h/t @Doomberg. The government’s approach to nicotine shares parallels with energy policy - a refusal to look at the fundamentals, no interest in respecting science, and no willingness to adopt any policy that embraces the idea that Better is Better.
If there will be any FDA action that leads to stricter enforcement of rules on the vaping market, it will not come out of concern about US consumers' health.
It will be the US government not allowing comrade Zhang Shengwei to make a fortune by breaking rules that US companies must follow.
That's an interesting angle, JF. Thanks for sharing. There is one point that needs to be cleared up in that AP article that has also been repeated by many other media sources. While the parent company of Elf Bar, iMiracle Shenzhen, has certainly taken actions to evade enforcement actions and skirt customs and import taxes, the specific action of rebranding of Elf Bar to EBDesign and EBCreate, at its core, is a function of losing a trademark dispute in the United States. The change appears to be in accordance with the decision of the courts - a sole instance of the parent company being interest in following the law. Outside of that, I believe it is a operator acting in bad faith, and the government has an imperative interest in cracking down on such actors.
This is a well researched article that showcases your investigating talents. I think you're spot on when you contrast what the FDA has been doing (deciding for people) to what we're expecting from the agency (providing evidence to help people make decisions).
> courts have found the FDA’s actions to be arbitrary and capricious
Earlier today Keller and Heckman reported on the latest such ruling: "the U.S. Court of Appeals for the Fifth Circuit ruled in favor of petitioner Triton Distribution in its PMTA Marketing Denial Order (MDO) challenge, holding that FDA acted arbitrarily and capriciously in denying Triton’s PMTA for its non-tobacco flavored open-system e-liquids."
The ruling starts with a bang: "Over several years, the Food and Drug Administration (“FDA”) sent manufacturers of flavored e-cigarette products on a wild goose chase."
Some of the dissenting judges probably need education on the relative risks of vaping vs smoking. They write: "As I discuss more fully below, the e-cigarettes are not safe. Just as being shot in the stomach might be less likely to cause death than being shot in the head, but neither one is wanted, neither e-cigarettes nor cigarettes are safe."
Today's ruling follows a string of many that reached similar conclusion. Will be very interesting to see how things develop. Thanks for your thoughts, Tian.
I agree with you that fentanyl crisis is much more concerning and warrants more law enforcement resource commitment. Further, teen vaping has decreased from the peak in 2019. As such, FDA can be a bit complacent even with the proliferation of illicit disposable vape, as it seems to be a less meaningful "KPI" than teen vaping rate. The authority has tons of reasons not to be held accountable for the current situation, considering there's limited disparity in health impact between legal and illicit vaping products (which seem to be insignificant for both anyway).
I am thinking whether the narrative may change if the U.S. starts levying excise tax on vaping, like Germany, Italy and some other European nations do? Because by then, distributors of illicit vaping products will be involved in tax evasion, which creates much stronger incentive for them to comply with law or otherwise risk law enforcement. Government authorities seldom take loss of tax revenue lightly.
I very much agree, Anthony. While many look at future taxation treatments of next-gen products strictly as a headwind, I think there are a number of reasons why such actions can help further provide stability and clarity as these categories evolve.
h/t @Doomberg. The government’s approach to nicotine shares parallels with energy policy - a refusal to look at the fundamentals, no interest in respecting science, and no willingness to adopt any policy that embraces the idea that Better is Better.
Hi Devin, thanks for sharing your thoughts.
If you haven't read it already, I think you will find this article here interesting: https://www.reuters.com/world/china/china-e-cigarette-titan-behind-elf-bar-floods-us-with-illegal-vapes-2023-12-06/?utm_source=substack&utm_medium=email
Thanks for sharing, Simon.
If there will be any FDA action that leads to stricter enforcement of rules on the vaping market, it will not come out of concern about US consumers' health.
It will be the US government not allowing comrade Zhang Shengwei to make a fortune by breaking rules that US companies must follow.
Maybe it has already started.
https://apnews.com/article/elf-bar-china-ecigarettes-teen-vaping-04bc1ce1c870043b1d3eeab4ce243bfc
That's an interesting angle, JF. Thanks for sharing. There is one point that needs to be cleared up in that AP article that has also been repeated by many other media sources. While the parent company of Elf Bar, iMiracle Shenzhen, has certainly taken actions to evade enforcement actions and skirt customs and import taxes, the specific action of rebranding of Elf Bar to EBDesign and EBCreate, at its core, is a function of losing a trademark dispute in the United States. The change appears to be in accordance with the decision of the courts - a sole instance of the parent company being interest in following the law. Outside of that, I believe it is a operator acting in bad faith, and the government has an imperative interest in cracking down on such actors.
This is a well researched article that showcases your investigating talents. I think you're spot on when you contrast what the FDA has been doing (deciding for people) to what we're expecting from the agency (providing evidence to help people make decisions).
> courts have found the FDA’s actions to be arbitrary and capricious
Earlier today Keller and Heckman reported on the latest such ruling: "the U.S. Court of Appeals for the Fifth Circuit ruled in favor of petitioner Triton Distribution in its PMTA Marketing Denial Order (MDO) challenge, holding that FDA acted arbitrarily and capriciously in denying Triton’s PMTA for its non-tobacco flavored open-system e-liquids."
Here's the 85-page ruling: https://vaping.org/wp-content/uploads/2024/01/bb9i.pdf.
The ruling starts with a bang: "Over several years, the Food and Drug Administration (“FDA”) sent manufacturers of flavored e-cigarette products on a wild goose chase."
Some of the dissenting judges probably need education on the relative risks of vaping vs smoking. They write: "As I discuss more fully below, the e-cigarettes are not safe. Just as being shot in the stomach might be less likely to cause death than being shot in the head, but neither one is wanted, neither e-cigarettes nor cigarettes are safe."
Today's ruling follows a string of many that reached similar conclusion. Will be very interesting to see how things develop. Thanks for your thoughts, Tian.
I agree with you that fentanyl crisis is much more concerning and warrants more law enforcement resource commitment. Further, teen vaping has decreased from the peak in 2019. As such, FDA can be a bit complacent even with the proliferation of illicit disposable vape, as it seems to be a less meaningful "KPI" than teen vaping rate. The authority has tons of reasons not to be held accountable for the current situation, considering there's limited disparity in health impact between legal and illicit vaping products (which seem to be insignificant for both anyway).
I am thinking whether the narrative may change if the U.S. starts levying excise tax on vaping, like Germany, Italy and some other European nations do? Because by then, distributors of illicit vaping products will be involved in tax evasion, which creates much stronger incentive for them to comply with law or otherwise risk law enforcement. Government authorities seldom take loss of tax revenue lightly.
I very much agree, Anthony. While many look at future taxation treatments of next-gen products strictly as a headwind, I think there are a number of reasons why such actions can help further provide stability and clarity as these categories evolve.