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Overview of Premarket Tobacco Application (PMTA) FDA Guidance for ENDS

Overview of Premarket Tobacco Application (PMTA) FDA Guidance for ENDS

When was the PMTA Guidance Released?

In May 2016, the FDA initiated planned requirements for e-liquid and tobacco chemicals testing. 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. In June of 2019, the FDA released an updated guidance for the submission of PMTA authorizations.

Many similarities exist between the guidance issued in May 2016 to that of the newly announced guidance in June 2019, but there are also some notable differences. We’ve outlined the major similarities and differences in the PMTA. Some aspects of the required testing differs subtly, and our consultative team offers a full-service solution to help you obtain PMTA authorization.

What’s NOT Different in the 2016 and 2019 New FDA Vape Regulations?

Analytical methods must be validated

Analytical methods used for the analysis of the e-liquids and their aerosolized form need to be validated. These analytical methods for HPLC, GC, and ICP-MS will need to be validated for accuracy, linearity, precision, specificity, robustness, limit of detection, and limit of quantitation.

Formulation details must be included

An understanding of all of the components of the formulation is required. This may require a deformulation (reverse engineering) of the e-liquid or a complete batch record that details which components are used in the manufacturing of the product.

The number of batches and replicates has not changed

The analysis of a minimum of 3 batches of material with a minimum of 7 replicates per vape flavor. This means that for every e-liquid flavor, a minimum of 21 replicates will be required for analysis.

A stability study is required

A stability study needs to be undertaken to ensure changes in the e liquid formulation do not occur during normal storage of the product.

How ARE the 2016 and the 2019 PMTA FDA Regulations on Vaping Products & E-Cigarettes Different?

PMTA compliance deadlines

The FDA defined compliance deadlines, and it is unlikely that the FDA will enforce regulations during the extended compliance period. Now that the June 2019 FDA guidance on PMTA for ENDS has been released, there is a tight window to initiate a PMTA strategy to ensure compliance and stay on the market. The compliance deadlines are:

  • August 8, 2021 for newly regulated combustible tobacco products
  • August 8, 2022 for newly regulated noncombustible products

What needs to be tested is defined

FDA clarifies what samples need to be tested. In the guidance, FDA states that components that are used in finished products do not need to be tested, but rather the finished ENDS device is required to be tested. Also, all e-liquids in final packaging need to be tested. These include:

  • All products made and distributed by manufacturers
  • All products sold in retail stores
  • Custom one-off bottles/products made in retail stores

An extractables and leachables study is required

An Extractables & Leachable (E&L) study must be performed on the container and container closure system. The onus of responsibility falls on both the e-liquid, ENDS, or e-cigarette manufacturer and the container manufacturer. Avomeen is a global leader in E&L studies and has a proven track record of extractables and leachables studies on container and container closure systems for successful FDA submissions for pharmaceutical products. Want to know more? Let’s talk.

A bridging study is defined

What is a bridging study? It’s been defined and clarified by the FDA in the new June 2019 PMTA guidance. The FDA states that the following strengths of nicotine in the finished e-liquid should be tested for each flavor:

  • Lowest strength
  • Middle strength
  • Highest strength

The approach had been thought of as an acceptable approach to test vapor juice flavors, and is now clarified in the new guidance.

If respiratory irritants are identified upon review, the product must be re-tested for those irritants

As before, the product must be tested for a defined list of constituents and chemicals. However, after a review of the flavor, if known respiratory irritants are present in the blend, these will need to be tested for as well.

How Can Avomeen Help with Your FDA PMTA Submission?

Avomeen is an independent e-liquid, e-cigarette, and ENDS product 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 Resources

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 the new PMTA guidelines? Check out our blog, What You Need to Know About the FDA’s New PMTA Guidance.

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.

With the court ruling on July 11, 2019, it’s highly likely the deadline for submissions will be moved up significantly. For more information, check out our blog, ENDS Industry Faces Tighter PMTA Deadlines with May 2020 Fast Approaching.

The 9 most commonly asked questions about PMTA requirements are answered in our blog, 2019 FDA PMTA Guidance FAQs.

FDA is actively enforcing PMTA guidance. Check out our blog, FDA Issues Warning Letters for E-Liquid Products without Marketing Authorization, for more details.

 

 

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.