Deeming Regulations Are In Effect
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Shops are closing in FL because of Deeming, just and FIY
Is the deeming more stringent in Florida ?
There's so much more to running your own business ( and making it successful ) than just having an idea and leasing a building, is everyone cut out for it ?
I have been vaping for over 6 years now. The prices that I got on vape gear just before regs were put into place were the lowest I have ever seen. There will be no new products allowed on the market. Stocking up was a win situation no matter which way this all goes
The "panic" shouldn't be centered around the fda as it should the states that owe the most to the big T lending programs.
LOTS of awesome devices will coming out this year, if your state allows it ....................
I have been vaping for over 6 years now. The prices that I got on vape gear just before regs were put into place were the lowest I have ever seen. There will be no new products allowed on the market. Stocking up was a win situation no matter which way this all goes
I think some signals got crossed during the stocking process. I believe the majority of us did it simply to avoid extra hassle and a declining market. Monday marked the beginning of market contraction so safe than sorry was more the mantra than the sky is falling.
To me it was pretty logical. Gear was easily available and prices were low. Nothing new can come out so holding off for new stuff didn't make sense. High quality nic base was cheaper than at any other time that I've seen for the most part. Since nic base lasts for probably 10+ years in the deep freeze it was an easy decision to take care of the most important part. Same with gear. Most of us have enough to not worry for quite a while. Now we can casually pick up extra stuff as we go while already knowing we're pretty insulated from market disruption.
Lastly, China can get cut off quickly if the Gov wants it to. I don't think they care that much yet but if they want to stop imports they can. I wasn't vaping in 2009 but if I was I would have freaked out a little. I won't say I particularly enjoyed prepared but I'm damn sure glad I did. I think many share the same sentiment.
Another factor about the August 8, 2016, date was that age-identification became required for online sales.
Quite a few online shops now require a scan of drivers licenses. Some even require a selfie of you with your drivers license.
Some people claim that this is exactly like getting carded in a bar. But there's a significant difference. If you're carded in a bar, the barkeep just glances at your license, and that's it. On the other hand, submitting a JPG, with highly private information, to a website that may keep it handy in electronic storage (even if offline) may very well subject you to identity theft. No thanks.
And that was one of my main reasons for stocking up before August 8th.
Quite a few online shops now require a scan of drivers licenses. Some even require a selfie of you with your drivers license.
Some people claim that this is exactly like getting carded in a bar. But there's a significant difference. If you're carded in a bar, the barkeep just glances at your license, and that's it. On the other hand, submitting a JPG, with highly private information, to a website that may keep it handy in electronic storage (even if offline) may very well subject you to identity theft. No thanks.
And that was one of my main reasons for stocking up before August 8th.
I agree, to me that is a real PITA and so glad I don't need anything else
Sure if you are able to find a US vendor willing to ignore the regs and sell the new product. Or you could always order it from China. I don't think that many legit US vendors are going to risk their business and carry products put on the market after 08/08/16. States would not over rule federal.
I could not believe the prices pre 8-8-16 there were bargins everywhere! Easy to buy, no hoops to jump thru, it was greatI have been vaping for over 6 years now. The prices that I got on vape gear just before regs were put into place were the lowest I have ever seen. There will be no new products allowed on the market. Stocking up was a win situation no matter which way this all goes
I could not believe the prices pre 8-8-16 there were bargins everywhere! Easy to buy, no hoops to jump thru, it was great
Yep. And it was fun too! Let the people that want to ridicule us for doing what we felt was right go about their business and do what they feel is right for them. I am willing to bet that we never look back with regret
I agree, so glad I don't have to worry about a thing now. What a relief!Yep. And it was fun too! Let the people that want to ridicule us for doing what we felt was right go about their business and do what they feel is right for them. I am willing to bet that we never look back with regret
I'm thinking your not aware of all the new devices that were sold ( as one item ) on or before the 8th with a receipt and then held back for later releases, in which they could have up to 3 years to sell ( legally ) these are very savvy corporate business minded multi million dollar company's in it for the long haul.Maybe a little googleing of all the youtube reviewers that just made large investments in developing there own new devices / juice line ( with very well paid lawyers ) just recently, could they all be that naive to think they couldn't market them "legally" here anymore ? your going to be seeing some pretty awesome stuff coming out within the next few months
Heh, unless I missed this page before the FDA just posted its FAQ section. I don't remember seeing anything with specific details like this.
