Today, by a vote of 326 to 102, the House of Representatives approved a bill that would authorize the Food and Drug Administration to regulate tobacco products. Assuming the Senate follows suit, a veto seems likely. Secretary of Health and Human Services Michael Leavitt has said he will recommend one. In a July 21 letter to Rep. Joe Barton (R-Texas), the ranking Republican on the House Energy and Commerce Committee, Leavitt said "the Administration would strongly oppose this legislation" and raised various objections:
The regulatory obligations created by the bill would be a significant added responsibility for the Food and Drug Administration and one that is inconsistent with FDA's mission of ensuring food safety and the safety and effectiveness of drugs, biologics, and medical devices.
Unlike the medical products FDA regulates, tobacco products cannot be made safe, and there is no medically established public health benefit associated with tobacco.
Adding tobacco to FDA's regulatory responsibilities could also leave the public with the misperception that tobacco products are safe, or at least safer, with the FDA regulating them….
Implementing H.R. 1108 would require the FDA to establish a new center for tobacco control. This would impose an enormous implementation and resource burden on FDA at a time when it is faced with implementing the numerous provisions of the FDA Amendments Act of 2007 and undertaking efforts to enhance food safety and improve oversight of imported drugs and devices.
FDA does not have expertise focused on tobacco products, and establishing such a center would require a huge staffing effort and infrastructure development….
The bill may spend more than it raises in revenues [from industry fees]. This could result in diverting personnel and resources from the current programs within the FDA, with the potential to seriously undermine the public health. Moreover, this regressive tax [i.e., the cigarette price increase necessary to cover industry fees] will be borne disproportionately by lower-income individuals. The Administration strongly opposes tax increases to expand the size and scope of government….
Our trading partners believe that by banning the sale of clove cigarettes but not prohibiting the sale of menthol cigarettes, the bill raises questions under U.S. international trade obligations. The government of Indonesia has repeatedly objected to the bill on the ground that this disparate treatment is unjustified and incompatible with WTO trade rules.