E-Liquids Testing and the Changing Regulatory Landscape
The FDA initiated planned requirements for e-liquid and tobacco chemicals testing in May of 2016. Premarket tobacco product applications (PMTAs) for electronic nicotine delivery systems (ENDS) are required to be submitted for every flavor at every nicotine strength, with supporting pre-clinical and clinical safety data. The FDA released an updated guidance for the submission of PMTA authorizations in June of 2019.
Outsourcing Tobacco Chemicals Testing to a Responsive Partner
Finding the right nicotine and tobacco chemicals testing lab for such an extensive regulatory submission can seem overwhelming. You can go it alone, but to carefully navigate the dynamic and uncertain e-liquids industry, you need an experienced, trustworthy and nimble partner with years of scientific and regulatory experience. As an FDA-accredited nicotine testing lab for in e-liquid and tobacco chemical testing, we can help you demonstrate the quality and purity of your products, while navigating this evolving regulatory landscape.
If you don’t know where to start when evaluating labs for PMTA, our blog offers some much-needed guidance and resources.
Avomeen’s Technical Expertise
Our qualified and consultative team has decades of experience supporting successful FDA submissions, and has access to a full range of dedicated instruments that help us fulfill both routine and challenging testing and analytical requirements required for PMTA. We will help you eliminate surprises or delays that could keep your ENDS, vaping, e-cigarette, and e-liquid products from the market. At Avomeen, it’s not just about compliance; we’re working to give you peace of mind now and in the future.
When Are Vaping Products Subject to New FDA Regulations?
FDA PMTA nicotine regulation and label requirements now apply to manufacturers of new or newly deemed finished tobacco products that were on the market as of August 8, 2016.
- To continue to legally manufacture, sell, or distribute vaping products, companies will need to file PMTAs by the planned deadlines:
- On April 22, 2020, a 120-day extension was granted, making the deadline for submission September 9, 2020.
- On July 11, 2019, a court ruling moved up deadlines to May 12, 2020.
- For new combustible tobacco products, the current deadline is August 8, 2021.
- For non-combustible products, the current deadline is August 8, 2022.
The Tobacco E-Liquid and Vaping Product Testing Process
As we work with you to develop a customized testing plan, Avomeen acts as an extension of your team, offering a range of services that can start simply today, and ultimately build toward your preparation of a comprehensive PMTA submission.
- We work with you to develop a customized testing and regulatory plan given your products, flavors, timing, and market ambitions.
- We perform 7 replicates on three batches of product for each analysis, as required by the FDA.
- Our analytical methods can be transferred-in or developed and validated for accuracy, precision, linearity, range, limit of detection and limit of quantitation (LOD/LOQ), and robustness.
- We can determine if any new chemical entities are created through the heating and vaporization process.
- Our analyses draw on a suite of state-of-the-art instruments, including LC/MS, NMR, HPLC, ICP, and GC/MS; as well as a wide range of other analytical techniques and other instrumentation.
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FDA and PMTA Reporting
- A full report will be provided with all source data, accreditation information, test validation information, and a complete description of the aerosol generating methodology used (the guidance, p.24). We also prepare you with the in vitro toxicology and clinical safety data that the FDA requires.
- We create a tobacco product master file (TPMF). This is a confidential filing with the agency regarding a product that may be used in manufacturing, such as a flavor package. The product’s safety and chemistry data can be incorporated into a PMTA by reference (with permission); a method preferred by the FDA.
- Large manufacturers/tobacco companies
- Mid-size manufacturers and distributors of specialty ingredients
- Small-scale “Mom & Pop” nicotine/tobacco e-liquid manufacturers
Avomeen provides all levels of service related to custom analysis and testing protocols for our customers.
Join Avomeen’s PMTA Consortium Program
To help minimize the overall cost burden for analytical testing, we have formed a consortium program of companies looking to begin or expand the PMTA process. By grouping companies to test their respective products at the same time, we are able to achieve economies of scale due to the overall volume as well as reduced setup time (as opposed to testing individually). As a result, we pass the cost savings on to you. Our goal is to apply our expertise to help bring safe and high quality ENDS products to the consumer, and we’re ready to partner with you!