E-cigarette products have been allowed to remain on the market for years, even though none have been given the official green light by the FDA. Manufacturers were given until September 9 of last year to submit applications for the agency’s authorization to remain on the market.
The FDA had a year to review those applications. Now, the agency says it needs to do more.
“However, there’s more work to be done to complete our remaining reviews and ensure that we continue taking appropriate action to protect our nation’s youth from the dangers of all tobacco products, including e-cigarettes, which remain the most commonly used tobacco product by youth in the United States,” acting FDA Commissioner Dr. Janet Woodcock and Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in a joint statement on Thursday.
Woodcock and Zeller said that, as of Thursday, the FDA has taken action on applications for more than 6 million products known as electronic nicotine delivery systems — rejecting most of them, including refusing to file one company’s applications for about 4.5 million products because required contents were missing. The FDA also issued 132 marketing denial orders for more than 946,000 flavored products, “including flavors such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal,” the statement said.
“We continue to work expeditiously on the remaining applications that were submitted by the court’s Sept. 9, 2020, deadline, many of which are in the final stages of review,” the statement said.
“We are committed to working as quickly as possible to transition the current marketplace for deemed new tobacco products to one in which all products available for sale have undergone a careful, science-based review by the FDA and met the statutory standard.”
While many products under review have been on the market, “all new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and subject to enforcement action at the FDA’s discretion,” the statement said. “The FDA is committed to completing the review of the remaining products as quickly as possible to provide regulatory certainty and will continue to keep the public informed of our progress.”
A July 2019 court decision placed a 10-month deadline on e-cigarette companies to apply to the FDA for public health review. Any products that missed the May 2020 application deadline could have been pulled from the market by the FDA, while those that did apply could stay on the market for up to a year while under review.
Then came Covid-19 — and a four-month extension of that deadline to September 9, 2020.
In the meantime, such products have stayed on the market, pending review.
Ahead of the FDA’s Thursday deadline, leading e-cigarette company Juul Labs said in a statement to reporters, “While millions of adult smokers have converted to our products from cigarettes, we will only be trusted to provide alternatives to adult smokers if we continue to combat underage use, respect the central role of our regulator and build on our shared commitment to science and evidence.”
The statement went on, “It would be inappropriate of us to speculate on what the FDA is going to decide, but we believe we have presented compelling science and evidence about our products abilities to convert smokers and data driven measures to combat underage use.”
‘A winnowing of the market’
“I suspect the large players, the big market players like Juul Labs, are less worried. They have submitted substantial applications with likely a significant amount of science base, but there are many other manufacturers that probably submitted applications with a less strong science base,” Hoke said.
“Whether they get to bootstrap on some of the data presented by the other manufacturers or not is a question,” she said. “So, I think we’re going to see a winnowing of the market — and so our major players will probably stay in the business and some of our smaller manufacturers will likely be out.”
“Ensuring new tobacco products undergo an evaluation by the FDA is a critical part of our aim to reduce tobacco-related disease and death,” Woodcock said. “We know that flavored tobacco products are very appealing to young people, therefore assessing the impact of potential or actual youth use is a critical factor in our decision-making about which products may be marketed.”
In deciding whether to greenlight certain vaping products, the FDA must decide their public health merit. Does the likelihood of smokers switching over to vapes outweigh the likelihood that others — especially young people — will start getting hooked on nicotine?
‘We are way past time’
“They’ve become more and more addictive over time, because of highly appealing flavors and other things that made them very attractive to young people — and we are way past time when the regulation that’s necessary to have these products marketed responsibly needs to happen,” Koval told CNN on Wednesday.
The long-term safety of vaping products is not yet known, Ohio State’s Brinkman wrote in her email.
“At the Center for Tobacco Research, we have measured short-term effects in lung and heart health; we have measured harmful and potentially harmful constituents in the vapor that user’s inhale from these products,” Brinkman wrote.
“It is already established that there is no safe way for people under the age of 25 years to use nicotine,” she wrote. “However, if you are a smoker, and you have failed at using FDA-approved cessation such as nicotine gum, lozenge, patch, etc., transitioning from combustible tobacco product use (meaning cigarettes, cigars, cigarillos, hookah) to ONLY using e-cigarettes may be result in an unknown reduction of harm.”
CNN’s Michael Nedelman contributed to this report.