Emily Sortor  |  August 7, 2020

Category: E-Cigarette

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What is the Juul FDA application?

As the company’s reputation takes a hit, JUUL has filed a Premarket Tobacco Product Application with the FDA, which would allow the e-cigarette company to continue selling certain vape products in the United States. The products on the table in the Juul FDA application are the vape pens themselves, as well as menthol-flavored and Virginia tobacco-flavored vape pods sold in concentrations of 3 and 5% nicotine.

The Premarket Tobacco Product Application is one that requires tobacco companies to demonstrate that their products can appropriately protect public health. According to Bloomberg News, a key element of this will be for the companies to demonstrate that the products will not attract teens and young people, and will instead, provide a benefit to adult users.

Bloomberg News explains that the stakes of this Juul FDA application are high for the company Recently, the company has been criticized for the possible healths effects of their devices, and for supposedly marketing to youth and young people. Critics say that this is an to attract an audience not yet cornered by Big Tobacco. Juul, on the other hand, maintains that they market only to adults, and their vape products can be an effective smoking cessation tool. 

According to Bloomberg News, the company has been working hard to shake this negative reputation, and receiving this approval from the FDA is one part of that. In order to set themselves up for success in the applications, the company reportedly has taken a number of steps like relocating its headquarters to Washington D.C., close to regulators, and away from the culture of San Fransisco and Silicon Valley.

The company has also reportedly hired executives who have backgrounds in health care and science, and even hired executives from Altria Group Inc., a Big Tobacco company.

In arguing that its products should stay on the market, Juul has asserted that its products can help smokers quit traditional tobacco products, saying that vapes are a healthier alternative. Bloomberg explains that smoking is the number one cause of preventable death in the country.

Juul FDA application has been filedIn the Juul FDA application, Juul has supposedly provided extensive evidence in support of their claim that Juul devices are good for adult users, are not targeted at youth, and do not have the deleterious health effects critics claim that they do.

Activists have criticized Juul’s attempts at gaining permission to sell certain vape products. The co-founder of activist group Parents Against Vaping E-Cigarettes, Meredith Berkman, does not think that the Juul FDA application represented a genuine effort to protect public health. She states, “if Juul really cared about protecting our youth or about initiating youth through its products, it wouldn’t be submitting menthol.” 

In this statement, Berkman refers to a common critique that Juul intentionally produces vape liquid in flavors that appeal to children and young people. Allegedly, the products originally were released in attractive flavors like fruit, candy, and others. According to critics, the effort was to attract kids and youth by presenting vaping as appealing and not dangerous.

To curb youth use of vapes, the FDA has already raised the legal age for tobacco use from 18 to 21. Now, the FDA is requiring vape makers to apply to the FDA to continue selling their existing products. New products are not allowed to be produced in flavors other than menthol and tobacco. 

The American Cancer Society notes that Juul had voluntarily withdrawn most flavored vape products from the market, after the FDA scrutinized the appeal of flavored vapes to youth. Reportedly, the users who had previously used flavored vapes merely switched to menthol or tobacco flavored products, as opposed to quitting altogether.

According to the American Cancer Society, this information was reported in a study published online by the American Journal of Public Health on April 16, 2020. The same study indicated that these vape users also pivoted to using other brands that did continue to sell flavored vape products, rather than quitting. 

While the removal of flavored vapes from U.S. stores did indeed temper Juul sales briefly, this did not last long. Overall, sales increased, as users switched to mint, menthol, and tobacco-flavored products.

This represents a different trend from that reflected in 2017 and 2018, when Juul’s sale of fruit-flavored devices increased. During that period, sale of tobacco-flavored e-cigarettes fell from 39.7% of the company’s sales to just 16.6%. This trend may speak to the popularity of flavored devices over tobacco and menthol-flavored ones — many regulators and critics had hoped that reducing flavored vape product sales would affect overall sales.

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If you or your child suffered seizures after vaping with a JUUL e-cigarette, you may benefit from participating in a free JUUL class action lawsuit investigation.

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

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