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®: CRE Regulatory Action of the Week

Center for Regulatory Effectiveness Invokes Data Quality Act Against FDA Menthol Studies
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.

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.

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.

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