Six leading public health and medical organizations today urged the U.S. Food and Drug Administration (FDA) to stop the sale of new electronic cigarette products that have been illegally introduced in recent months without the agency’s prior review and authorization. These include numerous products similar to the Juul e-cigarettes that have become wildly popular with teens across the United States.
The groups sending a letter to FDA Commissioner Scott Gottlieb are the Campaign for Tobacco-Free Kids, American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association and Truth Initiative. The letter was accompanied by images of the new e-cigarette products.
Over the last year, the use of Juul has skyrocketed among youth across the country, as Commissioner Gottlieb has acknowledged and reports by news media and educators have documented. It is about to happen again. As Commissioner Gottlieb wrote in a blog post last week: “We’ve also become aware of reports that some companies may be marketing new products that were introduced after the FDA’s compliance period and have not gone through premarket review. These products are being marketed both in violation of the law and outside of the FDA’s announced compliance policies. We take these reports very seriously. Companies should know that the FDA is watching and we will take swift action wherever appropriate.”
As the health groups’ letter states, the FDA has the tools to prevent this from happening. The FDA’s 2016 rule extending its authority to e-cigarettes (called the “deeming rule”) prohibits the introduction of any new product after August 8, 2016, unless the manufacturer files a premarket review application with the FDA and the FDA issues an order authorizing the marketing of the product. While the FDA delayed this review requirement until 2022 for e-cigarettes that were already on the market as of August 8, 2016, the premarket review requirement still applies to new or changed products introduced after August 8, 2016, and it is those products that this letter addresses.
Despite this requirement, the letter documents that manufacturers recently have introduced numerous new e-cigarette products without any evidence that they have filed premarket applications or received a marketing order from the FDA. These include products that look like and seek to capitalize on the success of Juul, which is sleek, high-tech and easy to hide (it looks like a USB flash drive), comes in sweet flavors including mango and fruit medley, and delivers a powerful dose of nicotine.
Manufacturers that have recently introduced or announced Juul-like products include big tobacco companies Altria (with its MarkTen Elite product), ITG Brands (with myblu) and R.J. Reynolds (with its recently announced Vuse Alto). Similar products introduced by independent manufacturers include Kandy Pens’ Rubi, MLV’s PHIX and Mylé Vapor’s Mylé.
“Manufacturers of e-cigarette products have introduced new products at an alarming pace in total defiance of law, with no apparent concern for FDA enforcement,” the health groups wrote. “We urge FDA to take quick and aggressive action to enforce the law before one or more of these products become the next Juul phenomenon among our nation’s youth.”
In April, the same six organizations urged the FDA to take action to address Juul’s popularity among youth, including removing from the market Juul flavors such as mango and cool cucumber that appear to have been introduced after August 8, 2016, without FDA review.
The health groups’ letter poses the core question: The issue is not whether FDA has the authority to prevent the introduction and marketing of products that appeal to kids; it is whether FDA will exercise the authority it clearly possesses.
