From: SMOKEFREE@compuserve.com
Date: Tue, 09/14/04
From Anne Landman:
FDA Message / Message Track
Company/Source: Philip Morris
Document Date: 05 Jan 2000
Length: 2 pages
Bates No. 2075733345/3346
URL: http://tobaccodocuments.org/landman/2075733345-3346.html
PDF Version:
http://legacy.library.ucsf.edu/cgi/getdoc?tid=qst52c00&fmt=pdf&ref=results
This "Privileged and Confidential" 2000 Philip Morris document was
generated during PM's Regulatory Strategy Project , an effort the company
began in 1999 to try and enact Food and Drug Administration (FDA)
regulations on the company's own terms. The document lists what PM terms
"sensible" FDA regulations.
The document is heavily edited by John Holleran of Philip Morris
Management's Legal Department. The "Quotes" section (below) contains the
document transcribed as it was originally written, without the annotations.
The document states, "We [PM] support strong but sensible FDA regulation of
cigarettes based on five core principles."
The first principal is that FDA "not infringe on the right of adult
Americans to choose to take the risks of smoking" and that FDA be
prohibited from banning cigarettes and having the power to alter cigarettes
to make smoking unpalatable to smokers. This principal would both preserve
a market for cigarettes and assure that cigarettes remain available.
The second requirement is that FDA regulate cigarette design and
manufacturing processes "to assure that no additives increase the inherent
risks of smoking" and that cigarette ingredients be "fully disclosed to FDA
in a framework that protects trade secrets." The simultaneous requirements
of full disclosure while maintaining trade secrets seem contradictory,
since full disclosure usually means the absence of secrets.
The third principle says that "The long-range goal of FDA regulation
should be to reduce the risks of smoking by encouraging industry
innovations," and that "FDA should set standards that allow products to be
certified as 'reduced risk' and marketed as 'reduced risk.' " This measure
seems to have a goal of transferring liability for tobacco products onto
the FDA.
The 4th principle PM requires that FDA "assure continuous, updated
disclosures to smokers as science evolves so that people continue to be
fully informed of the risks of smoking." As it is written, this measure
presumes that smokers are already currently fully informed about the risks
of smoking, and places the burden of public health education about tobacco
products on FDA and not on the manufacturers.
Two alternatives are listed for the fifth requirement, which nominally
claims to address youth smoking:
" 5. (Alternative 1) In the area of youth smoking prevention, FDA should
set policies that acknowledge the significant changes created by the MSA
and, like the MSA, recognize the legitimacy of marketing communications to
adult smokers..."
The first alternative it further says that, "Marketing to adults...should
not be regulated by the FDA." Instead of addressing youth smoking as the
introduction suggests, this principle appears to be aimed at protecting
marketing to adults.
The second version of principle #5 says, "FDA should NOT be given a
specific regulatory responsibility regarding how cigarettes are marketed
and sold. Through the [Master Settlement Agreement], states have a strong
legal framework for preventing tobacco marketing to you. The FDA's mission
is and should be scientific in nature -- focusing on the products and its
risks." The document threatens to embark on a Constitutional legal
challenge if FDA makes any effort to regulate tobacco marketing. The second
version of principle #5 also says, somewhat haughtily, "There is no need
for the FDA to use its scarce resources on youth smoking prevention. That
is best left to others."
This paper represents the starting point for laying out the elements of
what PM wants in its preferred FDA regulation. Taken as a whole, the
document indicates that PM's goals in pressing for FDA regulation are:
1) To assure a future market for cigarettes,
2) To preserve the company's ability to make cigarettes that appeal to
their market,
3) To safeguard the company's ability to market cigarettes without
restrictions,
4) To keep FDA from engaging in smoking prevention efforts, particularly
among youth,
6) To prevent FDA from obtaining any authority to restrict the marketing
and promotion of cigarettes,
7) To give FDA the responsibility of fully informing the public about the
dangers of tobacco use, rather than the manufacturers,
8) To transfer legal liability for the safety of tobacco products onto the
FDA, while allowing cigarette companies the continue to design and market
cigarettes as they see fit.
