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Battelle Life Sciences Research CRO+ Today

Battelle Life Sciences Research CRO+ Today

October 2015 - Issue 2

Battelle to Support New Tobacco Research for FDA

Battelle is pleased to have been awarded a five-year, $9 million Indefinite Delivery/Indefinite Quantity (IDIQ) contract by the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP). Through this contract, Battelle’s Life Sciences Research team in West Jefferson, Ohio, will help the FDA characterize the toxicity of the various ingredients in tobacco products, including new harm-reduction products like e-cigarettes.

The research will help the FDA define the regulations needed to implement the Family Smoking Prevention and Tobacco Control Act. This act gives the FDA authority to regulate the manufacturing, marketing, and distribution of tobacco products to protect the public health. 

“This contract win demonstrates that the FDA sees the breadth of capabilities available at Battelle to accomplish their tobacco research goals. We can help them understand tobacco products from a variety of aspects – from human behaviors and addiction to toxicological effects,” said April Brys, a manager in the Life Sciences Research business unit. 

In recent years, there has been an explosion of new tobacco and nicotine product options, including e-cigarettes and oral nicotine delivery products. While use of traditional cigarettes has declined, interest in newer products like tiny flavored cigars, waterpipes and vaporizers with flavored tobacco products has grown, especially among youth. Research is desperately needed to study exposure levels, toxicity and behavioral impacts of these new products. 

Battelle has a long history of work in tobacco research. Since the 1970s, Battelle researchers have been on the front lines of tobacco research with extensive experience in testing cigarettes and tobacco products to uncover any toxic effects on users. The Battelle Public Center for Tobacco Research is nationally and internationally known for cutting-edge work with a wide variety of tobacco and nicotine products, including cigars and cigarettes, smokeless tobacco products, e-cigarettes, waterpipes and other emerging tobacco and nicotine delivery products.

Under this new award, Battelle Life Sciences Research will perform in vivo inhalation studies to understand the toxicity of tobacco product components, ingredients, byproducts (smoke, aerosols, etc.), and additives, including other constituents, flavors, humectants, essential oils, resins, and herbal extracts, from traditional tobacco products (cigarettes, cigars, cigarillos, etc.), electronic cigarettes, electronic cigarette solutions, and other nicotine delivery systems.

“What are the toxic effects of tobacco products? And, how can we ensure that new products marketed as safer are indeed safer? These are important questions to answer as the FDA seeks to regulate the tobacco industry. We’ll do our best science to help them understand and calculate consumer risk,” said April.