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The U.S. Food and Drug Administration on Tuesday authorized the marketing of fruit-flavored e-cigarettes, marking the first time it has authorized fruit-flavored vaping products.
The FDA said the products are pods made by Los Angeles-based Glas Inc., a vaping manufacturer that uses age-verification technology to restrict access.
The pods come in mango, blueberry and two menthol varieties and will be marketed 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 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 agency said in a statement.
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The FDA has authorized the sale of certain fruit-flavored vaping products for the first time. (Michael M. Santiago/Getty Images / Getty Images)
The decision follows a Wall Street Journal report that President Donald Trump had rebuked FDA Commissioner Marty Makary over the weekend for not approving flavored vapes more quickly.
U.S. regulators have historically been reluctant to authorize flavored vaping products, citing concerns about their appeal to youth. The FDA said it will continue to require strong evidence that such products benefit adult smokers.
Public health and parent groups have long warned that flavored vaping products can appeal to teenagers, and some advocates said the FDA should closely monitor whether the new restrictions are effective. The Campaign for Tobacco-Free Kids criticized Tuesday’s decision, arguing it could undermine progress in reducing youth vaping, according to The Associated Press.
The Truth Initiative told Fox News Digital that the FDA’s authorization represents a “key test case” for whether such products, combined with marketing restrictions, can limit youth use.
“The FDA has a responsibility to ensure that products meet a rigorous public health standard that considers both the potential benefit for adults who smoke and the risks to youth,” Truth Initiative said in a statement. “With these products now authorized, the agency must closely monitor how they are marketed and used to confirm that they continue to meet that high bar—and take swift action if they don’t.”
Earlier this year, the agency modified its approach to flavored vapes amid increased industry lobbying and political pressure to expand access.
The White House pushed back on past restrictions, with spokesperson Kush Desai telling FOX Business that flavored vapes help adults quit smoking.
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A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. (Sarah Silbiger/Getty Images / Getty Images)
“The Biden administration cracked down on flavored vapes despite an abundance of evidence finding that these products are beneficial for adults trying to quit smoking,” Desai said.
“The only factor guiding the Trump administration’s health policy making is Gold Standard Science, and the FDA under Commissioner Makary’s trailblazing leadership will continue to make evidence-based decisions that rectify the Biden administration’s missteps and that are in the best interest of the American people,” he added.
Following Tuesday’s decision, the FDA has authorized 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 U.S., accounting for about one in five deaths.
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Federal regulators approved select flavored vape products, citing potential benefits for adult smokers. (Matthew Horwood/Getty Images / Getty Images)
Federal regulators authorized select flavored vape products, citing potential benefits for adult smokers.
“Under President Trump’s leadership, the FDA has authorized a number of less harmful alternatives for smokers,” the agency said.
The FDA said marketing of the products will be limited to adults ages 21 and older, and Glas’ technology is designed to reduce youth access.
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 function if separated from the user’s phone.
“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,” he added.
FOX Business has reached out to the White House and FDA for comment.
Reuters contributed to this report.