Commonly Asked Questions: About the Center for Tobacco Products
I'm interested in this one. Is it truthful or just a way to temporarily put out some fires?
"
What are the costs associated with submitting an application?
The costs associated with submitting an application to market a tobacco product can vary greatly and depend on a number of factors, such as the pathway to market being applied for, the type of tobacco product and the availability of data on the specific product or other similar products. Generally, high costs may come from needing to conduct original research and testing to inform the application, as well as staff time spent compiling it. For further information on the different premarket pathways, please refer to the Tobacco Product Review & Evaluation webpage.
On page 94 (Table 14) of the "deeming" Regulatory Impact Analysis (RIA), the FDA has estimated the average cost for each premarket review pathway for newly regulated tobacco products to be:
Recognizing that some of the costs associated with this process may be challenging to small businesses, the FDA is taking several steps to ease this process. Those steps include:
Commonly Asked Questions: About the Center for Tobacco Products
I'm interested in this one. Is it truthful or just a way to temporarily put out some fires?
"
What are the costs associated with submitting an application?
The costs associated with submitting an application to market a tobacco product can vary greatly and depend on a number of factors, such as the pathway to market being applied for, the type of tobacco product and the availability of data on the specific product or other similar products. Generally, high costs may come from needing to conduct original research and testing to inform the application, as well as staff time spent compiling it. For further information on the different premarket pathways, please refer to the Tobacco Product Review & Evaluation webpage.
On page 94 (Table 14) of the "deeming" Regulatory Impact Analysis (RIA), the FDA has estimated the average cost for each premarket review pathway for newly regulated tobacco products to be:
- an SE exemption report = around $1,500
- an SE report = anywhere from around $3,500 to around $22,700
- a premarket tobacco application (PMTA) = in the low to mid hundreds of thousands of dollars (around $117,000 to around $466,000), not in the millions of dollars described by some others
Recognizing that some of the costs associated with this process may be challenging to small businesses, the FDA is taking several steps to ease this process. Those steps include:
- issuing final guidance on Tobacco Product Master Files (which can help applicants use existing information, rather than developing their own, when submitting premarket applications),
- issuing draft guidance on submitting PMTAs for ENDS products (which, when final, will reflect the agency's current thinking on what information the FDA recommends an applicant submits and how the FDA intends to review PMTAs),
- issuing two Small Entity Compliance Guides for deeming and user fees,
- revising and updating several other previously issued guidances to include the newly-regulated products,
- posting training videos and live webinars to the website to assist industry, and
- providing a final "deeming" rule web hub to help industry navigate the new regulations."
I love this one:
"Is the FDA banning e-cigarettes?
No, the FDA has not banned any class of tobacco products, including e-cigarettes. We expect that many products will remain on the market while manufacturers apply for authorization to market their products."
Yea, they aren't banning anything yet. That will come later when they deny 90+% of all PMTA's submitted.
"Is the FDA banning e-cigarettes?
No, the FDA has not banned any class of tobacco products, including e-cigarettes. We expect that many products will remain on the market while manufacturers apply for authorization to market their products."
Yea, they aren't banning anything yet. That will come later when they deny 90+% of all PMTA's submitted.
Yeah, that's a fairly recent addition. The estimate of "millions" is based on the estimate that each PMTA could be(in their estimate) $500,000 and the fact that most vapor products come in sets, i.e. 1 liquid/flavor in 0mg, 3mg, 6mg, 12mg is four applications, estimated at $2M total, and that's ignoring various PG/VG ratios.
Of course, much of that will depend on this:
Of course, much of that will depend on this:
Some pmt's will actually have 3 years ..................
You have to file within the next 24 months. If you have a PMTA pending by 8/whatever/2018, you may continue to sell for an additional 12 months until either approved or remove immediately from the market if denied. So you only get 3 years if you file a completed PMTA with all the attendant costs within the first 2 years, and are still waiting for an answer.
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