SREC Project Overview
The SREC was developed as a collaboration between NJOY LLC and NIDA. The goal of the Project is to facilitate clinical research into the impact of e-cigarettes on public health.
- The SREC was designed to be a standardized device that produces a consistent, well-characterized aerosol.
- The SREC has an associated data package sufficient to support FDA-authorized clinical investigations.
- The SREC is available to researchers in four flavors, with placebo and nicotine containing pods/cartridges.
- The design criteria recognized that clinical studies occur over several years. The SREC device is intended to remain constant over time with no unreported modifications.
- The SREC is intended for use in NIH-funded human subject studies. Requests to purchase for any other use will be reviewed by NJOY, LLC on a case by case basis.
- Please go to www.srecproduct.com to get further information about purchasing the SREC.
Inquiries to NIDA Program
For inquiries on the SREC and NIDA Research please contact NIDA_SREC_INFO@nih.gov
- In order to use the SREC in human subject studies, an Investigational Tobacco Product (ITP) authorization must first be obtained from the FDA. Guidance on how to file an ITP
- When filing the ITP application, you will need to include a Letter of Authorization (LOA) from NJOY, LLC.
- The LOA indicates that your application has NJOY’s permission to cross-reference the SREC Tobacco Product Master File, which is on file with The FDA Center for Tobacco Products.
- You should request the LOA when you contact NJOY, LLC, regarding your purchase of SREC.
- Submit the ITP application to:
Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Avenue
Attn: Document Control Center
Building 71, Room G335
Silver Spring, MD 20993-0002