"The FDA proposalwouldsignificantly delay the implementation of premarket review for newly covered products. Most egregiously, the proposal creates a twenty-four month provisional period for the submission of tobacco product marketing applications. Applicationsreceived during the provisional period enable thecontinued marketing of the productuntil the FDA acts on the application which may be wellbeyond the twenty-fourmonth period. A similar loophole was established during the passage of the Act to apply to cigarettes and smokeless products. The FDA received 3,517 applications but three years later has only issued an order removing four products from the market. After the withdrawal of 117 applications, the tobacco companies are still able to market the unapproved products represented by the 3,396 outstanding applications."

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