It takes the FDA longer to decide on e-cigarettes

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Electronic cigarette products have been allowed to remain on the market for years, although the FDA has not given an official green light to any. Manufacturers received until September 9 last year to apply for authorization from the agency to stay in the market.

The FDA had a year to review these applications. Now, the agency says it needs to do more.

“However, more work needs to be done to complete our remaining reviews and ensure that we continue to take appropriate action to protect our nation’s youth from the dangers of all tobacco products, including e-cigarettes, which remain the most used youth tobacco product in the United States, “FDA Acting Commissioner Janet Woodcock and Mitch Zeller, director of the FDA’s Tobacco Products Center, said in a joint statement Thursday.

Woodcock and Zeller said that as of Thursday, the FDA has taken action on requests for more than 6 million products known as electronic nicotine delivery systems, rejecting most of them, including the refusal to submit applications from a company of about 4.5 million products, as necessary content was missing. The FDA also issued 132 marketing denial orders for more than 946,000 flavored products, “including flavors like Apple Crumble, Dr. Cola and Cinnamon Toast Cereal,” the statement said.

“We continue to work swiftly on the remaining applications that were filed before the court’s 9 September 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 make the transition from the current market for tobacco products considered new to one in which all products available for sale have undergone careful science-based review by the FDA and they have complied with the legal norm “.

Although there have been many products on the market under review, “all new tobacco products that do not have the necessary prior legal authorization are marketed illegally and are subject to FDA enforcement action.” , is stated in the statement. “The FDA is committed to completing the review of the remaining products as soon as possible to provide regulatory safety and will continue to keep the public informed of our progress.”

The debate on vaporism
Although e-cigarette products have been sold for years, and are often marketed as tools to help adults quit traditional cigarettes, none have been officially authorized by the FDA. This means that e-cigarettes have been on the market illegally, according to the FDA.
Prior to August 8, 2016, the FDA did not regulate e-cigarettes, cigars, and hookah products. This is because, as the FDA points out, “the original Congressional grant of authority in 2009 only covered cigarettes, smokeless tobacco, cigarette tobacco, and roll-your-own tobacco.”
Then, e-cigarettes and other vape products came under FDA tobacco authorities and, since August 2016, have been somewhat in regulatory suspension, according to the FDA. Products on the market at the time required FDA authorization to be marketed legally, but the agency had postponed the application of the authorization requirements and no product had been authorized.

A July 2019 court ruling set a ten-month deadline for e-cigarette companies to apply to the FDA for a public health review. Any product that had not passed the May 2020 application deadline could have been withdrawn from the market by the FDA, while those that did could remain on the market for up to a year while under review.

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

Thus, for e-cigarette products and other products considered a “new tobacco product,” the FDA issued a policy that allows manufacturers to apply for authorization before September 9 last year. . This gave the FDA a year (until Thursday) to review product requests and decide to approve or reject the sale of each product.

Meanwhile, these products have remained on the market, pending review.

“The FDA review for each product may or may not allow it to be legally sold in the U.S.,” Marielle Brinkman, a senior researcher at Ohio State University’s Comprehensive Cancer Center, told CNN.

Before Thursday’s FDA 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 rely on offering alternatives to adult smokers if we continue to combat the use of minors, respect the central role of our regulator and build on our shared commitment to science and evidence. ”

The statement continued, “It would not be inappropriate to speculate on what the FDA will decide, but we believe we have presented compelling science and evidence about the capabilities of our products to convert smokers and data-driven measures to combat child use.”

“A take-off of the market”

Large vaporization companies, such as Juul, probably have limited concerns about the FDA review, while smaller manufacturers might be concerned, Kathleen Hoke, a law professor at the University of Maryland, said Wednesday.

“I suspect big players, big market players like Juul Labs, are less concerned. They’ve submitted substantial applications with probably a significant amount of scientific basis, but there are many other manufacturers that have probably submitted applications with a less strong scientific basis, “Hoke said.

“It’s a matter of whether they get to rip off some of the data submitted by other manufacturers or not,” he said. “So I think we’re going to see a downturn in the market, and so our main players are likely to stay in business and probably some of our smaller manufacturers will be out.”

The FDA is blocking the sale of 55,000 e-cigarette products with gusto
By the end of July, companies had submitted more than 6.9 million tobacco products to the FDA for review, all but a chip related to e-cigarettes. In late August, the FDA denied marketing applications for some 55,000 flavored e-cigarettes, saying the products posed a public health threat to U.S. youth.
“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 that new tobacco products are evaluated by the FDA is a key part of our goal of reducing tobacco-related illnesses and death,” Woodcock said. “We know that flavored tobacco products are very attractive to young people, so assessing the impact of potential or actual youth use is a critical factor in our decision-making about which products can be marketed.”

When deciding whether to give the green light to certain vaping products, the FDA must decide their merit for public health. Is the likelihood of smokers switching from vaporizing to higher than the likelihood that others (especially young people) will start hooking up on nicotine?

“We have passed the time”

In recent years, while e-cigarette products have been on 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 been urging the FDA to act more quickly to limit the sale of e-cigarettes.

“We are encouraged that it seems that the FDA recognizes that flavors should be taken off the market to protect youth and public health, and menthol should be absolutely included. But we are very concerned that they do not prioritize and complete the reviews of companies with more than 75% of the e-cigarette market as they pledged to do, especially the leader in the JUUL category, which started the e-cigarette epidemic, followed by Vuse, blu and NJOY, which complete the best brands “. Robin Koval, president and CEO of the Truth Initiative, said in a statement.

“Postponing decisions about those who have the most market makes big, rich tobacco companies continue to grow their business and profits behind the backs of young people, putting millions of people at risk for living an addiction to nicotine, ”added Koval, whose group was formed from the 1998 Master Liquidation Agreement between states and major tobacco companies.

The FDA bans menthol cigarettes and flavored cigars

“In addition, we believe that adult smokers who can benefit from a carefully regulated market with products that have proven to be safe and do what they promise are not well served by the continuation of a free commercial market for all “.

The use of e-cigarettes among high school students and high school students decreased significantly from 2019 to 2020, but remains high. A study published in June in the journal JAMA Network Open found that the top 20% of high school students and nearly 5% of high school students reported last year that they are currently saving, 27.5% and a 10.5% in 2019. Most young students were routinely informed of fruit-flavored products.
Leading e-cigarette company Juul Labs stopped selling several flavored products in the United States in 2019. They have only been left to sell tobacco and menthol flavors.

The long-term safety of vaporization products is not yet known, Brinkman wrote in Ohio State 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 components of vapor that the user inhales from these products,” Brinkman wrote.

“It is already established that there is no safe way for people under the age of 25 to use nicotine,” he wrote. “However, if you are a smoker and have failed to quit FDA-approved smoking, such as nicotine gum, pill, patch, etc., by switching from using combustible tobacco products (i.e. cigarettes, cigars, cigars, hookah) electronic cigarettes can cause an unknown reduction in damage “.

CNN’s Michael Nedelman contributed to this report.

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