493 



facts that would support regulation of cigarettes as drugs under 

 current law. 



Certainly the Congress in its wisdom may decide to change the legal 

 standcirds under which cigarettes are regulated. I have serious 

 reservations, however, about burdening the FDA with the 

 implementation of another major regulatory program. The agency 

 already is responsible for the regulation of about 25% of the 

 consumer's purchases, and Congress has added important new 

 regulatory responsibilities over the past 15 years without significant 

 additional resources to carry these out. Indeed, when I served on 

 Secretary Sullivan's advisory committee on the FDA only three years 

 ago. agency officials stressed their needs for additional resources to 

 perform effectively. Adding the regulation of cigarettes to the agency s 

 responsibilities will only jeopardize its ability to serve the public 

 through the approval of new drugs, biologicals and devices, and to 

 monitor the safety of the food supply. 



I thank you for your attention, and will be pleased to respond to the 

 Subcommittee's questions. 



SHER W JN GARDNER is a consultant in regulatory policy and strategy. He was tbrnierly Senior 

 Vice President. Science and Technology at the Grocery Manufacturers of America. Inc. In that role, 

 he was responsible for GMA activities with respect to the scientific and technological issues affecting 

 the grocery industry Mr. Gardner provided staff support for the GMA Technical Regulatory- Affairs 

 Committee, and directed the GMA international affairs program. Prior to joining the GMA. Mr 

 Gardner held the position of Deputy Commissioner of the FD.A for over seven years, having been 

 appointed to that position on June I. 197:^. .\s Deputy Commissioner. Mr. Gardner shared with the 

 Commissioner the responsibility for managing agency programs, and served as Acting Commissioner 

 during three extended periods when the position of Commissioner was vacant. Mr. Gardner has also 

 served as an engineering research and development evpert specializing in areas of instrumentation 

 and control. Mr Gardner has authored several papers on food safety and related subjects. He 

 received awards from the FDA and the Public Health Service for his work, and was honored by FDLI 

 in I'JgO. Mr Gardner received his Bachelors degree in mechanical engineering, cum laude. from Cit>' 

 College of New York and completed his graduate studies in industrial amnagemcnt at Polytechnic 

 Institute. Brooklyn, New York. He is a licensed Professional Engineer in the State of New York and 

 a member of the Institute of Food Technologists. 



