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FDA Issues Proposed Rule for ENDS PMTA Pathway

FDA Issues Proposed Rule for ENDS PMTA Pathway

On September 20, 2019, FDA issued a proposed rule which will clearly define requirements for the regulatory pathway for Premarket Tobacco Applications (PMTA). The rule will:

  • Detail content requirements
  • Establish the format for PMTA submissions
  • Specify electronic submission requirements
  • Detail requirements for filing amendments, withdrawal of applications, changes in ownership, and post-market reporting
  • Set requirements for keeping and maintaining records related to the legal marketing status of ENDS products

The proposed rule will also detail FDA procedures and requirements, including:

  • Procedures the agency will use to review PMTAs, including application acceptance, application filing and inspections, and time for review
  • FDA communications with an applicant
  • Disclosure procedures

The Purpose of the Proposed PMTA Rule

The proposed rule, once finalized, will serve to ensure PMTAs submitted to the Agency for review contain adequate information for a thorough examination and understanding of the e-liquid, vape, and/or ENDS product the PMTA is being submitted for. The rule, in conjunction with the previously released and finalized guidance, will ensure that PMTA submissions include vital information needed in order to determine whether a PMTA will receive authorization, including information regarding the potential public health benefits and harm that would result from use of an e-cigarette, vape, or e-liquid product.

PTMA Submission Deadlines Aren’t Impacted by the Rule and Remain the Same

In July of 2019, a U.S. District Court judge issued an order requiring that ENDS manufacturers submit PMTAs by May 12, 2020, for deemed tobacco products, including e-cigarettes, which were on the market as of August 8, 2016.

FDA has stated that the final rule does not need to be in place for e-liquid, e-cigarette, and vape manufacturers to continue to submit applications. Furthermore, FDA encourages ENDS manufacturers to use available FDA resources and the published guidance as they work to complete and submit PMTAs in keeping with the established deadline.

Compliance Policies are Being Finalized

Prior to releasing the proposed rule, FDA announced compliance policies, which will prioritize the enforcement of flavored (non-tobacco flavored) e-liquid and e-cigarette products, are expected to be finalized in the coming weeks. Once finalized, FDA will be actively working to enforce the compliance policy with the purpose of clearing the market of such unauthorized ENDS products.

Supplemental PMTAs and Resubmission Pathways are Detailed in the Proposed Rule

Supplemental PMTAs and resubmissions are also discussed in the proposed rule. A supplemental PMTA may be submitted for a modified version of an ENDS product which has already received PMTA authorization, also known as PMTA marketing order. For failed PMTA applications which were issued a “No Marketing Order” due to deficiencies in the application, applicants may resubmit the PMTA with cited deficiencies addressed.

Be Heard

FDA welcomes feedback regarding the proposed rule, and it is open for public comments for a 60 day period – through November 25, 2019.

How Avomeen Can Help

Avomeen is an independent testing lab proudly serving entrepreneurs, manufacturers, distributors, lawyers, other laboratories, and companies of all sizes. We are experienced with new testing standards pertaining to the e-liquids/e-cigarettes and the FDA’s Premarket Tobacco Application (PMTA) requirements, and are offering a Research and Development Screen of the e-liquid. During this analysis, we will assess the risk associated with the components identified in the liquid. This screen should identify products that based on constituents identified will not receive a favorable PMTA.

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

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.

 

 

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.