FDA Releases Final Guidance Banning Flavored Cartridge-Based E-Cigarettes

The U.S. Food and Drug Administration (FDA) on Jan. 2 published final guidance banning most flavored cartridge-based e-cigarettes, except for tobacco and menthol flavors. The guidance permits the sale of e-liquid flavors used in open vaping systems and in disposable, single-use vape products.

Unlike the initial proposal from FDA, the final guidance does not contain language that discriminates between type of retail outlet and ensures a level playing field among retailers. Instead, it focuses on which products can (and cannot) be sold rather than the locations where those products are sold. 

Retailers have 30 days following publication of the guidance in the Federal Register to sell current flavored cartridge-based products (such as Juul, NJoy and Vuse) before they must be removed from stores.  

It is important to note that manufacturers may file Premarket Tobacco Product Applications, which would allow flavored cartridge-based products to come back onto the market. Products for which premarket approval applications are filed before the May 12 deadline can be sold 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. Premarket approval applications are also required for vape shops or other retailers that mix their own vape juice.

Manufacturers of e-cigarettes that are not impacted by the guidance (including tobacco and menthol flavored cartridge-based products, open vaping systems, and other tobacco products such as flavored cigars, smokeless tobacco and hookah products) that were not on the market as of the February 15, 2007, predicate date in the Tobacco Control Act must submit Premarket Tobacco Product Applications by May 12, 2020, to remain on the market.

On Aug. 8, 2016, all e-cigarettes and other electronic nicotine delivery systems (ENDS) products became subject to the FDA’s tobacco authorities, including the premarket authorization requirements. All e-cigarettes and other ENDS products on the market at that time needed to have authorization from the FDA to be legally marketed. To date, no ENDS products have been authorized by the FDA — meaning that all ENDS products currently on the market are considered illegally marketed and are subject to enforcement, at any time, in the FDA’s discretion.

Beginning 30 days from the publication of the notice of availability of its guidance in the Federal Register, FDA intends to prioritize enforcement by focusing on the following groups of products that do not have premarket authorization:

1. Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product);
2. All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
3. Any ENDS product that is targeted to minors or likely to promote use of ENDS by minors.

After May 12, 2020, the FDA intends to also prioritize enforcement against any ENDS products that continue to be sold and for which the manufacturers have not submitted a premarket application.

According to the FDA guidance, manufacturers also 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 as well as manufacturers conducting stings of retailers and imposing fines on retailers for violations.