From: anne@tobaccodocuments.org
Date: Tue, 03/06/07
Anne LandmanSound Bites
Company/Source: Philip Morris
Document Date: 22 Dec 1999
Length: 1 page
Bates No. 2075733351
URL of this Posting: http://tobaccodocuments.org/landman/2075733351.html
Document Image: http://legacy.library.ucsf.edu/tid/nst52c00
This one-page document marked "Work Product" was found in the files of
Philip Morris Management Corporation attorney Jack ("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 Philip Morris' requirements for FDA regulations. Not
surprisingly, the requirements attempt to focus FDA on managing the risks
inherent in existing tobacco products rather than reducing the morbidity and
mortality caused by smoking. Re-focusing 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 (See Bates Nos. 507604726, 2025818970, 2500118564,
2024023252). 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 tenets 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."
-------------------------------------------------------
Quotes
Draft 2
Work Product
12/22/99
SOUND BITES
• We will support strong, but sensible FDA regulation.
• 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.
• Cigarettes should be regulated under a new chapter of the FDA and not as a
drug or medical device since that gives the agency the power to ban cigarettes.
• FDA regulation should focus on three things:
- Regulating manufacturing-to make sure that all manufacturers follow rigorous
and transparent procedures and 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.
• In the area of youth smoking prevention, FDA should build on the foundation
of the MSA, and, like the MSA, respect the legitimacy of cigarette marketing to
adult consumers.
OR
• Because of the MSA and its enforcement powers to prevent tobacco marketing
to youth, the FDA does not have to focus on cigarette 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.
• The FDA should focus on regulating the manufacture, development and sale of
the product -- that is the best way to use their expertise and to avoid
Constitutional issues.
------------------------------
Company
Philip Morris
Author
N/A- Found in the area of
John Holleran of Philip Morris Management Corp. Legal Department
Recipient
Presumed corporate recipient, Philip Morris
Region
United States
Litigation
Feda/Produced
Operation/Project
Regulatory Strategy Project 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,"
Bates No. 2075733381), using the 1998 Master Settlement Agreement as a shield to
keep FDA from regulating sales and marketing 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 present 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)
Named Organization
FDA, Food and Drug Administration
Type
REPT, REPORT, OTHER
Subject
FDA jurisdiction over tobacco
--------------------------------------------------------------------------------
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