SAN FRANCISO—JUUL Labs said last week it filed a Premarket Tobacco Product Application (PMTA) with the U.S. Food and Drug Administration seeking approval for its e-cigarette cartridge device and tobacco-flavored and menthol-flavored nicotine pods and also shared the data-driven measures it is taking to address underage use of its products.
The company, which is 35% owned by Altria Group, said it has provided scientific data from more than “110 studies totaling over 125,000 pages evaluating the product’s impact on both current users of tobacco products and nonusers, including those who are underage.”
The FDA requires makers of e-cigarettes, flavored cigars, smokeless tobacco and hookah products to submit premarket applications by Sept. 9, providing data to show their products are appropriate for public consumption. Companies can then keep selling their products for a year from the date of the deadline while the FDA reviews their applications, or until the agency takes a negative action. If vaping companies miss the deadline, they must pull their unapproved products from the market.
Manufacturers had faced a May 12 deadline to submit PMTAs to the agency, but a U.S. District Court in May granted the FDA’s request for a 120-day extension of the deadline in light of the global outbreak of the novel coronavirus.
NACS is urging FDA to provide a public list of which manufacturers have filed PMTAs for their products and which have not. Under FDA regulations, if a manufacturer does not file a PMTA by the September 9th deadline for a product, the product will be considered illegal and subject to enforcement. Whereas, manufacturers that have submitted applications for their products by the deadline are permitted to keep their products on the market for up to one year while their applications are reviewed. NACS sent a letter to FDA Commissioner Stephen Hahn in June asking for transparency in the process and highlighting that retailers could unwittingly sell products that are illegal and face regulatory penalties.
“Without this needed transparency, regulated businesses will have no way to know which products are legal and which are illegal,” stated NACS.
NACS has not received a response from FDA.
Earlier this year, the FDA published guidance banning flavored cartridge-based e-cigarettes, with the exception of tobacco and menthol flavors, which took effect on February 6. However, flavored single-use disposable e-cigarettes and flavored e-liquids used in open-tank systems were allowed to stay on the market provided the manufacturers file PMTAs by the FDA deadline.