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02/22/2023
2:22PM

Menthol Vape Pens From Logic Receive MDOs

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Many Marketing Denial Orders (MDOs) have already been issued for vaping products. However, a large number of menthol vapes have been stuck awaiting a decision from the FDA. Menthol vapes were in an unusual place due to ongoing talk of a menthol tobacco product ban. However, the FDA seems to have finally made up their mind on menthol electronic cigarettes. Logic’s menthol flavored vaping devices have received an MDO, and are not legal in the U.S.

A ban on menthol tobacco products sounds simple. A ban on menthol tobacco products sounds like it would ban all menthol tobacco products, regardless of type of product. That is not what happened. A menthol combustible cigarette, Menthol King cigarettes, has been given PMTA approval and is legal to sell. On the other hand, Logic’s menthol vape devices have received the same rejection as many other vapes.

What were Logic's rejected menthol vape pens like?

The Logic products that received MDOs are the Logic Pro Menthol e-Liquid Package and Logic Power Menthol e-Liquid Package. Both devices are cartridge style devices that have received authorizations for their tobacco flavored packages. 

The FDA’s reasoning for rejecting the Logic Pro and the Logic Power was: 

“The evidence provided within the application does not demonstrate that these menthol-flavored e-cigarettes are more effective in promoting complete switching or significant cigarette use reduction relative to tobacco-flavored e-cigarettes among adult smokers.”

Basically, the Logic Pro and Logic Power were rejected for the same reason almost all vapes were rejected. The FDA did not believe Logic’s applications proved vapes benefitted adult smokers more than they threatened youth. 

The FDA implied they rejected more of Logic’s applications than the Logic Pro and the Logic Power. As stated in their press announcement: 

“The MDO letter that Logic, LLC received today is not limited to the two products named above; in general, the FDA publicly names only products that the applicant is marketing to avoid potential disclosure of confidential commercial information.”

The above quotes suggested there were additional products that received MDOs that were not made public. 

Logic has the option to resubmit their PMTA applications if they feel they can provide the data that shows their vape can provide more benefit than harm. However, given the unlikeliness of approval and the high cost of filing a PMTA, it is unlikely that Logic will take that path. 

Why is going against menthol vapes a big deal?

The FDA is taking a solidly anti-vape stance. Letting a menthol cigarette be sold while refusing menthol vapes suggest they are concerned about the tobacco product that is flavored. This means menthol cigarettes will be available in the future. But there is a menthol vape ban, there will be no option for legal menthol vapes. Any hopes for no nicotine menthol vape products are low as well. Generally, no nicotine e liquids are not considered marketable by the FDA. The FDA does not want to leave loopholes for users to add their own nicotine to vaping devices.

Despite lack of legal menthol vape options, many black market vapes do and will continue to provide users with dangerous, disposable menthol vape pen options.

The issue is people will continue to want nicotine and menthol flavors. For them, the only options will be combustible cigarettes and dangerous, black market menthol vape  disposable pens. Black market vapes are generally of questionable quality. Both the vaping devices and the liquids can be dangerous when not held to safety standards. Additionally, cheap, disposable vapes are the most popular type of vape on the black market. Disposable vapes create much more problematic waste compared to any other type of vaping device.

As of now, the only FDA authorized e liquids are tobacco flavored. Tobacco is the only flavor the FDA does not consider tempting to youth non-smokers. However, there are still many flavors and companies tied up in court battles against the FDA’s rulings. Sadly, given the FDA’s history and public opinion against vaping, it is unlikely we will see legal menthol vape products being sold for a very long time.


References

FDA Denies Marketing of Logic’s Menthol E-Cigarette Products Following Determination They Do Not Meet Public Health Standard

FDA Issues Marketing Denial Orders for Logic Menthol Based E-Cigs 

FDA Issues First Marketing Denials for Menthol Vapes - Vaping360

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