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Successful PMTAs need to demonstrate the ENDS product is of benefit to smokers wanting to stop smoking cigarettes and that they are not appealing to non-users.
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Paul Hardman, Broughton Nicotine Services’ head of scientific affairs.
Frustration? Confusion? An anticlimax? All of the above were felt among the ENDS community following FDA’s recent statement on the regulation of e-cigarettes.
By Paul Hardman, Head of Scientific Affairs, Broughton Nicotine Services
The sheer amount of premarket tobacco product applications (PMTAs) received led to the announcement that FDA did not fully meet its court-imposed deadline. September 9, 2021 had been a long-awaited end point for US manufacturers that had been given a year’s grace to continue selling their products. The resulting announcement left many still none the wiser as to how to proceed, and others with work to do to improve their applications.
Successful applications will come from those companies that can not only demonstrate their products are of benefit to public health, enabling smokers to wean themselves off combustible cigarettes, but also demonstrate that they are not appealing to non-users, who have the potential to initiate nicotine use via such products. A particularly important group are youth potentially initiating nicotine use via products with characterizing flavors other than tobacco.
Some companies chose to reduce their product portfolios to only tobacco and menthol flavors as is the case with JUUL Labs, based on the perceived likelihood of youth initiation via flavored products. Yet it seems to be the larger organizations that have the means to make this switch. Adult smokers continue to attempt to have their voices heard on the utility of flavor choice in their journeys away from combustible cigarettes. The balance between smokers quitting and potential new nicotine users must be carefully weighed to assess the appropriateness for protection of public health across the population as a whole.
As of September 8, FDA completed acceptance review for all of the applications and completed filing review for about 90% of applications submitted by the September 9, 2020 deadline. Many of these applications were ultimately knocked back at the first hurdle, receiving a refuse-to-file (RTF) letter at the filing stage due to missing some of the required information, with 4.5 million products receiving RTFs from just one company’s application. Reasons given for this included the lack of ingredient listings, labels for each product, and ad-equate environmental assessments.
As of September 8, FDA said it issued substantial equivalence (SE) marketing orders covering more than 120 (non-ENDS) products and exemption from substantial equivalence requests (EX REQ) marketing orders covering more than 230 products.
Marketing denial orders (MDOs) were issued on August 26 for about 55,000 flavored products – this may seem like a dead end for those manufacturers whose products were considered to have potential appeal to youth. This number subsequently grew to roughly 1 million products during September.
For those submitting applications by the September 9, 2020 deadline but left with no ruling on their applications (currently numbering 100,000 - 200,000 products), there is no doubt a predicament to be faced. To continue to sell their products until a decision is reached would be to do so, officially, unlawfully. Many set out their ultimate aims of improving public health through promoting the replacement of combustible tobacco. These companies, awaiting the results of their PMTAs, believe their products achieve these aims and improve the health of adult smokers. The choice they face is between continued sale of their products, and removing items from sale, which creates an ethical dilemma. Imagine a world where companies decided to take their products off the United States market, resulting in limited choice for users, and we could surely envisage that a return to combustible tobacco would seem a likely option for many.
FDA makes it clear that any company that remains in the PMTA review process and continues to sell these products will be doing so unlawfully, although any enforcement action for doing so is highly likely to be deferred. FDA retains discretion over how and whether it will take action.
With the backlog of PMTAs to deal with, and further applications entering the system, it remains to be seen whether FDA has the resources to deal with these companies in a timely manner. Companies will decide whether they take a chance and wait for FDA to take enforcement action against them.
There is a fear of products becoming increasingly available via black market channels, as we have seen happening with advertising and sale of unauthorized products across the United States on social media platforms. This likely occurs without manufacturers’ permission or knowledge and the risks in these cases go without saying. There was, however, some good news to be taken from the statement for ENDS companies anxious y awaiting decisions. A reason for some of the MDOs was said to be the lack of sufficient evidence of overall benefit to the population as a whole provided within the submission as opposed to them simply being considered better for users’ health than smoking cigarettes. With FDA showing potential for positivity towards ENDS products and their ability to safeguard public health, there is still time for companies in the process to submit supplementary data to improve their submissions and by doing so the potential to secure a marketing order. This is where service companies such as Broughton Nicotine Services may help by providing companies with the evidence needed to complete this process if further documentation is required.
The PMTA process is complex, but companies need not feel downhearted. The industry is now awaiting news on how often FDA plans to announce the results of PMTA submissions that have been completed. In my experience, at least monthly would be preferential to ensure ENDS companies and the industry have a clearer picture the state of the process.