FDA final rule for PMTA applications

Broughton's Head of Regulatory Affairs, Lloyd Smart discusses Food and Drug Administration (FDA) final ruling for Premarket Tobacco Product Applications (PMTA) and what this means for Electronic Nicotine Delivery System (ENDS) companies.

The Final Rule

FDA released their final rule and response to comments for PMTA applications on 5th October 2021 (effective from 5th Nov 2021). Since the previous withdrawn guidance (2019) the FDA has received thousands of premarket applications that have “ranged widely in the level of detail they contain”, some of which we know have been moved into substantive review and many others (1000’s) which have received Marketing Denial Orders (MDOs). The final rule describes and sets forth requirements related to both the content and format of PMTAs and aims to provide applicants with a better understanding of the information a PMTA must contain.

Updates between draft and final ruling

The FDA was clear that the final ruling reflects clarifying changes made from the previous (withdrawn) versions, but no significant substantive changes. Our review of the final guidance has highlighted a few points of consideration for PMTA Applicants, and these are summarised below:

Premium cigars - FDA will not finalize the PMTA rule for premium cigars but will look to act once further research is concluded.
Marketing Plans - FDA has added further emphasis on how it may review and/or interpret submitted marketing plans, specifically - “the Agency may require additional information related to marketing plans on a case-by-case basis if the agency determines during the review that additional information is needed to help determine if a product is appropriate for the protection of the public health."
Marketing plans and behavioral activities - definitions clarified for "switching (i.e., complete transition to a different tobacco product)” and “polyuse (i.e., using the new tobacco product in conjunction with one or more other tobacco products)."
Likely users - FDA has further commented that when identifying likely users the Applicants should consider use "patterns, including abuse liability and unintended use,..”
Public database - FDA disagreed with comments that a public database would be of benefit on many levels:
Required design parameter Information - changes to terminology, measuring equipment, and/or additional information has been added to certain Tables. For example, Waterpipe heating (Table 16) updated concerning the Power Delivery Unit (PDU), and Heated Tobacco Product (HTP) (Table 23) additional information provided on the “heating element” and “battery” requirements.
Stability testing- clarity provided to cover that where deviations from the methods provided occur and then should be present in the submission.
Vulnerable populations - clarity provided and definition enhanced “are not limited to, youth and young adults, those with lower socioeconomic status, certain races or ethnicities, sexual or gender minorities, underserved rural populations, those pregnant or trying to become pregnant, those in the military or veterans, and those with mental health conditions or substance use disorders.”

Requirements and Recommendations

PMTA’s are required to be thorough and in this final rule FDA set out both requirements and recommendations for applicants to ensure all mandatory areas are covered in submissions. The achievement of a Marketing Granted Order is a significant task but as we have now seen in October 2021, FDA has started this process. Amongst other topics, the rule addresses:

The submitting of detailed information regarding the physical aspects of the new tobacco product and full reports of information regarding investigations that may show the health risks of the new tobacco product.
• Whether the product presents the same or different risks compared to other tobacco products. FDA requires the submission of these health risk investigations to ensure it understands the full scope of what is known about the potential health risks of a new tobacco product.
• That any Marketing Order is appropriate for the protection of public health (APPH).
• Electronic submission of the PMTA and Tobacco product Master File (TPMF).
• Post-market reporting requirements for applicants that receive marketing granted orders.
• Retention of records requirements for PMTAs.
• Procedures by which FDA reviews a PMTA.
Download our more detailed review of the final rule which also includes a link to the formal FDA document:

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