Vaporizer Device Expiration Date Testing

The implementation of Vaporize Delivery Device expiration dates began on July 1, 2022. We have been getting many questions from clients on how they are able to determine expiration dates effectively and compliantly. While we always recommend reaching out to your compliance team for verification, this page will cover how to establish expiration dates for your product based on our interpretation of the rules set forth by the MED.

On page 124 and 125 of the Colorado Marijuana Rules, Section 3-335(M) details the requirement for licensees to provide expiration dates on their Vaporize Delivery Devices by July 1, 2022. There are a few key takeaways from this section:

1. The MED is very explicit that you must collect data through testing in order to assign an expiration date for vaporizers produced after July 1st. The best way to do this is by creating your own in-house R&D study. This can be accomplished by retaining a certain amount of R&D vaporizers from a production batch and submitting them for potency/contaminant testing monthly over a set period of time. This R&D batch should never be used for sale and should begin with an initial R&D test followed by monthly. Each month your R&D batch passes testing is an additional month to your expiration date.
 
For example, if you create an R&D batch on May 30th that passes testing and then submit the same batch on June 30th and it passes too, that product would have an expiration date of 30 days. On July 30th, you would then submit the R&D batch again for the next monthly testing. If it passes, that extends your expiration date another 30 days for that item, and you can now label your products with a two month expiration. It is up to you how long you conduct this study. In the next section, we provide more detail on what to take into consideration when making this decision.
 
2. The period of time in which you study the Vapor Delivery Devices should take into account the following:
a. The known expiration of any additives you use in the product (terpene blends, flavor additives, etc.)
b.The behavior of the hardware (ex: if it leaks after a certain amount of time)
c. How the final formulation acts over time (if it separates, if it crystalizes, etc.)
d. The ideal storage conditions for the product (in a dark, cool area, within specific packaging, etc.)
For example, if you add a terpene blend to your vape that has a known expiration of six months but the hardware will start to leak/malfunction after four months, the maximum amount of time you should spend on your expiration study for this product is four months. 
3. Licensees are required to establish separate expiration dates for each SKU within your product line. If there are multiple variations of a SKU (strains/flavors) and they are formulated in the exact same way as one another, they can be grouped into one SKU for the purposes of the expiration date study. However, if you have a few variations of a SKU that are made in different ways (different terpene ratios/oil types), you would technically have to do separate studies for each variation. 
 
For example, if your company creates 500mg and 1000mg distillate vapes, you would need to create two separate R&D batches for each size.
 

Now that we’ve covered our interpretation of the new rule, here are some tips to ensure your study goes smoothly. 

When your R&D batch is created, it is very important that you have enough product set aside to comfortably test over the study period. For example, if you are performing a six month study on a vape product, you will need to make sure you have six months worth of full panel testing. We require about six grams for full panel vaporizer testing (potency, residual solvents [if solvent-based], microbial contaminants, pesticides, heavy metals). This means you should save at least 36 grams worth of product for a six month study. 

In the event of an MED audit, they will be looking to see your testing records to confirm your expiration date on your products. We recommend creating a spreadsheet that logs the SKU/product being studied, the date of R&D submissions, and the results of each test at the very least.

Questions or concerns? Contact our Denver or Pueblo laboratory today to request more information or visit our homepage for more details on Nordic Analytical Laboratories!