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2019 FDA PMTA Guidance FAQs

2019 FDA PMTA Guidance FAQs

9 Common Questions About the FDA’s new PMTA Requirements

With the new FDA PMTA guidance that was released in June 2019, we have received a myriad of questions regarding the guidance, regulatory pathways, and the testing required for a successful PMTA submission.

So if you’re wondering about the FDA’s new PMTA requirements, here are the answers to nine of the most  the most commonly asked questions about the PMTA that aren’t about cost.

1) Is a stability study required for my PMTA submission?

A stability study will determine the life span, or shelf life, of the product. This study could be an accelerated (higher temperature and relative humidity storage) or a real time study (stored in typical environmental conditions. The PMTA requires:

2) Is Avomeen an FDA registered lab and does Avomeen have experience with the FDA?

Avomeen is an FDA-registered, ISO 17025 accredited laboratory with a proven track record of completing, not only stability studies, but countless testing for many successful FDA submissions. Our regulatory experts have decades of experience supporting FDA submissions and responses, and have a full understanding of FDA guidance, processes and procedures.

3) Should I deformulate my E-Liquid?

The FDA will require a complete list of uniquely identified components, ingredients, and additives by quantity in each product. A deformulation will answer these questions, especially if you have minimal or no information about the composition. Our team of expert scientists have decades of experience deformulating products (including E-liquids), and have provided deformulation services in support of many FDA submissions.

4) Is an Extractables & Leachables study required?

Yes, FDA will require information about the product’s container closure system, and an extractables and leachables (E&L) study is required for every PMTA. A wide variety of industries rely on E&L studies to ensure the safety of finished products, including biopharma, medical devices, cosmeceuticals, dangerous goods, foods and beverages, and now the e-cigarette, e-liquid, and vaping industry.

5) Do I need to perform the Extractables & Leachables study, or does someone else in my supply chain need to do it?

This testing will need to be completed by either the container closure manufacturer, the E-liquid manufacturer, or some combination of both parties. If you are working with a bottle manufacturer, you could use the results of their study for your submission. As a point of clarification, it is expected that nicotine based e-liquids will have a different result than nicotine salts, with respect to E&L. This differentiation will need to be made during the submission of the PMTA to the agency.

6) What constituents do I need to test for?

The PMTA includes a list of uniquely identified Harmful and Potentially Harmful Constituents (HPHCs), including reaction products from leaching or aging and aerosol generated from heating of the product. Additionally, the premarket tobacco PMTA must detail physical characteristics of the e-juice product, such as pH, boiling point, and viscosity.

The e-liquid, vape flavor, and e-juice products for which the PMTA is being filed must also be tested for a defined list of compounds that pose a known potential health risk. Additionally, testing of other known constituents, as appropriate, that may have known respiratory irritants (i.e. Cinnamaldehyde) must also be performed and results included in the PMTA.

7) What standards are in place for E-cigarette, E-liquid, E-juice and vape juice product manufacturers?

The PMTA also requires the development of testing standards for product manufacturer as well as a plan to test to the voluntary industry standards.

8) What ENDS products are subject to the new PMTA guidance?

Any E-liquid or ENDS device that is sold directly to consumers are subject to enforcement. At this time, the FDA does not intend to enforce these requirements for components and products that are sold or distributed solely for further manufacturing into a finished ENDS product (the guidance, p. 8). However, the finished and assembled ENDS device is subject to the PMTA.

9) Will my e-liquid product receive a PMTA authorization?

This is a common question being asked by everyone in the industry. No one knows for sure what products will successfully pass and receive a PMTA. Avomeen is offering a Research and Development Screen of the E-liquid where we will assess the risk of the components identified in the liquid. This screen should identify products that based on constituents identified will not receive a favorable PMTA.

The above are questions commonly asked by our clients who are looking to receive a favorable PMTA. There are of course many other questions we get asked. If you have any questions or just want to discuss the PMTA, give us a call.

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.

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.

 

 

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.