The US Food and Drug Administration (FDA) has rejected more than 946,000 flavoured electronic nicotine delivery systems (ENDS) products, such as e-cigarettes and e-liquids, prohibiting them from being marketed or sold due to lack of sufficient evidence on health benefits.
The decision comes after a year-long review of millions of e-cigarette-related products by the global health body.
According to the FDA, flavoured tobacco products are very appealing to young people, with over 80 per cent of e-cigarette users aged 12 through 17 using them. Therefore, it is imperative to assess the potential impact of its use.
“We’ve made significant progress in the months since, working diligently to better understand these products and, as of today, taking action on about 93 per cent of the total timely-submitted applications,” Janet Woodcock, MD, Acting Commissioner of Food and Drugs — FDA, said in a statement on Thursday.
“This includes issuing Marketing Denial Orders (MDO) for more than 946,000 flavoured ENDS products because their applications lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products,” she added.
The FDA said it has reviewed 93 per cent of the applications submitted, which included 6.5 million products. It will continue to review the remaining 7 per cent of products. Notably, that group includes e-cigarettes made by Juul, a market leader and the company that drew federal attention for its product’s popularity among kids and teenagers, the Wall Street Journal reported.
Juul only submitted applications for its tobacco- and menthol-flavoured products — it stopped selling its fruit and mint flavours in 2019.
The health body also said that the applications for 4.5 million products were missing materials that the agency required to make a decision. All of those products must also be removed from the market.
The announcement marks the end of a year-long period where companies were allowed to sell vaping and e-cigarette products while the FDA reviewed applications from manufacturers. It’s also a turning point for the industry, which spent years operating outside the typical regulations around tobacco products, the Verge reported.
The new FDA rules state that any new tobacco products have to submit an application and get authorisation before they’re marketed and sold. Now, any vaping and e-cigarette products that stay on the market without authorisation are “marketed unlawfully,” the FDA warned in its statement.
“Continuing to take appropriate regulatory actions to protect the public, especially youth, from the harms of tobacco products remains one of the agency’s highest priorities,” Woodcock said.