Dissolvable Tobacco Products

James E. Dillard Senior Vice President, Regulatory Affairs Altria Client Services

1 l Altria Client Services (on behalf of PM USA and USSTC) I Presentation to the Tobacco Products Scientific Advisory Committee | July 22, 2011 l September 2010 Submission ƒ No statutory or regulatory definition of “dissolvable tobacco products” ƒ FDA should treat dissolvable tobacco products that are smokeless tobacco products in the same manner as other smokeless tobacco products – Smokeless tobacco products are “any tobacco product that consists of cut, ground, powdered, or leaf tobacco that is intended to be placed in the oral or nasal cavity.” (21 U.S.C. 387 (18)) – FDA request for comments characterized dissolvable tobacco products “a novel class of smokeless tobacco products” ƒ Should be marketed responsibly to adult tobacco consumers ƒ Subject to legislative, regulatory, contractual and other controls on tobacco product marketing and sales to youth ƒ Present an opportunity to reduce the harm from cigarette smoking 2 l Altria Client Services (on behalf of PM USA and USSTC) I Presentation to the Tobacco Products Scientific Advisory Committee | July 22, 2011 l December 2009 Harm Reduction Submission

ƒ Cigarette smoking is the most hazardous form of tobacco consumption ƒ Harm caused by cigarette smoking can be reduced in the following ways (greatest impact to least impact): – Not smoking – Decreasing the number of years smoked – Decreasing the number of cigarettes per day – Decreasing smoke exposure per day ƒ Discouraging initiation and promoting cessation, particularly among those not legally permitted to buy tobacco products because they are underage, are and should remain core strategies to reduce tobacco-related harm ƒ For those adults who continue to use tobacco products an approach is needed that focuses on reducing tobacco-related morbidity and mortality by making available tobacco products that are acceptable to consumers and proven to be lower on the continuum of risk

3 l Altria Client Services (on behalf of PM USA and USSTC) I Presentation to the Tobacco Products Scientific Advisory Committee | July 22, 2011 l Harm Reduction

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*Developing the science base for reducing tobacco harm. Hatsukami DK, Joseph AM, Lesage M, Jensen J, Murphy SE, Pentel PR, Kotlyar M, Borgida E, Le C, Hecht SS. Nicotine Tob Res. 2007 Nov;9 Suppl 4:S537-53.

4 l Altria Client Services (on behalf of PM USA and USSTC) I Presentation to the Tobacco Products Scientific Advisory Committee | July 22, 2011 l Responsible Innovation ƒ Meet evolving adult tobacco consumer interest ƒ Approximately 25 percent of adult smokers have expressed an interest in smokeless tobacco alternatives to cigarettes ƒ Dissolvable tobacco products may be more acceptable to current adult smokers than other current smokeless tobacco products ƒ Regulatory framework should provide opportunity to understand the role of dissolvable tobacco products in harm reduction ƒ Advertising and marketing restrictions in Tobacco Control Act and Final Tobacco Rule apply to all smokeless tobacco products

5 l Altria Client Services (on behalf of PM USA and USSTC) I Presentation to the Tobacco Products Scientific Advisory Committee | July 22, 2011 l Considerations Moving Forward

ƒ Dissolvable tobacco products that are smokeless tobacco products should be regulated in the same manner as other smokeless tobacco products ƒ Dissolvable tobacco products present an opportunity to reduce the harm from cigarette smoking ƒ FDA should encourage product innovation in this space

6 l Altria Client Services (on behalf of PM USA and USSTC) I Presentation to the Tobacco Products Scientific Advisory Committee | July 22, 2011 l Dissolvable Tobacco Products

James E. Dillard Senior Vice President, Regulatory Affairs Altria Client Services

7 l Altria Client Services (on behalf of PM USA and USSTC) I Presentation to the Tobacco Products Scientific Advisory Committee | July 22, 2011 l