JUUL Labs utilizes a complementary array of scientific methods to characterize the composition and impact of its products. Our studies span preclinical, clinical and behavioral / perceptual realms, and include randomized controlled trials, observational studies, durable surveys, and other designs. The latest draft FDA guidance for Pre-Market Tobacco Applications (PMTA)¹ highlights the following types of studies, which may include characterization of the product as well as its relative performance and impact compared to other tobacco products.

Compositional Analysis and Product Properties

A description and characterization of the manufacturing process, and components, ingredients and additives of the final product, including leachable and extractable constituents, and composition of e-liquid and aerosol over time (HPHC).

Nonclinical Toxicology

Impact of e-liquid and aerosol on model systems, including in vitro cellular assays of cytotoxicity, genotoxicity and mutagenicity; organ systems analyses; and literature reviews.

Environmental Analysis

Exposure levels and impact of product on others in the same room and on the environment.

Clinical Studies

Characterization of topography (patterns of inhalation), pharmacokinetics (nicotine exposure patterns), abuse liability, and patterns of use and displacement of cigarettes, inclusive of impact on key biomarkers of exposure associated with complete switching.

Perceptual, Behavioral, and Observational Studies

Surveys which examine real-world use patterns, population prevalence, and perceptions of marketing and labeling. These types of studies span the likelihood of both positive and negative patterns of use, including impact both on adults and youth.

• Adult smokers successfully displacing cigarettes
• Current non-users (re)initiating tobacco use
• Consumers adopting the product and then switching to cigarettes
• Consumers using the product in conjunction with other tobacco products
• Relative rates of quitting use of nicotine
• Integrated modeling of net population impact

1. “Draft Guidance for Industry – Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems.” U.S. Food and Drug Administration, May 2016,
   https://www.fda.gov/downloads/tobaccoproducts/labeling/rulesregulationsguidance/ucm499352.pdf
   Last accessed: 29 Nov. 2018