The US Food and Drug Administration (FDA) recently published a “Proposed Rule” for the Electronic Nicotine Delivery Systems (ENDS) sector. This guide outlines how the new Proposed Rule relates to the recent Premarket Tobacco Application (PMTA) Final Guidance and highlights key implications for ENDS companies.
What is a Proposed Rule?
The FDA recently confirmed final guidance regarding the PMTA process for companies who intend to continue to sell e-cigarette products within the US market – as detailed in our Final PMTA Final Guidance has arrived – what’s changed? article.
Whilst guidance documents are non-binding recommendations which are generally followed by the FDA, rules are binding on both the FDA and industry.
A rule is generally considered as “final agency action”, however the recent Proposed Rule, is only one step in the rule making process. The next stage is a Final Rule, which must be published in order for its requirements to become mandatory. In this sector Final Rules are typically substantially the same as related Proposed Rules, so no major changes are expected as rule making progresses.
What does this Proposed Rule for PMTAs cover?
The Proposed Rule indicates what FDA want to see in a PMTA, so ENDS companies and consultants within the sector are advised to give the Proposed Rule serious consideration. However, it is not entirely prescriptive as to the content and type of scientific investigations needed, as each product raises unique questions of public health that need to be addressed specifically.
The Proposed Rule announces FDA’s intention to stipulate format and content requirements for PMTAs, and also codify their procedures when evaluating PMTAs.
Additionally, the Proposed Rule establishes requirements for the following:
· Filing amendments to an application
· Review periods
· Application withdrawal
· Changes in ownership
· Post-market reporting and maintenance of records
· FDA communications with applicants
· FDA disclosure procedures
· Electronic submission requirements
The Proposed Rule also explains how to submit a supplemental PMTA or make a re-submission. A supplemental PMTA may be applicable when seeking authorization for a product which is a modified version of a product which has already received a PMTA marketing order. A re-submission would apply when seeking to address application deficiencies following the issue of a “No Marketing Order”.
Finally, the Proposed Rule also establishes record keeping requirements regarding the legal status of tobacco products without a PMTA, such as those not required to undergo premarket review or those that have previously received authorization.
What action do ENDS companies need to take?
ENDS companies, in conjunction with scientific and regulatory partners, are recommend to examine in detail the Proposed Rule (in particular sections § 1114.7 - Required content and format and § 1114.27 – Review Procedure) to ensure PMTA strategies being applied are appropriate and compliant.
Also, the Proposed Rule is open for comment until November 25, 2019. This is the only formal mechanism to engage with FDA and present data to substantiate any appropriate changes to the Proposed Rule. Hence ENDS companies and advisors are strongly encouraged to take up this opportunity to submit comments to the formal Proposed Rule docket, if appropriate.
There is no deadline for FDA to finalize the rule, however, both FDA and industry appreciate the need for clarity regarding the PMTA process, therefore FDA are expected to prioritize finalization within the next 12 months.
It should also be noted that the deadline for ENDS companies, with products that were on sale in the US as of August 8th 2016, to submit a PMTA to FDA is May 12th 2020. A validated submission by this date leads to substantive review of the application by FDA and legal sale of such products for an additional 12 months while the submission is evaluated.
Scientific and regulatory partners for your PMTA
Broughton offer a team of scientific and regulatory experts to manage the full PMTA process on your behalf. We’ll generate and compile the data you require, consult with the FDA, and submit your PMTA.
To discuss how to ensure your PMTA strategies comply with the requirements outlined in the recent Proposed Rule, contact us to arrange a meeting.