[Congressional Record Volume 141, Number 130 (Saturday, August 5, 1995)]
[Extensions of Remarks]
[Page E1658]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]


                     REGULATION OF TOBACCO PRODUCTS

                                 ______


                          HON. JOHN S. TANNER

                              of tennessee

                    in the house of representatives

                         Friday, August 4, 1995

  Mr. TANNER. Mr. Speaker, I rise today to express my concern over 
recent press reports that the President is currently considering giving 
FDA the green light to assert regulatory jurisdiction over tobacco 
products. The notion of FDA asserting regulatory jurisdiction over 
tobacco products as drugs runs counter to statutory, regulatory, and 
agency precedence in this area.
  For decades, Congress has expressly reserved to itself the authority 
to regulate tobacco products. As one congressional report made clear:

       The clear mandate of Congress [is] that the basic 
     regulation of tobacco and tobacco products is governed by 
     legislation dealing with the subject . . . any further 
     regulation in this sensitive and complex area must be 
     reserved for specific Congressional Action.

  This position has long been acknowledged by none other than the FDA 
itself. As early as 1972, FDA Commissioner Charles Edwards testified 
that: ``[T]he regulation of cigarettes is to be the domain of 
Congress.'' Historically, the FDA has rejected petitions calling on FDA 
to regulate tobacco products noting that since manufacturers do not 
make therapeutic claims, tobacco products should not be declared 
``drugs'' under the Federal Food, Drug and Cosmetic Act and regulated 
by FDA. This is a position which has been upheld in the courts as it 
relates to tobacco. Further, in every meaningful case on the subject of 
whether a product could be regulated as a drug, the courts have found 
that absent the therapeutic claims by the manufacturer, they cannot.
  Even Dr. Kessler has recognized that this issue raises serious public 
policy questions that must and should involve Congress. In February of 
last year, Dr. Kessler wrote anti-smoking groups stating:

       We recognize that the regulation of cigarettes raises 
     societal issues of great complexity and magnitude. It is 
     vital in this context that Congress provide clear direction 
     to the Agency.

  These statements are equally applicable to tobacco products other 
than cigarettes.
  Congress has consistently rejected every attempt to give FDA the 
authority that Dr. Kessler seems to desire. Congress has considered and 
rejected numerous bills to give FDA regulatory authority over tobacco 
products. During the last Congress, a bill, H.R. 2147, would have 
amended the Federal Food, Drug and Cosmetic Act.

     to regulate the manufacture, labeling, sale, distribution, 
     and advertising and promotion of tobacco and other products 
     containing nicotine, tar, additives and other potentially 
     harmful constituents. * * * 

was introduced and rejected. In fact, on no occasion has a bill 
granting FDA authority to regulate tobacco products as drugs even 
passed out of subcommittee.
  Mr. Speaker, the FDA does not have the authority to regulate tobacco 
products as ``drugs'', absent the explicit authorization of Congress. 
Congress should be working meaningful to reduce access to tobacco 
products by minors.


                          ____________________