FDA’s Tobacco Advisory Committee’s Failure to Address the Health Effects of Contraband Cigarettes is an Invitation to a Legal Challenge

FDA’s tobacco advisory committee continues to ignore statements by the Center for Regulatory Effectiveness that its organic statute requires it to address the negative health impacts of contraband cigarettes, see http://www.thecre.com/tpsac/?p=1119

 Consequently, in the attached letter CRE is requesting that the General Counsel of the FDA apprise the  FDA Center for Tobacco Products and TPSAC of their statutory responsibilities to study, and report, in detail on the well documented negative impacts that counterfeit cigarettes have on the health of smokers and the violence sustained by non-smokers resulting from attacks by  drug cartels.

 The letter states, in part,

 I am writing to express my concern that the Tobacco Products Scientific Advisory Board (“TPSAC”), which has been charged by Congress with providing a report to FDA on the public health effects of menthol cigarettes, apparently does not intend to comply with the Congressional mandate that its report examine the potential health effects that would arise from creating a contraband market for menthol cigarettes if FDA were to decide to ban or otherwise regulate menthol cigarettes.  Such disregard of the Congressional mandate would surely give rise to legal challenges based on a significant procedural defect in the rulemaking process

CRE  Letter to General Counsel of the FDA is attached herewith.

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