Friday, April 23, 2010

FDA Tobacco Control Score Card: Are FDA's Actions on Tobacco So Far Evidence-Based?

Today, I am issuing my first of a series of periodic FDA Tobacco Control Score Cards. The primary purpose of this score card is to monitor and evaluate how well the FDA is doing with its new-found authority to regulate tobacco products. Specifically, I will be evaluating the FDA on its actions by two criteria:

1. The degree to which the Agency's actions are evidence-based; and
2. The degree to which the Agency's actions will actually make a significant difference in either:
a. Reducing youth or adult smoking; or
b. Reducing disease by making cigarettes safer.

Today's evaluation includes the major actions that the FDA has taken so far in terms of regulating tobacco products. The information for the scorecard is summarized in the table below:

Scorecard #1: FDA Tobacco Control Actions as of April 2010

Issue

Evidence-Base

Action

Flavored cigarettes (non-menthol)

No youths are using any Big Tobacco flavored cigarette product

Banned

Electronic cigarettes

No documentation that any youths are using electronic cigarettes

Banned (though only enforced through interception of two shipments)

Dissolvable tobacco products

No documentation that more than an occasional youth is using these products

Considering ban

Regular cigarettes

Clear documentation that more than 3 million youths regularly use these products

None – no action taken yet that will significantly reduce the number of youth smokers or make cigarettes substantially safer to use


Grade: D

Explanation

The actions taken by the FDA to date have not been evidence-based. The ban on flavored cigarettes affected not a single Big Tobacco brand used by a youth in America and thus resulted in absolutely no reduction in youth smoking. The ban on electronic cigarettes, although not being enforced, has scared many vapers into returning to cigarette smoking, thus causing increased disease and adding to Big Tobacco profits. The Agency's pre-occupation with orbs, which are not a significant problem among youths, and its suggestion that these products are marketed to lure youths, are contradictory to the entire literature on tobacco and youth smoking. Most importantly, the Agency has not yet taken a single action that will significantly reduce either youth or adult smoking, and it has not yet taken a single action that will result in a reduction of disease by virtue of safer cigarettes. Thus, the Agency's grade at this first Rest of the Story score card is a D.

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