Deeming Regulations have been released!!!!
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This just in from VTA--sorry, folks.
FDA Says It Will NOT Extend September 9 Deadline: Late on Friday afternoon, we received an e-mail from FDA, responding to our request for an extension of the PMTA deadline, saying that FDA will not extend the September 9 deadline. The FDA wrote, in part:
"Dear Mr. Abbound [sic]: Thank you for contacting the U.S. Food and Drug Administration’s (FDA’s or the Agency) Center for tobacco Products (CTP) to request an additional extension of the premarket application deadline on behalf of your members with deemed new tobacco products. […]
FDA has received many individual requests for a further extension of the September 9, 2020, premarket application deadline. After considering your request, FDA has determined that it will not grant a further extension of the September 9, 2020, premarket application deadline set by the Court for members’ products. Any additional delay would impede FDA’s critical public health priority to promptly require submission of premarket tobacco applications.”
Important Guidance for Companies Filing Applications: In the email, FDA went on to explain that it “intends to prioritize enforcement decisions on a case-by-case basis such as prioritizing enforcement based on the likelihood of youth use or initiation. However, FDA intends to take individual circumstances into account as it considers your members’ premarket tobacco product applications that are submitted by the September 9, 2020, deadline.”
Because FDA is making decisions on a case-by-case basis, it is imperative that you make your specific case if, for example, there are certain elements that may be incomplete in your application. Specifically, FDA said: “FDA encourages your members to explicitly identify any content that may be missing from an application and clearly explain how COVID-19, a recent natural disaster, or other unforeseen circumstance has affected ability to provide such information.”
Also, FDA has said that it will work with companies to get their applications through the process during the 12-month review period under certain circumstances: FDA wrote: “If an application is sufficient to be accepted, filed, and proceed to scientific review and, during such review, your member would subsequently provide the needed information and make substantial progress toward addressing deficiencies in an application, we intend to take that into account in deciding whether to initiate enforcement action against products for being on the market without premarket authorization, even where FDA is reviewing applications after September 9, 2021. The decision as to whether to enforce after the one-year review period may take into account responsiveness to our requests, the particular nature and extent of scientific evidence that is lacking, and evidence of demonstrated hardship due to the COVID-19 pandemic, recent natural disasters, or other unforeseen circumstance in obtaining such evidence.”
In addition to extending the deadline, VTA has encouraged FDA to work with companies as they navigate the process. Last Friday's email sends the message that, while they are not moving the deadline further, they are planning to take into account each companies’ special circumstances.
Today, FDA published another statement regarding upcoming PMTA submissions. The “Perspectives” piece published today by FDA today covers a number of topics. Here are the most relevant:
FDA Expects a Large Number of Applications and the One Year Review Timeline May Be Exceeded. FDA acknowledged “there are over 400 million deemed products listed with FDA. Even if applications are submitted for only a portion of those products, the likelihood of FDA reviewing all of these applications during the one-year review period is low, given that this would be an unprecedented number of applications and several orders of magnitude greater than anything the Agency has experienced.” […] Depending on the number of new applications we receive by the deadline—which could be anywhere from a few hundreds of thousands to millions—as a matter of practicality we may not be able to fully complete review of all tobacco product applications that we receive by Sept. 9, 2020 within the year.”
FDA Will Work With Companies By Sending Deficiency Letters: “Further, although we expect high quality and complete applications to come in by Sept. 9, if we do find deficiencies, it is likely FDA will issue a Deficiency Letter with a 90-day deadline for companies to respond.” Giving companies an opportunity to cure deficiencies in their applications, rather than simply rejecting the application, is something we have encouraged FDA to do.
FDA Says It Will Devote Resources to Expedite Review for both Small and Large Manufacturer Applications: Director Zeller wrote, “As always, FDA intends to be fair in allocating FDA resources to review applications from both small and large manufacturers and importers, and from applications received through different pathways. Additionally, we intend to maximize the resources that we have to review the most products in the shortest timeframe—with the above guiding principles in mind. To help with this, we are refining our review processes to shorten the overall review time."
