Deeming Regulations have been released!!!!
- Thread starter Oliver
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While nicotine keeps smokers addicted, it’s the smoke and the 7,000 chemicals contained in it that causes the disease and death.
At least it is being acknowledged.
This could also include products such as electronic nicotine delivery systems like electronic cigarettes, but which would need to be proven safe and effective for smoking cessation and regulated as a drug product.
The stranglehold begins......
This is different from our regulation of e-cigarettes as tobacco products.
But what the hell does this mean?
At least it is being acknowledged.
This could also include products such as electronic nicotine delivery systems like electronic cigarettes, but which would need to be proven safe and effective for smoking cessation and regulated as a drug product.
The stranglehold begins......
This is different from our regulation of e-cigarettes as tobacco products.
But what the hell does this mean?
They will sell you a pen vape at an inflated price provided by their buddies at CVS.
I HATE that font color. I use the dark theme and it's almost unreadable unless I highlight it.
Well as long as it's regulated as an OTC drug and the same companies are still allowed to make and sell their products, it might not be too terribly bad. If they make it Prescription only (which would be dumb AF considering none of the other NRT's are prescription only) and/or only allow Big Pharma and Big Tobacco do the manufacturing, then it's going to suck horribly for anyone not prepared for the vapocalypse.
after you spend $300+ for the 15 min Dr office visit...
and you get a 30 day supply...have to return for a new script
It almost sounds like they are going to do both, the Deeming, and Pharma route??
With the Pharma route as an option, they could get away with being strict on the Deeming.
I predicted awhile ago that vaping could possibly be limited to prescription use only. That opinion wasn’t seriously received.
I don't see that happing anytime soon. At least Not under the Authority of the FSTCA.
The Tobacco Control Act does not:
The law makes clear that FDA's role is to regulate and protect the public health, but it places a few restrictions on FDA's powers. FDA cannot:
- Require prescriptions to purchase tobacco products.
- Require the reduction of nicotine yields to zero.
- Ban face-to-face sales in a particular category of retail outlets.
- Ban certain classes of tobacco products.
If they somehow reclassify vaping (period) as a drug/treatment for smoking cessation, any/every product would have to go through clinical trials for efficacy and safety and probably other serious and costly hurdles ... and would be bad news indeed.
A more hopeful reading would be that he means that in addition to the current situation with vaping products being under a tobacco product classification, products could also be introduced as official smoking cessation "treatments/drugs/therapy" under FDA drug regulations.
A more hopeful reading would be that he means that in addition to the current situation with vaping products being under a tobacco product classification, products could also be introduced as official smoking cessation "treatments/drugs/therapy" under FDA drug regulations.
The Guidelines they released today would keep all but the big boys out of the OTC route. The clinical trials required would be onerous in terms of cost.
The 1st Part is a Possibility. Especially after 2020.
The 2nd Part, with regards to making e-Cigarettes Prescription Only without New Legislation from Congress, that would be a Very Tough Sale in Federal Court. Even with a Judge that leans heavily of Judicial Deference.
You give our judiciary more integrity than I do. But yes, it should be a tough sell (if not impossible).
What should be Alarming is when Laws are Vague enough, or when New Legislation hasn't kept pace with Markets/Society that Judges need to Extend as much Judicial Deference as many Judges feel that Should/Have to/Can.
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I think it would be Interesting to Step Back for a Moment and consider How Viable a prescription e-Cigarette would be as a Drug Deliver System (DDS) while Co-Existing in parallel to e-Cigarettes as Tobacco Products in the Tobacco Product Market?
Because is that what Our FDA Commissionaire is advocating as a Possibility?
Or is Scott attempting to Open a Legislative door which would provide a Solution to His Epidemic?
Or, perhaps, something else?
If big BT/BP gets into the OTC business, they will have motivation to squeeze vape shops out of the market.
Now, we have an opportunity to build on these NRTs, with novel products that may provide an opportunity to save even more lives by empowering adults to safely and effectively quit smoking.
Yo, Scott, those novel products already exist. They were invented in 2003, hit the market 10-12 years ago, and have been improved and refined ever since.
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