Regulation of Tobacco Products

by John S. Tanner

                     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.

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