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drugs and or devices under the Food. Drug and Cosmetic Act. Because Re>nolds 

 decided not to go forward with the marketing of the product, the petitions were 

 never acted upon In attempting to convince the public that this product should 

 have been allowed on the market. Reynolds produced a 743 page monograph 

 entitled. "New Cigarene Prototypes that Heat Instead of Bum Tobacco." This 

 document reflects the intensive research of the industi7 to develop and 

 manufacture a product that clearly should be considered a drug under the FDC 

 Act. Segments of the study included discussion of "nicotine-free particulate." 

 "nicotine elimination," "nicotine absorption," "inhalation studies," and other topics 

 related to the chemical and toxic effects of cigarette smoking. The intended 

 objectives of the development of the cigarette were stated in the monograph as 

 follows: 



- to simplify the chemical composition of mainstream and sidestream 

 smoke emitted by the new cigarette. 



- To minimize the biological activity of the mainstream and sidestream 

 smoke emitted by the new cigarette. 



- To achieve significant reduction of environmental tobacco smoke from 

 the new cigarette. 



While being touted by Reynolds as a "cleaner" cigarette. Premier was known to 



contain carbon monoxide as well as nicotine. Concern was expressed by the 



public health community that if the product escaped regulation, the industry 



would have been free to add any chemical additives to the flavor chamber as well 



as adding or subtracting levels of nicotine at will without the FDA having any 



federal regulatory oversight. Premier was just one more example of how the 



tobacco industry has been intensifying its research and development activities to 



develop and promote products that are not sold for smoking pleasure only but are 



in fact drugs under the Act, designed to affect function and structure of the body 



and designed to mitigate and prevent disease. 



