Demonstration of Benefits

Dr. Henningfield stated that if menthol were a new drug application, industry would have to demonstrate the benefits of menthol.  The Chair’s response  was that TPSAC is  to give views on science, FDA will handle the benefit considerations.  FDA, much to its credit, concurred.  

Dr. Connolly raised the possibility of incorporating the precautionary principal into the committee deliberations.

 Editors note: It appears the committee has a tendency to migrate from their statutory requirements to look at science — and only science–  into policy considerations.  The incorporation of the  precautionary principal into a scientific assessment would be a blatant violation of the Data Quality Act.

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