FDA takes more time to decide on e-cigarettes

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

Advocacy groups slammed the delay.

The American Cancer Society’s Cancer Action Network, the lobbying arm of the American Cancer Society, had joined a lawsuit to enforce the September 9 deadline.

“The fact that the FDA is not responding today to requests from JUUL, the manufacturer with the largest market share for e-cigarettes, is extremely disappointing and will allow the industry to further endanger public health and increase the number of children on their highly addictive products.” to bind,” says Lisa Lacasse. , ACS CAN president said in a statement.

“The FDA has had ample time to review the applications and allowing additional delays is unreasonable. There is overwhelming data to demonstrate the negative impact these types of flavored products have had on public health and their role in e-cigarette epidemic among young people. The time to act is now,” Lacasse added.

“Delaying decisions on those with the lion’s share of the market allows the big, wealthy tobacco companies to continue to grow their businesses and profits on the backs of young people who risk millions for a lifetime of nicotine addiction,” he said. Koval in a statement.

Woodcock and Zeller said the FDA has been taking action since Thursday regarding applications for more than 6 million products known as electronic nicotine delivery systems — most of them turned down, including refusing to accept applications from one company for about 4, 5 million products to submit because required content was missing. The FDA also issued 132 marketing denials 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 diligently on the remaining applications filed by the court’s 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 transition from the current market for presumed new tobacco products to one in which all products for sale have undergone careful, science-based assessment by the FDA and comply with regulatory requirements. norm.”

While there are many products on the market that are under review, “any new tobacco products on the market without the legally required pre-market authorization will be illegally marketed and subject to enforcement action at the discretion of the FDA,” according to the statement. the explanation. “The FDA is committed to completing the review of the remaining products as soon as possible to provide regulatory assurance and will continue to update the public on our progress.”

A July 2019 court decision placed a 10-month deadline for e-cigarette companies to file an application with the FDA for a public health review. Any products that missed the May 2020 application deadline may have been withdrawn from the market by the FDA, while those that did could remain on the market for up to one year during the review.

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

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

Ahead of Thursday’s FDA deadline, leading e-cigarette company Juul Labs said in a statement to reporters, “While millions of adult smokers have switched to our products from cigarettes, we will only be trusted to provide alternatives for adult smokers if we can. 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 be inappropriate for us to speculate about what the FDA will decide, but we believe we have presented compelling science and evidence about the potential of our products to convert smokers and data-driven measures to to combat use by minors.”

‘A delusion of the market’

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

“It’s a question of whether they can use some of the data presented by the other manufacturers or not,” she said. “So I think we’re going to winnow the market — and so our big players will probably stay in the business and some of our smaller manufacturers will probably leave.”

“Ensuring that new tobacco products undergo evaluation by the FDA is a critical part of our goal to reduce tobacco-related illness and death,” Woodcock said. “We know that flavored tobacco products are very attractive to young people, so assessing the impact of potential or actual use by young people is a critical factor in our decision-making about which products to market.”

When deciding whether to green-light certain vaping products, the FDA must decide on their public health merit. Does the likelihood of smokers switching to vaping outweigh the likelihood of others – especially young people – becoming addicted to nicotine?

‘We are way past the time’

Health advocates have urged the FDA to act more quickly to limit e-cigarette sales.

“We are encouraged that the FDA seems to recognize that flavors should be taken off the market in the interest of protecting youth and public health, and that menthol should absolutely be included. But we are very concerned that they have not prioritized to the ratings of the companies with more than 75% of the e-cigarette market as they promised to do, especially category leader JUUL which started the e-cigarette epidemic in the first place, followed by Vuse, blu and NJOY which round out the top brands said Koval, whose group was formed from the 1998 Master Settlement Agreement between states and the major tobacco companies.

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

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 measured short-term effects on lung and heart health; we measured harmful and potentially harmful compounds in the vapor that the user of these products inhales,” Brinkman wrote.

“It has already been established that there is no safe way for people under the age of 25 to use nicotine,” she wrote. “However, if you smoke and have failed to get FDA-approved discontinuations such as nicotine gum, lozenges, patches, etc. e-cigarettes can lead to an unknown reduction in harm.”