WASHINGTON, D.C. — The U.S. Food and Drug Administration authorized four Glas electronic nicotine delivery system products through the agency’s premarket tobacco product application pathway, marking the first authorization of non-tobacco and non-menthol flavored vaping products in the United States.
The authorized products are Glas e-liquid pods containing 5% tobacco-derived nicotine in the flavors Classic Menthol, Fresh Menthol, Gold and Sapphire. The FDA said the products include device access restriction technology intended to reduce youth access and use.
According to the agency, the system requires users to verify their age and identity using a government-issued identification card and connect the device to a smartphone through Bluetooth technology. The device becomes inoperable if separated from the verified phone, and the accompanying app conducts periodic biometric verification checks to confirm the registered user is operating the product.
The FDA said its scientific review found adult users age 21 and older were generally able to complete the age-verification process and understand the device instructions, while youth and young adults were unable to do so successfully.
Bret Koplow, acting director of the FDA’s Center for Tobacco Products, said the authorization reflects the agency’s view that access-control technology could help reduce youth nicotine use.
“By helping to prevent youth use, device access restrictions are a potential game changer,” Koplow said. “This technology is also an indication of the role innovation may serve in the effort to protect young people from threats posed by nicotine use and addiction while helping to enable availability of an expanded array of flavored options for adults who smoke who may use these products to completely switch away from regular cigarettes.”
The FDA also imposed marketing restrictions requiring the company to target advertising only to adults 21 and older and to track and report the effectiveness of youth prevention measures. The agency said it could suspend or withdraw authorization if youth usage increases or if the products no longer meet public health standards.
The authorization applies only to the four Glas products covered by the order and does not extend to other Glas vaping products.
The FDA said it has now authorized 45 electronic nicotine delivery products for legal sale in the United States. A list of authorized products is available at FDA Authorized E-Cigarettes.
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