Tuesday, March 22, 2011

TPSAC Was Charged By Law to Weigh Public Health Benefits of Menthol Ban with Black Market Concerns; Panel Failed to Fulfill Its Mandate

As I discussed here yesterday, the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) punted on the menthol cigarette issue, refusing to make any recommendation to the FDA about whether or not to ban menthol cigarettes. Today, I reveal that by failing to make a recommendation, the TPSAC actually failed to fulfill its Congressional mandate under law.

The Rest of the Story

The Family Smoking Prevention and Tobacco Control Act mandated that the TPSAC issue not only a report, but also a recommendation to the FDA regarding the regulation of menthol cigarettes.

Moreover, the Act mandated that TPSAC examine not only the public health impact of menthol cigarettes, but also the potential black market and contraband concerns. The Committee was to weigh these factors in making its recommendation to the Agency.

Here is the text of the Congressionally-mandated charge to TPSAC, in section 907(e) of the Tobacco Control Act:

‘‘(1) REFERRAL; CONSIDERATIONS.—Immediately upon the establishment of the Tobacco Products Scientific Advisory Committee under section 917(a), the Secretary shall refer to the
Committee for report and recommendation, under section 917(c)(4), the issue of the impact of the use of menthol in cigarettes on the public health, including such use among children, African-Americans, Hispanics, and other racial and ethnic minorities. In its review, the Tobacco Products Scientific Advisory Committee shall address the considerations listed in subsections (a)(3)(B)(i) and (b).
‘‘(2) REPORT AND RECOMMENDATION.—Not later than 1 year after its establishment, the Tobacco Product Scientific Advisory Committee shall submit to the Secretary the report and recommendations required pursuant to paragraph (1).

It should be immediately apparent to readers that TPSAC failed to complete its mandate because it did not issue any "recommendations" to the Agency regarding the regulation of menthol cigarettes.

What may not be so apparent is that TPSAC was charged not only with examining the public health impact of menthol, but also the black market/contraband concerns.

According to the law, TPSAC "shall address" the considerations in subsections (a)(3)(B)(i) and (b).

What exactly are these considerations?

The consideration in subsection (a)(3)(B)(i) is simple. It's the public health impact of menthol cigarettes. Specifically: "(i) CONSIDERATIONS.—In making a finding described in subparagraph (A), the Secretary shall consider scientific evidence concerning— (I) the risks and benefits to the population as a whole, including users and nonusers of tobacco products, of the proposed standard; (II) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (III) the increased or decreased likelihood that those who do not use tobacco products will start using such products."

In other words, TPSAC was mandated to consider the effects of a menthol ban on disease risk, smoking initiation and smoking cessation. It did carry out that mandate.

However, TPSAC was also charged with addressing the considerations in section 907(b):

"The Secretary shall consider all other information submitted in connection with a proposed standard, including information concerning the countervailing effects of the tobacco product standard on the health of adolescent tobacco users, adult tobacco users, or nontobacco users, such as the creation of a significant demand for contraband or other tobacco products that do not meet the requirements of this chapter and the significance of such demand."

Thus, the law specifically mandates that TPSAC must consider the potential concerns regarding a black market or contraband in developing its report and recommendations. TPSAC did not carry out this mandate. Instead, it simply punted the issue back to FDA, urging the FDA to conduct the analysis that TPSAC was supposed to conduct.

More importantly, the clear intent of the legislative mandate was that TPSAC weigh the public health benefits of a menthol ban against the black market/contraband concerns and come up with an overall recommendation taking both into account. This is what would have been helpful to the FDA and this is what the law called for.

The rest of the story, then, is that not only did the TPSAC do the public a disservice by wasting all this time studying the issue but failing to make a recommendation. In addition, the TPSAC failed to carry out or fulfill its Congressional mandate.

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