September 21, 2010 - The Center for Regulatory Effectiveness (CRE has notified the FDA that the smoking initiation/cessation studies identified by the FDA and reviewed by CRE can not be used to formulate a policy on menthol cigarettes.
Previous related new briefs: CRE states that the FDA Tobacco Advisory Committee is in violation of the Federal Advisory Committee Act.. Federal Advisory Committee Act.
The Data Quality Act prohibits federal agencies from using studies that are non-compliant with the DQA. The FDA has sixty days to respond to the CRE petition. Center for Regulatory Effectiveness Invokes Data Quality Act Against FDA Menthol Studies
In its petition CRE painstakingly reviews eight of the studies identified by the FDA and explains the reasons for their non-compliance with the Data Quality Act.