The Food and Drug Administration has authorized Juul Labs to market an updated version of its e‑cigarette device, which the company plans to sell as Juul2. The authorization permits Juul to offer an updated system and accompanying tobacco‑ and menthol‑flavored cartridges. The FDA noted that the determination is not an approval or endorsement and reiterated that people who do not smoke should not use Juul or any other e‑cigarette.
The agency also indicated, as part of its determination, that smokers who switch completely to Juul products can reduce their exposure to some carcinogens and other chemicals found in traditional cigarettes.
The updated device gives users the option to enable an age verification mechanism that requires authentication via an online application before the e‑cigarette can be unlocked. That capability is presented as a tool intended to reduce underage access to the device.
Juul plans to market the device under the brand name Juul2 and will offer updated versions of its existing tobacco‑ and menthol‑flavored cartridges alongside the device.
In recent years Juul Labs has experienced significant operational and financial disruption. The company has laid off hundreds of employees and has paid roughly $3 billion to settle a combination of government and private lawsuits related to teen use of its products. Those legal and financial outcomes are part of the context surrounding the company’s reintroduction of an updated device.
According to company studies that the FDA reviewed, between 20% to 50% of smokers who used Juul products were able to stop smoking at the end of six weeks. The reported cessation rates varied depending on the flavors and nicotine strengths used. These company‑provided data were among the materials the FDA considered in reaching its determination.
The FDA’s messaging accompanying the action reiterates harm‑reduction language: complete switching from combustible cigarettes to certain e‑cigarette products can reduce exposure to some toxicants present in traditional cigarette smoke. The agency, however, maintains that authorization of a product is not an endorsement and that non‑smokers should not initiate vaping.
Juul discontinued several flavors in 2019 — including mango, mint and creme — flavors that previously accounted for a large share of sales and were reported to be favored by teens. In announcing the new device, Juul’s CEO K.C. Croswaite said the company intends to market Juul2 with “a portfolio of flavors — beyond tobacco and menthol — that are targeted to adult nicotine consumers.”
The company frames the updated product and its flavor portfolio as intended for adult smokers, while regulators and public‑health messages caution against initiation by non‑smokers and youth.
Juul is no longer the top‑selling e‑cigarette brand in the United States; it trails Vuse, which is sold by Reynolds American, the maker of Camel and Newport cigarettes. Federal figures reported that teen vaping has declined from previous peaks, and that teens who continue to vape predominantly use unauthorized disposable e‑cigarettes imported from China, often available in fruit and candy flavors.
The shift of youth away from Juul has occurred amid broader market changes and regulatory scrutiny that contributed to Juul’s fall from its earlier market dominance.
The FDA has previously authorized several e‑cigarette products intended to help adult smokers quit or reduce cigarette use. In a notable recent action, the agency authorized the first fruit‑flavored electronic cigarettes intended for adult smokers; that decision represented a shift in regulatory disposition toward certain flavored products for adult nicotine consumers.
The current FDA determination for Juul2 was presented with cautionary language: the authorization is not a blanket endorsement, and the agency stressed that e‑cigarettes are not appropriate for people who do not currently smoke.
This summary is based on reporting from the Associated Press as published on STAT News. The AP Health and Science Department acknowledged support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation; the AP is solely responsible for the article’s content.