FDA rejects nearly 1 million flavoured  vape products in landmark American clampdown

The Food and Drug Administration (FDA), the federal agency that regulates tobacco and e-cigarettes in America, has ruled on whether millions of vaping products can remain on sale.

After a year-long review, ordered by a federal judge following calls for stricter regulations, it has processed 93% of the submitted applications, totalling around 6.3 million products. 

946,000 flavoured products have been banned, alongside 4.5 million product applications which have also been rejected. The FDA stated they didn’t contain the correct documentation and must now be immediately removed from the market. 

As part of their applications, manufacturers had to be able to prove their products had a positive impact on public health and did not encourage underage users to start vaping. The FDA said the applications it has rejected "lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products."

The regulatory body has also asked for more time to finish their review, with 7% of the existing applications left. This includes market leader Juul, who’ve hit headlines recently after paying a $40 million settlement following a US lawsuit claiming it marketed its products to teens. 

Juul makes up 40% of America’s vape market, and the FDA has faced criticism for failing to prioritise their applications and allowing their products to remain on the market. 

In their published report, the FDA stated; “The large number of applications submitted by the Sept. 9, 2020 deadline was unprecedented. However, over the last year, we’ve taken action on a significant number of the applications we received by Sept. 9, 2020. We will continue working to review all pending and incoming applications.

What does it mean for American Vapers?

The US has fallen behind the UK in terms of e-cigarette regulation for several years, including a lack of nicotine concentration and marketing rules. 

America experienced a so-called “high school vaping epidemic”, with many advocates blaming flavoured vapes, for the rise in teen uptake and none smokers. A study published in June by JAMA Network Open found that almost 20% of high school and 5% of middle school students reported that they currently vaped in 2020. The study only surveyed 14,531 students and these results show a reduction from 2019, but they are still worrying figures for America’s young population. 

The FDA appears to be taking this on board and has banned many fruity and colourful products ahead of others, but it fails to consider the fact that the lack of regulations on vape marketing and imports has likely made it easier for under 21’s to access vape products. 

For ex-smokers in the US who are legally allowed to vape and have used e-cigs to successfully kick the habit, it could mean a blanket ban on flavoured e-liquid, including menthol products. For many vapers, this may push them back towards cigarettes as the lack of flexibility will inevitably lead to an increase in cost and a lack of choice. 

How does this compare with the UK vaping industry?

In contrast to American research, many studies in the UK have identified positive impacts of vaping on smoking cessation, including the fact that using e-cigarettes has a 60% higher success rate of quitting than going cold turkey. Furthermore, Public Health England state that vaping is at least 95% safer than smoking - a stat that America doesn’t recognise. 

Whilst some international manufacturers and retailers are coming under fire for selling and promoting illegal vape products in the UK, it’s unlikely that we’ll see the same ban on flavoured vapes over here. 

More research is needed into the long term effects of vaping, but so far findings here are positive. As Juul still await their fate in America, the brand’s products remain on sale. If they are the driving force behind youth vaping in the US as research suggests, the problem won’t be solved any time soon, despite smaller brands facing complete bans. 

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