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STATEMENT OF DAVID A. KESSLER, COMMISSIONER OF FOOD 

 AND DRUGS, FOOD AND DRUG ADMINISTRATION, ACCOM- 

 PANIED BY JACK E. HENNINGFIELD, CHIEF, CLINICAL PHAR- 

 MACOLOGY BRANCH, NATIONAL INSTITUTE ON DRUG 

 ABUSE 



Mr. Kessler. Thank you very much, Mr. Chairman. 



The cigarette industry has attempted to frame the debate on 

 smoking as the right of each American to choose. The question we 

 must ask is whether smokers really have that choice. Consider 

 these facts. Two-thirds of adults who smoke say they wish they 

 could quit. Seventeen million try to quit each year, but for every 

 one who quits, at least nine try and fail. Three out of four adult 

 smokers say they are addicted. By some estimates, as many as 74 

 to 90 percent are addicted. Eight out of 10 smokers say they wish 

 they had never started smoking. 



Mr. Chairman, the issue I will address today is simple: Whose 

 choice is actually driving the demand for cigarettes in this country? 

 Is it a choice by consumers to continue smoking? Or is it a choice 

 by cigarette companies to maintain addictive levels of nicotine in 

 their cigarettes? 



FDA has not regulated most tobacco products as drugs. One of 

 the obstacles has been a legal one. The law requires an intent that 

 the product be used either in relation to a disease or to affect the 

 structure or function of the human body. Intent is a key word in 

 our statute. We have not had sufficient evidence of such intent 

 with regard to nicotine in tobacco products. The assumption has 

 been that the nicotine in cigarettes is present solely because it is 

 a natural and unavoidable component of tobacco. 



Mr. Chairman, that assumption needs to be re-examined. The 

 amount of nicotine in a cigarette may be there by design. Cigarette 

 companies must answer the question, what is the real intent of this 

 design? In my testimony this morning, I will describe some of the 

 information that has prompted our re-examination. 



First, I want to address the addictive nature of nicotine. Second, 

 I will talk in some detail about the apparent ability of cigarette 

 companies to control nicotine levels in cigarettes. 



My first point is that the nicotine delivered by tobacco products 

 is highly addictive. As the chart shows, that fact is acknowledged 

 by the world's preeminent medical organizations. As with any ad- 

 dictive substance, some people can break their addiction, but I sus- 

 pect that everyone in this country has seen a friend or relative 

 struggle to extricate himself or herself from a dependence on ciga- 

 rettes and the nicotine they contain. 



Remarkably, we see that nicotine exerts its grip even on patients 

 for whom the dangers of smoking could not be starker. After sur- 

 gery for lung cancer, almost half of the smokers resume smoking. 

 Even when a smoker has his or her larjmx removed, 40 percent try 

 smoking again. 



I am equally struck by the statistics about our young people. 

 Seven out of 10 teenage smokers say they believe that they are al- 

 ready dependent on cigarettes. About 4 out of 10 high school sen- 

 iors who smoke have tried to quit and failed. Most adult smokers 

 today began smoking as teenagers. 



