FDA RELEASES FINAL GUIDANCE BANNING FLAVORED CARTRIDGE-BASED E-CIGARETTES

January 2, 2020

ALEXANDRIA, Va. – Today, the U.S. Food and Drug Administration (FDA) 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.

The new FDA policy is the result of the Trump Administration’s effort to crackdown on youth vaping. 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 even 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. 

The final FDA guidance recognized those concerns and contains no language that discriminates between the type of retail outlet.

“Given the urgent need to address the dramatic rise in youth use, this Final Guidance prioritizes enforcement with respect to any flavored, cartridge-based ENDS products (other than a tobacco and menthol-flavored ENDS product) without regard to the location or method of sale,” states FDA.

Lyle Beckwith, NACS senior vice president of government relations stated, “It would appear that FDA heeded our concerns regarding a level playing field among retailers and adjusted their final guidance policy accordingly.”

All e-cigarette manufacturers are required to file 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.

The FDA guidance policy will become effective 30 days after it is published in the Federal Register, which should occur in the next several days. It should be noted, however, that there is a pathway for flavored cartridge-based products to come back onto the market if the manufacturers file Premarket Tobacco Product Applications. Products for which premarket approval applications are filed before the May 12th 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.

Manufacturers of e-cigarettes that are not impacted by the guidance, such as 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. 

The guidance also provides 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. FDA’s guidance states that retailers will have 30 days following publication of the guidance in the Federal Register to sell-through current flavored cartridge-based products (such as Juul, NJoy and Vuse) before they must be removed from stores.