ENDS US 2019

Regulatory Support for Tobacco & Nicotine Delivery Products

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 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. 

We provide support for:

  • Premarket tobacco applications (PMTA)
  • Substantial equivalence applications (SE)
  • Modified risk tobacco product applications (MRTP)

Learn more about our capabilities and services here.