US Reverses Ban on Juul Vaping Products

The US has reversed its ban on products sold by Juul, one of the country's leading e-cigarette companies. This ban was initially implemented in 2022 by the US Food and Drug Administration (FDA) due to a rapid increase in vaping among teenagers across the nation. The reversal marks a significant win for Juul Labs, which had been ordered to remove its e-cigarettes and vaping products from stores and online shops.

However, the FDA has clarified that this change does not equate to authorising the products for sale, emphasizing that a comprehensive review of Juul's products is still pending. Despite the ban, Juul's products have remained on store shelves while the company appealed the FDA's initial decision, and they will continue to be available for the time being.

In a statement released on Thursday, Juul expressed its appreciation for the FDA's decision and affirmed its commitment to working with the agency to secure marketing authorisation for its products. It is a regulatory requirement that all e-cigarette products obtain FDA authorisation to be legally marketed.

The FDA stated on Thursday that the action is "being taken, in part, as a result of the new case law, as well as the FDA’s review of information provided by the applicant." Juul, founded in California in 2015 by two former smokers, has positioned itself as a healthier alternative to traditional cigarettes. The company has claimed that its products could help users quit smoking cigarettes, coinciding with a significant rise in e-cigarette usage.

However, the high nicotine content in Juul's products has faced significant criticism, especially as teenage usage surged in recent years. Critics have attributed this surge to Juul's colorful packaging, wide variety of flavors, and the use of young models in their marketing campaigns. Last year, about one in every ten high school students reportedly used an e-cigarette in the past 30 days, although this figure is somewhat speculative. Additionally, one in every 22 middle school students reported similar usage, according to the US Centers for Disease Control and Prevention.

In 2022, when the FDA initially banned Juul's products, the agency cited the company's applications for lacking "sufficient evidence" to demonstrate that the marketing of the products met the public health standards required by law. The FDA specifically noted concerns about potentially harmful chemicals leaching from e-liquid pods. After a two-year review, the FDA found that the documents "lacked sufficient evidence regarding the toxicological profile of the products."

Now, the FDA has announced it would rescind the ban due to new case law and the review of information provided by Juul. This decision does not indicate whether Juul's marketing applications will ultimately be authorized or denied, as the application is still pending. Agency regulations limit what officials can say regarding pending applications.

Juul Labs, in response to the update, stated they "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. 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."

Congress had previously granted the FDA the authority to regulate the manufacturing and distribution of tobacco products. E-cigarette companies were required to submit their products for reapproval, but they were allowed to continue selling e-cigarettes in the meantime.

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- Sharri Van Zyl | 12/06/2024