Evaluation of the Microbial Parameters of E-Liquids (ENDS)

The Food and Drug Administration (FDA), Center for Tobacco Products (CTP) requires a contractor to provide microbiological analyses of the following parameters in electronic nicotine delivery systems (ENDS) e-liquids:

• water activity (aw)
• antimicrobial effectiveness testing (AET)
• total aerobic microbial counts (TAMC)/total yeast and mold count (TYMC)
• endotoxin
• (1→3)-β-D-glucan
• N-nitrosnornicotine (NNN) and 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK)

The purpose of this project is to determine baseline levels of each parameter in a variety of ENDS e-liquids.  We will test laboratory-prepared e-liquids first, in order to examine the role of specific parameters (PG/VG levels, nicotine levels, flavors) in anti-microbial properties of the e-liquid.  Next, we will test commercial e-liquid samples (at least three batches per e-liquid).  Samples will be stored at ambient temperature in original containers and may be pooled by batch using aseptic techniques in order to obtain enough volume for all testing.   Triplicate samples will be tested for each parameter at defined time points from initiation of study in order to provide data over a simulated stability period.  Expiry of each product should be noted at the time of purchase prior to initiation of the study. 

The contractor needs to have the following skills/capabilities: Ability to perform work as stated in the SOW. Ability to have the equipment and facilities necessary to perform the work and be ISO 17025 certified.

The Contractor is expected to complete these tasks within 18 months of the award. We anticipate delivery of samples within two monthsafter the award. This may provide the contractor time to access validated methods and methods that need to be validated.