FDA-authorized new tobacco products gain momentum

• Facebook
• Twitter
• LinkedIn

The U.S. Food and Drug Administration’s review of vapor and nicotine pouches has entered an important new phase in 2026, with the agency granting a growing number of marketing granted orders (MGOs) through the premarket tobacco product application (PMTA) pathway.

For retailers and adult nicotine consumers, the developments are promising. After years in which the number of FDA-authorized new tobacco products remained relatively limited, 2026 has brought a steady stream of new authorizations across vapor and nicotine pouch categories. 

A growing list of authorized products

The agency has now authorized 48 vapor products. The list includes products that encompass tobacco, menthol and other flavors. 

One of the most notable developments came in May, when the FDA granted marketing authorization to Glas Inc. for its G2 age-gated device and five pods. The authorization included mango- and blueberry-flavored products, along with menthol and tobacco varieties. FDA’s scientific review found that the products provided benefits for adult smokers, including substantial rates of complete switching from cigarettes, while also considering youth-access protections and other safeguards. 

The Glas authorization was particularly noteworthy because it demonstrated that the PMTA process can result in authorization of flavored vapor products when FDA determines that the statutory public-health standard has been met.

The pace continued in late August when FDA authorized three Juul 2 products, which include the Juul 2 age-gated device, a tobacco-flavored pod and a menthol-flavored pod.

The agency has continued adding products to the authorized marketplace. In August, the FDA authorized 11 Zyn Ultra nicotine pouch products, including one 11 milligram variant, followed by four additional On Plus nicotine pouch products. As a result, there are now 43 nicotine pouch products that have received marketing authorization from the FDA.

The FDA’s actions have not been limited to new products. In June, the agency issued modified-risk granted orders for 20 Zyn nicotine pouch products, allowing those specific products to be marketed with an FDA-authorized modified-risk claim concerning their use instead of cigarettes. 

More transparency needed

In May 2026, the FDA released a guidance document titled, “Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization.” 

Under the policy, the FDA generally does not intend to prioritize enforcement against unauthorized vapor and nicotine pouch products if the manufacturer has a pending PMTA that has been both accepted and filed for scientific review by the FDA. For non-tobacco-flavored vapor products, the FDA also expects the application to include the scientific data needed to determine whether the product is appropriate for the protection of public health, e.g., switching data showing added benefit to adult smokers. The policy also applies to supplemental applications (sPMTAs) for modifications to already FDA-authorized products that have been accepted by the FDA and have been pending for more than 180 days.

The FDA has stated that it may still prioritize enforcement against products that appear to appeal to underage users. Examples include products that feature cartoon-style characters, disguise the fact that they are vaping products, or resemble children’s toys, phones, or gaming devices. The FDA also may prioritize enforcement against products that present a “significant public health or safety concern that is greater than generally presented by ENDS or nicotine pouch products or other tobacco products.” As examples, the FDA listed products with high nicotine levels, products associated with serious adverse events or a larger number of unexpected adverse experiences compared with authorized products, products without child-resistant packaging, or products that may pose a fire risk.

Notably, in issuing this guidance, the FDA indicated that it plans to create a public-facing list of manufacturers and products that generally fall within this enforcement policy. NATO has long advocated for greater transparency from the FDA so retailers can better understand which products the agency does not currently intend to prioritize for enforcement. The FDA has not announced a launch date for the webpage. For NATO’s retail members, the availability in the near future of a reliable and complete list of products that fall within the enforcement policy would be particularly important.

NATO looks forward to hearing additional insights from the FDA later this month at NATO’s 25th Anniversary Conference, where Bret Koplow, director of the FDA’s Center for Tobacco Products, will speak.

Members help make our journalism possible. Become a CSP member today and unlock exclusive benefits, including unlimited access to all of our content. Sign up here.