SILVER SPRING, Md. — The U.S. Food and Drug Administration will make public a list of the tobacco products subject to the premarket tobacco application (PMTA) deadline of Sept. 9—something NACS and other retail associations had urged the agency to do.
The move will help convenience-store retailers identify illegal products that must be pulled from shelves following the deadline.
With the PMTA deadline quickly approaching, the FDA is preparing to receive a large volume of applications, particularly from manufacturers of e-liquids, e-cigarettes and other electronic nicotine devices (ENDS), Mitch Zeller, director of the FDA’s Center for Tobacco Products (CTP) said on Aug. 31. The FDA has one year to review products that were filed on time—but it might not make that deadline.
While the FDA does not know how many applications will be submitted by Sept. 9, there are more than 400 million deemed products listed with the FDA.
Manufacturers of cigars, pipe tobacco, electronic cigarettes, vapor products, hookah, alternative nicotine products and heated tobacco products introduced after Feb. 15, 2007, were required to file substantial equivalence (SE) or PMTA marketing authorization requests by Sept. 9. The deadline was originally May 12, 2020, but the FDA asked for more time due to the COVID-19 pandemic.
The likelihood of the FDA reviewing all of the applications during the one-year review period is low, the agency said, given that this would be an unprecedented number of applications and “several orders of magnitude greater” than anything the FDA has experienced.
The FDA said, however, that it has been laying the groundwork for years to receive, process and review the applications in a timely manner. To date, the FDA has received applications for about 2,000 deemed products, of which about 40% have been resolved.
For products with timely applications, the FDA may continue to defer enforcement of the premarket requirements for up to one year through Sept. 9, 2021, unless a negative action is issued by the FDA on an application during that time.
The FDA plans to release data on the monthly progress it has made it the review process, including metrics like the number of applications accepted and filed.
“Although there may be some delays in the release of this information in the first few months, we will release information as quickly as possible,” Zeller said.
The FDA plans to make a public list of the deemed new tobacco products that are subject to the Sept. 9 deadline, were on the market as of Aug. 8, 2016 and for which a premarket application is submitted by Sept. 9, it said. Before doing so, the FDA will need to ensure the publishing of any information complies with federal disclosure laws and regulations.
The FDA asked for patience as it works through this process and suggested, in the meantime, retailers refer to public statements made by the companies or to contact the companies directly to get information about applications they may have submitted.
Zeller also noted that some deemed tobacco products may be eligible for “grandfathered status” because they were commercially marketed in the United States as of Feb. 15, 2007. These products aren’t “new tobacco products” and, therefore, do not need to submit premarket applications unless they were since modified, according to the FDA. Many cigar, hookah tobacco and pipe tobacco products fall into this category, he said.
NACS was part of a group of retail associations that urged the FDA to publish the ENDS products for which the agency received PMTAs.
“The PMTA list will be critical to support compliance across the tobacco trade channel, helping inform distributors, wholesalers and retailers which ENDS products are being marketed legally in accordance with FDA’s compliance policy,” the letter, dated Aug. 25, read. “Such a list also would facilitate enforcement against those manufacturers that continue to introduce illegally marketed products without premarket authorization or, in the case of deemed, currently marketed products, without a PMTA submitted by the deadline.”
Without a published PMTA list, “distributors, wholesalers, retailers and adult consumers will have no centralized and credible way of determining which ENDS products are being marketed in compliance with FDA policy,” the associations said in the letter.
Other agencies that signed along with the National Association of Convenience Stores included The Food Industry Association (FMI), the National Association of Truck Stop Operators (NATSO), the Petroleum Marketers Association of America (PMAA) and the Society of Independent Gasoline Marketers of America (SIGMA).