FDA clears e-cigarettes for the first time in agency history
The Food and Drug Administration announced Tuesday that three electronic cigarette products could be released publicly, a first for the agency.
All three products – known to the agency as electronic nicotine delivery systems, but known to the public as electronic cigarettes, electronic cigarettes, or vapes – have been submitted to the FDA by RJ Reynolds Vapor Company, which stated that the marketing of the articles would be appropriate for the protection of public health.
Products include a Vuse Solo e-cigarette and accompanying tobacco flavored pods.
“Today’s approvals are an important step in ensuring that all new tobacco products pass the FDA’s pre-market scientific review,” said Mitch Zeller, director of the Center for Tobacco Products at the FDA. Company data, he said, shows that e-cigarettes could help adult smokers move away from traditional cigarette use, thereby reducing their consumption of harmful chemicals.
Electronic cigarettes have the potential to be of benefit to non-pregnant adult smokers as a substitute for regular smoking, the Disease Control Centers said. But researchers are still investigating whether e-cigarettes have a noticeable effect in helping smokers reduce their use of traditional products. The CDC also said that young people, young adults and people who have never used tobacco should not use e-cigarettes.
The authorization process requires manufacturers to demonstrate that their product could protect public health. By reviewing electronic cigarette products, the FDA determined that users were exposed to less harmful materials and aerosols than they would use with regular cigarettes.
The FDA, in approving all three products, also denied 10 other products from the same company, but did not specify which items they were.
Data reviewed by the agency showed that 10% of high school students who use e-cigarettes cite Vuse Solo as their usual brand. But the FDA also said the evidence showed that tobacco-flavored e-cigarettes, like the ones approved on Tuesday, were not as influential in getting young people to traditional cigarettes as other flavors. Most young people who start 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 products, especially if the company does not comply with regulatory requirements or if there is credible evidence of significant use by people who have not previously used a tobacco product, including youth. “Zeller said.” We will take appropriate action, including revoking the authorization. “
In 2019, Massachusetts Governor Charlie Baker temporarily banned the sale of vaping products after reports of illness from vaping users. At the time, five people in Massachusetts had died along with 68 others across the country.
A MassLive investigation revealed a disproportionate amount of vaping-related illnesses at Harrington Hospital in South Worcester County.