court found that if cigarettes and smokeless tobacco were under FDA jurisdiction as outlined by the proposed regulations, the agency’s only choice would be to ban the products in light of their known dangers to health. Any other consideration would not be within the scope of FDA’s regulatory powers. The court concluded that Congress did not intend the FDCA to be used for the regulation of tobacco products and that Congress has never equipped the FDA with the power to regulate tobacco products. This decision was upheld by the Supreme Court on March 21, 2000. The majority opinion stated that the FDA’s regulatory actions were incongruous with what was intended by Congress and that Congress has historically denied FDA the authority to regulate traditional tobacco products.

It is important to recognize that this recent Supreme Court decision in no way limited the authority of FDA to regulate any product, tobacco containing or not, that makes an explicit health claim that would bring the product under the definition of a drug or device. For example, an exposure-reducing claim for a smokeless tobacco product, to the effect that it (like nicotine patches) promotes cessation of smoking, could be judged by the FDA as a drug claim requiring approval under a new drug application. Similarly, the newly emerging set of smoked nicotine-containing products is not necessarily excluded from FDA regulatory authority by the recent Supreme Court decision. An interesting consequence of the current regulatory situation is that a tobacco manufacturer may not be able to make a legitimate exposure-reducing or reduced-risk claim for a new product, even if truthful, without bringing the product under the jurisdiction of the FDA.

It is also important to note that as a result of the Supreme Court’s decision overturning FDA jurisdiction, all current regulatory provisions over tobacco relate only to labeling, promotion and advertising, and taxation. None relate to the technical or scientific standards required of new products or to product safety. Unlike pharmaceutical or device manufacturers, cigarette manufacturers may introduce new curing, blending, and manufacturing techniques into tobacco products without regulatory oversight of any kind. Similarly, new additives, new filters, new aeration mechanisms, new papers, and new constituents may be introduced without regulatory scrutiny. Neither the extent nor the results of toxicology testing of new ingredients in animals are known outside the manufacturer. The effects of new product design and of changes in constituents on the composition of inhaled smoke are not reported to any health authority. Clinical studies on new products are conducted without regulatory oversight over protocols (except for institutional review board review) or review of the results. Once research and development on a new product has been completed, the product is marketed based on the manufacturer’s



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