The Food and Drug Administration said on Tuesday it has authorized the marketing of four e-cigarette products made by Glas Inc., an independent vaping technology company based in Inglewood, California. The authorized pods include Classic Menthol; Fresh Menthol; Gold, a mango flavor; and Sapphire, a blueberry flavor, marking the FDA’s first authorization of non-tobacco and non-menthol e-cigarette products.
Each product is an e-liquid pod containing 50 milligrams/milliliters (or 5%) of tobacco-derived nicotine, and do not apply to any other Glas products, the agency said. The FDA said its review found the products demonstrated that their access-restriction technology, combined with FDA-required marketing restrictions, is expected to limit youth use.
The Glas system requires users to verify their age and identity with a government-issued ID and to pair the device with a smartphone via Bluetooth. The device will not operate if separated from the phone and the app 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, 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 agency said the company showed that most adults aged 21 and older were able to complete the verification process, while youth and young adults were not.
Glas CEO Sean Greenbaum called the authorization a significant milestone.
“With this latest decision, the agency has now extended authorization to our flavored products, confirming that they meet the statutory standard of being appropriate for the protection of public health (APPH),” Greenbaum said in a statement. “Today’s decision is an important step forward—not only for Glas, but for a clear, science-based path for responsible innovation in the United States.”
The agency said it would continue to monitor the products and could suspend or withdraw authorization if there is evidence of increased youth use or if the public health benefits no longer outweigh the risks.
“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,” the agency said. “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.”
In March the FDA issued marketing granted orders for the company’s Glas G2 Device and its Blonde Tobacco pod, which contains 50 milligrams/milliliters of nicotine.
To date, the FDA said there are 45 e-cigarettes authorized by the agency. These are the only e-cigarettes that may be lawfully sold in the United States.
The latest authorization comes following a Wall Street Journal report that President Trump rebuked FDA Commissioner Marty Makary over the weekend for not approving flavored vapes more swiftly.
In an April 29 article penned by Greenbaum on LinkedIn he said the "FDA’s own scientists concluded that age-gated flavored products met the legal and scientific standard for authorization. Yet senior leadership appears to have blocked them without citing any new scientific basis for doing so."
Tuesday's announcement has also come under scrutiny, including from Yolanda Richardson, president and CEO of Campaign for Tobacco-Free Kids, who called it a “big step” backward for preventing youth e-cigarette use.
"Today’s decision puts at risk the progress our nation has made in reducing youth e-cigarette use. It conflicts with overwhelming scientific evidence and the FDA’s own repeated conclusions that flavors pose a substantial risk to young people," Richardson said in a statement.
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