FDA Sound Bites

FDA Sound Bites

This one-page, 1999 document marked "Work Product" was found in the files of Philip Morris Management Corporation attorney Jack Holleran (also known as "John Holleran"), a legal architect of PM's Regulatory Strategy Project. It is an early document and thus is more transparent than some other documents from later in the Project. It clearly lays out PM's requirements for U.S. Food and Drug Administration (FDA) regulations. The requirements attempt to keep FDA's focus on managing the risks inherent in existing tobacco products rather than reducing the morbidity and mortality caused by smoking. Refocusing or changing the topic of debate is a standard strategy the industry has employed over the years to evade health and safety-based discussions on topics ranging from cigarette-caused fires to clean indoor air laws to taxes. PM's requirements for FDA regulations would essentially turn FDA into the tobacco industry's new Research & Development and Quality Control Departments, working within strict limits proscribed by PM itself:


 * "The purpose of FDA regulation should not be to eliminate cigarette smoking, but rather to encourage reduction in the risks of smoking."


 * "FDA should be expressly forbidden from banning cigarettes or making them so unpalatable that Americans would turn to a black market."


 * "FDA regulation should focus on three things:


 * Regulating manufacturing - to make sure that all manufacturers...add nothing to the product that increases its inherent risks.


 * Disclosure - so that everyone-particularly adult smokers- continue to have the information they need to make an informed choice.


 * Reducing the risks of smoking - by setting standards which, if manufacturers meet them, will allow reduced-risk cigarettes to be marketed without consumers turning to the black market."


 * "FDA should focus on regulating the manufacture, development and sale of the product--that is the best way to use their expertise and avoid Constitutional issues."

Despite the statement in the last bullet that FDA should focus on regulating the sale of the product, the document seeks to prevent FDA from focusing on marketing and sales by utilizing provisions of the Master Settlement Agreement, which in reality has had very little active enforcement since its signing in 1998:

"Because of the MSA Master Settlement Agreement and its enforcement powers to prevent tobacco marketing to youth, the FDA does not have to focus on marketing and sales. The states, through the MSA, are fully equipped to regulate cigarette marketing without raising the Constitutional issues that FDA regulation would raise."

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