---------------------------------------------------
Notes - Some additional relevant documents:
The following Philip Morris document, a "Talking Points" paper about FDA
regulation, states that FDA regulation of tobacco would be "good for our
business" (PM Bates No. 2081523047)
http://legacy.library.ucsf.edu/cgi/getdoc?tid=yko84a00&fmt=pdf&ref=results
In the same document, dated April 11, 2000, PM also states "We have learned
from the past that it would be better for us to listen and to engage in
dialogue rather than present specific proposals," yet in February of 2002
PM commissioned law firm Arnold and Porter to draft model FDA legislation
containing all of its core principles ( The model legislation was prepared
in bill format so as to be ready to introduce as-is into the U.S. House of
Representatives. PM Bates No. 2075733243).
http://legacy.library.ucsf.edu/cgi/getdoc?tid=rst52c00&fmt=pdf&ref=results
NOTE: the author of the above document is listed as "Congress," but the
author is not Congress, it is Arnold and Porter. The document is prepared
to look as if it was a U.S. House of Representatives bill.
The above-mentioned draft legislation was commissioned of Arnold and Porter
by Mark Berlind, Assistant General Counsel of PM's Worldwide Regulatory
Affairs office, (Bates No. 2081522996).
-------------------------------------------------------
Quotes:
FDA Messages/Message Track
We support strong, but sensible FDA regulation of cigarettes based on
five core principles:
1) The FDA should be expressly prohibited from banning cigarettes and
from having the power to change cigarettes to the point where adult smokers
can no longer enjoy them.
--FDA must not be given an ability to infringe the right of adult
Americans to choose to take the risks of smoking.
--FDA should NOT be authorized to create "de facto prohibition" through
mandated product changes that make cigarettes unpalatable to adult smokers
and lead to a flourishing black market.
-- Congress should tell the FDA that they do NOT have the authority to
eliminate smoking in America either directly or indirectly.
2. The FDA should regulate cigarette design and manufacturing processes to
assure that no additives increase the inherent risks of smoking and that
the industry uses "good manufacturing practices" suitable for
agriculturally-based products.
--Brand-by-brand ingredients should be fully disclosed to the FDA in a
framework which protects trade secrets.
--Safety assessments of ingredient added to tobacco should be required.
--Manufacturing regulations should be based on a good regulation model.
3. The long-range goal of FDA regulation should be to reduce the risks of
smoking by encouraging industry innovations.
--FDA should set standards and procedures that allow products to be
certified as "reduced risk" and marketed as "reduced risk."
--FDA must only regulate tobacco under a new chapter of the FDA where
"risk reduction" is the regulatory goal, not "safe and effective" (i.e.,
the standard for drugs and medical devices).
4. The FDA should assure continuous, updated disclosures to smokers as
science evolves so that people continue to be fully informed of the risks
of smoking. This would include
--Establishing the content of Health Warning Labels,
--Determining smoke constituent testing methods and disclosure ("tar,"
nicotine and other constituents deemed relevant),
--Setting standards for the use of descriptors such as "light" and
"ultralight".
--Determining appropriate ingredient disclosure which protect[s] trade
secrets.
5. (Alternative 1): In the area of youth smoking prevention, FDA should
set policies that acknowledge the significant changes created by the MSA
and, like the MSA, recognize the legitimacy of marketing communications to
adult smokers.
--Marketing to adults in adult-only media and in adult-only
environments should not be regulated by the FDA.
--FDA should establish national standards requiring face to face
transactions with appropriate age verification. This would include
--Banning mail order and Internet sales of tobacco,
--Banning vending machine sales except in adult-only venues,
--Requiring age verification.
5. (Alternative 2): The FDA should not be given a specific regulatory
responsibility regarding how cigarettes are marketed and sold. Through the
MSA, states have a strong legal framework for preventing tobacco marketing
to youth. The FDA's mission is and should be scientific in
nature--focusing on the products and its risks.
--Any effort by the FDA to regulate tobacco marketing would be subject to
Constitutional challenges. The MSA process is designed to deal with these
issues without raising Constitutional concerns.
--Thanks to the MSA -- and the ability of Congress to pass youth smoking
legislation separately--there is no need for the FDA to use its resources
on youth smoking prevention. That is best left to others.
-------------------------
Company: Philip Morris
Author: Presumed Philip Morris legal department
Recipient: Holleran, Jack (PMMC Legal Department c. 1998)
Philip Morris Management Corporation Legal Department 1998, PM USA
Legal 2001
Region: United States
Operation/Project:
Regulatory Strategy Project (PM's effort to enact FDA regulations on its
own terms)
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 keeping FDA from
requiring unpalatable modifications to cigarettes, keeping FDA from banning
cigarettes, preventing FDA from regulating cigarette marketing and sales
("Sound Bites," (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 the appearance of not suggesting 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 was prepared in bill format as though ready to
be introduced into the U.S. House of Representatives, and 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: Congress
United States Food and Drug Administration
Litigation: Feda/Produced
Type: REPT, REPORT, OTHER
Subject: Corporate strategy
marketing
regulation
FDA jurisdiction over tobacco
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