Regulation of Tobacco Products

REGULATION OF TOBACCO PRODUCTS

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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.