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FDA Begins Issuing MDO’s for Menthol Vapes

UPDATE:

The U.S. Circuit Court of Appeals for the Third Circuit has issued a temporary stay for Logic’s menthol-flavored products, which received marketing MDOs just over a week ago. 

Logic filed a petition for review of the products, as well as an emergency motion for a temporary stay, the day after being issued their MDOs, October 27. 

The stay granted has given Logic seven days respite from having to pull the products in question from the shelves within the US. Logic has filed for a further motion to stay the products. 

This response to MDOs has been done before by Juul and several other companies in the past, with varying degrees of success on the behalf of the vape companies.

The Food & Drug Administration has issued its first round of marketing denial orders (MDOs) for menthol-flavored vape products. 

Logic Technology Development LLC (Logic) received a ban on their Logic Pro Menthol e-Liquid and Logic Power Menthol e-Liquid Package on October 26, 2022. 

This is the second batch of marketing orders issued to the Japan Tobacco brand since the premarket tobacco application (PTMA) process began at the end of 2019. 

As with nearly all of the MDOs issued to flavored vape products, the FDA has cited that Logic was unable to provide sufficient evidence in its case to prove that the benefit to adult smokers does not outweigh the risk of attracting underage populations from using their menthol products. 

It is very likely that this will not be the first and only round of MDOs for menthol-flavored vape products, as the FDA has finally broken its long silence on these products despite already banning most flavored e-liquids and vapes already.


Logic’s Other Marketing Orders

Logic was granted market authorization for a number of the Japanese company’s products on March 24, 2022. 

As with all of the marketing authorizations granted to date, only a select few of Logic’s tobacco-flavored products made the cut. All of their flavored products, except for menthol, were met with the same fate as countless other vape companies – MDOs. 

The products to be granted marketing authorization consists of the Logic Vapeleaf, Logic Power, and Logic Pro brands.

The FDA withheld information about the decision regarding the menthol-flavored products until this point, claiming that the menthol-flavored products were pending review.


The FDA Cares More About Menthol E-Cigarettes Than Real Cigarettes

Under the Biden administration, the FDA has set out to place a ban on all menthol-flavored tobacco products, including cigars, cigarettes, and heat-not-burn products. 

Reducing harm within specific communities that are more susceptible to these products has been cited as the main goal of these menthol-flavored tobacco product bans.

“One study suggests that banning menthol cigarettes in the U.S. would lead to an additional 923,000 smokers to quit, including 230,000 African Americans in the first 13 to 17 months after a ban goes into effect,” said an FDA statement. 

With an estimated smoking population of 30.2 million people in 2020, this figure roughly works out to be less than 0.3% of the total smoking population that would benefit from the menthol bans.

Despite this information, this latest round of MDOs against Logic’s menthol-flavored offerings represents a point where there have been decidedly more actions taken against vape products than traditional menthol cigarettes. 

There has not yet been a single menthol cigarette banned yet. Conversely, this first bout of MDOs for menthol-flavored vape products will likely signify the opening of the floodgates for other such vape products.

Menthol or not, cigarettes are simply more harmful than vapes. And yet, the FDA has done little to nothing to reign in the more dangerous products.


Vaping Can Be More Effective At Tobacco Harm Reduction Than Bans

A recent study by the National Institutes of Health (NIH) found that vaping showed promise as a tool for smokers looking to quit within the context of the United States. 

“The researchers looked at 1,600 adults who smoked cigarettes daily, did not use e-cigarettes, and who were not planning to quit smoking at the beginning of the study,” the statement reads.  “About 6% quit cigarettes altogether during the study. Another 4.5% reduced their smoking to less than one cigarette a day.”

While a test group of that size cannot correlate to the 30.2 million smokers in the US, it certainly demonstrates more promise than the studies that the government is using to push their menthol and flavor prohibition. 

“The team compared quit rates between those who took up e-cigarettes and those who did not. Those who were using e-cigarettes daily at the end of the study were 8-fold more likely to quit cigarettes altogether. They were also almost 10-fold more likely to stop smoking cigarettes every day.”

While the estimated results from a flavor ban may optimistically be over 900,000 smokers, it pales in comparison to the potential 1.81 million that could be helped by adopting vaping policies such as promoting menthol-flavored vapes while simultaneously focusing efforts to ban menthol cigarettes. 

While the intention of reducing harm in certain populations is good, the methodology behind the FDA’s decision-making has the potential to do more harm than good. 


Flavor Bans As a Whole

There has understandably been huge criticism around the movement since its inception. These are essentially prohibition tactics, which history has demonstrated only leads to black market illicit trade. 

The worst factor of this is that a person does not even need to look back in history to see this. Australia’s vape industry is a prime example of not only how these bans do not work, but how they directly lead to the rise of illegal trading of unregulated, low-quality products. 

This is something that the Biden administration and the FDA seem to have fully ignored. The US is certainly not immune to illicit trade, and this extends to the vape industry. 

In the context of using vaping as a smoking cessation tool, it is incredibly misguided to believe that vapes hold the same appeal to smokers without the various flavors on offer. 

This misguidedness is taken a step further with the FDA’s belief that banning these products will simply force smokers to quit smoking or vaping, rather than opting for black market products of subpar quality and questionable production standards.


In Summary

The Food & Drug Administration has issued Logic Technology Development marketing denial orders for their menthol-flavored vape products. This marks the first round of denials for menthol-flavored products, which have remained under review despite other denials for flavored vape products.

This represents a pivotal point where the agency is putting more pressure on menthol-flavored vape products than actual menthol cigarettes, further highlighting its skewed methodology and decision-making.

Robert Barnes Author Picture

Robert Barnes

Robert is the Senior Editor for News and Reviews here at Versed Vaper. Robert previously worked in tech journalism and even wrote commercials. Initially, he joined our team to cover important vaping industry news. Now, he oversees and produces news, reviews, and deals content across a wide variety of topics ranging from law and policy changes, ENDS (Electronic Nicotine Delivery Systems) products and Cannabis and CBD vaping products. When he’s not keeping track of all the latest vaping trends, he can most likely be found marathoning television series or playing with his awesome dog, Lupa.

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