FDA Final Guidance on Flavored E-Cigarettes
Last Updated: January 8, 2020
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 states 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 must submit Premarket Tobacco Product Applications by May 12, 2020. Premarket approval applications are 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 must submit Premarket Tobacco Product Applications by May 12th 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 may choose to submit premarket approval applications as well, but it is highly unlikely any such application would be approved and those products would not be allowed to be sold while the application was being considered.
The FDA’s final guidance states that retailers will have until February 6, 2020 to sell-through current flavored cartridge-based products (such as Juul, NJoy and Vuse) before they must 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.