g., initiation, continued use, and reuptake), including those products that are smuggled and unregulated. Understanding the impact of a product on population harm will http://www.selleckchem.com/products/Paclitaxel(Taxol).html require risk assessment and modeling methods that take into consideration all these interacting factors. Using this framework, the research opportunities addressed in this article are primarily focused on testing the toxicity and potential health effects, examining the abuse liability and product appeal and consumer perception of a product and assessing the extent of uptake, continued use, and pattern of product use and other tobacco use. These topics will be touched upon in the four main areas covered in this paper: modified risk products, products used to treat tobacco dependence, tobacco product standards, and consumer perception testing.

Identifying and addressing research questions in these areas will help to enable good science to guide the implementation of tobacco product evaluation so that sound policy decisions are made that will benefit overall public health. Modified Risk Products What the Law Provides A modified risk product is defined as ��any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.�� Section 911, Modified Risk Tobacco Products, states that ��the Secretary shall issue regulations or guidance (or any combination thereof) on the scientific evidence required for assessment and ongoing review of modified risk tobacco products��.

Regulations and guidance shall ��(a) establish minimum standards for scientific studies needed prior to approval to show that a substantial reduction in morbidity or mortality among individual tobacco users occurs �� or is reasonably likely; (b) include validated biomarkers, intermediate clinical endpoints, and other feasible outcome measures, as appropriate, (c) establish minimum standards for postmarket studies that shall include regular and long-term assessments of health outcomes and mortality, intermediate clinical endpoints, consumer perception of harm reduction, and the impact on quitting behavior and new use of tobacco products, as appropriate; (d) establish minimum standards for required postmarket surveillance, including ongoing assessments of consumer perception; and e) require that data from the required studies and surveillance be made available to the Secretary prior to the decision on renewal of a modified risk tobacco product.

�� History of Regulation To date, there has been no precedent for regulating the evaluation of modified risk tobacco products. What is Known Modified risk tobacco products Anacetrapib have entered the U.S. market with implicit or explicit claims for reduced toxicant exposure or reduced health risk.