In what is certainly a huge victory and sigh of relief for Lorillard, the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) today released its recommendations regarding menthol cigarettes and did not directly recommend that the FDA ban these products. Instead, the Committee merely noted that banning menthol cigarettes could benefit the public's health by inducing many smokers to quit, and recommended that the FDA merely consider the issue further. Moreover, the Committee explicitly warned about the potential black market consequences that could be associated with a menthol ban and urged the FDA to carefully study such potential effects before taking any such action.
After a one sentence recommendation that states: "Removal of menthol cigarettes from the marketplace would benefit public health in the United States," the report emphasizes that it "has no specific suggestions for follow-up by FDA to this recommendation."
The report emphasizes that "TPSAC is not proposing specific policy actions that should be taken by FDA... ."
After the one sentence "recommendation," the report then provides a full two and a half pages of details about the potential adverse effects of a menthol ban related to contraband cigarettes and a black market, and concludes that the FDA would need to carefully assess the potential for contraband menthol cigarettes.
The Rest of the Story
If I worked for Lorillard, I would be breathing a huge sigh of relief this afternoon. This is essentially a best-case scenario for Lorillard, as the the TSPAC took the least drastic action that could possibly have been expected given the make-up of the panel and the conclusions regarding the marketing and impact of menthol in its report.
Here is what TPSAC did not do:
Most importantly, the Committee did not recommend a ban on menthol cigarettes. This is a huge victory for Lorillard.
Second, the Committee did not recommend reductions in levels of menthol. Another victory for Lorillard
Third, the Committee did not recommend marketing restrictions on menthol cigarettes. Yet another victory for Lorillard.
And fourth, the Committee did not put any particular time frame or specific recommendation for action on the FDA. It merely noted that a menthol ban would benefit the public's health and leaves it at that.
Here is what TSPAC did do:
Most importantly, TPSAC gave the FDA a huge out by elaborating in detail all of the potential adverse consequences of a menthol cigarette ban.
Second, TPSAC gave the FDA the benefit of time by emphasizing the importance of further review of the possible ramifications of a menthol ban.
In essence, what the TPSAC did is what legislative committees do when they want to reject a measure without insulting its sponsors: they send it to committee for further review.
The FDA now has exactly what it needs to avoid having to take on a difficult political issue. I have made clear my opinion that the FDA is not going to ban menthol, regardless of the TPSAC recommendations, purely for political reasons. Taking on a menthol ban is the last thing in the world that the Administration needs right now, at a time when it is fighting with every last breath just to maintain the health care package that passed last year and to fend off political damage from attacks that big government has taken over health care.
The political prospects for a menthol ban were low to zero even before this report. But now, the FDA has all the justification and back-up it needs to save face even to the most staunch health advocates. The FDA can say that its expert panel warned about potential black market effects and emphasized that the Agency needs to study the issue further before taking any drastic actions.
It is important to note that all of the major conclusions of the report are things that we already knew. We didn't need a full year of research and taxpayer expenditures to find out that "Menthol cigarettes have an adverse impact on public health in the United States" (what cigarettes do not?) We also didn't need a full year of effort to conclude that "There are no public health benefits of menthol compared to non-menthol cigarettes" (what cigarettes do have benefits compared to others?).
We knew a year ago that banning menthol would have public health benefits (this is precisely why Lorillard was so worried about a potential ban).
What we didn't know a year ago was whether the TPSAC would recommend that the FDA ban menthol.
Now we know the answer. And it is a resounding NO. Although TPSAC made it clear that banning menthol would benefit the public's health, the Committee did not make such a recommendation. Instead, TPSAC swept the issue under the rug by giving the FDA an out, taking the pressure off the FDA by removing any time pressure, not calling for any specific FDA action, and emphasizing in the great detail all the potential adverse effects of a ban that the FDA must carefully study prior to implementing a ban.
The rest of the story is that TPSAC punted and Lorillard returns this punt for a touchdown.