From: anne@tobaccodocuments.org
Date: Mon, 03/12/07
Anne Landman, Research SpecialistRe-Posted on: Monday, March 12, 2007
Original Posting Date: Wednesday, September 15, 2004
Tobacco Regulation Strategy Recommendation: Design, Manufacturing and
Marketing of Tobacco Products; Towards a Sensible Regulatory Framework
Company/Source: Philip Morris
Date: 19981001
Length: 23 pages
Bates No. 2065346777/6799 (Cover page is separate document Bates No.
2065346776)
URL: http://www.smokefree.net/doc-alert/messages/246971.html
PDF Version:
http://legacy.library.ucsf.edu/cgi/getdoc?tid=lgs32a00&fmt=pdf&ref=results
This 23-page "privileged and confidential" Philip Morris (PM)
discussion piece outlines the thinking behind Philip Morris' 180-degree turn
from stringently opposing U.S. Food and Drug Administration (FDA) of cigarettes
to in fact seeking such regulation, the company's logic in proceeding down this
path and what the company hopes for and fears in FDA regulation. It was written
in by Mark Berlind (Assistant General Counsel of Philip Morris Worldwide
Regulatory Affairs) in 1998.
Berlind first recaps the history of PM's opposition to FDA regulation
and recommends instead that PM USA advocate for regulation as a way to maintain
the status quo, or "perpetuate the existing framework's philosophy that adults
continue to be permitted to assume" the inherent risks of cigarette smoking:
"...enactment of a new regulatory regime that would (a) permit the
federal government to assure itself that the industry's design and manufacturing
processes do not exacerbate the inherent risks of cigarette smoking and (b)
perpetuate the existing framework's philosophy that adults should continue to be
permitted to assume -- without governmental interference -- those risks so long
as they have been adequately informed of them. In addition, [this paper] will
recommend that the company continue to support federal measures legitimately
aimed at reducing youth access to cigarettes, and oppose proposals that would
infringe on its First Amendment rights without its consent."
Berlind compares potential regulatory regimes for cigarettes to
consumer safety regimes that have been applied to other risky products, such as
high fat foods, guns, alcohol and gambling. Among these Berlind finds "no
instance in which the government has established a regime that would permit
unelected agencies to either ban the product or mandate significant design
changes intended to reduce consumer risk." Berlind concludes that rather than
banning products, the FDA's role instead has been "on labeling and ensuring that
consumers are not misled." He points out that the gun industry is "largely
unregulated," and that the few restrictions placed upon guns were created by
legislative action and not regulatory action. He states with respect to guns
that "current law largely leaves it to consumers to discern the riskiness of the
products by themselves..."
Berlind also observes that gambling laws "are not directed nearly as
much at trying to discourage gambling as they are at ensuring that only
state-sanctioned (or sponsored) gambling occurs, and that the revenues are
directed through the proper channels. The view that gambling is addictive and
socially destructive does not, however, seem to have dampened official
enthusiasm for perpetuating the practice."
With regard to alcohol, Berlind states that while many laws exist
regulating misleading brand names, posting of health warnings, prohibitions on
false statements, etc. "...there are no regulations whatsoever on product design
or manufacture of alcoholic beverages either at the state or federal level. No
agency is charged with the responsibility of attempting to reduce alcohol
consumption by adults...The prevailing philosophy appears to be that...even
though the product allegedly can impair health and has been characterized as
addictive, the consumer should be left along to decide to consume alcohol or
not, in accordance with his or her individual preferences."
After these comparisons, Berlind says the FDA's "safe and effective"
requirement for regulated products would be "troubling," saying that FDA is
required to ban any drug or medical device not found to be safe and effective.
"Unless the law is amended, FDA jurisdiction over tobacco products could
ultimately lead to a new Prohibition."
Berlind concludes that "sensible regulation would continue to permit
adults to assume the inherent risks of smoking, while allocating to the
government the twin tasks of ensuring that manufacturers don't created
additional risk though their design and manufacturing processes, on the one
hand, and continuing to conduct appropriate research about the nature of the
inherent risks and keeping consumers informed of them, on the other." These
limited parameters for regulation appear to be the broad goals PM seeks in FDA
regulation: that such regulation will generally preserve the status quo of
"adult choice" about smoking, assure cigarette manufacturers don't create any
more risks than their products currently pose, to place FDA in charge of
informing citizens about the risks of smoking, to prevent FDA from getting any
authority to reduce or eliminate any naturally-occurring harmful constituents in
cigarettes (to relegate this only to Congress).
----------------------------------------------------------
NOTE: Originally unavailable to the public, privilege has been
removed from the document and it became available for public viewing in 2003.
Berlind seems to be emerging as the mastermind behind PM's pursuit of FDA
regulation. Many other Berlind-authored documents on the topic of PM's FDA
strategy are still privileged and not available for viewing.
-----------------------------------------------------
Company: Philip Morris
Author: Berlind, Mark - (Assistant General Counsel, Philip Morris
Worldwide Regulatory Affairs)
Commissioned the drafting of sample FDA bills based on PM's "core
principles" from Arnold and Porter, Feb. 2000 (2081522996)
Recipient: Friedman, Mark - Assistant General Counsel, Philip Morris
Worldwide Regulatory Affairs, Asia/Australia/Japan, Philip Morris Corporate
Services Inc., USA Sourced from: PM2060564912
Murphy, Virginia - Philip Morris Legal Department
Region: United States
Type: Report
Subject: FDA Regulation strategy
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