127 



tobacco products in a way comparable to that in which other legal products are regulated, but 

 will prohibit any regulations banning the sale and distribution of a tobacco product solely 

 because it causes disease. 



TTie issue of the availability of resources within FDA to administer new regulatory authority for 

 tobacco products is addressed m H.R. 2147. The bill would require manufacturers of tobacco 

 products to pay an annual fee to cover the costs of implementing the new requirements. The 

 fees would be credited to the FDA"s salary and expenses appropriation account and could be 

 used only for the costs of implementing the new authority. A similar "user fee" is in place for 

 certain regulatory requirements for pharmaceutical manufacturers. 



You also raise the question of whether tobacco product regulation is a good use of scarce FDA 

 resources. Preventing the death and disease caused by use of tobacco products is a very high 

 public health pnority. Tobacco is the greatest preventable cause of disease in this country, 

 killing 420,000 people a year. 



Compared to other very important major initiatives undertaken by FDA, tobacco product 

 regulation would not be a huge burden. Cigarettes and smokeless tobacco products are 

 manufactured by seven companies. Only about 65 brands of cigarettes are currently on the 

 market in this country. The pharmaceutical and food industnes, which are already regulated by 

 the FDA. include hundreds of manufacturers and tens of thousands of products. The payoff in 

 public health benefits would more than justify the expenditure of resources to regulate tobacco 

 products, especially if the manufacturers paid the bill through a user fee. 



We would be happy to discuss these issues with you in greater detail. A proposal is ready for 

 committee consideration and we urge you to do what you can to move forward with legislation 

 for tobacco product regulation through the committee process. For 30 years the tobacco industry 

 has surrounded itself with a fortress that has protected it from government oversight and 

 regulation. The public supports FDA regulation of tobacco products. The public's health 

 deserves such regulation. 



/ 

 Sfhcerely^ 



§tottb. Ballin" 



Chairman Deputy Managing Director 



Coalition on Smoking OR Health Amencan Lung Association 



Vice President for Public Affairs 



American Heart Association 



). Ballin ^ Fran Du Melle 



A-^ 



Michael F. Heron 



National Vice President 



Advocacy and Relationship Management 



American Cancer Society 



cc: Members of the Energy and Commerce Committee 



