Tuesday, 25 June, 2024
HomeHarm ReductionFDA delays Juul e-cigarettes’ decision but culls almost a million products

FDA delays Juul e-cigarettes’ decision but culls almost a million products

The Food and Drug Administration last week put off a long-anticipated ruling on whether Juul Labs and other major e-cigarette companies could continue to sell their products in the United States, writes Matt Richtel for The New York Times. By then, the FDA had denied the applications of 946,000 flavoured e-cigarette products to remain on the market.

E-cigarette companies are at the centre of a review of the vaping industry that the agency has been conducting for the past year.

No e-cigarettes have been approved through the application process, an agency official said. The rejected applications were mostly from small companies.

“The FDA is committed to completing the review of the remaining products as quickly as possible,” the agency said in a statement on Thursday 9 September 2021.

The FDA had earlier signalled that it would rule on the larger companies by Thursday, one year after applications to stay on the market were due. Many public health experts had hoped a ruling on the market leaders would clarify the conditions under which companies could operate, The New York Times reported.

“They still haven’t made any of the tough decisions,” said Eric Lindblom, a tobacco policy expert at the Georgetown University Law Centre. “I expected a little bit more, and I’m not an optimist.”

Advocates of e-cigarettes see the products as a way to wean smokers from traditional cigarettes, which are more toxic, while critics say they are just another nicotine delivery system and one that is luring young people to the drug.

Juul, the market leader, whose sleek devices led to a surge in vaping among teenagers who had never smoked, has been at the centre of the debate. By pushing back its decision on the company, the FDA appears to be delaying a larger decision about whether the agency sees these devices as creating more harm than good.

The FDA is considering applications for e-cigarette products from around 500 companies, many of them small, wrote The New York Times in its 9 September story. Companies have to show that their vaping products are less harmful than traditional cigarettes, and that their usefulness in helping smokers quit outweighs the risk that some people will start using nicotine through the products.

Matthew Myers, president of the Campaign for Tobacco-Free Kids, said that the FDA’s denial of thousands of products was “significant” progress but that much more was needed, such as action on Juul and a ban on all flavoured e-cigarettes, including menthol.

Since e-cigarettes came on the market in the US in the mid-2000s, youth vaping has increased steadily. By 2019, more than 27% of high school students reported in surveys that they vaped. That figure dropped to less than 20% during the coronavirus pandemic.

The fate of Juul and other market leaders is part of a larger conversation about the best way to further discourage cigarette use. Some experts believe the most effective step would be to limit the amount of nicotine levels in traditional cigarettes, making them less appealing.

The New York Times story continued: Juul initially pitched itself as a foe of Big Tobacco. But in December 2018, the company sold a 35% stake to Altria, one of the world’s largest cigarette companies, for $12.8 billion. The company recently agreed to pay $40 million to settle a lawsuit with the state of North Carolina over its marketing practices, and it still faces thousands of other lawsuits.

Juul officials have long said that the company never sought a youth market. They have argued that Juul has taken aggressive steps to discourage youth use, including suspending its advertising in the United States and pulling almost all of its flavours from the market in 2019. It has since submitted applications for only menthol- and tobacco-flavoured products.

Several major health organisations – the American Heart Association, the American Lung Association, the American Academy of Paediatrics and the American Cancer Society Cancer Action Network – have asked the FDA to reject Juul’s application.


FDA statement

FDA Makes Significant Progress in Science-Based Public Health Application Review, Taking Action on Over 90% of More Than 6.5 Million ‘Deemed’ New Tobacco Products Submitted

Dr Janet Woodcock, Acting Commissioner of Food and Drugs at the FDA, and Mitch Zeller,
Director of the FDA’s Centre for Tobacco Products.

On this day last year, the US Food and Drug Administration faced the unprecedented task of reviewing applications for over 6.5 million “deemed new tobacco products” – many of which were already on the market.

A majority of the applications submitted by a court-ordered deadline of 9 September 2020, were for electronic nicotine delivery systems (ENDS) products such as e-cigarettes and e-liquids, which had never been through the FDA review process.

We’ve made significant progress in the months since, working diligently to better understand these products and, as of today, taking action on about 93% of the total timely-submitted applications.

This includes issuing Marketing Denial Orders (MDO) for more than 946,000 flavoured ENDS products because their applications lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products.

Flavoured ENDS products are extremely popular among youth, with over 80% of e-cigarette users ages 12 through 17 using them. 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.

As required by statute, a key consideration in our review of premarket tobacco product applications submitted for products like e-cigarettes is to determine whether permitting the marketing of the product would be “appropriate for the protection of the public health,” taking into account the risks and benefits to the population as a whole.

This determination includes consideration of how the products may impact youth use of tobacco products and the potential for the products to completely move adult smokers away from use of combustible cigarettes.

Importantly, we know that flavoured tobacco products are very appealing to young people. Therefore, assessing the impact of potential or actual youth use is a critical factor in our determination as to whether the statutory standard for marketing is met.

As of today, the agency has taken action on applications for over six million ENDS products, including refusing to file (RTF) one company’s applications for approximately 4.5 million products because required contents were missing, as well as issuing 132 MIDOs for more than 946,000 flavoured ENDS products, including flavours such as Apple Crumble, Dr Cola and Cinnamon Toast Cereal.

We continue to work expeditiously on the remaining applications that were submitted by the court’s 9 September 2020, deadline, many of which are in the final stages of review. For premarket tobacco product applications, our responsibility is to assess whether applicants meet the applicable statutory standard for marketing their new products.

As we have said before, the burden is on the applicant to provide evidence to demonstrate that permitting the marketing of their product meets the applicable statutory standard.

Our continued review also includes a smaller number of pending applications that are being reviewed under the “substantial equivalence” standard, for cigars, pipes and hookah tobacco and for which we’ve granted marketing orders covering over 350 products.

All new tobacco products on the market without the statutorily required premarket authorisation are marketed unlawfully and subject to enforcement action at the FDA’s discretion.

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.

In the meantime, products for which no application is pending, including, for example, those with a Marketing Denial Order and those for which no application was submitted, are among our highest enforcement priorities.

If such products are not removed from the market, the agency intends to follow its usual enforcement practices in these circumstances and will issue a warning letter before initiating enforcement action (such as civil money penalties, seizure, or injunction) and afford the recipient an opportunity to respond.

Since January 2021, we have issued a total of 170 warning letters to firms that collectively have listed more than 17 million ENDS with the FDA and that had not submitted premarket applications for these products.

Among those warning letters, and in an effort to take action on products with a likelihood of youth use or initiation, the FDA issued a warning letter in July to a single company that did not submit an application and has more than 15 million products listed with the FDA.

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.

Continuing to take appropriate regulatory actions to protect the public, especially youth, from the harms of tobacco products remains one of the agency’s highest priorities.

See the link to the full The New York Times story below.


The New York Times story – F.D.A. Delays Decision on Juul’s E-Cigarettes but Orders Others Off the Market (Restricted access)


FDA statement – FDA Makes Significant Progress in Science-Based Public Health Application Review, Taking Action on Over 90% of More Than 6.5 Million ‘Deemed’ New Tobacco Products Submitted (Open access)


See also from the MedicalBrief archives


E-cigarette use plummets among American youth – FDA survey


Is the FDA's cigarette ban just smoke and menthols? – MedPage Today op-ed


WHO versus Public Health England over e-cigarettes


Some smokers say e-cigarettes saved their lives – Does that matter?


US FDA warns companies of ‘illegal’ e-cigarettes in crackdown on youth vaping




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