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FDA Approves New E-Cigarette Products
FDA Expands Market Access, Authorizes New ENDS Products
The U.S. Food and Drug Administration (FDA) today authorized the marketing of four Glas electronic nicotine delivery systems (ENDS) through the premarket tobacco product application (PMTA) pathway. Each product is an e-liquid pod containing 50mg/ml (or 5%) of tobacco-derived nicotine. The authorized pods include Classic Menthol, Fresh Menthol, Gold, and Sapphire. This action marks the FDA’s first authorization of non-tobacco and non-menthol ENDS products. Smoking is the leading preventable source of chronic disease and premature death in the U.S. Last year, one in five deaths resulted from cigarette smoking. More than 25 million Americans still smoke combustible cigarettes, and they deserve better, less harmful alternatives. Under President Trump’s leadership, the FDA has authorized a number of less harmful alternatives for smokers, including 11 ENDS products from American companies. The FDA’s rigorous, scientific review of these products found that the applicant sufficiently demonstrated that Glas’s device access restriction 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. In addition, the applicant showed that most adults (aged 21 and older) successfully completed age verification and found the device use instructions and age-verification software easy to understand and activate, while youth and young adults could not. With these orders, the FDA confirms the availability of an additional way for demonstrating that a non-tobacco flavored product meets the public health standard by using effective age-gating. It remains the case that a non-tobacco flavored product may be authorized where the application demonstrates its benefit in helping adults quit cigarette smoking outweighs its potential risks.
“By helping to prevent youth use, device access restrictions are a potential game changer,” said Bret Koplow, Ph.D., J.D., 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.”
To help further mitigate potential youth use by limiting youth exposure to the authorized products’ advertising, marketing, and promotion, the marketing orders also require the company to ensure its advertising is carefully targeted to adults ages 21 and older. In addition to these and other requirements, the company must also track, measure, and report to FDA the effectiveness of its youth prevention measures and provide analyses of the demographics of the audiences reached by its advertising, marketing, and promotional activities. The FDA 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. The FDA may suspend or withdraw authorization if the agency determines that continued marketing of the authorized products is no longer appropriate for the protection of the public health, including if there is a notable increase in use of the products among youth, or evidence that the benefits of the products no longer outweigh the risks. Today’s actions permit these specific ENDS products to be legally marketed in the U.S. to adults 21 and older. Importantly, today’s actions are specific to these 4 products only; the authorizations do not apply to any other Glas products. There is no safe tobacco product. Those who do not currently use tobacco products should not start. Youth should never use tobacco products. With today’s marketing orders, the FDA has now authorized 45 ENDS products for marketing in the U.S. These 45 products are the only ENDS products that may currently be lawfully sold in the U.S. and are clearly listed at www.fda.gov/authorizedecigs. The agency also continues to take actions aimed at addressing unauthorized ENDS products that remain on the market illegally, such as a recent initiative to help U.S. retailers comply with relevant laws and regulations and ongoing joint enforcement operations with federal partners, including at our borders and ports. FDA will continue enforcement against those that target youth with tobacco products.
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