FDA authorizes NJOY e-cigs without disclosing reasoning; inaction allows menthol to remain on the market

Today FDA continued its trend of authorizing the sale of tobacco-flavored eicgs — this time the NJOY while leaving menthol versions on the market by not acting. On the NJOY website, menthol and tobacco pods are sold side-by-side, with menthol shown first (screen shot below).

Following the precedent set when it authorized the sale of Logic, rather than addressing the serious scientific problems in its earlier authorization of Vuse Solo, FDA did not publish the full Technical Project Lead (TPL) document detailing the scientific justification for its decision. As with Logic, FDA only released 4 (of the 44) TPL pages, most of which was the same boilerplate about legal requirements that they published for Logic.

In particular, there are no specifics on how many youth they are willing to addict to nicotine as part of FDA’s chasing the golden fleece of smokers “completely switching” to e-cigs in the face of strong and consistent evidence that, over the long run on a population level, e-cigarettes make it harder to quit smoking.

So much for transparency.

Published by Stanton Glantz

Stanton Glantz is a retired Professor of Medicine who served on the University of California San Francisco faculty for 45 years. He conducts research on tobacco and cannabis control and cardiovascular disease/

5 thoughts on “FDA authorizes NJOY e-cigs without disclosing reasoning; inaction allows menthol to remain on the market

  1. Why do most people blindly accept the premise that vaping and secondhand vaping are less harmful than smoking and secondhand smoke? My experience in the tobacco control movement tells me that in 20 years, we will learn of diseases caused by vaping and secondhand vaping that we don’t even know the names of today.

    EVALI, a new vaping lung disease, has already caused thousands of teen hospitalizations and dozens of teen deaths, a feat that pales in comparison to teen cigarette smoking. EVALI is the first heretofore unknown vaping disease. There will be others, including brain disease (as evidenced by preliminary studies).

    Fifty years ago, people were told that smoking and secondhand smoke were harmless, even good for you. Now we are being told that vaping and secondhand vaping are less harmful. The truth won’t be known for another 20 years. In the meantime, should we believe the tobacco cartel again?

    E-cigarette and vaping dispensers (especially those that open to allow users to add flavors, chemicals, and other substances) are particularly troublesome. Currently, there exists over 100 flavors/chemicals (such as cotton candy, popsicle, candy-cane, mint, etc.) easily available online as well as in the ever expanding number of e-cig/vape stores. The danger signs are flashing and government, as always, is hand-tied by tobacco cartel influence.

    Australia has shown us one solution to the problem. REQUIRE A DOCTOR’S PRESCRIPTION TO OBTAIN ANY ELECTRONIC NICOTINE DELIVERY DEVICE. It makes sense since nicotine delivery devices are medical devices supposedly only intended to help people with a medical problem (nicotine addiction). E-cigarettes are not intended to create a new generation of addicts (wink, wink), which is unfortunately what is happening. Youth smoking is soaring for the first time in thirty years.

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  2. The lackluster disclosure is unconscionable at best. We all realize that e-cigarettes were invented by the tobacco industry to counter effective tobacco control measures. Leaving anything but tobacco-accustomizing flavors on the market will endanger a whole new generation. Henceforth a full investigation into the PMTA processing seems apt, if the FDA wants to avoid the appearance of coordinating with the tobacco industry.

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  3. Dr. Vallone’s comment that “e-cigarettes were invented by the tobacco industry to counter effective tobacco control measures” is particularly important. While most people think e-cigarettes were invented by a Chinese pharmacist in around 2005 as a smoking cessation aid, the reality is that Philip Morris had a functioning e-cigarette by the mid-1990s (see https://pubmed.ncbi.nlm.nih.gov/27852893/). And they didn’t develop it as a cessation aid or for harm reduction. They developed it to hold on to health-concerned smokers who would otherwise quit.

    FDA and other e-cigarette advocates continue to ignore this reality.

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  4. Very astute point, Prof. Glantz! It’s also relevant to point out whilst the original electronic smoking devices were still diluted with monoamine oxidase inhibitors, acetaldehyde and the minor tobacco alkoloids, their newer ENDS contain pure unrefined nicotine at staggering levels. Which is why they’re near impossible to quit. (Except with our new Truth AI-driven SMS quitting assistant.)
    In an upcoming human-equivalent epidemiological paper, we’re also hoping to show that those can induce autism-related behavioral changes given sufficient exposure. Which should also put to rest the claim that EVALI was the only injury exclusive to the novel electronic smoking deception.

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