"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."

With the release of its deeming regulations, the FDA is poised to give a huge gift to combustible tobacco and to the diseases and death caused by cigarettes. If promulgated as is, the regulations will be devastating to the public's health by protecting the combustible cigarette market at the expense of the introduction and promotion of much safer alternative products that would otherwise have the potential to substantially reduce lung disease, heart disease, stroke, and cancer.

Frankly, as I predicted prior to the enactment of the Family Smoking Prevention and Tobacco Control Act, the FDA's regulation of tobacco products is a national public health embarrassment.

Fortunately, the fine print in the regulations did not escape the attention of the ACLU, which is this special interest exemption.

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