The e-liquid and vaping industry is evolving and maturing, and you’re going to need a full service lab and partner to help you navigate the regulatory landscape to obtain Premarket Tobacco Application (PMTA) authorization for ENDS, per the June 2019 guidance. You’ll need to weigh your options and choose the right partner – one that you can trust and rely on not only to provide high-quality scientific data, but also to provide you with consultative support every step of the way. If you’re in the process of evaluating partners, you’ll want to consider:
FDA Registration is Fundamental
Working with an FDA registered lab with a proven track record of successful FDA inspections can be the key to a successful PMTA submission that meets the new FDA regulations on vaping. Although PMTA guidance does not require ENDS companies work with an FDA registered lab, an FDA registered lab, such as Avomeen, has an in-depth understanding and knowledge of FDA submissions, guidance, and regulations that other labs do not possess. With regulatory compliance and the acceptance of your application on the line, rely on a lab that has the regulatory experience to ensure compliance and a smooth approval process.
Location is Key
We’ve all heard it before – location, location, location. It’s no different when selecting a lab to partner with for PMTA. The e liquid and vaping industry is uniquely American, and is now being governed and regulated by the FDA. When US-based e-liquid, e-cigarette, and vape companies partner with a US-based lab, they’ll no longer have to deal with:
- Long lead times to ship samples to another country
- Customs paperwork and unexpected holds
- Limited availability due to international time differences
- Fluctuating currency exchange rates
- International tax requirements and obligations
Robust Regulatory & Scientific Expertise is Vital
You’ll want to do your homework to understand who will be working on your project. Does the lab you’re considering have one single scientist working on your submission, or will a full team of scientists be available to consult and work on your PMTA FDA submission?
The PMTA consists of a diverse range of analytical testing, and you’ll want to be sure that your lab of choice has a proven track record of success in all testing areas of the PMTA. Do you want to know more about our team of regulatory and scientific experts? Contact us.
Communication is Crucial
Will you have a primary, single point of contact throughout the duration of your project? Even though there may be several scientists working on your submission, you should have a single point of contact throughout the PMTA process. Your team at Avomeen will consist of a broad and diverse group of scientists and administrators, all of which will led by a single point of contact.
A Full-Service Solution Provider is Essential
You don’t want to – and shouldn’t – have to use several service providers for your PMTA submission. When such an extensive regulatory submission is done piecemeal, there’s room for error, inconsistencies, and omission, which can lead to findings or rejection. Partnering with a lab that offers a full-service solution can make or break PMTA authorization.
Are you ready to start the conversation about the full-service PMTA solutions that Avomeen provides? Let’s talk.
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.
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.
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 featured blogger is Katie Morgan, Avomeen’s Senior Director of Marketing and Business Development. She has over a decade of experience establishing and implementing client development strategies, and her broad range of experience includes strategic contract development and marketing and content development.
Learn more about Katie’s expertise and experience.