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Anne Landman's Collection

FDA Message / Message Track

Date: 05 Jan 2000
Length: 2 pages
2075733345-2075733346
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Abstract

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.

Fields

Notes

The following PM 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

The same document, dated April 11, 2000, 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 PM commissioned the law firm of Arnold and Porter to create draft model FDA legislation containing all of its core principles in February of 2002 (PM Bates No. 2075733243). The model legislation is prepared so as to be ready to introduce as-is as a bill in the U.S. House of Representatives. URL: http://legacy.library.ucsf.edu/cgi/getdoc?tid=rst52c00&fmt=pdf&ref=results Note the author of this document is listed as "Congress." The author is NOT Congress, it is Arnold and Porter. The draft legislation was commissioned 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 separatelyy--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
Litigation
Feda/Produced
Operation/Project
Regulatory Strategy Project (PM's effort to enact FDA regulations on its own te)
Named Organization
Congress
United States Food and Drug Administration
Type
REPT, REPORT, OTHER
Subject
Corporate strategy
marketing
regulation
FDA jurisdiction over tobacco

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Page 1: qst52c00
SAN 17 '00 12:24PM PMMCiLEGAL-USA P.4%S C0r.5~--~5 4) The FDA should assure co nuous, updated disclosures to smeicers as science evolves so that peepW continue to be fully informed of the risks of smoking. This would include 6u zc ? - Establishing the contentlof Xe'alth Y(arning jla.bels, - 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 4ultra- ~ light" - Determining appropriate ingredient disclosure whichrprotect,(trade secrets df4o 5) (Alternative 2): The FDA should not be given a specific regulatory 19(la+t responsibility regarding how cigaret~`es are marketed and soId. Through the ,,,N d.a' sU0°J MSA,,states have a strong legal framework for preventing tobacco marketing A , 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 tol tuho c enges. e 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 FD~ie, to use its scarce resources on youth smoking prevention. That is b~fst left to others. ~ 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 adnlt-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 , 7 + Banning mail order and Internet sales of bacc Banning vending machine sales except in adult-only venues Requiring age verification a
Page 2: qst52c00
JAN 17 '00 12:23PM PMMC/LEGAL-USA l"1 P.3/5 Iwa4 f~[i,lwtca ~ ~ar*^^^.°r{' rFDA Messages/ Message Track PRIVILEGED AND CONFIDENTIAL We support stxonen but sensi le FDA regulation of cigarettes based on five core principles: 1) The FDA should be e ressly prohibited from banning cigarettes and from having the power to change igarettes to the point where adult smokers no longer can enj oy them MWa 40 ~ i hC,~ ~Z oF ~ i s~g ir.uxp,-Hti.~ ~°~. - FDA must not be given an ability to in#~in`geµtright 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 smoki4in America either directly or indirectly A 3) Wm long-range goal of FDA regulation should be to reduce the riskAqof assure that no ditives ' crease the inherent risks of smoking and that the industry uses "good ufacturing practices" suitable for agriculturally-based products. -- ca+~~- Srand•by brand in edients hould be fully disclosed to the FDA in a framework which protects trade secrets r}+,0 '{,' G&~= c.^ u-aa.00ss? - Safety assessments of ingredients added to tobacco should be required - Manufacturing regulations should be based on a food regulation model ~ Q'4"D/t5 . 2) The FDA should re ate cigarette design and manufacturing processes to smoking by encouraging industry innovations • FDA should set standards and procedures that allow~produets to be certified as "reduced risk" and marketed as "reduced risk" ~'rD W a AVi" - FDA must only regulate tobacco under a new chapter of the I~Hfc where "risk reduction" is the regulatory goal not `°safer'and (i.e.,,the standard for drugs and medical devices). ~ ~ 'e~iGG `~ 1 ~;S(MsS i~- r5 44k,. Vr) 4A J Ve ~oo.P, a"W4 Gw~ 1V ePtiS'Lt WLYg ~ Se.1. :~- 4.

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