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The following letter regarding the proposed FDA tobacco legislation
was sent to members of US Congress from New York State.
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August 11, 2004

Dear :

As you are well aware, Roswell Park Cancer Institute has a world-renowned
tobacco control program and was one of the first, in 1948, to publish 
studies of the harmful effects of smoking has on health.  To that end, 
our researchers have been intimately involved in the formation of 
public policy as well as measuring the effect of those decisions.

The researchers and administration at Roswell Park Cancer Institute agree 
that strong Food and Drug Administration (FDA) regulation of tobacco 
products is needed and long overdue.  However, the proposed legislation
(S.2461/H.R.4433) has a number of flaws that hinder the laudable public 
health goals outlined in the legislation.

- The legislation limits the FDA's authority to implement science-based
  regulations that would allow the legislation to achieve its mandate to 
  reduce the disease burden caused by tobacco.

* Precludes FDA from banning any class of tobacco products.
* Precludes FDA authority to eliminate nicotine from tobacco products.
* Precludes FDA from reducing cigarette access by increasing the legal
  age of cigarette purchase.
* Precludes FDA from reducing cigarette access by regulating the sale
  of tobacco products in certain types of establishments.
* Precludes FDA from reducing cigarette access by eventually phasing
  in some sort of prescription-only access system.

- The legislation makes it extremely difficult for companies to attempt 
  to introduce new, potentially reduced risk products.  It establishes 
  standards for new tobacco products that are far more stringent than 
  for existing products, helping to institutionalize existing products 
  in the marketplace.

- The marketing restrictions imposed by the bill have already been well
  researched and found NOT to be effective in reducing youth smoking,
  or even in reducing youth exposure to cigarette advertising.

- The performance standards provision of legislation will not necessarily 
  improve the public's health.  It is simply not known which of the 
  50+ carcinogens and which of the 4000+ chemicals in tobacco smoke
  are responsible for causing which diseases.  It is not known what 
  quantities of these chemicals produce what effect, and what the effect 
  of removing or reducing these chemicals will be.  The proposed 
  legislation could save lives if it encouraged and funded research 
  to answer these questions.

- The bill may do more harm than good because the public will perceive
  FDA regulation as making tobacco products safer when this may not be 
  the case.  We should avoid inadvertently creating a regulatory framework
  which allows tobacco companies to market their products as reducing 
  exposure to selected toxins when this may have no meaningful 
  relationship to actual disease risk.

- The bill focuses on tobacco product toxicity and not on how product 
  design changes may influence smoking behavior.  A product that is 
  toxic but less acceptable to use is safer than one that is less toxic, 
  but highly acceptable to smokers.

If you would like to discuss any of these points in greater detail or have 
further comments or questions, feel free to contact me through Lisa 
Damiani, Executive Director of Government Affairs at (716) 845-3079.

Sincerely,

David C. Hohn, MD
President and CEO

K. Michael Cummings, PhD, MPH
Senior Research Scientist
        
.