In what many are viewing as a "split decision" on menthol, the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) has concluded that while menthol cigarettes are no more hazardous than non-menthol cigarettes, they may contribute to smoking initiation by masking the harshness of tobacco. These conclusions are expressed in a draft report on menthol that was made available on the TPSAC web site in advance of its meeting today to discuss the menthol report which is due March 23.
In its draft of Chapter 6 of the report, TPSAC reviews the evidence on whether menthol cigarettes are more hazardous than non-menthol cigarettes, including smoking typology, biomarker, toxicology, and epidemiologic studies. The Committee concludes that:
1. "The evidence is insufficient to conclude that it is more likely than not that menthol cigarette smokers inhale more smoke than non‐menthol cigarette smokers."
2. "The evidence is insufficient to conclude that it is more likely than not that menthol cigarette smokers are exposed to higher levels of nicotine and other tobacco smoke toxins, at least in regular daily smokers of more than 5 or 10 cigarettes per day. There are insufficient data to know if among smokers of relatively few cigarettes per day menthol cigarettes result in greater smoke intake and more exposure to tobacco smoke toxins."
3. "The evidence is insufficient to conclude that smokers of menthol cigarettes face a different risk of tobacco‐caused diseases than smokers of non‐menthol cigarettes."
On the other hand, in Chapter 3 of its draft report, TPSAC reviews evidence regarding whether menthol may enhance the smoking initiation and maintenance processes by masking the harsh taste of tobacco. That chapter concludes that:
1. "The evidence is sufficient to conclude that menthol has cooling and anesthetic effects that reduce the harshness of cigarette smoke."
2. "The evidence is sufficient to conclude that menthol makes low‐tar, low‐nicotine cigarettes more acceptable to smokers. Like nicotine, menthol has irritant effects that contribute to the impact or “throat grab,” of tobacco smoke. In light or ultralight cigarettes with lower nicotine delivery, menthol can be used to provide impact. Thus menthol is likely to make low yield cigarettes more satisfying, and smokers who switch to low yield cigarettes for health concerns may be more likely to continue to smoke rather than quit."
3. "The evidence is sufficient to conclude that it is biological plausible that menthol makes cigarette smoking more addictive."
The Rest of the Story
First of all, there is nothing new or unexpected here. I could have told you all of this eight months ago, when the committee first began its deliberations. In fact, I did argue months ago that the Committee's recommendations on menthol ultimately rest on the criteria it uses to assess menthol policy. If the Committee's decision is based on whether menthol cigarettes are more hazardous than non-menthol cigarettes, I argued that it would not be able to recommend a menthol ban because there is no evidence to support such an assertion. If the Committee's decision is based on whether menthol makes cigarettes more palatable because it is an appealing flavoring, then there would be grounds to ban menthol, I argued, because there is little doubt that menthol enhances the cigarette smoking experience (if it didn't, there would be no menthol cigarettes).
Of course, the fact that I came to these conclusions months ago speaks to the tremendous waste of time and resources involved in the TPSAC and its "investigation." As I have argued, this ultimately is not an issue of science, but of policy and ultimately, politics.
From a policy perspective, the Family Smoking Prevention and Tobacco Control Act takes the position that if a flavoring makes cigarettes more appealing it must be banned. That's why the Act banned strawberry, chocolate, mint, cherry, pineapple, vanilla, coconut, banana, raspberry, blackberry, licorice, grape, pina colada, lime, and snozzberry cigarettes. Of course, the Act didn't ban menthol not for any science or policy reason, but simply because none of its supporters had the political courage to actually go up against Big Tobacco in any meaningful way.
Thus, the FDA was left in the untenable position of having to pretend to "analyze" the menthol issue from a scientific perspective to determine an appropriate policy for menthol cigarettes. Yet the issue is not a scientific one, and it never was.
The issue is two-fold:
1. On what criterion should the FDA make a decision about whether or not to ban menthol?
2. Does the FDA (and the Administration) have the political fortitude to actually ban menthol if that is the policy recommended by the advisory committee?
It is not clear what the criterion should be for the FDA to decide whether to ban menthol. If the FDA applies the criterion that was used to ban the other cigarette flavorings (i.e., whether the flavorings might enhance the taste of the product), then it would be forced to ban menthol cigarettes. In fact, the FDA would also be forced to ban all cigarette flavorings and additives, since all of them are added to enhance the ultimate bottom line: the quality and appeal of the smoking experience. If the product's appeal were not enhanced by an additive, then that additive would not be added. This is a tautological issue, not a legitimate scientific question.
If the FDA applies the criterion suggested by Lorillard - that to be banned, menthol cigarettes must be more hazardous than non-menthol cigarettes - then the FDA would have no grounds to ban menthol cigarettes.
Ultimately, however, it doesn't matter what the TPSAC recommends. The ultimate decision by FDA will be made on political grounds. Does the FDA, and the Administration, have the courage and willingness to stand up to Big Tobacco and to political attacks if it pulls the plug from under Lorillard and a huge segment of the cigarette industry?
Given the way President Obama is already backing out of his own health care legislation, it is pretty clear that the Administration will not have the least desire to tackle a menthol ban. It is having a hard enough time defending the idea that insurance companies should not be able to deny coverage for people with pre-existing health conditions. The last thing it needs right now is to add a menthol cigarette ban to the list of initiatives that the Republican-led House will try to repeal.
The rest of the story is that the TPSAC's almost year-long consideration of menthol is a tremendous waste of time and taxpayer resources. The issue is simply one of policy and politics and it didn't require a long, expensive scientific review. In fact, Congress has already declared the criterion that it thinks ought to be used to make the decision; it just didn't have the political courage to actually carry it out. It's leaving the dirty work for the FDA specifically because it knows that the Administration will have no part of owning a decision to ban menthol.
In fact, this is what the plan was for the Tobacco Act's supporters (including the anti-smoking groups) from the very start:
1. Make it look like you really care about youth smoking by banning all the flavors that aren't actually used.
2. Pretend that there will be a meaningful process of reviewing scientific issues regarding menthol.
3. Regardless of the final report of the advisory committee, rest assured that the Administration will not take on ownership of a menthol ban.
4. Sleep well at night, knowing that you got political brownie points for "helping save the children" without actually having to stand up to Big Tobacco.