U.S. Small Business Administration is urging the U.S. Food and Drug Administration to impose a one year moratorium on enforcement actions against manufacturers of ENDS (electronic nicotine delivery systems) that have submitted a premarket tobacco application (PMTA) in a timely manner. This moratorium would give time for the FDA to review all of the applications received rather than prioritizing those of larger brands.
Previously, the FDA indicated that it would be reviewing PMTAs based on the size of the manufacturer and their market share [read more here]. This approach would favor those with market dominance over small businesses, a move that the U.S. Small Business Administration says would not be “in line with the American tradition of support for small businesses as announced in such statutes as the Regulatory Flexibility Act, as well as several executive orders and presidential memoranda.” The U.S. Small Business Administration also encourages the FDA to reverse its policy and review the PMTAs from those with the smallest market share which would allow more small businesses to keep their products on store shelves and keep them from being pushed out of the ENDS industry all together.
“While Advocacy understands and appreciates the monumental task before the FDA, it is imperative that the agency do all that it can to help small businesses in the vaping industry remain in the marketplace and a part of the industry they created. Advocacy is concerned that many small ENDS manufacturers and retail stores will permanently close if the moratorium on FDA enforcement actions is not extended for those who timely submitted PMTAs and are awaiting FDA approval of their applications. Additionally, reversing the order of review of submitted PMTAs from largest market share to smallest will enable more small ENDS manufacturers to keep their products in the marketplace after September 9, 2021,” states the U.S. Small Business Administration in its letter to the FDA.
Due to many factors including lawsuits and the COVID-19 pandemic, the PMTA timeline has been altered and tweaked since it was first announced. Though the deadline has been changed, the requirement that products with an timely submitted PTMA be allowed to remain on the market without FDA enforcement for a period “not to exceed one year from the date of application while the FDA considers the application” has remained in place. On Feb. 29, 2020, Mitch Zeller, director of the Center for Tobacco Products, stated that 30 premarket tobacco product applications were pending for electronic cigarette products. As of May 20, 2021, there was a list of over 6 million new ENDS products with a PMTA that had been filed in a timely manner via the FDA’s website.