“Soft” scientific studies dealing with menthol, those focused on initiation/cessation, have been reviewed in detail by CRE, see http://www.thecre.com/scur/
The Center for Regulatory Effectiveness, CRE, does not arbitrarily dismiss the “soft” science studies; to the contrary, in a number of instances they highlight areas of possible concern. However, very few of the “soft science studies are definitive.
In repeated statements to the FDA Advisory Committee, TPSAC, CRE has stated that the “hard” science studies, those based upon the toxicology of specific disease endpoints clearly demonstrate that there is no reason for concern; on the other hand the “soft” science studies fail to meet the mandatory standards set forth in the Data Quality Act.
Consequently, the game changer in the menthol issue could be contraband; a statutory required factor to be considered by TPSAC in making its final recommendation.
In a last minute attempt to make “soft” science studies determinative, federal employee advocates of a menthol ban have resorted to a “Hail Mary” pass– in American football, a “Hail Mary pass” refers to any very long forward pass made in desperation with only a small chance of success”.
We understand one “Hail Mary” pass, but two?
The FDA is about to release eleven studies dealing with initiation/cessation; this is a defensive action in that the FDA released the results of the studies to TPSAC before the studies themselves were made available.
In a like manner, federal employee advocates of a menthol ban have also orchestrated a rush to publication of a litany of initiation/cessation studies by demanding that a Supplement be published in the house organ publication called Addiction, only the second time this has occurred in the history of the publication.
CRE has reviewed one such study in the Supplement to Addiction:
“Nicotine dependence and quitting behaviors among menthol and non-menthol smokers with similar consumptive patterns”
By: Pebbles Fagan, Eric T. Moolchan, Alton Hart, Jr., Allison Rose, Deirdre Lawrence, Vicki L. Shavers, & James Todd Gibson
The CRE review of this study is attached. Upon reading the CRE review, we are confident our readers will conclude that the study is a “Hail Mary” pass.