Wednesday, July 20, 2011

TPSAC Has Second Chance to Make Menthol Cigarette Recommendation to FDA But Declines; FDA Will Now Have to Do the Work on Its Own

Earlier this year, I criticized the Tobacco Products Scientific Advisory Committee (TPSAC) for failing, in its menthol cigarette report, to make a recommendation to the FDA regarding what action the agency should take. Recently, the Committee had a second chance to make a recommendation. Of its own initiative, the Committee requested an opportunity to issue an amended report with a number of changes.

When I first learned that TPSAC wanted to issue an amended report, I considered the possibility that maybe the committee took to heart the nation's reaction -- that the report did not in fact include any recommendation that the FDA ban or proceed to ban menthol cigarettes -- and decided to definitively clarify the issue. The chair of the committee had stated in a newspaper article, in response to my criticism, that the committee did in fact make a clear recommendation. I thought that perhaps the committee was taking advantage of this opportunity to make its recommendation clear to the public and to the FDA.

No such luck, however. The changes in the report were minor, and they did not alter the report's failure to deliver a recommendation on what policy the FDA should adopt regarding menthol cigarettes.

The report's "recommendation" remained a self-evident conclusion rather than a recommendation: removing menthol cigarettes from the market would benefit the public's health.

As I explained earlier, this is a conclusion, not a recommendation. I could just as easily conclude that removing all cigarettes from the market would benefit the public's health. That may be true, but it does not amount to a recommendation that cigarette sales be prohibited. One can believe that removing cigarettes from the market would benefit the public's health and still be free to either recommend a ban on cigarettes or not to recommend such a ban.

Thus, the simple statement that removing menthol cigarettes from the market would benefit the public's health does not amount to a recommendation either way. In fact, the report goes on to insist that it has no particular position on the issue or advice to the FDA, other than that the agency be sure to consider the potential contraband effects of a menthol ban if it does consider such a policy.

The Rest of the Story

The rest of the story is that, once again, the TPSAC has shirked its Congressionally-mandated responsibility to weigh the costs and benefits of a menthol cigarette ban and instead, it has again punted the issue right back to the FDA. This leaves the agency with little choice other than to initiate its own review of the issue and make its own decision. In fact, this is precisely what the agency announced it will now do. Thus, the TPSAC's report and deliberations were largely a waste of time and resources, as I argued previously.

The TPSAC has played perfectly into Philip Morris' hands by displaying the utmost of bureaucratic piddling and diddling. Knowing that it would be almost impossible to get a menthol ban promulgated via administrative actions by federal agencies, Philip Morris happily agreed to a compromise Tobacco Act that exempted menthol from its flavoring ban but delegated the advisory committee to study the issue. Philip Morris knew full well that the chances of a menthol ban being implemented by regulation, rather than by legislation, are minimal.

Now that TPSAC has squandered its opportunity to direct the FDA one way or another, the chances of a menthol cigarette ban become even lower.

And it is now eminently clear that the lack of a recommendation by the TPSAC was not a simple omission or oversight; it was an intentional act of bureaucratic inertia and weakness.

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