FDA Says It Will NOT Extend September 9 Deadline: Late on Friday afternoon, we received an e-mail from FDA, responding to our request for an extension of the PMTA deadline, saying that FDA will not extend the September 9 deadline. The FDA wrote, in part:
"Dear Mr. Abbound [sic]: Thank you for contacting the U.S. Food and Drug Administration’s (FDA’s or the Agency) Center for tobacco Products (CTP) to request an additional extension of the premarket application deadline on behalf of your members with deemed new tobacco products. […]
FDA has received many individual requests for a further extension of the September 9, 2020, premarket application deadline. After considering your request, FDA has determined that it will not grant a further extension of the September 9, 2020, premarket application deadline set by the Court for members’ products. Any additional delay would impede FDA’s critical public health priority to promptly require submission of premarket tobacco applications.”
Important Guidance for Companies Filing Applications: In the email, FDA went on to explain that it “intends to prioritize enforcement decisions on a case-by-case basis such as prioritizing enforcement based on the likelihood of youth use or initiation. However, FDA intends to take individual circumstances into account as it considers your members’ premarket tobacco product applications that are submitted by the September 9, 2020, deadline.”
Because FDA is making decisions on a case-by-case basis, it is imperative that you make your specific case if, for example, there are certain elements that may be incomplete in your application. Specifically, FDA said: “FDA encourages your members to explicitly identify any content that may be missing from an application and clearly explain how COVID-19, a recent natural disaster, or other unforeseen circumstance has affected ability to provide such information.”
Also, FDA has said that it will work with companies to get their applications through the process during the 12-month review period under certain circumstances: FDA wrote: “If an application is sufficient to be accepted, filed, and proceed to scientific review and, during such review, your member would subsequently provide the needed information and make substantial progress toward addressing deficiencies in an application, we intend to take that into account in deciding whether to initiate enforcement action against products for being on the market without premarket authorization, even where FDA is reviewing applications after September 9, 2021. The decision as to whether to enforce after the one-year review period may take into account responsiveness to our requests, the particular nature and extent of scientific evidence that is lacking, and evidence of demonstrated hardship due to the COVID-19 pandemic, recent natural disasters, or other unforeseen circumstance in obtaining such evidence.”
In addition to extending the deadline, VTA has encouraged FDA to work with companies as they navigate the process. Last Friday's email sends the message that, while they are not moving the deadline further, they are planning to take into account each companies’ special circumstances.
Today, FDA published another statement regarding upcoming PMTA submissions. The “Perspectives” piece published today by FDA today covers a number of topics. Here are the most relevant:
FDA Expects a Large Number of Applications and the One Year Review Timeline May Be Exceeded. FDA acknowledged “there are over 400 million deemed products listed with FDA. Even if applications are submitted for only a portion of those products, the likelihood of FDA reviewing all of these applications during the one-year review period is low, given that this would be an unprecedented number of applications and several orders of magnitude greater than anything the Agency has experienced.” […] Depending on the number of new applications we receive by the deadline—which could be anywhere from a few hundreds of thousands to millions—as a matter of practicality we may not be able to fully complete review of all tobacco product applications that we receive by Sept. 9, 2020 within the year.”
FDA Will Work With Companies By Sending Deficiency Letters: “Further, although we expect high quality and complete applications to come in by Sept. 9, if we do find deficiencies, it is likely FDA will issue a Deficiency Letter with a 90-day deadline for companies to respond.” Giving companies an opportunity to cure deficiencies in their applications, rather than simply rejecting the application, is something we have encouraged FDA to do.
FDA Says It Will Devote Resources to Expedite Review for both Small and Large Manufacturer Applications: Director Zeller wrote, “As always, FDA intends to be fair in allocating FDA resources to review applications from both small and large manufacturers and importers, and from applications received through different pathways. Additionally, we intend to maximize the resources that we have to review the most products in the shortest timeframe—with the above guiding principles in mind. To help with this, we are refining our review processes to shorten the overall review time."
But wait, there's more:
Many of our retailers are asking about what they can expect and what they should do regarding the upcoming PMTA deadline. Here’s a quick update on FDA planned actions that affect retailers.
