FDA reverses marketing denial orders on Juul vaping devices, products
The FDA announced that it has revoked its previous marketing denial orders to Juul Labs in part because of new case law and further review, according to a press release from the agency.
As Healio previously reported, the FDA issued marketing denial orders (MDOs) to Juul Labs for all of its vaping devices and related products on June 23, 2022. The company was required to stop selling and distributing these products, as well as remove the ones on the U.S. market at the time.
But on July 5, 2022, the FDA suspended but did not rescind the MDO, saying that there were scientific issues unique to the company’s application that warrant additional review.
With the MDO rescission, Juul Labs’ premarket tobacco product applications are back up for FDA review. From here, the FDA will issue either marketing granted orders or MDOs to the company.
“Rescission of the MDOs is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied,” the FDA stated in the release.
Notably, e-cigarette products can be legally marketed only if they have received FDA authorization.
“We appreciate the FDA’s decision and now look forward to re-engaging with the agency on a science- and evidence-based process to pursue a marketing authorization for Juul products,” the company said in a statement.
“We remain confident in the quality and substance of our applications and believe that a full review of the science and evidence will demonstrate that our products meet the statutory standard of being appropriate for the protection of public health,” the company continued.
In response to the ban reversal, Anne C. Melzer, MD, MS, vice chair of the ATS Tobacco Action Committee, expressed her disappointment in the decision.
“FDA's announcement that they are reconsidering the Juul application adds further delay and uncertainty to the already poorly regulated and chaotic e-cig market,” Melzer was quoted in a post on the X (formerly Twitter) ATS account.
References:
- American Thoracic Society (@atscommunity). June 6, 2024. X (Twitter).
- FDA denies authorization to market JUUL products. https://www.fda.gov/news-events/press-announcements/fda-denies-authorization-market-juul-products. Updated July 5, 2022. Accessed June 7, 2024.
- Juul Labs statement on the FDA’s recission of its 2022 marketing denial orders. https://www.juullabs.com/juul-labs-statement-on-rescission-of-marketing-denial-orders/. Published June 6, 2024. Accessed June 7, 2024.
Perspective
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The Lung Association is deeply troubled that the marketing denial orders for Juul have been rescinded. Juul is largely responsible for the youth e-cigarette epidemic from 2017 to 2019. These products and its manufacturer clearly do not meet the standard for protecting the public health and need to be removed from the market.
It is important for clinicians to know that youth vaping continues to be a serious public health concern with more than 2.1 million middle and high school students reporting that they have used e-cigarettes in the last 30 days. Juul was a large part of creating the current public health crisis around e-cigarettes, and unfortunately, it is still on the market.
If they aren’t already, clinicians should be speaking with their younger patients about the health risks of vaping and nicotine addiction. For clinicians working with adult patients, it is important to remind them that e-cigarettes are not an FDA-approved treatment to quit smoking and there are several FDA-approved treatments on the market to recommend to patients.
E-cigarettes are tobacco products and are extremely addictive. Numerous studies have shown the negative health impacts of e-cigarettes and we are learning more every day. The American Lung Association recommends that no one use e-cigarettes and reminds patients that e-cigarettes are not an FDA-approved treatment to quit smoking.
FDA must not permit any Juul product or other tobacco product to be sold in the U.S. prior to it receiving a premarket authorization. We’d also add that it is past time for the Department of Justice to act and crack down on products that are on the market illegally — either because they are waiting for an application to be processed or because they’ve never even submitted an application. The number of illegal e-cigarettes on the market isn’t just an FDA problem; in addition to it being a public health problem, it is a federal government problem — one the Department of Justice, Customs and Border Protection and FDA must address together.
Juul, just like every other e-cigarette, is a tobacco product; they are not quit smoking products. We’d urge that people who are ready to quit talk with their medical provider, call 1-800-QUIT NOW or visit www.Lung.org. All of these sources can help people end their addiction for good by using evidence-based treatments including the seven FDA-approved quit smoking products.
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