As an accredited reduced-risk product (RRP) testing lab with e-liquid and tobacco chemical testing facilities, Element has the scientific expertise and in-depth knowledge of the FDA premarket tobacco application (PMTA) regulatory pathway to help demonstrate the quality of your nicotine and tobacco products, while navigating the evolving regulatory landscape. This includes RRPs such as electronic nicotine delivery systems (ENDS) and alternative nicotine delivery systems (ANDS).
The FDA initiated planned requirements for e-liquid and tobacco chemicals testing in May 2016, and in June 2019, the Agency released updated guidance for PMTA submissions. The FDA requires premarket tobacco product applications (PMTAs) must be submitted for every flavor and nicotine strength, with supporting pre-clinical and clinical safety data for electronic nicotine delivery systems (ENDS) to demonstrate the new tobacco product is “appropriate for the protection of public health”. These regulation and label requirements apply to manufacturers of new or newly deemed finished tobacco products that were on the market as of August 8, 2016. As an FDA-registered and inspected independent testing lab, GMP-Compliant, DEA-Licensed, and GLP-Compliant chemical analysis partner, our team has decades of experience supporting successful regulatory filings and submissions with the FDA and other regulatory agencies.
Our expert team has access to a range of specialized instruments to fulfill both routine and challenging testing and analytical requirements. Eliminate surprises or delays that could keep your reduced-risk products from the market, including e-liquids, electronic nicotine delivery systems (ENDS), next generation products (NGP), and alternative nicotine delivery systems (ANDS), including pouches, gums, lozenges, and a wide range of smokeless tobacco products. Finding the right nicotine and tobacco chemicals testing lab for such an extensive regulatory submission can seem overwhelming. A partnership with Element is not just about compliance; our consultative teams of industry and regulatory experts will work to provide you with peace of mind now and in the future. As an experienced, trustworthy, and nimble partner with years of scientific and regulatory experience, we will help you to navigate the dynamic and uncertain e-liquids and nicotine industry and evolving regulatory landscape carefully and successfully.
The testing process for e-liquid and vaping products
● Customized testing and regulatory plans will be developed, thoroughly considering products, flavors, timing, and market ambitions
● Seven replicates on three batches of product will be performed for each analysis, as the FDA requires
● Analytical methods can be transferred-in or developed and validated for accuracy, precision, linearity, range, robustness, and limit of detection and limit of quantitation (LOD/LOQ)
● A determination can be made as to whether any new chemical entities are created through the heating and vaporization process
● A suite of state-of-the-art instrumentation and analytical techniques will be utilized, including LC/MS, LC-MS/MS, NMR, HPLC, ICP-MS, and GC/MS
● All source data, accreditation, and test validation information, as well as a complete description of the aerosol generating methodology used (PMTA guidance, p.24) will be provided
● Required in vitro toxicology and clinical safety data required by the FDA will be prepared
● A tobacco product master file (TPMF) will be created (confidential filing with the FDA in relation to 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; FDA preferred)
The Element advantage
Element provides all levels of service related to custom analysis and testing protocols for our customers, including large manufacturers and established tobacco companies, mid-size manufacturers and distributors of specialty ingredients, and small-scale “Mom & Pop” nicotine/tobacco e-liquid manufacturers. Our goal is to apply our scientific and regulatory expertise to help bring safe and high-quality nicotine-containing vape, e-liquid, ENDS, alternative nicotine delivery system and next generation products to the market. Confidently navigate the PMTA and evolving nicotine product regulatory landscape and demonstrate the quality and purity of your products with Element by your side.
To learn more about our nicotine and PMTA testing services, or to speak with one of our experts, contact us today.
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