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​Are Manufacturers Ready for New e-Cigarette Regulations?

Electronic cigarettes will soon face the same regulatory requirements as traditional cigarettes and smokeless tobacco products. E-cigarettes deliver nicotine to the respiratory tract without exposure to the more than 7,000 compounds (some of which are known to be toxic) produced by products that combust tobacco. But testing these emerging products will require new methods for conducting required inhalation exposure studies. Researchers at Battelle have been working for the last three years to perfect aerosolization methods and in vivo methodologies to help manufacturers meet the new requirements.

While some manufacturers have long conducted in vivo toxicology studies of cigarettes and other combustible and smokeless tobacco products, the Tobacco Control Act of 2009 established regulations requiring extensive characterization of regulated tobacco products before new products are marketed in the United States. The new FDA Deeming ruling, published in the Federal Register May 10, extends these requirements to e-cigarettes, hookahs, pipe tobacco, premium cigars, little cigars and other emerging tobacco products.

Unlike some tobacco products that burn tobacco to produce smoke, e-cigarettes heat liquids containing a vehicle, nicotine, flavorings and other chemicals to generate an inhalable aerosol. Complicating matters, there are dozens of different types of e-cigarettes on the market with different shapes, delivery systems, heating mechanisms and vehicle formulations. Each of these variables, along with variations in user behavior, may impact product performance. 

Researchers began working on these challenges in 2013 as an internal research project in order to prepare for the eventual FDA regulation of e-cigarettes. This foundational research will allow Battelle to conduct well-controlled and characterized studies of e-cigarette products. Battelle is also working with manufacturers to optimize specialized aerosol generation equipment for future e-cigarette studies.

To better meet the needs of the industry, Battelle has recently doubled its lab space for inhalation toxicology studies. The Battelle Inhalation Toxicology Center is now among the largest specialized in vivo laboratories in the United States, with capacity to perform specialized inhalation studies to help manufacturers accelerate study timelines. In addition to standard study types, Battelle has the ability to work with a customer to design studies to address unique challenges. The Inhalation Toxicology Center brings together expertise in toxicology, pathology, biochemistry, engineering, aerosolization, and many other related fields in order to develop and validate new methods. In addition to tobacco studies, the Center performs extensive research for the National Toxicology Program and the pharmaceutical industry. 

Battelle has been working at the forefront of tobacco and nicotine research since 1960 and has extensive experience conducting in vivo inhalation toxicology studies for traditional tobacco products, including cigarettes and other combustible products. In addition to extensive in vivotoxicology work, Battelle also provides product characterization as well as human exposure and behavioral studies through the Battelle Public Health Center for Tobacco Research. The e-cigarette research is a continuation of Battelle’s historical tobacco Harm Reduction efforts.   

Battelle’s ongoing internal research will inform development of a knowledge database that will help the FDA and manufacturers better understand how all of the different variables in e-cigarette design and product formulation impact exposure risks.