In May 2016, the FDA ushered in planned requirements for e-cigarette, e-liquid and tobacco chemicals testing. Premarket tobacco product applications (PMTAs) for electronic nicotine delivery systems (ENDS) will eventually need to be submitted for every flavor, with supporting pre-clinical and clinical safety data. The FDA released new guidance in June 2019 – check out our summary:
Were you feeling confident that you knew the requirements detailed in the 2016 PMTA guidance and want to know what’s stayed the same – and more importantly, what’s different in the new 2019 FDA vaping and electronic cigarette regulations? We’ve outlined the major differences and similarities in our blog:
If you’ve been reviewing the new 2019 PMTA guidance, you’ll have noticed that an Extractables & Leachables (E&L) study is now required for e-cigarette, e-liquid and vaping products. If you’re not familiar with E&L studies, take a look at our blog:
Finding the right lab to partner with for such an extensive submission can seem overwhelming. If you don’t know where to start when evaluating labs for PMTA, our blog offers some much-needed guidance:
As an accredited, FDA-registered nicotine lab with e-liquid, electronic cigarette, and tobacco chemical testing facilities, we can help you demonstrate the quality of your products, while navigating this evolving regulatory landscape. Our expert team has decades of experience supporting successful FDA submissions, and has access to a range of specialized instruments that help us fulfill both routine and challenging testing and analytical requirements. 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.
What Products Are Subject to New FDA Regulations on Vaping Products?
- FDA 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 deadline.
- For new combustible tobacco products, the current deadline is August 8, 2021.
- For non-combustible products, the current deadline is August 8, 2022.
- On July 11, 2019, a court ruling moved up deadlines to May, 2020. Check out our blog for more information.
- FDA review requires a harmful and potentially harmful constituents (HPHCs) testing report with the PMTA. Avomeen can work with you to determine and test the primary analytes most likely expected to be included in the revised HPHC reporting requirements. As an FDA-registered lab, we’ve supported numerous successful FDA submissions, and have the scientific expertise, regulatory knowledge, and experience to provide the support and technical expertise you need for a successful submission.
- 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).
- E-liquids that are sold directly to consumers are subject to enforcement.
The Tobacco E-Liquid, E-Cigarette, and Vaping Product Testing Process
Despite the changing regulatory climate, it is not too soon to get a leg-up on your competition by starting to test what we and other experts agree the FDA will require. 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 10 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.
- Official methods will not require validation.
- The pH must be measured and reported.
- 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.
Become an HPHC Testing Expert Learn More
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
Avomeen is an FDA-registered and inspected independent testing lab, and a DEA-Licensed (Schedule I-V), GMP-Compliant, and GLP-Compliant chemical analysis partner.
We proudly serve e-liquid, e-cigarette, and ENDS manufacturers of all sizes and stages, including:
- 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.
*The FDA considers “small-scale tobacco product manufacturers” to be a manufacturer of any regulated tobacco product with 150 employees or fewer and annual total revenues of $5,000,000 or less.
Click here for more information on HPHC testing for successful PMTAs.
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