Repurposing of FDA-approved medications as novel smoking-cessation agents represents an opportunistic way most to accelerate the process of drug discovery and has the potential to save considerable financial resources usually devoted to developing, testing, and obtaining regulatory approval for new drugs. Table 3 highlights examples of FDA-approved medications for other indicati
New tobacco control measures are urgently needed. As of 2010, 19.3% of adults in the United States continue to smoke, and about half of those smokers are expected to die prematurely from illnesses related to their use of tobacco (CDC, 2002, 2011). The United States Food and Drug Administration (FDA) was recently given the authority to regulate tobacco products under the Family Smoking Prevention and Tobacco Control Act (FSPTCA; U.
S. Congress, 2009). This legislation provides a powerful tool for reducing the harm associated with smoking at the policy level. One important implication of this law is that cigarettes��the most lethal tobacco product of all��will now be evaluated with respect to the public health consequences of use. This increased authority to regulate tobacco in the United States echoes a global change. Article 9 of the World Health Organization Framework Convention on Tobacco Control (WHO FCTC), ratified by over 170 countries, states that the countries agree to establish shared guidelines for evaluating and regulating the content and emission of tobacco products (WHO, 2003). The FSPTCA and WHO FCTC render scientific investigations into the abuse liability, harm, and effects of tobacco more critical than ever.
With this changing landscape, researchers who study tobacco using animal models have the opportunity to conduct studies that could impact regulatory decisions. This type of work��regulatory science��strives to contribute to the development of standards that regulatory agencies can use to assess the performance of the products they regulate (IOM, 2011). These efforts go beyond the basic science purpose of elucidating the mechanisms and enhancing the understanding for various phenomena; rather, they serve to provide the empirical basis for policy decisions that may impact the lives of many. The demand for this information places responsibility on nicotine and tobacco Cilengitide scientists with a wide range of expertise to answer critical questions related to the FSPTCA and WHO FCTC (Hatsukami et al., 2010). A key area for investigators to explore relates to the potential regulation of nicotine content. In the United States, the FSPTCA enables the FDA to establish tobacco product standards, including limits on the constituents in tobacco products (U.S. Congress, 2009).