On August 24, 2020, Keller and Heckman LLP filed a citizen petition (here) with the U.S. Food and Drug Administration (FDA) on behalf of a group of small vapor product manufacturers, retailers, and trade associations requesting that the agency seek a 180-day extension of the September 9, 2020 deadline (until March 8, 2021) for filing Premarket Tobacco Product Applications (“PMTAs”) due to continuing delays experienced by manufacturers in preparing the applications caused by the COVID-19 pandemic.
The current PMTA deadline was set by a federal district court in Maryland as part of a lawsuit filed by anti-vaping groups challenging an earlier August 2022 deadline established by FDA through guidance issued in 2017. Attached to the petition were 20 declarations demonstrating that many small vapor companies, without an extension, will either have to file incomplete PMTAs or not submit applications at all, thus forcing them to layoff thousands of employees, close their doors permanently, and remove from the market less risky vapor products that addicted adult smokers rely on to move away from cigarettes.
The petition specifically asks FDA to request from the district court an extension on the court-imposed deadline that would apply only to small manufacturers that demonstrate to the agency that they have been working in good faith to complete PMTAs by the September 9, 2020 cutoff and have otherwise taken steps to ensure that their products will not contribute to underage use. In particular, each manufacturer would need to show that it:
- Has fewer than 50 employees and/or 10MM in annual revenue
- Only manufactures open system products (g., e-liquids) and does not produce products used in cartridge or pod-based systems
- Has taken steps to prohibit access by and sales to underage consumers for its brick-and-mortar stores and/or retail websites
- Will only market to adults and not rely on kid-friendly advertising (g., using age-gated social media accounts)
- Is otherwise in compliance with TCA and Deeming Rule requirements (g., facility registration, product listings, etc.)
- Has already made progress in completing PMTAs prior to the September 9, 2020 deadline, but has been materially delayed in one or more tasks due to COVID-19
The court had previously granted a similar request by FDA for a 120-day extension at the beginning of the COVID-19 outbreak, which extended the court’s initial May 2020 deadline to September 9, 2020. The FDA justified the need for the extension based on the extensive impact that the spread of coronavirus was having on U.S. workers and businesses, and particularly on the ability of vapor product manufacturers to complete tasks necessary to file compliant PMTAs. The agency cited to: (i) laboratory testing delays; (ii) the inability of consultants to complete required Environmental Assessments; (iii) suppliers who were unable to provide products (e.g., devices) for testing; (iv) travel restrictions associated with China where key PMTA information is located; and (v) stay-at-home orders forcing employees to work remotely.
The petition and accompanying declarations request an additional 180-day extension given that the COVID-19 conditions justifying the first court extension still exist today and show no signs of improving. Many small manufacturers are still: (i) unable to secure lab testing and consulting services; (ii) obtain PMTA-related information from suppliers (e.g., where flavor producers have not been able to complete Tobacco Product Master Files); (iii) retain or dedicate a sufficient number of employees to work on the applications; and (iv) overcome a steep decline in revenues that would otherwise be used to complete the PMTAs. To prevent a mass exit from the marketplace of small manufacturers and their products, the petition also points to Executive Order 13924, in which President Trump directs agencies like the FDA to grant temporary extensions from regulatory requirements and otherwise exercise enforcement discretion to promote job creation and economic growth during the coronavirus outbreak.
Also critical to the petition’s extension proposal is that it is limited to manufacturers of open system vapor products. FDA has concluded, based on extensive data collected as part of the 2019 National Youth Tobacco Survey (“NYTS”), that flavored, cartridge or pod-based systems are driving underage use, and that open systems should remain on the marketplace to help adult smokers transition away from more dangerous cigarettes. The proposed extension would therefore not be available to larger manufacturers who make products that may attract young consumers. This approach is consistent with FDA’s repeated statements over the years that the agency must balance concerns about minors having access to vapor products with potential health benefits to adults of using less risky, non-combustible options.
Since the petition was filed just over a week ago, nearly 6,000 public comments have been submitted to FDA’s docket (FDA-2020-P-1797) (here). Additional comments can be filed here.