Regulatory Support for Tobacco Products

We provide support for:

• Premarket tobacco applications (PMTA)
• Substantial equivalence applications (SE)
• Modified risk tobacco product applications (MRTP)
• Investigational tobacco product applications (ITP)
• Preclinical and clinical studies
• Human factors studies

At Battelle, we’ve been studying nicotine and tobacco products for more than 50 years and have a deep understanding of Food and Drug Administration (FDA) regulatory requirements. We bring together experts from a broad range of disciplines to provide high quality, defensible data and find novel solutions for out-of-the-ordinary research challenges. 

Our research experience spans the full range of tobacco products available, including cigarettes, cigars, smokeless tobacco, waterpipes, electronic cigarettes (e-cigarettes), many other types of Electronic Nicotine Delivery Systems (ENDSs), heated tobacco cigarettes and other products. 

Literature Analysis To Support Bridging And Premarket Tobacco Applications 
We use advanced analytical methods to scan the available literature for published studies that provide evidence for premarket tobacco applications. The algorithm automatically extracts and represents the knowledge contained in scientific, technical, or general text in a form that enables complex query and knowledge discovery/ visualization. This allows us to streamline the process of finding and leveraging data for a PMTA and discover connections hiding in large bodies of published studies. 

Product Characterization and Analyses 
We apply, develop and validate regulatory-compliant chemical measurement methods to characterize product components, ingredients, liquids, additives and flavors. Our staff conduct highly accurate and reliable chemical analysis for precise measurement of volatile and semi-volatile organic compounds (VOCs/SVOCs), heavy metals, particulates and tobacco-specific nitrosamines in complex mixtures, including vapors and aerosols. 

Toxicology Studies
We have one of the largest specialized in vivo laboratories in the United States, with more than 30 years of experience conducting specialized inhalation toxicology studies for government and commercial clients in the pharmaceutical, agricultural, chemical and tobacco industries. Our research team provides accurate, objective data for preclinical toxicology studies under regulatory compliant (FDA) guidelines. Learn more.

Preclinical and Clinical Participant Studies 
We conduct both preclinical and clinical participant studies at our specialized facilities to collect data on user behavior, abuse liability, nonclinical health risk, human health impact and biomarkers of exposure. Our studies are designed to help you understand how product characteristics, user behavior and exposure interrelate so you can make informed decisions and gather the data you need to support market approval. Learn more.

Human Factors Studies 
We can help you understand pre-market evaluation and post-market activities. Our human factors team will guide you on how product design and labeling impact user behaviors (including initiation, cessation, and dual use) as well as consumer perceptions and risks.

At Battelle, you’ll find all the expertise you need under one roof. We can reach back across Battelle to find expertise in a broad range of disciplines—including chemistry, bioinformatics, economics, engineering, mathematics, medicine, psychology, pharmacology, statistics and toxicology—to develop new methods and solve difficult study challenges. We’ll make sure you get the accurate, reliable data you need while streamlining study costs and timelines.