In 2019, some significant dates and timelines for the Premarket Tobacco Application (PMTA) were established. In June of 2019, the FDA issued its final guidance on the PMTA stating that vaping manufactures need to submit their PMTA by August 2021. This time frame was very short lived, as in July of 2019, the Maryland District Court issued its final decision that the due date for PMTA submissions was shortened to May of 2020.
FDA Has Banned Flavored E-Cig Cartridge Products
Now on January 2, 2020, the FDA has formally banned all fruit and mint flavored e-cigarette cartridge products. The FDA is specifically banning fruit and mint flavored cartridge based nicotine pod systems, such as Juul and NJOY. However, FDA is allowing vape shops to continue selling tank-based flavored nicotine liquids.
What’s Next for Non-Pod Based E-Liquids
With the news that non-pod based e-liquids are allowed under the current ruling, non-pod based ENDS and e-liquid products are facing an even tighter timeline to complete and submit their PMTA to comply with FDA regulations.
Avomeen Helps Vape Companies Comply with PMTA Guidance
Avomeen is ready to assist our clients that serve the vaping industry comply with the FDA’s PMTA guidance for flavored e-liquid based products. With years of experience supporting regulatory submissions in our FDA-registered, GMP-compliant facility, Avomeen is a trusted partner for industry-leading ENDS companies. Get in touch with us to see how we can help you meet the May 2020 deadline.
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.
Unsure how you’re going to meet PMTA submission deadlines and comply with 2-year stability requirements? Look to our blog for more information.
Our expert blogger is Dr. Derek Beachamp, Avomeen’s Senior Technical Director of Analytical Sciences. His PMTA regulatory pathway expertise has been featured in industry publications including Vapor Voice and Smoke & Vape Business Solutions.
Learn more about Derek’s expertise and experience.