The Family Smoking Prevention and Tobacco Control Act was approved by Congress on June 12, 2009, and is on its way to President Obama. The bill for the first time gives the U.S. Food and Drug Administration (FDA) the power to regulate tobacco, but not ban tobacco products outright. The agency may also limit nicotine, but may not require it to be removed completely. Particular tobacco products, just like other FDA-regulated products, may be found to be “misbranded” or “adulterated” by FDA and subject to an array of enforcement actions, including seizure of the products. The new tobacco center will be partially funded by user fees, similarly to other centers.
What’s at Stake
The act marks a significant shift in focus at FDA. The relative weight within FDA of the tobacco center compared to existing centers, such as those for drugs, devices or foods, has yet to be determined, but it will certainly absorb time, funds and senior talent. Tobacco is estimated to be responsible for 400,000 deaths per year, according to the Centers for Disease Control and Prevention, far more than any other single product FDA regulates, and as such is a critical public health issue. A lengthy conversation internally at FDA over balance among the centers will undoubtedly occur over the next months and years. The bill’s implementation will likely receive a great deal of attention from the No. 2 at the U.S. Department of Health and Human Services, Deputy Secretary Bill Corr, former executive director of the Campaign for Tobacco-Free Kids.
Steps to Consider
Because the new tobacco center at FDA may divert resources and focus from other centers, and may slow down initiatives (or possibly even approvals) at the drug, biologics or devices centers, interested parties should watch this space closely and stay alert to the potential impact on approvals and needed initiatives being carried out by FDA and its other centers.