FDA Good Video about Deeming, The OMB/OIRA and what You can Do.
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Smoke free radio did this one. This is really for manufactures and venders and it would be not be good for individuals to request a meeting.
That figures. They get to jockey for the best seats on the bus.
When the bus stops for us, standing room only.
Regards
Mike
Really have no idea what you mean by the above.That figures. They get to jockey for the best seats on the bus.
When the bus stops for us, standing room only.
Regards
Mike
Contrary to what Jeff Stier is advocating, individuals going into the OMB office and telling their individual story will do nothing but clog up the process. We really need people who are on top of the game and understand all of the ramifications of the deeming. An individual story is part of it, but there is a lot more that needs to be included. There are only so many meetings that will happen. It would be much better for someone from ProVape or Johnstone Creek to have a meeting then Joe or Jane vaping enthusiast.
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Who's interest do you think Johnson Creek and Provari will be looking out for?
Regards
Mike
It would be a pretty safe bet to say that their interest and the consumers interest have a whole lot of crossover.
I agree with Much of This.
What I would like to see is B&M/Online owners contacting the OMB. I'm not saying that an Individual's views (or Participation) is not Welcome. But at this stage, Business Owners input is more what the OMB is looking for.
I agree with Jeff Stier. The personal stories are the most relevent at this point and may be some science to see how many others are having the same experiences.
And I disagree with this. I'm very worried that the "industry", meaning the juice business and the vape shops are going to sell us down the river when the time comes. What benefits them is bans on DIY and mail order.
I have to assume from what you are saying that you haven't a clue as to what the deeming is about. If it goes as many think it will there will be no industry in the USA, or vape shops. At this point in time there has been no talk of banning internet sales as that would likely fall on congress. I doubt the FDA has it in their authority to do so.
Apparently you think it would be wise for a few hundred vaping enthusiast babbling to the OMB instead of people who have been on the front line of THR advocacy and actual understand the issues, all because of your irrational fear that someone would take away your DIY.
Not to be the Big Black Fly in the Frosting. But Face-2-Face Only sales is a Key Provision of The Family Smoking Prevention and Tobacco Control Act of 2009.
"Calls for new rules to prevent sales except through direct, face-to-face exchanges between a retailer and a consumer."
Family Smoking Prevention and Tobacco Control Act - Wikipedia, the free encyclopedia
And that act was Passed by Congress and then Signed into Law by the President exactly 2 Months after you joined the ECF.
So... Yeah, some of us have been Talking about it.
Before the deeming, banning of internet sales were considered:
FDA Discusses Banning Online Sales of E-Cigarettes
... but rejected as part of the deeming:
Was there any mention of banning internet sales?
No.
The word "internet" only appeared in the document three times, once to indicate explicitly that the FDA was not banning internet sales as part of the deeming regulations. ***
The PACT ACT, a 2009 bill banning the sale of cigarettes online, might have established precedent that Congress must act to ban online sales of tobacco products, although this has not been tested.
Given the FDA's broad authority on tobacco, it's impossible to rule anything out of their control at this moment and it's important to remember that the proposed regulations are foundational.
FDA F.A.Q. | halfwheel
*** From the deeming doc:
The proposed rule also would prohibit the sale of covered tobacco products to
individuals under the age of 18 and prohibit the sale of covered tobacco products using the
assistance of any retail-based electronic or mechanical device (such as a vending machine)
except in facilities where the retailer ensures that no person younger than 18 years of age is
present, or permitted to enter, at any time. This prohibition on sales from electronic or
mechanical devices is not intended to impact the sale of any tobacco product via the Internet.
FDA faq:
3. What is the Center for Tobacco Products (CTP) authorized to do?
The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) allowed FDA to establish CTP and granted CTP the authority to:
- Require tobacco product manufacturers register with FDA
- Establish standards for tobacco products, such as tar and nicotine levels, in an effort to reduce their toxicity and addictiveness
- Establish limits on sale and distribution of tobacco products
- Require premarket review for new and modified risk tobacco products to protect the public health
It appears they have the authorization to do so, but chose not to include it in the original deeming doc - not saying it won't be in the final rule. Or that they wouldn't ask Congress to include ecigs in the PACT ACT... but that would have to be Congress' decision.
I hope you are Right about Face-2-Face sales.
I would be Very Surprised if the Final FDA Version of the OMB Reviewed Rule Set didn't include some amount of No Net Sales.
Oh, I think that's possible. Just filling in what has been discussed earlier and the faqs, authorizations, etc.
BTW - I was poking around in the RIN: 0910-AG38 ...
