FDA authorizes e-cigarettes marketing for first time in agency’s history - masslive.com

2021-12-30 11:31:21 By : Ms. Fanny Feng

The Food and Drug Administration on Tuesday said that three e-cigarette products could be marketed publicly, a first for the agency.

The three products — known to the agency as electronic nicotine delivery systems, but known to the public as electronic cigarettes, e-cigarettes or vapes — were submitted to the FDA by R.J. Reynolds Vapor Company, which said that marketing the items would be appropriate for the protection of public health.

The products include a Vuse Solo e-cigarette and accompanying tobacco-flavored pods.

“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said. The company’s data, he said, demonstrates that the e-cigarettes could help adult smokers move away from traditional cigarette use, thereby reducing their consumption of harmful chemicals.

E-cigarettes have potential to benefit non-pregnant adult smokers as a substitute for regular smoking, the Centers for Disease Control has said. But researchers are still exploring whether e-cigarettes have a notable effect in helping smokers reduce their use of traditional products. The CDC has also said that youth, young adults and people who have no prior tobacco use should not take up e-cigarettes.

The authorization process requires that manufacturers demonstrate their product could protect public health. In reviewing the e-cigarette products, the FDA determined that users were exposed to fewer harmful materials and aerosols than they would be using regular cigarettes.

The FDA, in approving the three products, also denied 10 other products from the same company, but would not say which items they were.

Data reviewed by the agency showed that 10% of high school students who use e-cigarettes cited Vuse Solo as their usual brand. But the FDA also said that evidence showed that tobacco-flavored e-cigarettes, like those approved Tuesday, are not as influential in leading young people to traditional cigarettes as other flavors are. Most youth who begin vaping start with fruit, candy or mint flavors — not tobacco flavors — the FDA said.

“We must remain vigilant with this authorization and we will monitor the marketing of the products, including whether the company fails to comply with any regulatory requirements or if credible evidence emerges of significant use by individuals who did not previously use a tobacco product, including youth,” Zeller said. “We will take action as appropriate, including withdrawing the authorization.”

In 2019, Massachusetts Gov. Charlie Baker temporarily banned the sale of vaping products after reports of illnesses from vape users. At the time, five individuals in Massachusetts had died along with 68 others nationwide.

A MassLive investigation found a disproportionate amount of vaping-related illnesses at Harrington Hospital in Southern Worcester County.

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