For vape, e-liquid, and ENDS companies looking to comply with the quickly approaching May 2020 Premarket Tobacco Application (PMTA) filing deadline, stability data must be included in their PMTA submission. If you’re familiar with the PMTA guidance, you may be wondering how 2 years of stability data can be generated in a few months’ time to include in a PMTA. In short, it can’t – but you can still submit the PMTA on-time and remain in compliance.
FDA Regulatory Submissions Can Include a Commitment to Complete a Stability Study
It’s common in the biopharma industry to provide regulatory submissions to FDA without complete stability information, and it’s no different with the PTMA. To meet the stability requirements of the PMTA, e-cigarette companies must complete both an accelerated and real-time stability study. A PMTA can be submitted to FDA with stability data that’s been generated up until the time of submission, with a commitment to complete the study. It’s then the responsibility of the company filing the PMTA to submit data for each time point the product is tested while on stability, once the testing for each pull is complete.
Accelerated & Real-Time Stability Studies Explained
Accelerated Stability Studies of ENDS Products
An accelerated stability study is just what it sounds like – a stability study that’s completed on an expedited time frame. E-liquid, e-juice, and vape flavor products are subjected to elevated temperature and humidity levels in a controlled environment. Typically, 1 month in accelerated conditions is equivalent to 4 months at ambient (room) temperature. Samples of the product are removed from stability chambers at regular intervals and tested for physical and chemical characteristics. The rate of chemical and physical degradation of the product provides data that allows scientists to calculate the degradation and expiry at ambient temperature. However, regulatory submissions also require real-time stability data to ensure that projected expiry and degradation rates are accurate.
Real-Time Stability Studies of E-Liquid, E-Cigarette & Vape Products
Real time stability studies are conducted in real-time. For a 2 year study, like the one required for PMTA submissions, ENDS, e-cigarette, and e-juice products must remain in a controlled environment with consistent ambient temperature and humidity levels for a 2 year period. At regular intervals (also known as time points or pulls), samples of the product are tested for physical and chemical characteristics, per an established protocol. The real-time stability study is completed concurrently with the accelerated stability study, and FDA requires the results of the real-time stability study be submitted to confirm product expiration and shelf life.
How Avomeen Helps ENDS Companies Comply with PMTA Regulatory Requirements & Filing Deadlines
Avomeen is an FDA-registered, GMP-compliant lab and we have years of experience supporting regulatory submissions and filings. We’re ready to assist our clients that serve the vaping industry comply with the FDA’s PMTA guidance for e-liquid products. Get in touch with us to see how we can help you meet the May 2020 deadline and learn more about our role as a trusted partner for industry-leading ENDS companies.
To help you understand some of the important methods and relevant equipment required for e-liquids testing, we’ve put together some Cliff Notes to help you navigate this complicated environment.
Want to know more about the new PMTA guidelines? Check out our blog, What You Need to Know About the FDA’s New PMTA Guidance.
We’ve outlined the major similarities and differences between the 2016 and 2019 PMTA guidance in our blog, Overview of Premarket Tobacco Application (PMTA) FDA Guidance for ENDS.
The 9 most commonly asked questions about PMTA requirements are answered in our blog, 2019 FDA PMTA Guidance FAQs.
Is finding the right lab to partner with stressing you out? Our blog, Choosing the Right Lab for PMTA Compliance, offers some guidance.
Extractables & Leachables (E&L) testing is required in the new PMTA guidance. Our blog, E-Liquids Extractables and Leachables Testing for the PMTA, outlines what you need to know about this integral part of the submission.
Want to know more about bridging studies and how they’re utilized in the PMTA? Check out our blog, The Use of Bridging Studies in the PMTA.
With the court ruling on July 11, 2019, the deadline for submissions has been moved up significantly. For more information, check out our blog, ENDS Industry Faces Tighter PMTA Deadlines with May 2020 Fast Approaching.
FDA is actively enforcing PMTA guidance. Check out our blog, FDA Issues Warning Letters for E-Liquid Products without Marketing Authorization, for more details.
We’ve outlined some common regulatory strategies that have emerged amongst leading ENDS manufacturers in our blog, Will my E-Liquid Product Receive PMTA Authorization?
Concerned about state-led e-liquid bans? Check out our blog, Proposed E-Liquid Bans and the PMTA, for insight into how state-led policies are impacting submission strategies.
In January of 2020, FDA banned flavored e-cigarette cartridge products. Learn more in our blog.
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