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awake, but when it's added to soda, it's not a drug. But when it's 

 added to No-Doz, it is a drug. 



Can you explain this to me? 



Mr. James Johnston. Mr. Congressman, our 



Mr. Bliley. Turn your mike on. 



Mr. James Johnston. Yes, sir. My common sense understanding 

 is the same as yours, that No-Doz is a drug because of the manu- 

 facturer's intent. But this is really a technical and legal question 

 and I would like Mr. Cooper, our outside counsel, to respond to 

 that question, sir. 



Mr. Cooper. Mr. Bliley, the law here doesn't necessarily follow 

 common sense, but it does have its own logic. In the definition of 

 the term "drug" in the Food, Drug and Cosmetic Act, there are two 

 branches of the definition that employ the concept of intended use. 



One is intended use in the diagnosis, cure, mitigation, treatment 

 or prevention of disease. That's not the definition that Dr. Kessler 

 invoked and I don't think it's the one that's particularly relevant 

 here. 



The other branch is intended to effect the structure or function 

 of the body, and that branch of the definition has an explicit ex- 

 emption for foods. Now, the intended use of a product, in almost 

 all cases, is determined by the claims and representations made by 

 the manufacturer of the product in connection with its distribution. 



Thus, if I put out a product and claim that it will keep you 

 awake, that brings the product within the second branch that I re- 

 ferred to because I am claiming that the product will, indeed, have 

 an effect on the function of the body. It will keep you awake when 

 otherwise you might be drowsy or fall asleep. 



So if I put caffeine in such a product and I make that claim and 

 caffeine is the active ingredient that makes the claim true, then 

 the caffeine is what is making that product a drug, along with the 

 claim. 



If, however, I put caffeine in a cola beverage and I don't make 

 such a claim, even though the caffeine may be having the same ef- 

 fect, it doesn't make the product a drug, at least as the law has 

 been currently understood, 



Mr. Bliley. Thank you. Mr. Johnston, I heard the industry say 

 that it doesn't want kids to smoke. Is that true? 



Mr, James Johnston, Yes, Mr, Congressman, That is correct, 



Mr. Bliley, What is your company doing about the serious prob- 

 lem of under-age smoking? 



Mr. James Johnston. It is a serious issue for parents and for the 

 society. I would like to put it in brief perspective, if I may. David, 

 the chart, the government chart on under-age smoking, please. 



Great progress has been made in this society of reducing under- 

 age smoking. We'll have a chart up in a moment. It is important 

 that we as a company do something about it. I want to mention 

 just two of the programs we have. 



What the science, social science, and what parents know and 

 what children know is the driving force in an under-age person 

 starting to smoke is peer pressure. The next most important issue 

 is whether an older brother or sister smoke. Those are the most 

 powerful driving forces. We have a program that deals with the 



