US regulator authorises first fruit-flavored vapes

The US Food and Drug Administration on Tuesday (5 May) allowed the marketing of fruit-flavoured e-cigarettes in a first authorisation of non-tobacco-flavored vaping products, amid mounting political pressure on the agency.

The authorised pods from Los Angeles-based Glas Inc, a small vape maker that uses technology to age-gate its devices, include flavors such as Classic Menthol, Fresh Menthol, Gold and Sapphire, the FDA said.

Earlier in the day, the Wall ​Street ​Journal reported that US president Donald ​Trump over the weekend rebuked ‌FDA commissioner Marty Makary for not moving quickly enough to approve flavoured vapes and nicotine products.

Previously the FDA had only granted permission to tobacco or menthol-flavoured vaping products, but earlier this year the agency published a new draft guidance, setting out how flavoured vape products could gain regulatory authorization.

The guidance, which outlines evidentiary requirements for Premarket Tobacco Product Applications (PMTAs) for flavoured electronic nicotine delivery systems (ENDS), is the first time the FDA has formally set out a framework under which such products could be assessed for approval.

It introduced the concept of device access restrictions (DAR), including biometric authentication, geofencing and continuous age verification, as potential tools to meet the agency’s “appropriate for the protection of public health” (APPH) standard.

The FDA said its review of the Glas products found that the company “sufficiently demonstrated” that its DAR technology, combined with FDA-required marketing restrictions, is expected to effectively mitigate the ability of youth to use the product.

The technology requires the user to verify their age and identity with a government-issued ID and pair the device with a smartphone via Bluetooth. Following verification, the device will not operate if separated from the phone. The app also conducts random biometric check-ins to periodically confirm the registered user is the one using the device.

“By helping to prevent youth use, device access restrictions are a potential game changer,” said Bret Koplow, acting director of the FDA’s Center for Tobacco Products.

“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 added that it will closely monitor how these products are marketed and will act appropriately if the company fails to comply with any applicable statutory or regulatory requirements.

With Tuesday’s marketing orders, the FDA has now authorised 45 ENDS products for marketing in the US.