Ya, that is what I mean by small win the fact that the court has recognised that the FDA changed the goalposts halfway thru the game may open the door to many other companies that had MDOs issued. Here is hoping anyhow.
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Interesting @woftam…
The court found the FDA moved the goalposts for companies submitting Premarket Tobacco Applications (PMTAs) in the years following its 2016 Deeming Rule. The agency changed the date for submission multiple times, wrote Judge Andrew S. Oldham for the panel, and after explaining that manufacturers could submit PMTAs without long-term scientific evidence, the FDA “changed its mind and required the very thing it said it would not—namely, long-term studies of e-cigarettes.”
In its reasoning for issuing MDOs to companies manufacturing non-tobacco and -menthol vaping products, the FDA cited a new standard of evidence that was not explained in advance. On Aug. 26, the agency explained that manufacturers of flavored products must show “sufficient product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth,” and that the evidence would “likely be in the form of a randomized controlled trial or longitudinal cohort study.”
The court rejected the FDA’s last-minute change of evidentiary standards. “Many e-cigarette companies relied on the FDA’s repeated insistence that it did ‘not expect that applicants will have to conduct long-term studies to support an application’ and did not perform or submit such evidence,” Judge Oldham wrote.
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If you have a spare 4 hrs
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Wow, I might have to break this down into pieces/parts, but thank you for the share @woftam.
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Thank you Simon.
Following months of debate and wooing extreme members of Congress, the proposed federal excise tax (FET) on nicotine is being added back into the funding bill for President Biden’s so-called Build Back Better plan.
Notably, instead of raising taxes on combustible tobacco products, the new language imposes a new tax on nicotine (synthetic or derived) that is equivalent to the tax on cigarettes ($50.33 per 1,810 milligrams of nicotine).
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If the Build Back Better bill passes with the nicotine tax language, the law would establish a federal tax on vaping products for the first time: $50.33 per 1,810 milligrams of nicotine, or 2.8 cents/mg. It would essentially double or triple the price of most bottled e-liquid, and it would apply to both tobacco-derived and synthetic nicotine.
The price of a 60 milliliter bottle of 12 mg/mL e-liquid would increase by $20. A 30 mL bottle of 50 mg/mL nicotine salts would jump by more than $40. And a liter of 100 mg/mL DIY nicotine—which typically costs less than $100—would increase by $2,780.
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Be aware you may get triggered by the anti position from Mathew Peters
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Not triggered, but for the few minute’s I listened to Peter’s, it sound’s to me as he was reading from the gov’t approved script!
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Ya it is the rhetoric that the AMA (Australian Medical Association) has been spewing out forever.
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I don’t have time to hit it right now @woftam, but thank you, and I WILL.
Some smokers say vaping nicotine has helped them quit cigarettes for good, but how strong is the evidence for the efficacy and long term safety of this approach? Plus a discussion about the way we consider and treat wild animals, and stories of lust, love and loss from war.
Duration: 54min 34sec
Broadcast: Wed 1 Dec 2021, 9:05am
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Too early to crack a beer I think not. This should be good for Australia in general and good for vaping in Australia
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ATTENTION USA MEMBER’S…
Language that would add synthetic nicotine to the FDA’s premarket authorization process may be included in the 2022 Omnibus Budget Bill. In no uncertain terms, this would be a near-immediate ban on vapor and smoke-free products containing synthetic nicotine (like nicotine pouches, toothpicks, etc.).
Please take a moment TODAY and send a message to your federal officials urging them to reject a ban on synthetic nicotine!
This is a must-pass budget bill which is even more urgent due to the inclusion of support for Ukraine.
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Finally, an Australian Politician understands. Well done Sarah Game MLC
I wish you were in Victoria. Thanks also to Colin Mendelsohn for your tireless work
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SARAH GAME MLC has proposed Australia’s first parliamentary bill to correct the flawed prescription-only vaping model.
The Controlled Substances (Nicotine) Amendment Bill 2022 aims to allow adult smokers in South Australia to purchase regulated nicotine supplies for vaping from licensed retail outlets without a prescription,
If passed, this Bill will save thousands of lives and bring South Australia into line with other western countries.
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Keep us in the loop, Simon, as to how, or if this moves through your gov’t.
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