FDA Commissioner Dr. Marty Makary discusses President Donald Trump’s psychedelic drug push for veterans and shifts in peptide policy on “Mornings with Maria.”
The U.S. Food and Drug Administration on Tuesday authorized the marketing of fruit-flavored e-cigarettes, marking the first time it has approved fruit-flavored vaping products.
The FDA said the products are pods made by Los Angeles-based Glas Inc., a vape manufacturer that uses age verification technology to restrict access.
The pods are available in mango, blueberry and two menthol varieties and will be marketed under the names Gold, Sapphire, Classic Menthol and Fresh Menthol, the agency said.
“FDA’s rigorous, scientific review of these products found that the applicant has sufficiently demonstrated that Glas’s device access restriction technology, combined with FDA-required marketing restrictions, is expected to effectively reduce the ability of youth to use the product,” the agency said in a statement.
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The FDA has approved 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 last weekend reprimanded FDA Commissioner Marty Makary for not approving flavored vapors more quickly.
U.S. regulators have historically been reluctant to allow flavored vaping products, concerned 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 could appeal to teens, and some advocates say 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 vaping among young people, according to The Associated Press.
“The FDA has a responsibility to ensure that products meet a strict public health standard that considers both the potential benefit to adults who smoke and the risks to youth,” Truth Initiative said in a statement. “With these products now approved, 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 do not.”
Earlier this year, the agency changed its approach to flavored vapes due to increased industry lobbying and political pressure to expand access.
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A sign for the Food And Drug Administration is seen outside its headquarters in White Oak, Maryland on July 20, 2020. (Sarah Silbiger/Getty Images/Getty Images)
“The Biden administration has cracked down on flavored vapes, despite an abundance of evidence showing that these products are beneficial for adults trying to quit smoking,” Desai said.
“The single factor driving the Trump Administration’s health policy is Gold Standard Science, and the FDA, under Commissioner Makary’s pioneering leadership, will continue to make evidence-based decisions that right the Biden Administration’s missteps and are in the best interests of the American people,” he added.
Following Tuesday’s decision, the FDA has 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 U.S., accounting for about one in five deaths.
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Federal regulators approved select flavored vape products, citing the potential benefits for adult smokers. (Matthew Horwood/Getty Images/Getty Images)
Federal regulators have approved select flavored vape products, citing the potential benefits for adult smokers.
“Under President Trump’s leadership, the FDA has approved a number of less harmful alternatives for 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 reduce access for young people.
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 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 indicative of the role that innovation can play in the effort to protect young people from the threats posed by nicotine use and addiction, while also enabling the availability of an expanded range of flavored options for adults who smoke and can use these products to completely transition away from regular cigarettes,” he added.
Reuters contributed to this report.
