According to this act, a product is a drug if its manufacturer in- 

 tends it to be used to affect the structure or function of the body. 

 Because of the enormous social consequences of such a decision, we 

 have asked Congress for guidance as we try to answer this ques- 

 tion. The information that I presented about industry control and 

 manipulation of nicotine at that hearing was suggestive. 



Today, as a result of an extensive investigation over the past sev- 

 eral months, I am here to provide you with actual instances of nico- 

 tine control and manipulation in the tobacco industry. 



My first example involves the deliberate genetic manipulation of 

 nicotine even before tobacco seeds were planted in the fields. A 

 major American tobacco company spent more than a decade quietly 

 developing a tobacco plant with exceptionally high nicotine levels 

 growing it in Central and South America, and ultimately using it 

 in American cigarettes. 



My second example involves the addition of chemical compounds 

 to tobacco. Based on our investigation, I will describe the use of 

 chemical compounds to manipulate nicotine delivery. 



Let me begin with the story of a high-nicotine tobacco plant that 

 was code named Y-1. The story begins in Portuguese with our dis- 

 covery of a Brazilian patent for a new variety of a flue-cured to- 

 bacco plant. 



One sentence of its English translation caught our eye: "The nic- 

 otine content of the leaf of this variety is usually higher than ap- 

 proximately 6 percent by weight, which is significantly higher than 

 any normal variety of tobacco grown commercially." 



In fact, this Y-1 plant has almost double the nicotine that natu- 

 rally occurs in flue-cured tobacco. 



The holder of the Brazilian Y-1 patent is the Brown & 

 Williamson Tobacco Corporation. 



Let me tell you why this discovery interested us. Industry rep- 

 resentatives have repeatedly stated for the public record that they 

 do not manipulate nicotine levels, that they do not design for nico- 

 tine. 



Moreover, when we asked company officials whether plants were 

 bred specifically for higher nicotine content, we were told that this 

 was not feasible. We were told that tobacco growers and cigarette 

 manufacturers have an agreement that the nicotine level of new 

 varieties of tobacco grown in the United States can vary only 

 slightly from the levels of standard varieties if they are to be sold 

 commercially. 



Nevertheless, we learned that interest in developing a high-nico- 

 tine tobacco plant dates back to at least the mid-1970's. In 1977, 

 Dr. James F. Chaplin then of both the USDA and the North Caro- 

 lina State University, stated: "Manufacturers have means of reduc- 

 ing tars, but most of the methods reduce nicotine and other con- 

 stituents at the same time. Therefore, it may be desirable to de- 

 velop levels constant or to develop levels higher in nicotine so that 

 when the tar and nicotine are reduced, there will still be enough 

 nicotine left to satisfy the smoker." 



In fact, Dr. Chaplin had actually begun work on genetically 

 breeding tobacco plants to increase nicotine levels. Dr. Chaplin re- 

 ported that tobacco could be bred to increase nicotine levels specifi- 

 cally by cross-breeding commercial varieties of tobacco with Nicoti- 



