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ENDS Industry Faces Tighter PMTA Submission Deadlines with May 2020 Fast Approaching

ENDS Industry Faces Tighter PMTA Submission Deadlines with May 2020 Fast Approaching

FDA June 2019 PMTA Guidance Deadline for Submission

In June of 2019, the FDA issued its final guidance on the Premarket Tobacco Application (PMTA) which detailed that e-cigarette, e-liquid, and vaping manufacturers need to submit their PMTA by August 2021.

E-liquid manufacturers, along with their partners in the testing space, including analytical laboratories, toxicology and clinical partners, and attorneys and consultants, were under the impression they had just 2 years to start and complete their PMTA submission to the FDA.

However, submission deadline has recently been shortened to May of 2020.

Why was the PMTA Submission Deadline Moved Up to May 2020?

Back in March of 2018, a group of plaintiffs including the American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, American Academy of Pediatrics, Truth Initiative, and the Campaign for Tobacco-Free Kids filed a lawsuit against the FDA for delaying the commencement of the PMTA.

On July 11, 2019, the Maryland District Court made its final decision that PMTAs for products already on the market are due in just 10 short months (May 2020) with a 1 year marketing exemption period for new products.

As of July 11, 2019, the FDA has 30 days to appeal this decision, and there is some speculation that the FDA will not appeal this decision. If the 30 day window passes, May 2020 will remain the date for PMTA submissions.

How Can Avomeen Help You Meet the Accelerated Timeline for FDA PMTA Submission?

Avomeen is an independent e-liquid, e-cigarette, and vape testing lab proudly serving entrepreneurs, manufacturers, distributors, lawyers, other laboratories, and companies of all sizes. We are an FDA-registered lab with years of experience working on successful FDA regulatory submissions. Our team of regulatory and industry experts are experienced with new testing standards pertaining to the e-liquids/e-cigarettes and the FDA’s Premarket Tobacco Application (PMTA) requirements.

We customize our approach for every customer we serve and offer full support for your projects. Our regulatory consultants can aid your team in their efforts to gain FDA approval, both during and after a project is completed. Get in touch with us to discuss your project.

Additional Resources

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.

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.

 

 

Our expert blogger is Dr. Derek Beachamp, Avomeen’s Senior Technical Director of Analytical Sciences. His knowledge of the PMTA and nicotine testing have been showcased in vape industry publications including Smoke and Vape Business Solutions and Vapor Voice. 

Learn more about Derek’s expertise and experience.