A federal judge recently ruled that, due to e-cigarette health concerns, JUUL Labs must seek FDA approval by May 2020.

“Given the uncertainty in the efficacy of e-cigarettes as smoking cessation devices, the overstated effects that a shorter deadline may have on manufacturers, the industry’s recalcitrance, the continued availability of e-cigarettes and their acknowledged appeal to youth, and the clear public health emergency, I find that a deadline is necessary,” wrote U.S. District Judge Paul Grimm.

Grimm’s ruling resulted from a civil court case brought against JUUL Labs by public health advocacy groups. The groups argues that e-cigarette health concerns warranted an early review of their safety and that the FDA had a duty to regulate the potentially dangerous products.

The FDA reportedly supports Grimm’s ruling and calls his decision an “important step forward for public health.” The FDA started to oversee e-cigarette health concerns in 2016. However, the deadline for safety and public health review applications was pushed back to August 2022 under the Trump administration.

“The FDA stands ready to accelerate review of these products and will continue its vigorous enforcement and public education efforts to protect kids from e-cigarettes,” said FDA acting commissioner Ned Sharpless.

Once JUUL Labs submits an application for review, their products can stay on the market for a full year while the FDA considers the health and safety implications of the e-cigarettes. JUUL Labs is reportedly not concerned about their application and is “confident in the content and quality” of their products.

E-Cigarette Health Concerns

All e-cigarettes can pose a risk for nicotine addiction. Most e-cigarette fluids contain a significant amount of nicotine and the amount of nicotine dispensed by the electronic devices is higher than that found in traditional cigarettes.

According to the National Center for Health Research, JUULs are especially risky because of the amount of nicotine they contain. While comparable brands such as Blu contain 2.4 percent nicotine by volume, JUUL pods reportedly contain 5 percent nicotine by volume. This means that one JUUL pod is equivalent to an entire pack of cigarettes in terms of nicotine.

Additionally, JUUL pods reportedly use nicotine salts opposed to the freebase nicotine used by other companies – allowing the nicotine from vaping to reach the bloodstream faster.

There are also concerns that the fluid used in JUUL pens and other e-cigarettes is unregulated. Because the FDA does not require testing for e-cigarette fluids, it is harder to tell whether or not these components are safe. Although future standards may require strict testing of e-cigarette fluids, current regulations may allow unsafe products to reach the market.

E-cigarettes such as JUULs have also been linked to a potential risk for seizures. In April 2019, FDA Commissioner Scott Gottlieb released a press statement informing the public that they had received reports of seizures with e-cigarettes. Although the agency only received 35 reports between 2010 and 2019, they note that there could be more unreported cases. Regardless, the FDA will reportedly be investigating the issue and will update the public as more information becomes available.

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This article is not legal advice. It is presented
for informational purposes only.