Sunday, January 9, 2011

A Nod Towards Regulating Tobacco Products Similar to a Medical Device: The Significance of the Menthol Review

/PRNewswire/ -- A recent article in Inside Health Policy entitled New Tobacco Review Process states:

"A new tobacco approval process that mimics device 510(k) clearance procedures could also require that industry supply clinical trial data and other information as the agency implements a mandate from the 2009 law that brought tobacco regulation under FDA's purview."

"Companies will have until March 11 to submit information comparing their products to a predicate product grandfathered into the system before February 2007 to prove that they are as safe or safer than tobacco products already on the market."

The determination regarding "safe or safer" is a scientific decision. It is likely that the FDA tobacco advisory committee, TPSAC, will be involved in reviewing a number of these determinations.

The menthol review will establish the precedent for the role scientific data will play in the regulation of the tobacco industry and its attendant products, whether or not they are regulated under a section that mimics Section 510(k) clearances.

The menthol review has already established one important precedent. The TPSAC is writing its own reports in lieu of editing drafts prepared for them by the FDA. The menthol review is about to establish another precedent–how the Center for Tobacco Products addresses petitions filed under the Data Quality Act, in particular the petition filed by CRE at

Recognizing that TPSAC will be the gatekeeper to ensure that the regulation of the tobacco industry is based upon sound science -- not polemics -- the Center for Regulatory Effectiveness will make a major statement to TPSAC on January 10 regarding a serious omission in its review of the impact a ban on the sale of menthol cigarettes will have on contraband cigarettes.

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