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FDA Prioritizing Enforcement of ENDS Products without Premarket Authorization

FDA Prioritizing Enforcement of ENDS Products without Premarket Authorization

FDA is Prioritizing the Enforcement of Flavored, Cartridge-Based E-Liquid and ENDS Products without Premarket Authorization

Beginning February 6, 2020, FDA is prioritizing the enforcement of ENDS products which are currently marketed without FDA authorization, focusing on the following products which have gained popularity with minors:

  • Any flavored, cartridge-based e-cigarette, e-liquid, and ENDS product (other than a tobacco- or menthol-flavored ENDS product)
  • All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access
  • Any vape and/or ENDS product that is targeted to minors or whose marketing is likely to promote use of ENDS by minors

In the Final Guidance regarding FDA’s enforcement priorities for ENDS products without premarket authorization, FDA’s use of the term “minor” refers to individuals under the age of 21.

Enforcement of New Vape Products on the Market after May 12, 2020 without Authorization will be Prioritized

Any e-liquid, e-juice, e-cigarette, vape, or ENDS product without a Premarket Tobacco Application (PMTA) filed with the FDA that’s offered for sale after May 12, 2020, will also be on FDA’s priority enforcement list. Additionally, the same will be in effect if an ENDS product is offered for sale if a negative action has been taken by FDA on a PMTA that has been submitted in a timely fashion.

The May 2020 date is a result of a court ruling that required a PMTA be submitted for all new tobacco, e-liquid, e-cigarette, vape, and ENDS products be submitted to the Agency by May 12, 2020. As per the court order, deemed “new tobacco products” are classified as E-liquid, ENDS, and vape products which meet the following requirements:

  • On the market as of August 8, 2016; and
  • Premarket authorization applications are not filed with FDA by May 12, 2020

FDA’s Enforcement Priorities for E-Liquid, E-Cigarette and ENDS Products

FDA’s enforcement guidance states that FDA will prioritize enforcement of flavored, cartridge-based (also known as pod-based) e-liquid and ENDS products primarily produced by large manufacturers. Tobacco and menthol-flavored products are not included in FDA’s prioritization recommendations.

In the guidance, the Agency states that the impact on small manufacturers and vape shops should be minimal, given that these vape shops predominantly sell non-cartridge-based ENDS products. However, if FDA finds that small manufacturers or vape shops fail to take adequate measures to prevent youth access to e-cigarette, e-liquid, and ENDS products, or market to youth, FDA will take enforcement action.

Additional 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.

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.

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.

Unsure how you’re going to meet PMTA submission deadlines and comply with 2-year stability requirements? Look to our blog for more information.

 

 

Our featured blogger is Katie Morgan, Avomeen’s Senior Director of Marketing and Business Development. She has over a decade of experience establishing and implementing client development strategies, and her broad range of experience includes strategic contract development and marketing and content development.

Learn more about Katie’s expertise and experience.