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From Anne Landman: anne@tobaccodocuments.org
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 
.