Earlier today, FDA issued a 52-page Industry Guidance document announcing that, effective on or around February 1, 2020 (30 days from today), it will “prioritize enforcement action” against (implicitly banning from lawful sale) all “flavored, cartridge-based” ENDS products on the market (other than tobacco- or menthol-flavored ENDS products). The Guidance defines a cartridge-based product as a product that “consists of, includes, or involves a cartridge or pod that holds liquid that is to be aerosolized through product use,” and defines a “cartridge or pod” as “any small, enclosed unit (sealed or unsealed) designed to fit within or operate as part of an electronic nicotine delivery system.” As such, the FDA is not seeking to ban at this time the sale of flavored ENDS products that are not cartridge-based, such as e-liquid flavors produced in vape shops or numerous smaller manufacturers. The agency reiterated its intent to prioritize enforcement action against any ENDS product offered for sale after May 12, 2020 that has not submitted a premarket application (and is not the subject of negative agency action on a submitted application).
FDA’s Guidance also significantly increases pressure on the downstream supply chains of ENDS manufacturers. It indicates that the agency will prioritize enforcement action against ENDS products “for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access” as well as any ENDS product “that is targeted to minors or whose marketing is likely to promote use of ENDS by minors.” It also contains several suggested mitigating factors that FDA will consider in taking enforcement action, such as retailer compliance monitoring and penalty programs.
The Guidance is the FDA’s attempt to balance the agency’s concerns with restricting youth access to flavored vapor products with the potential for ENDS to act as a substitute for cigarettes and to provide current and former adult smokers with an alternative that allows them to transition completely away from combusted tobacco products. Notably, the agency specifically declined to include other deemed new tobacco products, such as flavored cigars and hookah tobacco products, among its new enforcement priority, citing the lower youth prevalence of those segments. However, in addition to reiterating the requirement for cigar premarket applications by May 12, 2020, FDA also reiterated its intention to issue a regulation that would ban the use of characterizing flavors in cigars, indicating it is “actively working” towards that proposed rule.