The Ninth Circuit Decision on Medical Marijuana: Implications for TPSAC Menthol Review– Prime Time #2

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.

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