably more sensitive to any harshness in tobacco.

Therefore, the central question that comes before TPSAC is not: (1) whether menthol cigarettes are more harmful than others; (2) whether menthol cigarettes are more addictive or more difficult to quit than others; (3) whether menthol cigarettes are more likely to be smoked by youth; or (4) whether menthol cigarettes are specifically marketed toward youth.

Instead, the central question is simply: does menthol enhance the appeal of cigarettes, especially among youth?

If it does, then the same reasoning that Congress used in its decision to ban chocolate and strawberry flavorings would also apply to menthol.

The FDA cannot escape this. If it presents the TPSAC with a different question than whether menthol enhances the appeal of cigarettes, then it is using different criteria to assess menthol than was used to assess other cigarette flavorings. This would not only be inappropriate, but it would be a travesty of justice because it would constitute institutional racism to use a much different and more rigorous standard to make decisions about a flavoring which appeals most particularly to African Americans than about flavorings which appeal most particularly to whites.

The TPSAC cannot escape this either. If it asks different questions than whether menthol enhances the appeal of cigarettes, then it is using different criteria to assess menthol than was used to assess other cigarette flavorings. Again, this would not only be inappropriate, but it would be a travesty of justice because it would constitute institutional racism to use a much different and more rigorous standard to make decisions about a flavoring which appeals most particularly to African Americans than about flavorings which appeal most particularly to whites.

Having established that the central question the TPSAC needs to answer is whether menthol enhances the appeal of cigarettes, especially among youth, we are now ready to consider the rest of the story.

The Rest of the Story

The rest of the story is that the TPSAC is asking all the wrong questions and that the FDA itself appears to be presenting TPSAC with the wrong set of questions and the wrong data. The information being sought by the TPSAC is largely the wrong set of information. The data being presented to the TPSAC is the wrong data.

Simply put, the question of whether menthol enhances the appeal of cigarettes, especially to youth, is a near no-brainer. Of course it enhances the appeal of cigarettes! The companies themselves admit that. R.J. Reynolds testified that menthol adds a "cooling sensation" and "minty flavor" to cigarettes. R.J. Reynolds also acknowledges, on its web site, that menthol is used to "impart or help impart, or enhance or modify, a taste or aroma" in cigarettes.

That menthol is used to, and succeeds in, enhancing the taste of cigarettes is therefore a matter of public record at this point. There is no debate or dispute about the issue. Since menthol enhances the taste of cigarettes, it obviously enhances the appeal of the product. How could it not? It is obvious that people prefer products that taste better.

So the rest of the story is that the TPSAC is piddling and twiddling around the margins of the central issue, wasting incredible time and resources, when what it clearly needs to do is entertain the focused question of whether menthol, like chocolate, strawberry, vanilla, banana, and pineapple flavorings, enhance the taste and therefore the appeal of cigarettes, especially to youth. This is a matter that could be dispensed with quickly, based on the public record alone, with no speculation or long, two-day meetings and one year of deliberation necessary. No hour long testimony from cigarette companies and tobacco control scientists and researchers is needed. There is no need to waste the taxpayers' money as is being done when the question before the Committee is such a simple one. There is no need for a detailed Agency report and for a review of thousands of pages of research studies.

By the way, I do not disagree with the tobacco companies' statements to the Committee that the scientific evidence fails to support the conclusion that menthol cigarettes are more hazardous or more addictive than non-menthol cigarettes. But if you ask an irrelevant question, you're going to get an irrelevant answer. Sadly, the Committee has responded by asking for even more evidence regarding these irrelevant questions.

According to an NPR story: "it isn't menthol's taste that is under scrutiny at the hearing." Well it should be! After all, that's why flavored cigarettes were banned and that's why the FDA was asked by Congress to examine the menthol issue in the first place. The issue is precisely whether menthol's taste enhances the appeal of these cigarettes, especially to youth, thus contributing towards the uptake of smoking these menthol brands among new youth smokers. And despite all the collective experience on the Advisory Committee, they don't seem to understand that, as one might say: "It's the taste, stupid!"

Of course, as I have also argued, there are hundreds of other flavorings which are also used to enhance the taste, and thus the appeal of cigarettes, and so the reasoning behind the Family Smoking Prevention and Tobacco Control Act also supports the elimination of these flavoring additives as well.

All of this should highlight for you the absurdity of this entire approach to the tobacco problem. You don't address the problem of cigarettes by asking the Food and Drug Administration to develop "safety standards" for a product that kills more than 400,000 people each year. You don't ask the FDA to approve such a product. You don't ask the FDA to deceive the public by pretending that it is setting science-based standards which will result in a safer product.

In my frank opinion, the FDA should go back to the drawing board. Save the taxpayers the wasted expense of spending so much time and effort piddling and fiddling over issues that are not relevant to the actual question at hand. Examine the scientific literature to identify the tried and true methods of decreasing smoking which we know work. Put the money into aggressive anti-smoking media campaigns, statewide programs, smoking cessation resources and support -- including the Pathways to Freedom guide for African American smokers trying to quit and other culturally specific programs and interventions -- and community mobilization, organization, and tobacco control infrastructure.

