Many Marketing Denial Orders (MDOs) were issued in the past for vaping products. But, many menthol-based vapes have been waiting for a decision by the FDA. Menthol vapes have been placed in an odd position due to the ongoing debate about banning tobacco products made of menthol. However, the FDA appears to have settled about electronic cigarettes with menthol. The FDA has approved Logic’s menthol-flavored vaping devices as an MDO, but they aren’t legally legal within the U.S.
A ban on products made from menthol seems simple. A ban on tobacco products containing menthol could mean banning all tobacco products, including menthol, regardless of the product type. This isn’t the case. A menthol combustible tobacco, Menthol King cigarettes, has received PMTA acceptance, and it is now legal to sell. However, the same authorities have rejected the menthol vapes from Logic as other vapes.
WHAT WERE LOGIC’S REJECTED MENTHOL VAPE PENS LIKE?
It is worth noting that the Logic products that have received MDO include the Logic Pro Menthol e-Liquid Pack and the Logic Power Menthol e-Liquid Package. Both cartridge-style devices have been granted permission to use tobacco in their packages.
The FDA’s rationale for denying both the Logic Pro and the Logic Power was that:
“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.”
The basic idea is that Logic Pro and Logic Power were ruled out because all vapes were disapproved. The FDA did not believe that Logic’s applications demonstrated that vapes helped adults who smoke more than they posed a threat to young people.
The FDA stated they could not approve more of Logic’s apps than Logic Pro and Power. According to their press release:
“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 quotations suggested other products that received MDOs were not released and accessible to the public.
Logic can revise the PMTA application if it believes they have evidence proving that its product will bring more benefits than harm. However, due to the uncertainty of approval, the hefty cost of making a PMTA, and the high cost of filing a PMTA, Logic will likely choose to follow this route.
WHY IS GOING AGAINST MENTHOL VAPES A BIG DEAL?
The FDA is taking an anti-vape solid position. Allowing a menthol cigarette to be sold while denying cigarettes flavored with menthol suggests that they are worried about the tobacco product with a flavor. So, menthol cigarettes could be on the market shortly. However, a menthol vape ban means there are no legal menthol vapes. Hopes for a non-nicotine vape containing menthol are not likely to. In general, nicotine-free E-liquids aren’t considered marketable by the FDA. The FDA will not allow users to create their nicotine vaping devices.
Even though there are no legal menthol vapes that are legal, however, numerous black market vapes offer and continue to offer users hazardous disposable vape pens for menthol.
The issue is that people will always want nicotine and menthol flavorings. Smoking combustible cigarettes or black-market menthol vape disposables will be the only choices. The vapes sold in black market stores are generally of questionable quality. The vaping device and the liquids could be risky if they do not adhere to the safety standards. In addition, disposable, inexpensive vapes are the most sought-after kind of available vape sold on black markets. They produce more hazardous waste than any other kind of device for vaping.
At present, the only FDA-approved e-liquids are flavored with tobacco. Tobacco is the sole flavor that the FDA doesn’t consider appealing to young non-smokers. Several flavors and businesses are caught in court fights involving the FDA’s decisions. In the end, with the history of the FDA and the public’s opinion about smoking e-cigarettes, it’s unlikely that legal menthol vapes will be offered for an extended period.