Extractables & Leachables Studies are Required in the New PMTA Guidance
Extractable and leachable testing (E&L) is now a requirement of the PMTA per the June 2019 guidance. E&L studies are not new to the FDA, as they are mainstay requirement in pharmaceutical products and submissions. E&L studies are used to test product packaging to ensure the packaging will not leach harmful chemicals into the product during storage and use.
Avomeen’s expert chemists are trained to identify and quantify both extractables and leachables, validate the analytical methods utilized, and to work with your team to determine the safety implications present and suggest alternative packaging if necessary. E&L Studies are utilized by a variety of industries including pharmaceuticals, medical devices, cosmeceuticals, dangerous goods, foods and beverages, and now the e-cigarette, e-liquid, and vaping industry.
Why is Extractable & Leachable Testing Important for E-Liquids?
E&L Studies detect and identify the organic and inorganic compounds that may be inadvertently released into the product. These analytes include low molecular weight oligomers, additives, catalysts, mold release agents, dyes and colorants, plasticizers, antioxidants, and stabilizers. Certain extractable and leachable compounds can interact with drug, food, and beverage products, thus compromising the safety and efficacy of those products. Likewise, these compounds likely interact with vape flavors, e-liquids, and e-juices.
This type of extractable and leachable testing is critical for the pharmaceutical and medical device industries where packaging safety and toxicology studies are required for product registration. Let our scientists guide you through the process to access and profile your products’ extractables and leachables while meeting FDA regulations.
What Does the PMTA Guidance Say For E-Liquids, E-Cigarettes, and Vape Flavors?
The June 2019 guidance specifically address the product container closure system. It also states that a PMTA application should include information on how the container closure system protects and preserves the product, such as damage from transport, environmental contamination, leaching and migration of the container closure system into products.
The FDA expects this part of the study to be either completed by container closure manufacturer or by the applicant using the container closure for their products. Allow Avomeen, a leader in extractables and leachable testing, help you determine the safety of your container closure system for your ENDS product.
How Can Avomeen Help with Your FDA PMTA Submission?
Avomeen is an independent e-liquid and e-cigarette testing lab proudly serving entrepreneurs, manufacturers, distributors, lawyers, other laboratories, and companies of all sizes. We are an FDA-registered lab with years of experience working on successful FDA regulatory submissions. Our team of regulatory and industry experts are experienced with new testing standards pertaining to the e-liquids/e-cigarettes and the FDA’s Premarket Tobacco Application (PMTA) requirements.
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.
Additional PMTA Resources
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.
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.
Additional E&L Resources
The FDA Gets Stricter with E&L Oversight, Can the Industry Keep Up? article in Contract Pharma, featuring Dr. Andrew Kolbert, Avomeen’s CTO, offers valuable insight.
In our years carrying out extractables and leachables testing, we’ve seen some common mistakes made in E&L study design. We’ve outlined what not to do in our blog, Common Pitfalls in Ectractables & Leachables Testing.
Looking for a summary of USP guidelines for E&L testing? Our blog, The Long and Short of USP Guidelines for E&L Testing, offers some guidance.
Our blog, The Growing Need for Extractables & Leachables Testing of Pharmaceutical Manufacturing Equipment, offers information about FDA oversight and how CROs can help companies navigate the E&L process.
Our expert blogger is Dr. Derek Beachamp, Avomeen’s Senior Technical Director of Analytical Sciences. His knowledge of the PMTA and nicotine testing have been showcased in vape industry publications including Smoke and Vape Business Solutions and Vapor Voice.
Learn more about Derek’s expertise and experience.