14 



sequence to the health and safety of our citizens, and our consider- 

 ation should not be waylaid by specious industry claims that trade 

 secrets are being jeopardized. 



Mr. Chairman, I congratulate you and Mike Sjniar and Dr. 

 Kessler for pressing forward with this inquiry and look forward to 

 our witnesses. 



[The prepared statement of Hon. Gary A. Franks follows:] 



Statement of Hon. Gary A. Franks 



Thank you, Mr. Chairman. This morning we will consider the issue of FDA regu- 

 lation of tobacco products. I appreciate the opportunity to comment on this matter. 

 Mr. Chairman, I have very serious concerns aoout the impact this action would have 

 on the FDA's current responsibilities and our economy. 



I have seen no evidence that their is a need for such action. The tobacco industry 

 is already regxilated by the Federal Government from the day the seeds are planted 

 to the purchase of a product. Tobacco also is subject to exceptionally heavy regula- 

 tion by taxation. Because of this regulation, cigarette manufacturers have been pub- 

 licly reporting "tar" and nicotine levels for more than 20 years. The manufacturing 

 Process for cigarettes are not new and have not been hidden from the Government, 

 he Department of Health and Human Services has been receiving cigarette ingre- 

 dients lists since the early 1980's and has never given any indication that these in- 

 gredients were harmful or that the manufacturing process was suspect in any way. 



I am concerned that the FDA's primary function, to test pharmaceutical to ensure 

 their safety for the public is not being handled in a timely manner. An increasing 

 number of new drugs await approval while staff and monetary resources diminish. 

 It is no secret that approval of new drugs to treat ailments such as asthma, cancer, 

 arthritis, Alzheimers and AIDS are way behind schedule. Those citizens in critical 

 stages of diseases (and who can afford it) often go out of the country to receive treat- 

 ment with drugs that have been widely accepted for years in other countries, but 

 have not received approval by the FDA. Given this unfortunate scenario, why would 

 we want to burden an already overburdened Agency with the enormous and unnec- 

 essary task of regulating and policing the manufacture, labeling and advertising of 

 tobacco products and the use of tobacco additives. 



The impact on our economy and the tobacco industry would be equally devastated 

 by the FDA's decision to ban the cultivation and consumption of tobacco. FDA Com- 

 missioner Kessler has steted publicly that the FDA would "have no choice under 

 current law" to do so if the FDA rules nicotine a drug. 



Thousands of jobs and entire economies could be wiped out with this decision. 

 State and Federal treasuries would be severely impacted. Even President Clinton 

 would have to re-think the financing of his healtji care plan if this decision were 

 to become law. 



We all know that a scenario like this would also ignite the largest black market 

 we have seen in this country since prohibition. 



The regulation of cigarettes by the FDA would cause irrevocable damage to our 

 economy and society, not just in the southern States represented by my colleagues 

 here today, but across the United States. I strongly urge all of my colleagues to re- 

 ject this plan of action. 



Mr. Waxman. Thank you. Our first witnesses this morning are 

 colleagues with long-standing interest in tobacco. Richard Durbin 

 of Illinois is chairman of the House Appropriations Subcommittee 

 of Agriculture, Rural Development, Food and Drug Administration, 

 and related agencies. Martin Lancaster is a member from North 

 Carolina, James Clyburn is a member from South Carolina. 



