The FDA approved the first non-tobacco and non-menthol electronic nicotine delivery systems for adult use.
RT’s Three Key Takeaways:
- Market Expansion: The Food and Drug Administration authorized four Glas electronic nicotine delivery systems, marking the first time non-tobacco and non-menthol flavored products have received marketing orders.
- Youth Prevention Technology: The authorized devices utilize Bluetooth pairing and biometric check-ins to ensure only verified adults aged 21 and older can operate the products.
- Public Health Standards: The agency determined that the potential benefits for adult smokers who completely switch from combustible cigarettes outweigh the risks of youth initiation when combined with strict marketing restrictions.
The US FDA authorized the marketing of four Glas electronic nicotine delivery systems (ENDS) through the premarket tobacco product application pathdway, according to the agency. This action marks the first time the FDA has authorized non-tobacco and non-menthol flavored ENDS products.
The authorized products include Classic Menthol, Fresh Menthol, Gold, and Sapphire e-liquid pods, each containing 50mg/ml of tobacco-derived nicotine. The FDA’s “rigorous, scientific review” of these products found that the manufacturer sufficiently demonstrated that device access restriction technology, combined with marketing restrictions, is expected to mitigate youth use.
The technology requires users 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, and the application conducts random biometric check-ins to 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, PhD, JD, acting director of the FDA Center for Tobacco Products, in a news release. “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 noted that smoking remains the leading preventable source of chronic disease and premature death in the US, with cigarette smoking resulting in one in five deaths last year. More than 25 million Americans still smoke combustible cigarettes, and the agency stated these individuals deserve less harmful alternatives.
To further mitigate youth exposure, the marketing orders require the company to ensure advertising, marketing, and promotion are targeted to adults aged 21 and older. The company must also track, measure, and report the effectiveness of its youth prevention measures to the agency.
The FDA states it will monitor how these products are marketed and may suspend or withdraw authorization if continued marketing is no longer appropriate for the protection of public health. With these actions, the agency has now authorized 45 ENDS products for marketing in the US.
