By Dr Pete Gibbons, Head of Reduced-Risk Product Analysis at Hall Analytical
September 9th was to be a significant milestone for suppliers of vaping products to the US market. This was the date a court order in the US required the FDA to review applications for “deemed” tobacco products submitted by the September 9th, 2020, deadline.
Applications submitted by this deadline were permitted to stay on the US market for 1 year pending FDA review. Due to the unprecedented number of PMTAs submitted by ENDS manufacturers, FDA had previously acknowledged the deadline would be missed for review of all correctly filed applications. The agency indicated PMTAs for ENDS products with the most significant market share in the USA would be prioritised for substantive review by FDA’s CTP scientists. Therefore, stakeholders in the US ENDS sector hoped the deadline would bring an announcement from the FDA of the first ENDS products to be granted marketing orders. So, what did happen? In truth, not a lot! No marketing orders for ENDS products were announced, instead, FDA issued a statement that more time was required to complete a scientific review of the PMTAs submitted for leading market share ENDS products. Mitch Zeller, director of the FDA’s CTP, published an update on the agencies progress on the premarket review of deemed tobacco products. This update highlighted the agencies action on 93% of applications submitted before the deadline, with over 946,000 flavoured e-liquid applications considered lacking sufficient scientific evidence. PMTA’s are evaluated on several factors, with a focus being on whether permitting the marketing of the new tobacco product would be appropriate for the protection of public health. The agency evaluates the evidence submitted in the PMTA to demonstrate the tobacco product is of benefit to adult smokers, with the risk of youth or non-smoker initiation mitigated.
Mitch Zeller, director of the FDA’s CTP, published an update on the agencies progress on the premarket review of deemed tobacco products. This update highlighted the agencies action on 93% of applications submitted before the deadline, with over 946,000 flavoured e-liquid applications considered lacking sufficient scientific evidence.
As of September 23rd, the FDA has issued a total of 323 Marketing Denial Orders (MDO’s) for more than 1.1 million flavoured ENDs products. Any vaping products subject to an MDO cannot be introduced or delivered for introduction into interstate commerce. Several of our clients at Hall Analytical have received such MDO’s for their flavoured e-liquid products, whilst their tobacco and menthol flavours remain under substantive review from the agency. Sensibly, a number of businesses subject to MDO’s for their flavoured e-liquid products are taking some time to consider their options. In an interesting development, Turning Point Brands Inc., a regulatory services company based in Kentucky, filed a “Petition for Review” with the U.S Court of Appeals for the Sixth Circuit requesting the court to review the Marketing Denial Orders (MDO’s) issued for vaping products submitted by TPB. Their legal argument for the review of MDO’s is based on the “grounds that it is arbitrary and capricious, an abuse of discretion, contrary to the FD&C act, and otherwise not in accordance with the law”. It certainly appears that all legal avenues are being explored by businesses on the receiving end of the latest round of MDO’s issued by the FDA.
Whilst we attended the GTNF 2021 conference in London last week, Todd Cecil, deputy director of regulatory management at the FDA centre for tobacco products, engaged in a “fireside” chat with delegates on the agencies progress on approximately 100-200,000 deemed products still under FDA review. He reaffirmed the agencies commitment to be guided by the scientific evidence provided in each remaining PMTA under substantive review and assured stakeholders that political influence was not a factor. He reiterated the requirement for a PMTA to provide robust scientific data that demonstrates a product is Appropriate for the Protection of Public Health (APPH). He also commented on the difficulties faced by flavoured ENDS PMTA’s in demonstrating sufficient mitigation of youth/non-smoker initiation, balancing this substantial risk against potential benefits for adult smokers wishing to quit. Interestingly, he also indicated that even the most comprehensive marketing plans to mitigate youth/non-smoker access are likely to be insufficient as the primary means to prevent youth use, as consistency of marketing restrictions cannot be guaranteed through all retail channels in the USA.
“Fireside” chat from GTNF 2021
So, this is the current situation the US ENDS sector finds itself in. For many of the vaping product businesses issued with Marketing Denial Orders from the FDA, the question is what to do next? And for those who submitted applications prior to the deadline and have not received an MDO? Technically, companies continuing to sell deemed tobacco products without a marketing order are doing so illegally; however, FDA has suggested enforcement actions would be prioritised for products having received an MDO or no pending application.
Recent events have reiterated the substantial challenges faced by businesses in navigating the FDA’s PMTA process. Substantial scientific evidence is required to demonstrate an ENDS product is “appropriate for the protection of public health”. We can certainly help businesses to meet these regulatory requirements at Hall Analytical. Delays in the FDA’s review of filed applications have allowed businesses in the queue to potentially augment the “story of their product” with additional data not available when initially submitted to FDA. Time is certainly of the essence, so please get in contact today for a no-obligation consultation.
If you’d like to read more about the FDA’s latest progress on PMTA review and enforcement, please click here: Perspective: FDA’s Progress on Tobacco Product Application Review and Related Enforcement | FDA