The Food and Drug Administration (FDA) has officially authorized three new vape products through its premarket tobacco product application (PMTA) pathway. The authorized vapes are part of the JUUL2 e-cigarette system and include a tobacco-flavored pod, a menthol-flavored pod and the JUUL2 device.
The FDA’s scientific review of data in the application found that “a substantial proportion of adults who smoke completely switched away from combustible cigarettes to the authorized JUUL2 products, with the menthol-flavored pod having a higher rate of complete switching compared to the tobacco-flavored pod,” the agency noted in a statement.
Specifically, the statement continued, 19.9 to 34.6% of those using the tobacco-flavored pod and 28.4 to 49.3% of those using the menthol-flavored pod stopped smoking cigarettes entirely at six weeks. Those who completely switched to the authorized products were exposed to lower levels of harmful chemicals than they would have been had they continued smoking cigarettes.
“The FDA determined that the added benefit to adults who smoke cigarettes is sufficient to outweigh the risks of the menthol-flavored product, including youth appeal,” the agency noted.
In July 2025, the FDA authorized several JUUL e-cigarette products, including tobacco and menthol-flavored pods in 3% and 5% nicotine concentrations.
“Today’s authorizations are another important step to provide greater access to products that can promote switching for adults who smoke and prevent downstream health risks associated with combustible cigarettes,” the statement concluded.
PMTA Push
The FDA has ramped up its focus on PMTA submissions and authorizations in recent months. Just last week, the agency announced that it had authorized 11 new nicotine pouch products — all from Swedish Match — under the Zyn Ultra brand.
“We are delighted with the FDA’s decision to authorize a range of Zyn Ultra products, which will build on Zyn’s position as America’s leading smoke-free product brand,” said Stacey Kennedy at the time, PMI U.S. CEO. “We look forward to expanding our portfolio of better choices for the 45 million Americans who consume nicotine products.”
The review of the products, according to a statement from the FDA, was part of the agency’s nicotine pouch pilot program, which aims to increase efficiency and streamline the review process for nicotine pouches through the PMTA pathway. The pilot streamlined the FDA’s review processes, which has led to faster resolution of issues, decreased time needed for applicants to respond to deficiency letters and more efficient scientific reviews.
The FDA’s evaluation found that the new Zyn products contain “lower levels of most harmful and potentially harmful constituents when compared to other oral and smokeless tobacco products, many of which were too low to be quantified in the new products.”
This decision followed the FDA’s early August move to authorize the marketing of four new on! nicotine pouches from Helix Innovations, sold under the brands Rich Berry 2 mg, Capuccino 2 mg, Cappuccino 4 mg and Autumn Spice 2 mg.
Additionally in July, the agency authorized 20 Zyn pouch products, which were the first to receive modified risk tobacco product (MRTP) orders from the agency, allowing the company to market its nicotine pouches with the following claim: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.”
