US: FDA Tobacco Product Review Stalled

Source from:  Tobacco Journal  12/18/2012

Tobacco product reviews submitted to the Food and Drug Administration (FDA) are piling up at the regulatory agency, meaning almost no new products have come into the US market for the past 18 months, the Associated Press reported.
 
Almost 3,500 product applications for cigarettes and smokeless tobacco have been submitted to the FDA since the agency began regulating the industry in 2009, and none have received a ruling, according to the AP.

Many of those innovations are in the market because of a grandfather clause that allows introduction on a test basis of products similar to existing ones, and for which applications were submitted between February, 2007, and March, 2011, according to the story by AP tobacco writer Michael Felberbaum. About 400 product applications submitted since the 2011 deadline cannot be implemented until a ruling has been obtained.

Product reviews are supposed to take 90 days, the AP reported.

The agency's Center for Tobacco Products Director Lawrence Deyton told the AP delays are occurring because FDA tobacco regulation is still in its trial phase and that minor changes in a tobacco product can have substantial impact on the health of the consumer. Lorillard Chief Executive Officer Murray Kessler told the news agency cigarettes haven't changed in five decades, and called for the regulatory process to be speeded up. (pi) Enditem