FDA takes more time to decide on e-cigarettes

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.”

Even though e-cigarette products have been sold for years — and are often marketed as tools to help adults quit smoking traditional cigarettes — none have officially been authorized by the FDA. That means e-cigarettes have been on the market illegally, the FDA says.
Prior to August 8, 2016, e-cigarettes, cigars and hookah products were not regulated by FDA. That’s because, as the FDA notes, “the original grant of authority from Congress in 2009 only covered cigarettes, smokeless tobacco, cigarette tobacco, and roll-your-own tobacco.”
Then, e-cigarettes and other vape products became subject to the FDA’s tobacco authorities and have been somewhat in regulatory limbo since August 2016, according to the FDA. The products on the market at that time needed to have FDA authorization to be legally marketed, but the agency had deferred enforcement of the authorization requirements and no products had been authorized.

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.

So for e-cigarette products and others deemed as a “new tobacco product,” the FDA issued a policy allowing manufacturers to submit applications for authorization by September 9 of last year. That gave the FDA one year — until Thursday — to review applications for products and decide to approve or reject the sale of each product.

In the meantime, such products have stayed on the market, pending review.

“FDA’s review for each product can result in the product either being allowed or not allowed to be legally sold in the US,” Marielle Brinkman, a senior research scientist at The Ohio State University Comprehensive Cancer Center, told CNN in an email.

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’

Large vape companies, such as Juul, likely have limited concerns around the FDA’s review — whereas, smaller manufacturers could be worried, Kathleen Hoke, professor of law at the University of Maryland, said on NPR’s “All Things Considered” on Wednesday.

“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.”

FDA blocks sale of 55,000 flavored e-cigarette products
As of late July, companies had submitted more than 6.9 million tobacco products to the FDA for review, all but a sliver related to e-cigarettes. In late August, the FDA denied marketing applications for about 55,000 flavored e-cigarettes, saying the products posed a public health threat to youth in the US.
“Congress gave the FDA the authority to regulate tobacco products to protect the public from the harmful effects of tobacco use through science-based regulation,” Woodcock said in a statement at the time.

“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’

In the past several years, while e-cigarette products have been on the market without authorization, they have grown in popularity among young people, leading to a vaping epidemic in high schools nationwide.
“We have a situation where millions of products have been on the market illegally for years: e-cigarettes. And what we’ve seen happen in this environment is millions of young people becoming addicted to high, increasing levels of nicotine in these products,” said Robin Koval, president and CEO of the Truth Initiative, a nonprofit public health organization.

“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 use of e-cigarettes among high schoolers and middle school students declined significantly from 2019 to 2020 but remains high. A study published in June in the journal JAMA Network Open found that early 20% of high schoolers and almost 5% of middle schoolers reported last year that they currently vaped — down from 27.5% and 10.5% in 2019. Most of the young students reported commonly using fruit-flavored products.
Leading e-cigarette company Juul Labs stopped selling several flavored products in the United States in 2019. Only tobacco and menthol flavors have remained for sale.

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.


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