Flavored E-Cigarettes and the PMTA Process
Last Updated: March 25, 2022
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.
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 are 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.
Manufacturers of flavored cartridge-based products have submitted premarket approval applications as well, but it is highly unlikely any such application will be approved and those products are not allowed to be sold while the application was being considered.
The FDA’s final guidance required retailers to sell-through flavored cartridge-based products (such as Juul, NJoy and Vuse) by February 6, 2020, when they had to be removed from stores. Retailers can continue selling e-liquid flavors used in open vaping systems and in disposable, single-use vape products.
The guidance also says that manufacturers must take steps to try to prevent minors from purchasing their products. These steps may include manufacturers requiring retailers to use certain age verification systems and/or manufacturers conducting stings of retailers and imposing fines on retailers for violations.
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.
NACS asked FDA to publish a list of the products for which the agency has received premarket tobacco product applications (PMTAs) by the September 9, 2020 deadline. This is important to tobacco retailers, as products without PMTAs would be deemed illegal. FDA subsequently published the PMTA list.
In 2021, FDA began taking action on applications and announced they had issued marketing denial orders (MDOs) for a number of products. However, the agency only published the names of the manufacturers and not the products themselves. NACS has asked FDA for a list of product names for which it has issued MDOs if those products are on the market.