Of course, we know this will not happen. No one in the mainstream of tobacco control is willing to ever admit that they made a mistake. So given that we are stuck with the disaster that is the Family Smoking Prevention and Tobacco Control Act, the least I think the public can ask for is that FDA and TPSAC not participate in institutional racism by using different criteria to assess flavorings that are particularly preferred by African Americans versus white Americans. The least we can ask is that they not waste our taxpayer dollars on asking the exact wrong questions.

False Information from Center for Tobacco Products is Concerning; FDA Actions Should Be Guided by Science, Not Politics - Michael Siegel

The FDA's Center for Tobacco Products has issued a false statement to the public, one that is clearly motivated by political concerns and not scientific ones. As I will explain, while this is just one lie to the public, it is of eminent concern, because it suggests that the Center is going to be guided by politics and not by science. Hopefully, this commentary will alert the Agency and the public to this concern and result in a major change in the Center's approach.

In its 2009-2010 annual review, the FDA Center for Tobacco Products stated that "research has found that children are especially attracted to and begin using tobacco products very early because of all kinds of pressures and motivations, including access to cigarettes that have candy-like characterizing flavors, such as mint, chocolate, cinnamon, coconut, and strawberry."

In addition to telling the public that children start smoking because of mint, chocolate, cinnamon, coconut, and strawberry cigarettes, FDA also told the public that the Family Smoking Prevention and Tobacco Control Act will help reduce smoking among youth because of its ban on these flavors of cigarettes. The Center called the flavoring ban a "science-based" regulatory action:

"The Tobacco Control Act prohibits the manufacture, distribution, and sale of those cigarettes in order to protect our kids and gives FDA broad authorities to take many other science-based regulatory actions to protect the public health."

The Rest of the Story

If mint, chocolate, cinnamon, coconut, and strawberry cigarettes are a major reason for youth smoking, I challenge the Center for Tobacco Products to name a single brand of mint, chocolate, cinnamon, coconut, or strawberry cigarettes that was smoked by a significant number of youth during the past four years.

The only existing brands of cigarettes in those flavors that I am aware of were marketed by R.J. Reynolds for a brief period from 2004 to 2006, but were voluntarily removed from the market in 2006. Thus, mint, chocolate, cinnamon, coconut, and strawberry cigarettes play no role in youth smoking initiation and the Family Smoking Prevention and Tobacco Control Act's prohibition of these flavors will remove zero cigarette brands from the market and have no effect whatsoever on youth cigarette smoking.

Moreover, the policy is far from science-based since it removes zero flavored cigarette brands from the market that significant numbers of youth smoke but exempts the one flavoring which characterizes the brands that hundreds of thousands of kids smoke: menthol.

I have done extensive research on the topic of cigarette brand market shares among youth, dating back all the way to 1979. I have examined and published data on youth cigarette brand preferences and so I am quite familiar with the types of brands with which youth initiate cigarette smoking. And based on the science, I can tell you that mint, chocolate, cinnamon, coconut, and strawberry cigarettes play no role, and have played no role for many years in the addiction of youths to cigarette smoking. They were used by youths during a short period between 2004 and 2006, but R.J. Reynolds removed these products from the market in 2006, so they are no longer influences on youth smoking and the FDA tobacco legislation accomplishes nothing by "removing" these non-existent products from the market.

Frankly, I'd really like to know what brands of mint, chocolate, cinnamon, coconut, and strawberry cigarettes the Center for Tobacco Products is talking about when it boasts how the removal of these flavored cigarettes represents a science-based regulation that will improve the public's health by removing a major factor in youth smoking. If the Center is talking about Camel Exotic Blends, Kool Smooth Fusion, and Salem Silver Label cigarettes, then it is misleading the public because these products were removed from the market in a 2006 settlement between 38 Attorneys General and R.J. Reynolds. In that settlement, Reynolds agreed never again to market fruit- or candy-flavored cigarettes.

Unfortunately, the rest of the story is that there are no mint, chocolate, cinnamon, coconut, or strawberry cigarettes that youth were smoking prior to the implementation of the Family Smoking Prevention and Tobacco Control Act's prohibition of these flavorings.

So why would the Center for Tobacco Products make such a false assertion?

It appears that the statement was made for purely political reasons: it was made in the context of trying to praise the successes of the legislation. In other words, the false claim was issued in an attempt to make a political, rather than a scientific statement.

And this is what concerns me. If the Center for Tobacco Products is willing to distort the facts for political purposes now, what reason do we have to believe that it will not distort the science in the future? Is this really the kind of behavior that we want from a supposedly scientific agency making what are supposed to be scientific decisions and promulgating what are supposed to be science-based policies?

The rest of the story is that the Center has distorted the truth about flavored cigarettes and their role in youth smoking, apparently for political purposes. This is not an auspicious start for the Center, and I think the public deserves better.