Natalie Jakubowski

Associate Editor

Loyola University Chicago School of Law, JD 2024

On June 23rd, 2022, the U.S. Food and Drug Administration (FDA) announced that JUUL Labs, Inc., the notorious e-cigarette manufacturer, is ordered to cease distribution of their products in the United States. Since the company’s rise, one of the biggest pushes towards restricting JUUL products in stores across the nation has been fueled by discouraging youth vaping and the uncertainty regarding future health implications. The National Youth Tobacco Survey found that in 2021, approximately two million middle and high school students have reported using e-cigarettes. Meanwhile, more studies are surfacing regarding the adverse health effects that nicotine and e-cigarette products may have.

The order to cease distribution comes after JUUL’s failure to meet tobacco product standards in their premarket tobacco product application. A premarket tobacco product application must prove that the product does not put public health at risk. JUUL provided lackluster evidence and statistical data, raising concerns about what exactly makes up an e-cigarette and its potential long-term effects. This led to the denial of JUUL’s premarket tobacco product application and an issuance of marketing denial orders, which bans the products from being sold. These steps being taken by the FDA to better regulate e-cigarettes make many individuals and organizations hopeful for more transparency regarding the effects of nicotine or generally a decrease in new and young users.

Not so fast…

Even though the FDA issued marketing denial orders on JUUL products after review, JUUL is not ready to give up their grip on the vaping industry. JUUL requested a hold on the order as the case goes through the appeals process. JUUL avers in their appeal that over two million adults have chosen to use their e-cigarette devices as an alternative to their prior cigarette smoking. JUUL disagrees with the FDA’s findings, adamantly arguing that their data does in fact meet the necessary tobacco standard and their product provides a positive alternative to smokers.

The FDA granted the hold, and now JUUL products can live on the shelves for just a bit longer until a final decision is set. In order to save their products, JUUL will have to prove to the FDA, using clear statistical data, that their products do meet the standard. One reason for JUUL’s rejection was that the brand did not produce aerosol data regarding four chemicals found in the devices. JUUL alleges that they provided this data. The FDA will continue with further review through the agency’s private administrative operations to determine the sufficiency and accuracy of the data. As of September 7, 2022, the hold on the FDA ban is still in place. However, more news is surfacing on a separate investigation against JUUL regarding their marketing tactics aimed at teens.

While JUUL will no longer be able to distribute their products, other e-cigarette companies have not yet been placed on the chopping block. Since JUUL’s rise to vaping fame, multitudes of e-cigarette companies and products have hit the market. The FDA is still undergoing application review for similar e-cigarette products, and their fates will be determined by their ability to meet the necessary tobacco standard.

If JUUL is unable to prove that their products meet the necessary standard, JUUL users will have to say goodbye to the brand’s e-cigarette products. The FDA states that they are prioritizing enforcement of unauthorized e-cigarettes, and especially those with marketing denial orders. Any distributors that are caught continuing to sell the products will face enforcement actions from the FDA. It is unclear exactly how these enforcement actions will occur, and whether hidden and underground selling of the products will be rampant due to high demand from addicted users.

The FDA is also placing a burden on distributors to ensure that the products they are selling do not have a market denial order to avoid enforcement actions. Distributors are encouraged to communicate with manufacturers to learn whether a product is banned. By placing this burden on distributors, issues may arise regarding knowledge of market denial orders and the possible consequences of selling banned products. The order also raises the question of whether such a ban is even effective at all, especially with the multitude of alternative e-cigarette brands still awaiting authorization.

The future of vaping

While consumers soon might struggle to find JUUL products on the shelves, that does not mean there will not be other options. From alternative e-cigarette brands to alternative products such as nicotine gum or patches, consumers who have relied on these products to aid their addictions will continue to make these purchases or revert to traditional cigarette smoking. Many individuals and organizations hope that banning the products will lead to less usage of e-cigarettes by youth, which was a catalyst for the banning of flavored JUUL cartridges back in 2020 as more young individuals were becoming vape-addicted with no prior history of cigarette smoking. However, the number of available alternatives presents the issue of how much of an impact a ban on JUUL products will really have, especially with the rise of disposable e-cigarettes which were not included in the FDA’s 2020 flavored cartridge ban.

Until the frenzy of meeting the industry standard is widely understood across the supply chain, the burden on manufacturers to meet these standards will trickle down to distributors and retailers who still have plentiful inventories and high demand from consumers. While JUUL awaits a final determination on the safety of their products, the question is whether other companies undergoing authorization will be able to produce satisfactory evidence to the FDA, and whether e-cigarettes even really are a safe alternative.