Deeming Regulations have been released!!!!
- Thread starter Oliver
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Yet, this is what FDA put out today:
Youth E-cigarette Use Remains Serious Public Health Concern Amid COVID-19 Pandemic
Youth E-cigarette Use Remains Serious Public Health Concern Amid COVID-19 Pandemic
I wish they'd make up their minds. Actually, they're not gonna be happy until nobody, of any age, is vaping.
New data underscores arbitrary nature of FDA’s recent bans on vaping products
Is this good news for us? All the new regulations were supposedly based upon teen vaping epidemic
- If there is no epidemic and teens are vaping less might this cause the FDA to loosen up and start approving
'some' flavors and products and/or when some of the counter lawsuits by vape manufacturers get to court can't this be used as evidence that the FDA is not acting appropriately in denying all flavors ???
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All of my granddaughter's friends are currently on ISS for bringing vapes to school. One brought CBD. This is not a major city school, I was surprised.
my 14 y/o nephew says none of his mates smoke. But lots vape disposable pods
It should be good news that causes the FDA and state governments to reevaluate their positions on flavors, etc.
Should, but won't. The FDA and state governments have too much invested in the BS they've been peddling. Changes will have to be forced by a court.
We can't even think about a timely FDA PMTA approval.
(So, hey! Let's just Merck 'em and get an EUA.)
Good luck.
(So, hey! Let's just Merck 'em and get an EUA.)
Good luck.
"........The whole process has been unclear from the very beginning,” Wheeler told Filter. “Where we are now shouldn’t be a surprise.”
“The abstinence-only people are acting just like the groups that vigorously opposed pure food laws and science-based pharmaceutical regulations,” he continued. “For them, moralism trumps science. Such people perpetuate the very problems the FDA is set up to address, and the agency needs to be clear about the direction it plans to pursue.”
Vape Advocates and Prohibitionists Temporarily Unite to Slam the FDA
Well there certainly seems there's not enough people in government with this attitude to help us vapers but I got a positive reply from my senator when I wrote asking him to oppose the tobacco tax.
This sentence from his reply really stood out to me.
" In addition, this tax would disproportionately affect nicotine products that have no tobacco content, such as e-cigarettes and nicotine pouches"
This sentence from his reply really stood out to me.
" In addition, this tax would disproportionately affect nicotine products that have no tobacco content, such as e-cigarettes and nicotine pouches"
From Greg Conley's Twitter page:
"SCOOP: Turning Point Brands files emergency motion for a stay and for expedited review in their case pending before the 6th Circuit Court of Appeals."
"This is a quintessential case for staying unlawful administrative action pending judicial review."
Emergency Motion to Stay_TPB Filed.pdf
If the court grants a stay in the case, the FDA would not be able to enforce it's Marketing Denial Orders for TPB.
.
"SCOOP: Turning Point Brands files emergency motion for a stay and for expedited review in their case pending before the 6th Circuit Court of Appeals."
"This is a quintessential case for staying unlawful administrative action pending judicial review."
Emergency Motion to Stay_TPB Filed.pdf
If the court grants a stay in the case, the FDA would not be able to enforce it's Marketing Denial Orders for TPB.
.
From the Motion to Stay...
C The Order Contradicts FDA’s Stated Reasoning
The Order Contradicts FDA’s Stated Reasoning
FDA’s Order also violates the cardinal APA rule that the agency’s
rationale must actually support its decision. Motor Vehicle Mfrs. ...’n of U.S.,
25
Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983). FDA’s
reasoning exclusively focuses on evidentiary requirements for flavored ENDS
products, which FDA defines to exclude “tobacco-flavored” and “menthol”
products. A17 n.2, A19, A21.
Yet FDA is forcing TPB to pull non-flavored products from the market.
FDA’s Order applies to “Authentic Tobacco” and “Bold Tobacco,” yet not
“Classic Tobacco” (which FDA is still considering). Compare A5 and A12,
with A148. Those are the same flavors with the same formulations; they just
use different names across product lines. A147. The same goes for “Ripe
Tobacco” (forbidden) and “Smooth Tobacco” (reprieve), and for “Mint”
(banned) and “Mighty Menthol” (allowed for now). Compare A7 and A13, with
A146 and A148.
It is anyone’s guess why some of these products must exit the market
immediately, yet others might pass muster if FDA actually reviews TPB’s
studies. FDA has allowed competitors to sell similar non-flavored products
while FDA reviews other applications.
---
Seems like if you look up a the Arbitrary-or-Capricious Test for the Administrative Procedure Act (APA) in a Law Dictionary, the above text could be used as a Classic Example.
https://www.foreffectivegov.org/node/2625
C The Order Contradicts FDA’s Stated Reasoning
The Order Contradicts FDA’s Stated Reasoning
FDA’s Order also violates the cardinal APA rule that the agency’s
rationale must actually support its decision. Motor Vehicle Mfrs. ...’n of U.S.,
25
Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983). FDA’s
reasoning exclusively focuses on evidentiary requirements for flavored ENDS
products, which FDA defines to exclude “tobacco-flavored” and “menthol”
products. A17 n.2, A19, A21.
Yet FDA is forcing TPB to pull non-flavored products from the market.
FDA’s Order applies to “Authentic Tobacco” and “Bold Tobacco,” yet not
“Classic Tobacco” (which FDA is still considering). Compare A5 and A12,
with A148. Those are the same flavors with the same formulations; they just
use different names across product lines. A147. The same goes for “Ripe
Tobacco” (forbidden) and “Smooth Tobacco” (reprieve), and for “Mint”
(banned) and “Mighty Menthol” (allowed for now). Compare A7 and A13, with
A146 and A148.
It is anyone’s guess why some of these products must exit the market
immediately, yet others might pass muster if FDA actually reviews TPB’s
studies. FDA has allowed competitors to sell similar non-flavored products
while FDA reviews other applications.
---
Seems like if you look up a the Arbitrary-or-Capricious Test for the Administrative Procedure Act (APA) in a Law Dictionary, the above text could be used as a Classic Example.
https://www.foreffectivegov.org/node/2625
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