NIDA Standardized Research Electronic Cigarette (SREC) for Clinical Research
The SREC was developed as a collaboration between NJOY LLC and National Institute on Drug Abuse (NIDA), part of the National Institutes of Health. 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.
For more purchasing information please contact Mohamadi Sarkar. Pricing is $10 per Pod and $10 per Device containing battery.
For more information on SREC at NIDA please contact NIDA_SREC_INFO@nih.gov
- Volume of liquid per pod 1.9 mL
- Active (nicotine USP 5% wt/wt) and placebo (nicotine 0%)
- Propylene Glycol USP & Vegetable Glycerin USP – PG/VG Ratio 0.77
- Lactic Acid USP (5% nicotine pods only)
- Artificial flavor ingredients
- Flavors (Active and placebo)
- Rich Tobacco
Aerosol Characteristics (per 55 mL / 3 s puff)
- Aerosol Collected Mass ~ 6 mg
- Propylene Glycol ~ 2 mg
- Glycerol ~ 3 mg
- Nicotine ~ 0.3 mg
- Cotinine ~ 0.07 μg
- Myosmine ~ 0.05 μg
- Nornicotine ~ 0.04 μg
- Anabasine *BDL (0.004 μg #LOD)
- Anatabine BDL (0.004 μg LOD)
- Beta-nicotyrine BDL (0.004 μg LOD)
- Acrolein ~ 0.04 μg
- Acetaldehyde ~ 0.03 μg
- Formaldehyde ~ 0.03 μg
- Acetyl Propionyl BDL (0.0168 μg LOD)
- Butyraldehyde BDL (0.006 μg LOD)
- Crotonaldehyde BDL (0.006 μg LOD)
- Diacetyl BDL (0.006 μg LOD)
- Nickel ~ 0.005 μg
- Lead ~ 0.0002 μg
- Cadmium BDL (0.0006 μg LOD)
- Chromium BDL (0.0007 μg LOD)
*BDL = Below Detectable Limits, #LOD = Limit of Detection
Information is available upon request by researchers for use where needed for NIH grant application submissions or IRB review.
- The SREC cannot be used in human studies with a primary aim of eliminating nicotine use, i.e., nicotine cessation studies. If employed in this manner FDA would consider the SREC to be a drug /device combination, requiring an Investigational New Drug (IND) application approval. At the current time, the SREC Product Master File does not meet IND requirement guidelines.
- 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