The FDA has authorized four Glas e-cigarette products under the PMTA pathway, including the first-ever approvals for non-tobacco flavored ENDS products such as mango (“Gold”) and blueberry (“Sapphire”), alongside menthol variants. Each product contains 50mg/ml nicotine.

The agency said the decision is based on evidence that the products may help adult smokers switch from cigarettes, and on the use of device-based age verification technology requiring ID checks, smartphone pairing, and biometric confirmations to restrict youth access. The FDA also imposed strict marketing limits, requiring adult-only targeting and ongoing reporting on youth exposure and prevention effectiveness.

The FDA emphasized that all authorizations are product-specific and can be revoked if youth use increases or if public health benefits are not sustained. It also reiterated that these products are only permitted for adults 21+ and that non-users should not start.

Public health groups, including Campaign for Tobacco-Free Kids, strongly criticized the decision, warning that approving fruit flavors could increase youth uptake. They argue that most youth e-cigarette users already use flavored products and that flavors like mango have historically driven spikes in youth use. Critics also questioned the effectiveness of the FDA’s reliance on unproven device-based age restriction technology.

The FDA now lists 45 authorized ENDS products in the U.S., while continuing enforcement against unauthorized products.

Overall, the decision reflects a continued regulatory balance between harm reduction for adult smokers and ongoing concerns about youth nicotine initiation, particularly through flavored products.