Deeming Regulations have been released!!!!
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Informing Tobacco Regulation through Research
The Importance of Tobacco Research
At CTP, we consider scientific findings in all our activities. Our unique position as a regulatory agency allows for a framework of decision-making based on – and within the limits of -- both the science and the law. Although a vast and sound science base already exists for many areas of the Tobacco Control Act, new research will build upon that robust base of scientific evidence. CTP has identified seven categories of research priorities:
One category is:
- Economics and policy – estimating the economic impact of CTP's regulations; also understanding how CTP's actions change tobacco use and illness and death from tobacco use
Oh, you thought I was joking?
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Just seems that if e-Cigarettes are now "Deemed" to be a Tobacco Product, OK, so lets make All Comparisons to Tobacco Products. In specific: Cigarettes.
Because it is OK to Sell Cigarettes in this country. So shouldn't e-Cigarettes be Benchmarked to Cigarettes?
Remember, these are now tobacco products and as such, you cannot make ANY claim that one tobacco product is less harmful than another without filing, and subsequently being granted approval, an MRTP application.
I still think we as consumers, and possibly our consumer advocacy associations, can still talk about harm reduction. However, if there are any manufacturers associated with said agencies, they could potentially be fined for making health related claims by extension. I'm not even positive if a vendor could allow a customer review that says "this helped me quit smoking" on their website anymore.
Been awhile since I have read it, but I believe Judge Leon made some References to "Customer's Testimonials". And the Exercising of "Anecdotal" comments.
As I recall, he was OK with it. But I could be Wrong.
How does one spell relief now-a-days?
Good. You had me worried for a while there...
I love sarcasm
I think that as long as it can't possibly be interpreted that we're trying to sell
a product we can discuss it's possible health benefits in the same way we can discuss
herbal meds on non commercial sites.. But such discussions on a manufacturer's or retailer's site
would be interpreted as a sales rap even if only done by users/customers.
Like I said b4, don't hold your breath.
BTW, my first IGNORED email was ignored b4 Marco became a viable candidate
for the Rep nomination...Then when he began actually trying to get the nomination
his staff replied to the other 2 emails..probably 'cause they thought
I was a geriatric about to sick AARP on him.
Placebo effect is demonstrable. True it's more psychological.... and some of the dietary supplements are not completely inert and some are prescribed by MD's even. Again, if they didn't work for anyone, they would vanish.
Obama........... and the Millions involved in FDA Drug Administration/Child Protection/Public Health/State Governments and Pre2007 Tobacco Free Trade under the agreement
You know, the ones that stand to Loose Billions in incoming Cash
They cannot force that horse to Drink, but they can make it clear they CAN take away its water source.
https://www.glassdoor.com/Reviews/Employee-Review-FDA-RVW5299970.htm
Interesting read by a former FDA tobacco control employee. It seems, as a lawyer, clerical data entry wasn't exactly what she had in mind when she took the job. She envisioned herself as a noble crusader fighting BT.
This may sound harsh, but she got what she deserved. I'd like to think I could find something better to do with my law degree than snapping up a 9-5 job working at a federal bureaucracy.
Interesting read by a former FDA tobacco control employee. It seems, as a lawyer, clerical data entry wasn't exactly what she had in mind when she took the job. She envisioned herself as a noble crusader fighting BT.
This may sound harsh, but she got what she deserved. I'd like to think I could find something better to do with my law degree than snapping up a 9-5 job working at a federal bureaucracy.
I find myself in the unfortunate position of being more pessimistic than others here...I'm guessing about 40 with roughly 30 Closed Tobacco Flavor and another 4-6 bottled Tobacco Flavor.
I am not sure ANYONE can realistically get a PMTA through the process as it currently stands.
Therefore, I think that a few will be granted by special favor.
It will be fun to watch the tortured language and justifications the FDA uses...
For granting those few, while not granting others.
Assuming, of course, there are any others.
Also, it sounds like Zeller is saying that once you get something through...
It may be easier to get others through by Substantial Equivalence or special exemptions...
I don't see more than a handful of eliquids being available.
And most certainly in the end there will only be "tobacco" flavors, whatever that means.
And none of them will be in a bottle.
EDIT: By the way, I'm starting to wonder if posts should be qualified going forward?
EDIT: Is the underlying assumption of a given post in an HR 2058 world, or deeming as is?
EDIT: My post above was with the underlying assumption of deeming as is.
EDIT: If HR 2058 passes then my post above is null and void.
Setting aside the PMTA/grandfather issue. How many liquid lines out there do you think meet the other standards required to be a manufactured tobacco product?
It seems to me that as a lawyer or as a butcher she should be
neutral and unbiased in a position with any federal agency. But she wanted to harass BT.
The reason the attorney accepted the gig, in her own words;
"This position – and really, most positions at the FDA – lend themselves to a great narrative for future job interviews"
But if you read her cons:"who is your boss? It’s a mystery, with constantly-changing mid-level managers doing musical chairs every couple months." then compare that to her recommendations:
"Shake up middle-managers. Form a positive work culture." you get the gist of just why
the FDA and most of the other federal agencies don't work...
First she complains about musical chairs then she recommends them..
I call it Federal Cha-Cha-Cha...If you've ever danced the cha-cha
you know what I mean. Two steps forward one step back..
Obama........... and the Millions involved in FDA Drug Administration/Child Protection/Public Health/State Governments and Pre2007 Tobacco Free Trade under the agreement
You know, the ones that stand to Loose Billions in incoming Cash
They cannot force that horse to Drink, but they can make it clear they CAN take away its water source.
I could be wrong, but I believe that Hamburg appoint Mr. Zeller.
But Mr. Zeller no longer works for Hamburg. Because I think she is Busy Shredding Documents and Moving Assets to Off-Shore Accounts.
Mr. Zeller should answer to the Deputy Commissioner for The Office of Medical Products and Tobacco. But I think that seat is still Vacant? So I believe he answers directly to Califf.
And Califf answers ultimately to the HHS Secretary, Burwell.
So shouldn't we Also be Blasting our friends Califf and Burwell?
Be my guest...anyone can use it.....This is the type of comment that should be in all the Ron Johnson letters.
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