CRE has benefited from the comments of a number of experts in administrative law who have reviewed the ASA v. HHS decision of the Ninth Circuit. Based upon these reviews CRE concludes:
1. That the Ninth Circuit decision parallels the recent Prime Time decision in that the Ninth Circuit has invoked the DQA in reaching a judicial decision.
2. The judicial precedents established by both decisions support an inference that the DQA is judicially reviewable.
3. The fact that two divergent Circuit Courts have arrived at nearly identical conclusions, albeit for different reasons, suggests that if the DC Circuit were to opine directly on whether the DQA is reviewable, it would do so in the positive.
The consequences of the DC Circut and the Ninth Circuit decision on the TPSAC/FDA review of menthol are considerable:
1. If the FDA adopts all or a portion of a TPSAC report by incorporating the resultant conclusions into a rule, the said report must meet DQA standards.
2. When the FDA takes a final action on the pending CRE DQA petition, the said action will be judicially reviewable.
3. TPSAC, in issuing statements on menthol, should be mindful that its initial work products will establish its scientific integrity and will also establish the analytical threshold for making important scientific decisions on the totality of issues associated with the federal regulation of tobacco; the reputation of TPSAC should not be jeopardized by allowing individual policy preferences to migrate into its scientific analyses.