After a long wait, the Food and Drug Administration finally has control over the regulation of products like e-cigarettes, hookahs, and cigars. A 2016 District Court ruling stated that companies first marketing deemed tobacco products after February 2007 were required to submit a Pre Market Tobacco Product Application in order to remain compliant, but that they had until 2020 to do so.
Of course, everyone waited until the last minute. Despite the vastness of the industry, only 1451 products had been submitted as of August 2020. The agency saw this coming, however, and it has been preparing for the avalanche of paperwork for years now.
Currently, an estimated 400 million products are required to submit a PMTA, which involves extensive documentation including evaluations of health effects on both the general population and the individual; environmental impact; statements of all components, ingredients, and operation methods; descriptions of processes for manufacture, packaging, and distribution; proof the product meets established standards; samples of the product; examples of labeling; and anything else the FDA deems necessary to determine whether a product is compliant.
Review Challenges for the FDA
The voluminous nature of the PMTA creates serious challenges for an expedient review process, regardless of what the FDA does to ready itself for the onslaught. Altria (NYSE:MO), parent company e-cigarette company, JUUL, reports that it submitted more than 66 thousand pages of documentation for its application.
The FDA plans to spend the next year evaluating and processing applications, but there is a chance that the administration may not manage to get through all of them within the allotted time. Additionally, there will be a follow-up period for products that require more information in order for the FDA to make a determination of whether or not to approve the application. The agency does not currently have a plan of action for applications that are still left at the end of the processing period.
The Impact of COVID on FDA Evaluation
The FDA has already made it clear that the first priority for compliance enforcement will be electronic nicotine delivery systems (ENDs) that come in non-traditional tobacco flavors, and those that pose a risk for adoption by minors. Some speculate that COVID will also have an impact on the FDA’s evaluation process as it makes decisions about which products get approved and which are targeted for enforcement.
We know that people with lung damage endure more severe illness and are at a higher risk of death from COVID infections; so it seems reasonable to assume that as a result, the FDA will take a more critical look at products that may contribute to lung damage.
The Future of Tobacco Regulation
The next couple of years will likely be challenging for both the FDA and companies in the tobacco industry, as regulation and enforcement become solidified. There is an overwhelming number of products on the market; and because the PMDA process is expensive and arduous, many companies have certainly not submitted their applications in time. Some that make ENDs will pull their products off of shelves over the next few months, but others will likely attempt to operate under the FDA’s radar for as long as possible.
In addition to the sheer number of products presenting a challenge to finding and shutting down noncompliant companies, the FDA has been facing serious obstacles to efficient functioning. Between COVID being the focus of most policy-making since April and constantly-shifting leadership, the agency was dealing with a strain on its resources even before September 9th.
It will be interesting to see how this sector of new tobacco products fares, and how well the FDA will manage to regulate the industry. One thing is certain, however: Companies that have committed to the rigors of filing PMTAs for their products are more cognizant than ever of how to look out for their customers now and into the future.