It seems like everyone in the vape industry is asking if their e-liquid and ENDS products will receive Premarket Tobacco Application (PMTA) authorization. While there’s no guarantee as to whether or not FDA will grant authorization for your PMTA, a few common strategies have emerged amongst leading ENDS manufacturers.
With the final guidance and due dates established by the FDA, vape juice, e-cigarette, e-liquid, and ENDS device manufacturers are determining which products to include in their PMTA. A number of companies are choosing to first put their best-selling products through a PMTA, while others are selecting products which have a higher likelihood of being granted a successful PMTA.
How to Determine if an E-Liquid or Vape Flavor Has a High Likelihood of Being Granted PMTA Authorization
For a fraction of the cost of a complete PMTA, analytical testing allows e-liquid and ENDS manufacturers to better understand if there any ingredients in their formulation that are of concern which would likely lead a failing PMTA. In particular, reverse engineering, or deformulating, a vape flavor or e-liquid product provides valuable insights into the product formulation.
How ENDS Companies Benefit from Deformulation
By deformulating and analytically breaking down the product’s formulation to separate and determine the specific identity and exact quantity of both its major and minor constituent components, ENDS manufacturers can gather relevant and pertinent information about the likelihood of a being approved for a PMTA.
In summary, if an e-cigarette, e-liquid, or vape flavor product contains harmful and potentially harmful constituents (HPHCs) and other toxic chemicals, the product has a higher likelihood of not receiving PMTA authorization.
Data from Pre-Screening can be Included in a PMTA Submission
If, after deformulation is completed, an e-liquid product is found to be likely viable for PMTA authorization, the data generated during the initial R&D screen can and should be included in the full PMTA submission. As detailed in FDA guidance, a PMTA should include a full statement of all components, ingredients, and additives present in the product.
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.
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.
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