FDA takes longer to rule on electronic cigarettes

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Electronic cigarette products have been allowed to remain on the market for years, although none have received an official FDA green light. Manufacturers had until September 9 last year to file applications for the agency’s authorization to remain in the market.

The FDA had one year to review these requests. Now the agency says it needs to do more.

“However, there is still work to be done to complete our remaining reviews and ensure that we continue to take the appropriate steps to protect the youth of our country from the dangers of all tobacco products, including e-cigarettes, which remain. the most common tobacco product used by young people in the United States, ”FDA Acting Commissioner Dr. Janet Woodcock and Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in a statement on Thursday. joint.

Woodcock and Zeller said that as of Thursday, the FDA had taken action on more than 6 million products known as electronic nicotine delivery systems – rejecting most of them, including denying to file a company’s claims for around 4.5 million products, as it was necessary. the content was missing. The FDA also issued 132 denial-of-market orders for more than 946,000 flavored products, “including flavors such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal,” the release said.

“We continue to work expeditiously on the remaining applications that were submitted before the September 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 move the current market for reputable new tobacco products to a market in which all products available for sale have been scientifically reviewed by the FDA and meet to the legal standard. “

While many of the products under review have been on the market, “all new tobacco products on the market without the pre-market authorization required by law are illegally marketed and subject to control measures. ‘execution at the discretion of the FDA,’ the statement read. “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 been officially cleared by the FDA. This means that electronic cigarettes have been brought to the market illegally, according to the FDA.

Prior to August 8, 2016, electronic cigarettes, cigars, and hookah products were not regulated by the FDA. This is because, as the FDA notes, “the initial authorization from Congress in 2009 only covered cigarettes, smokeless tobacco, cigarette tobacco, and roll-your-own tobacco.”

Then e-cigarettes and other vape products have come under the FDA’s tobacco authorities and have been in regulatory limbo somewhat since August 2016, according to the FDA. Products on the market at that time had to have FDA clearance to be legally marketed, but the agency had deferred the application of clearance requirements and no products had been cleared.

A July 2019 court ruling imposed a 10-month deadline for e-cigarette companies to request a public health review from the FDA. Any products that passed the May 2020 application deadline could have been taken off the market by the FDA, while those that applied could stay on the market for up to a year during the review period.

Then came Covid-19 – and a four-month extension of that time until September 9, 2020.

For example, for e-cigarette and other products considered a “new tobacco product,” the FDA issued a policy allowing manufacturers to submit applications for authorization by September 9 of last year. This gave the FDA one year – until Thursday – to review product applications and decide whether to approve or deny the sale of each product.

In the meantime, these products have remained on the market, awaiting review.

“The FDA’s review for each product may result in the product being legally or banned for sale in the United States,” Marielle Brinkman, principal investigator at the Ohio State University Comprehensive Cancer Center, told CNN.

Ahead of Thursday’s FDA deadline, leading e-cigarette company Juul Labs said in a statement to reporters: Addressing underage use, respecting the central role of our regulator, and building on our commitment common to science and evidence. “

The statement continued, “It would be inappropriate of us to speculate on what the FDA is going to decide, but we believe we have presented compelling scientific data and evidence on the abilities of our products to convert smokers and measures based on them. data to combat the use of minors. “

“A winnowing of the market”

Large vape companies, such as Juul, likely have limited concerns about the FDA review – while smaller manufacturers might be concerned, said Kathleen Hoke, professor of law at the University of Maryland, on “All Things Considered ”from NPR on Wednesday.

“I suspect that the big players, the big market players like Juul Labs, are less worried. They have submitted substantial applications with probably a strong scientific basis, but many other manufacturers have probably submitted applications with a less solid scientific basis. , “Hoke said.

“Whether they manage to prime some of the data presented by other manufacturers or not is a question,” she said. “So I think we’re going to see a winnowing in the market – and so our major players will probably stay in the business and some of our smaller manufacturers will probably be out. “

FDA blocks sale of 55,000 flavored e-cigarette products

By the end of July, companies had submitted more than 6.9 million tobacco products to the FDA for review, all but one fragment related to electronic cigarettes. In late August, the FDA denied marketing claims for around 55,000 flavored electronic cigarettes, saying the products posed a threat to the public health of young people in the United States.

“Congress gave the FDA the power 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 that new tobacco products undergo FDA review is a critical part of our goal of reducing tobacco-related illness and death,” said Woodcock. “We know that flavored tobacco products are very appealing to young people. Therefore, assessing the impact of the potential or actual consumption of young people is a critical factor in our decision making about which products can be marketed ”.

In deciding whether or not to green light certain vaping products, the FDA must decide on their public health merit. Does the likelihood of smokers to vape outweigh the likelihood that others, especially young people, will start to become addicted to nicotine?

“We are over time”

In recent years, as e-cigarette products hit the market without authorization, they have grown in popularity among young people, leading to an epidemic of vaping in high schools across the country.

Health advocates have urged the FDA to act faster to limit sales of e-cigarettes.

“We are encouraged that the FDA appears to recognize that flavors should be taken off the market in the interest of protecting young people and public health, and that menthol should definitely be included. But we are very concerned that they have not prioritized and supplemented the reviews of companies with over 75% of the e-cigarette market as they had promised to do, especially the category leader JUUL. which started the e-cigarette epidemic in the first place, followed by Vuse, blu and NJOY which complement the top brands, ”Robin Koval, chairman and CEO of Truth Initiative, said in a statement.

“Deferring decisions to who owns the lion’s share of the market allows big and wealthy tobacco companies to continue to grow their businesses and profits on the backs of young people, putting millions of people at risk for lives of addiction. nicotine, ”added Koval, whose group was formed from the 1998 Master Settlement Agreement between states and major tobacco companies.

FDA decides to ban menthol cigarettes and flavored cigars

“Additionally, we believe that adult smokers who could potentially benefit from a carefully regulated market with products that have been proven to be safe and do what they promise are not well served by the pursuit of a market. free shopping for all. “

The use of electronic cigarettes among high school and college students decreased significantly from 2019 to 2020 but remains high. A study published in June in the journal JAMA Network Open found that 20% of high school students and almost 5% of middle school students said they currently vaped last year, up from 27.5% and 10.5% in 2019. Most of the young students reported as 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 remained for sale.

The long-term safety of vaping products is not yet known, Ohio State’s Brinkman wrote in his email.

“At the Center for Tobacco Research, we measured the short-term effects on lung and heart health; we measured the harmful and potentially harmful constituents in the vapor that the user inhales from these products, ”Brinkman wrote.

“It is already established that there is no safe way for people under 25 to use nicotine,” she wrote. “However, if you are a smoker and have failed to use the FDA approved withdrawal, such as nicotine gum, lozenges, patches, etc. Electronic cigarettes can lead to an unknown reduction in damage. “

CNN’s Michael Nedelman contributed to this report.

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