View Rule
... and was viewing the 79 FR 23142 from April 25th, 2014 ...
http://www.gpo.gov/fdsys/pkg/FR-2014-04-25/pdf/2014-09491.pdf#page=2
... and I couldn't help notice this...
(3) Except as otherwise provided in
§ 1140.16(c)(2)(ii), a retailer may sell
cigarettes or smokeless tobacco only in
a direct, face-to-face exchange without
the assistance of any electronic or
mechanical device (such as a vending machine);
So I looked up 1140.16(c)(2)(ii) ...
21 CFR 1140.16 - Conditions of manufacture, sale, and distribution.
(c) Vending machines, self-service displays, mail-order sales, and other “impersonal” modes of sale.
(1) Except as otherwise provided under this section, a retailer may sell cigarettes and smokeless tobacco only in a direct, face-to-face exchange between the retailer and the consumer. Examples of methods of sale that are not permitted include vending machines and self-service displays.
(2) Exceptions. The following methods of sale are permitted:
(i) Mail-order sales, excluding mail-order redemption of coupons and distribution of free samples through the mail; and
(ii) Vending machines (including vending machines that sell packaged, single cigarettes) and self-service displays that are located in facilities where the retailer ensures that no person younger than 18 years of age is present, or permitted to enter, at any time.
I hope that the Finial version includes (i) instead of just including (ii).
View Rule
... and was viewing the 79 FR 23142 from April 25th, 2014 ...
http://www.gpo.gov/fdsys/pkg/FR-2014-04-25/pdf/2014-09491.pdf#page=2
... and I couldn't help notice this...
(3) Except as otherwise provided in
§ 1140.16(c)(2)(ii), a retailer may sell
cigarettes or smokeless tobacco only in
a direct, face-to-face exchange without
the assistance of any electronic or
mechanical device (such as a vending machine);
So I looked up 1140.16(c)(2)(ii) ...
21 CFR 1140.16 - Conditions of manufacture, sale, and distribution.
(c) Vending machines, self-service displays, mail-order sales, and other “impersonal” modes of sale.
(1) Except as otherwise provided under this section, a retailer may sell cigarettes and smokeless tobacco only in a direct, face-to-face exchange between the retailer and the consumer. Examples of methods of sale that are not permitted include vending machines and self-service displays.
(2) Exceptions. The following methods of sale are permitted:
(i) Mail-order sales, excluding mail-order redemption of coupons and distribution of free samples through the mail; and
(ii) Vending machines (including vending machines that sell packaged, single cigarettes) and self-service displays that are located in facilities where the retailer ensures that no person younger than 18 years of age is present, or permitted to enter, at any time.
I hope that the Finial version includes (i) instead of just including (ii).
The PACT Act specifically states what products it applies to.
And would have to be modified by Congress to include electronic cigarettes.
That is my understanding anyway.
The question now is can the FDA write such requirements directly into their deeming regulations?
I don't think so, but that probably won't stop them from trying.
They are obviously trying to do so with the "intended use" angle which Judge Leon already shot down.
Where is Bill Godshall when you need him?
And would have to be modified by Congress to include electronic cigarettes.
That is my understanding anyway.
The question now is can the FDA write such requirements directly into their deeming regulations?
I don't think so, but that probably won't stop them from trying.
They are obviously trying to do so with the "intended use" angle which Judge Leon already shot down.
Where is Bill Godshall when you need him?
The PACT Act specifically states what products it applies to.
And would have to be modified by Congress to include electronic cigarettes.
That is my understanding anyway.
The question now is can the FDA write such requirements directly into their deeming regulations?
I don't think so, but that probably won't stop them from trying.
They are obviously trying to do so with the "intended use" angle which Judge Leon already shot down.
Where is Bill Godshall when you need him?
Fill me in.
How does the PACT Act Effect or Restrict what the FDA wants to do with regards to Deeming?
Don't know.
But I do know that Bill Godshall has stated that online sales are banned through the PACT Act.
And that what products the PACT Act applies to are specifically delineated in the Act.
And that Congress would have to modify the Act to add additional products.
This wording seems to verify that the FDA does not believe THEY can do it themselves...
But the FDA seems to be taking their own approach to this entire process.
So once again, the courts are where this will be decided if the FDA goes down that road.
The FDA appears to be pretty gung-ho about smashing us to smithereens.
I was under the Impression that the PACT Act was separate to what the FDA is doing right now.
But I could be Wrong.
It sure would be Nice is someone who had Lawyers like SFATA or TVECA or CASAA could outline a few Possible Scenarios of what is Likely to occur.
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