Philip Morris
Sound Bites
Fields
- Type
- REPT, REPORT, OTHER
- Document File
- 2075733209/2075733651/FDA - Proposed Regulatory Strategy Project (Jeh)
- 2075733342/2075733650/FDA - Proposed Regulatory Strategy Project Folder Number 1 (Jeh)
- Master ID
- 2075733343/3347
Related Documents: - Site
- R867
- Litigation
- Feda/Produced
- Named Organization
- FDA, Food and Drug Administration
- Area
- HOLLERAN,JOHN/STORED FILES
- Author (Organization)
- Pmmc, Philip Morris Management Corp
- Characteristic
- ATTY, ATTORNEY WORK PRODUCT
- CONF, CONFIDENTIAL
- DRFT, DRAFT
- MARG, MARGINALIA
- MISS, MISSING PAGES
- CONF, CONFIDENTIAL
- Date Loaded
- 26 Nov 2002
- UCSF Legacy ID
- pst52c00
Document Images
SRN 17 '00 12:24PM PMMCiLEGRL-IJSR
Draft 2 ,
Work Product
SOUND BITES
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' We will support str~, but sensible FDA regulation
eliminate
but rather to encourage reduction in the risks of sx`noTcing,
The,purpose of FDA regulation should not be t
P.5i5
garet<es~ig
PDA should be expressly fo'rbidden from banning cigarettes or making
them so unpalatable that Americans would turn to a black rnarke ~.
Cigarettes should be regulated under a new chapter of the FDA an'c~ not
as a drug or medical device since that gives the agency the power to ban
cigaretkes
FDA regulation should focus on three things:
- Re ulatin manufacturin -to make sure that all manufacturers follow
rigorous and ans az rocedures and add nothing to the product that
increases its inherent risks ? ~--}?
- Disclosure-- so that everyone -~articularly adult smokers> continue to
have the information they need to make an informed choice
- educing~ the risks of smoking - by setting standards which, if
anu
tfacturers meet them, will allow reduced-risk cigarettes to be
airketed without consumers turning to the black market
ema
tM
FDA
r s, '1kL M.SA T:aes 'FG.e ,4'tAte9 +t: u.fai G' I''2'
fO C6-']ti1'~ Yo ,~,,,v,,~- Ci~ ~ Lvs,~i''~.- /v cr.rt~r5'a dv au4`~
The FDA should f~ ocus on z'~g_ulating°the manufacture, evel ~ment and
sale of the 12roduct -- that is the best way to use their expertise and to
avoid Constitutional issues.
ctgare
and sales. V. . . , . e
Because of the MSA and its enforcement powers to prevent tobacco
marketing to youth, the FDA does not have to focus on cigarette marketing
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
4
