[Congressional Record Volume 142, Number 15 (Monday, February 5, 1996)]
[Extensions of Remarks]
[Page E172]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                CAN THE FDA REDUCE UNDERAGE TOBACCO USE?

                                 ______


                          HON. JOHN S. TANNER

                              of tennessee

                    in the house of representatives

                       Thursday, February 1, 1996

  Mr. TANNER. Mr. Speaker, almost six months go, claiming his desire to 
curb underage tobacco use, President Clinton announced that the Food 
and Drug Administration would be asserting regulatory jurisdiction over 
tobacco products. I share the President's concern for preventing 
tobacco use by minors. But, for the FDA to assume responsibility for 
this issue runs counter to statutory, regulatory, and agency 
precedence. I do not believe, it will prove effective in reducing 
underage tobacco use.
  The FDA's proposed assertion of jurisdiction over tobacco stands out 
as another example of the Federal Government attempting to assume 
powers rightfully within the purview of Congress and of the individual 
states. Congress has expressly reserved to itself the authority to 
regulate tobacco products, leaving the bulk of tobacco regulation to 
the states--including taxation, age of purchase, and certain aspects of 
tobacco use, including the manner and method of retail transaction.
  In its most recent action with respect to the regulation of tobacco, 
the ADAMHA Reorganization of 1992, Congress addressed this in the 
appropriate manner--it required states, as a condition for receiving 
certain federal grants, to enact statutes prohibiting tobacco sales to 
minors. Also required of the states are random inspections and certain 
reporting obligations.
  As a result of the congressional-established scheme, every state in 
the Union now has a law on its books banning tobacco sales to minors. 
But beyond this arrangement, Congress left to the States virtually 
every other aspect of underage sale of tobacco. All States accepting 
funds under the federal scheme remain free to enact or reject other 
steps relative to tobacco sales to minors.
  Proposed regulations for implementing this Act were issued on August 
23, 1993. Last week, after nearly 2 years and 5 months, the Department 
of Health and Human Services finally promulgated its final regulations. 
The fact that it took the Department so long to set forth these 
regulations underscores the inherent limitation of Federal action and 
further demonstrates that Congress was on the right track when it gave 
to the states the primary responsibility for handling this complex 
problem.
  Still, FDA has attempted to seize jurisdiction over tobacco products. 
For nearly 90 years, and on at least twenty different occasions 
congress has specifically rejected proposed legislation to grant FDA 
jurisdiction over tobacco. This includes seven occasion over the last 
decade.
  During this same period, FDA itself has concluded on numerous 
occasions that it has no jurisdiction over tobacco markets without 
claims of ``therapeutic benefit.'' It has recognized that Congress 
never granted it such authority, and it has acted only where a 
particular brand of cigarettes carried specious claims that it would 
prevent disease or affect the structure of the body. Indeed, as 
recently as last year, FDA Commissioner Kessler stated that Congress 
would need to provide some new direction before the FDA could assert 
jurisdiction over cigarettes.

  Despite this long history of Congressional denial of FDA jurisdiction 
over tobacco, and the long history of FDA concurrence in this 
jurisdictional arrangement, the FDA is now without any legislation or 
other guidance from Congress whatsoever, attempting to assert 
jurisdiction over tobacco products.
  The FDA proposal cites 21 U.S.C., section 352 (misbranded drugs), 
section 360 (registration of producers of drugs or devices), section 
360j (general provisions respecting control of devices intended for 
human use), section 371 (authority to promulgate regulations for the 
efficient enforcement of the Federal Food, Drug and Cosmetic Act), and 
section 374 (inspection of manufactures of food, drugs, devices or 
cosmetics) as authority. However, nowhere in these statutes is there 
any expression of congressional intent or grant of authority to the FDA 
to assume authority over tobacco sales to minors.
  The President recently addressed the Nation, sharing with American 
people his assessment as to the state of the nation--and the challenges 
the country faces in the coming year. Among the challenges he cited was 
reducing underage tobacco use. However, this is challenge which 
Congress has already addressed. With the promulgation of the final rule 
implementing the ADAMHA Reorganization Act of 1992, the tools for 
addressing this problem in the most effective and efficient manner are 
now in place. The Federal Government should continue to work with the 
individual states as they each undertake, as delegated to them under 
this Act, the challenge of preventing the distribution of tobacco 
products to minors.
  At the same time, for the purpose of preserving the integrity of the 
Constitutional framework of our government, the FDA must be prevented 
from assuming jurisdiction over this product. A precedent must not be 
set whereby a Federal bureaucrat, in contravention of the Constitution, 
can carve out for himself and his agency, rights and prerogatives 
specifically reserved by the Constitution to the Congress and the 
states.

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