Tobacco Documents Online

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

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.