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The US Food and Drug Administration on Tuesday approved the marketing of flavored electronic cigarettes, marking the first time it has approved flavored vaping products.
The FDA said the products are pods made by Los Angeles-based Glas Inc., a hot manufacturer that uses age-verification technology to limit access.
The pods are available in mango, blueberry and two menthol varieties and will be sold under the names Gold, Sapphire, Classic Menthol and Fresh Menthol, the agency said.
“The FDA’s rigorous, scientific review of these products found that the applicant has adequately demonstrated that the access-limiting technology of the Glas device, combined with the marketing restrictions required by the FDA, is expected to effectively reduce the ability of adolescents to use the product,” the agency said in a statement.
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The FDA has approved the sale of certain fruit-flavored spray products for the first time. (Michael M. Santiago/Getty Images/Getty Images)
The decision follows a Wall Street Journal report that President Donald Trump reprimanded FDA Commissioner Marty Makary over the weekend for not allowing instant flavored vapes.
US regulators have historically been reluctant to approve flavored vaping products, citing concerns about their appeal to youth. The FDA said it will continue to require strong evidence that such products benefit older smokers.
Public health groups and parents have long warned that scented products could appeal to teenagers, and some advocates say the FDA should keep a close eye on whether the new restrictions work. The Campaign for Tobacco-Free Kids has criticized Tuesday’s decision, saying it could undermine progress in reducing youth vaping, according to the Associated Press.
The Truth Initiative told Fox News Digital that the FDA approval represents an “important test case” that such products, combined with marketing restrictions, can limit youth use.
“The FDA is responsible for ensuring that products meet a rigorous public health standard that considers both the potential benefits to older smokers and the risks to youth,” the Truth Initiative said in a statement. “With these products now approved, the agency must carefully monitor how they are marketed and used to ensure they continue to meet that high standard — and take immediate action if they don’t.”
Earlier this year, the agency changed its approach to flavored vapes amid rising industry subsidies and political pressure to expand access.
The White House rolled back previous restrictions, with spokesman Kush Desai telling FOX Business that flavored vapes help seniors quit smoking.
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The Food And Drug Administration logo is seen outside the headquarters on July 20, 2020 in White Oak, Maryland. (Sarah Silbiger/Getty Images/Getty Images)
“The Biden administration has dismissed flavored vapes despite the overwhelming evidence that these products are beneficial for adults trying to quit smoking,” Desai said.
“The only thing guiding the Trump administration’s health policy is Gold Standard Science, and the FDA under the leadership of Commissioner Makary will continue to make evidence-based decisions that correct the mistakes of the Biden administration and are in the best interest of the American people,” he added.
After Tuesday’s decision, the FDA approved 45 e-cigarette products in the United States.
According to the agency, more than 25 million Americans smoke cigarettes, and smoking remains the leading preventable cause of chronic disease and premature death in the US, accounting for nearly one in five deaths.
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Federal regulators have approved select flavored vape products, citing potential benefits for older smokers. (Matthew Horwood / Getty Images / Getty Images)
Federal regulators have approved select flavored vape products, citing potential benefits for older smokers.
“Under President Trump’s leadership, the FDA has approved several alternatives that could be harmful to smokers,” the agency said.
The FDA said marketing of the products will be limited to adults 21 and older, and Glas’ technology is designed to limit access to youth.
The system requires users to verify their age with a government-issued ID and pair the device with a smartphone via Bluetooth. The device will not work if it is separated from the user’s phone.
“By helping prevent youth use, device access restrictions are a game changer,” said Bret Koplow, acting director of the FDA’s Center for Tobacco Products.
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“This technology is also an indication of the role of innovation that can work in the effort to protect young people from the threats caused by nicotine use and addiction while helping to enable the availability of a variety of tasty options for adult smokers who can use these products to completely break away from regular cigarettes,” he added.
FOX Business has reached out to the White House and the FDA for comment.
Reuters contributed to this report.
