149 



STATEMENT OF SHERWIN GARDNER 



Mr. Gardner. Thank you, Mr. Chairman. 



I will summarize my statement, if it could be included in its en- 

 tirety in the record. 



My name is Sherwin Gardner. I am an independent consultant 

 to industry specializing in issues arising from the regulation of food 

 and other products by FDA. 



I am here today at the request of Philip Morris USA, which re- 

 tained me to review its tobacco processing and cigarette manufac- 

 turing practices in light of recent allegations regarding manipula- 

 tion of the nicotine content of cigarettes. 



To do this I visited several Philip Morris manufacturing facilities 

 in the Richmond, Va. area and was accompanied by two consult- 

 ants who are expert in auditing FDA facilities in the United States. 



We did not fmd any basis for concluding that Philip Morris ma- 

 nipulates or intentionally adds measurably to the nicotine content 

 of cigarettes through its processing and manufacturing. 



Two of the facilities we inspected manufacture reconstituted to- 

 bacco products known as blended leaf and reconstituted leaf respec- 

 tively. In the blended leaf process from 30 to 40 percent of the nico- 

 tine is lost and 20 to 25 percent is lost in the reconstituted leaf 

 process. 



During our inspections of these facilities, we were able to see 

 manufacturing records of the controls used in producing these re- 

 constituted tobacco products. We did not observe any manufactur- 

 ing controls in reconstituted tobacco production for nicotine con- 

 tent. 



We also inspected the flavor center which prepares the content 

 rates for application to tobacco prior to cigarette making and also 

 the cigarette manufacturing facility, with the same results. 



In conclusion, the interviews and inspections at these four Philip 

 Morris facilities provided us with the information to find that the 

 nicotine content of cigarettes is not intentionally controlled by the 

 manufacturing processes, nor is nicotine added during the process 

 of preparing reconstituted tobacco nor as part of a flavoring agent. 



The inspections of Philip Morris that I describe further did not 

 disclose any facts that would support regulation of cigarettes as 

 drugs under current law. Clearly the question of FDA's authority 

 to regulate tobacco products is a legal matter. It hinges on a mar- 

 keter's intent and representation to consumers. 



The definitive court holding on this issue was in the case of Ac- 

 tion on Smoking and Health versus Harris in 1980. Nothing I have 

 learned during my service at FDA or since changes my understand- 

 ing of the act and its application in this area. 



Certainly the Congress in its wisdom may decide to change the 

 legal standards under which cigarettes are regulated. The question 

 is whether FDA should be burdened with the implementation of 

 another major regulatory program. The Agency already is respon- 

 sible for the regulation of about 25 percent of consumer purchases 

 and Congress has added important new regulatory responsibilities 

 over the past 15 years without significant additional resources to 

 carry these out. 



The regulation of cigarettes in the Agency's responsibility can 

 only jeopardize its ability to serve the public through the approval 



