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Regulatory Strategy Project

(PM's effort to enact FDA regulations on its own te)

Philip Morris strongly opposed regulation of cigarettes by the U.S. Food and Drug Administration (FDA) until 1997, after which PM reversed itself and started seeking FDA regulation on its own terms. The operation was called PM's "Regulatory Strategy Project." PM's Core Principles of regulation (what it would accept and what it would not) were laid out in a 1999 document (2075733381). The strategy included preventing FDA from requiring unpalatable modifications to cigarettes, stopping FDA from banning cigarettes, Keeping FDA from regulating marketing and sales ("Sound Bites," (2075733381), using the 1998 Master Settlement Agreement as a shield to keep FDA from regulating sales and marekting to youth, attempting to include an element of state preemption in the regulations (2075733243), and appearing to regulators and the public to want to "Focus on dialogue rather than present specific proposals" (2081523047, Dated 20000411). Despite wanting to appear to not be presenting any specific proposals, Mark Berlind of PM commissioned the industry law firm of Arnold and Porter to draft PM's favored proposed FDA legislation (2081522996). The Arnold and Porter draft contained all of PM's core principles (Draft legislation from A&P to PM, 27 pages, Starting Bates No. 2075733243, Dated Feb 2, 2000)