arrows arrow-right arrow-left menu search rss youtube linkedin twitter facebook instagram arrow-play linkedIn
Navigate the Regulatory Process with Confidence We'll help you find the fastest path to market approval for your new tobacco products.

Regulatory Support for Tobacco & Nicotine Delivery Products

From cigars and cigarettes to electronic nicotine delivery systems, Battelle has operated at the forefront of nicotine and tobacco research for decades. Our experienced team can help you navigate the regulatory process with confidence and define the needed studies while maximizing published literature and existing data sources to find the fastest path to market approval for your new tobacco products.

Applications

regulatory support for tobacco and nicotine delivery productsWe provide support for:
  • Premarket tobacco applications (PMTA)
  • Substantial equivalence applications (SE)
  • Modified risk tobacco product applications (MRTP)





Need tobacco or nicotine delivery study support?
Contact Us

Capabilities

various materials used for e-cigarettesAt 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 science, defensible data and identify novel methodological solutions to meet the regulatory needs of this highly variable marketplace. 

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 (ENDS), heat not burned  tobacco and other products. 

Services

battelle's tobacco expertise and servicesBattelle offers a comprehensive suite of regulatory-driven services for tobacco and nicotine delivery companies. We design and execute studies that give you the answers you need to make business decisions, minimize the risk and improve the quality of your products, and maximize your chances of a smooth regulatory submission.

Literature Analysis To Support Bridging And Premarket Tobacco Applications 
We use advanced analytical methods and tools to scan the available literature for published studies that provide evidence for premarket tobacco applications. Our proprietary bridging algorithm 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 literature for a PMTA and discover thematic connections across large bodies of published studies. 

Secondary Data Analysis to Support Bridging and Premarket Tobacco Applications 
Battelle offers expertise in the analysis of survey data that can be applied to a variety of U.S. government (e.g. PATH, NYTS/NATS, BRFSS, NHANES), commercial (e.g. Nielsen), and international (e.g. GATS/GYTS) datasets related to tobacco. We have experience using propensity score matching and longitudinal analysis methods to draw causal inferences from observational data. This experience can be applied to answer critical questions about real-world tobacco use behaviors across populations and over time to inform sections of the PMTA. Secondary analyses are often used to inform clinical and social science data collection and aid in the synthesis of findings from multiple sources and would be an appropriate source of findings to include in applications.

Chemical Analysis and Testing 
Either at Battelle or through partners, we conduct validated, regulatory-compliant chemical analysis of tobacco and nicotine products, and their smoke of vapor, for accurate characterization of all types of tobacco and nicotine products. We can also provide novel chemical analysis and method development to meet unique analytical needs and improve testing sensitivity, precision or speed. In addition to chemical analysis, can provide the physical analysis of products, including properties such as weight, amount, homogeneity, and color.

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 nonclinical toxicology studies under regulatory compliant (FDA) guidelines. Our studies are designed to provide a toxicological assessment of a product so you can make informed decisions about the impact on public health. Learn more.

Consumer Perception and Behavior
Our human factors team conducts studies on consumer understanding of product labeling and instructions, on the normal use and foreseeable misuse of your product, and on user-related hazards and misuse risk. Our team of experts will work with you to identify potential user risk and to develop appropriate risk minimization controls. Learn more
 
Clinical Studies 
We conduct  clinical 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.
 
ENDS Device and Battery Safety 
Battery safety is a growing concern among e-cigarette and vape consumers and regulators. Our battery safety experts will evaluate your device against FDA guidelines and UL Standards for ENDS battery safety and determine the most likely internal and external causes of battery failure and assign a severity risk to each cause, so you understand the overall risk profile. We will recommend solutions to reduce the risks of an adverse event and improve the safety of your product.   

Benefits

chew tobacco pouchesAt Battelle, you’ll find the expertise you need to generate the comprehensive information required for your regulatory submission. We can reach across Battelle to find expertise in a broad range of disciplines—including public health, toxicology, chemistry, engineering, human factors and environmental science—to employ a variety of scientific approaches to meet the diversity of the marketplace. We’ll make sure you get the right-sized, accurate, reliable data you need while streamlining study costs and timelines.