The Electronic Nicotine Delivery System (ENDS) industry continues to face a quickly-evolving regulatory landscape, which now includes several state-led bans on flavored e-liquid and vape products. Additionally, the industry faces the possibility of a federal ban which is supported by the Trump administration.
How Proposed Vape Bans Impact PMTA Strategy
While common regulatory strategies for Premarket Tobacco Application (PMTA) submission are emerging amongst leading e-cigarette, e-liquid, and ENDS manufacturers, flavored vape products continue to face scrutiny. For ENDS companies seeking a more conservative regulatory submission strategy, first completing a PMTA for tobacco flavored e-liquid products rather than flavored e-liquids may be preferred.
With Proposed E-Liquid Bans, is the PMTA Necessary?
The FDA PMTA guidance is in effect, and FDA is actively enforcing marketing authorization regulations. For ENDS manufacturers who want to maintain their market share and be in compliance with regulatory requirements, PMTA is not an option – it’s a must. E-Cigarette manufacturers/distributors and ENDS companies found to be in violation of regulatory requirements who fail to correct violations leave themselves open to further action from the agency, including fines or judicial actions, which may include seizures or injunctions.
How Avomeen Can Help
Avomeen is an independent testing lab proudly serving entrepreneurs, manufacturers, distributors, lawyers, other laboratories, and companies of all sizes. We are experienced with new testing standards pertaining to the e-liquids/e-cigarettes and the FDA’s Premarket Tobacco Application (PMTA) requirements, and are offering a Research and Development Screen of the e-liquid. During this analysis, we will assess the risk associated with the components identified in the liquid. This screen should identify products that based on constituents identified will not receive a favorable PMTA.
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.
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?
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.