Flavored E-Cigarettes and the PMTA Process
Last Updated: May 2023
On January 7, 2020, the U.S. Food and Drug Administration (FDA) published final guidance banning most flavored cartridge-based e-cigarettes, except for tobacco and menthol flavors, from the market. The guidance permits the sale of e-liquid flavors used in open vaping systems and in disposable, single-use vape products subject to the premarket approval process explained below.
The FDA first proposed guidance in March 2019 that would have effectively banned flavored e-cigarettes from convenience stores while allowing them to still be sold over the internet and in stores that don’t allow minors to enter. NACS strongly opposed the proposal in a comment letter to the FDA. The final guidance recognized those concerns and contains no language that discriminates between the type of retail outlet.
The guidance also stated that all manufacturers of deemed tobacco products (including all e-cigarettes, flavored cigars, smokeless tobacco and hookah products) that were not on the market as of the February 15, 2007 were required to submit premarket tobacco product applications (PMTAs) by September 9, 2020. PMTAs were also required for vape shops or other retailers that mix their own vape juice because they are, in those cases, manufacturing the product.
Manufacturers of e-cigarettes that are not impacted by the guidance, such as tobacco and menthol flavored cartridge-based products, as well as manufacturers and mixers of vape juice also were required to submit PMTAs by September 9, 2020 to remain on the market. However, FDA has determined these products were allowed to stay on the market for up to 12 months while those applications are being considered. Following that time period, the products can only be sold if FDA approves the applications.
In 2021, FDA began taking action on applications and to-date have reportedly taken action on 99 percent of those applications, issuing marketing denial orders (MDOs) for millions of products. However, the agency has only published the names of the manufacturers that have received MDOs and not the products themselves.
The FDA’s lack of clear information puts retailers in a difficult position. There is no clear way to know which products have received an MDO and therefore can no longer be sold. Retailers should check with manufacturers and suppliers of products as they are sources of information regarding the status of PMTA applications. NACS has repeatedly advocated for the FDA to provide the additional information that retailers need in order to ensure compliance with regulations.
Unlike the initial proposal from FDA, the final guidance focuses on which products can and cannot be sold rather than the locations in which those products are sold. NACS has been a vocal advocate for the fair treatment of retailers selling tobacco products and strongly opposed the initial efforts by the FDA to permit sales of flavored e-cigarettes in retail stores that are considered adult-only, such as vape shops and tobacco outlets, while prohibiting them in convenience stores.
Since FDA began taking action on PMTAs in 2021, NACS has asked the agency for a list of products for which it has issued marketing denial orders so that retailers know which items need to be removed from shelves. The agency has only shared manufacturer names and not a product list, even though NACS and lawmakers have requested transparency.