With the approval of President Clinton, the FDA asserted jurisdiction over cigarettes and smokeless tobacco products on August 28, 1996. In permitting the FDA to go forward, Clinton became the first sitting U.S. President to confront the tobacco industry. This historic move was made possible by FDA Commissioner David Kessler’s desire to take action on tobacco, and increasing evidence that the tobacco industry designs its products to provide pharmacologically active doses of nicotine.1-2
As a first step in asserting jurisdiction, in 1997, the FDA issued the Children’s Tobacco Rule, a comprehensive approach to reducing cigarette and smokeless tobacco use by children. The Rule included measures to limit youth’s access to tobacco products and decrease the appeal of tobacco products to youth. The Rule aims to reduce youth’s smoking by 50% within seven years of enactment; if this decrease is not reached, the FDA will consider taking more stringent measures. The Rule has been challenged in court by the tobacco industry; the Supreme Court will decide its ultimate fate.
1 Kessler DA, Barnett PS, Witt A, et al. The legal and scientific basis for FDA’s assertion of jurisdiction over cigarettes and smokeless tobacco. JAMA. 1997;277:405-409.
2 Kessler DA, Witt AM, Barnett PS, et al. The Food and Drug Administration’s regulation of tobacco products. NEJM. 1996;335:998-994. |