Will There Be a Sell-Through Period After September 9, 2020? No. Unlike with prior regulations for which FDA has permitted a “sell-through” period allowing the continued sale of non-compliant products (i.e., non-compliant labels), there will be no sell-through period allowed for non-compliant products after September 9, 2020. In other words, if a product SKU is not covered by a PMTA that has been accepted for review by the FDA, or if a manufacturer has simply failed to file any PMTA, those products cannot continue to be legally sold after September 9, 2020.
So What Happens on September 10, 2020? In the past, FDA has focused its initial enforcement activity around manufacturers and importers rather than at the distributor and retail levels of the supply chain as this is the most efficient use of its limited enforcement resources. Importantly, it will take FDA some time to compile a list of those products for which it has received PMTAs in order to begin its enforcement activity.
FDA to Publish PMTA List: Last month, VTA made a specific request to the FDA that it change its prior practice and publish a list of the products covered by PMTAs so that retailers and distributors have a clear understanding of the specific products (not just brands or manufacturers) for which FDA has received an application. Today, FDA announced, “In addition, we plan to make publicly available a list of the deemed new tobacco products that are subject to the Sept. 9 deadline, were on the market as of Aug. 8, 2016, and for which a premarket application is submitted by Sept. 9, 2020.” FDA will do this while also respecting the confidentiality requirements under the Federal Food, Drug and Cosmetic Act. FDA also noted that while the deadline is on September 9, 2020, it will take FDA some time for them to compile and confirm that their list is accurate before publication. The fact that FDA will be publishing such a list is dramatic change from their prior practice. In the meantime, we will do our best to inform you of VTA members which are participating in the process.
FDA Has Suspended In-Person Inspections: In March, due to COVID-19, FDA issued a partial stop-work order instructing all of the agencies with which it contracts at the state level to stop doing compliance checks and vape shop inspections. This suspension of in-person retail enforcement activity is likely to continue until COVID-19 restrictions begin to lift, but FDA has stated it plans to continue its monitoring of social media, websites and publications and will issue warning letters when needed.
FDA Will Continue Its Enforcement Priorities: In February 2020, and more recently the FDA outlined and reiterated its enforcement priorities. FDA will continue to focus its enforcement efforts on:
Many of our retailers are asking about what they can expect and what they should do regarding the upcoming PMTA deadline. Here’s a quick update on FDA planned actions that affect retailers.
Will There Be a Sell-Through Period After September 9, 2020? No. Unlike with prior regulations for which FDA has permitted a “sell-through” period allowing the continued sale of non-compliant products (i.e., non-compliant labels), there will be no sell-through period allowed for non-compliant products after September 9, 2020. In other words, if a product SKU is not covered by a PMTA that has been accepted for review by the FDA, or if a manufacturer has simply failed to file any PMTA, those products cannot continue to be legally sold after September 9, 2020.
So What Happens on September 10, 2020? In the past, FDA has focused its initial enforcement activity around manufacturers and importers rather than at the distributor and retail levels of the supply chain as this is the most efficient use of its limited enforcement resources. Importantly, it will take FDA some time to compile a list of those products for which it has received PMTAs in order to begin its enforcement activity.
FDA to Publish PMTA List: Last month, VTA made a specific request to the FDA that it change its prior practice and publish a list of the products covered by PMTAs so that retailers and distributors have a clear understanding of the specific products (not just brands or manufacturers) for which FDA has received an application. Today, FDA announced, “In addition, we plan to make publicly available a list of the deemed new tobacco products that are subject to the Sept. 9 deadline, were on the market as of Aug. 8, 2016, and for which a premarket application is submitted by Sept. 9, 2020.” FDA will do this while also respecting the confidentiality requirements under the Federal Food, Drug and Cosmetic Act. FDA also noted that while the deadline is on September 9, 2020, it will take FDA some time for them to compile and confirm that their list is accurate before publication. The fact that FDA will be publishing such a list is dramatic change from their prior practice. In the meantime, we will do our best to inform you of VTA members which are participating in the process.
FDA Has Suspended In-Person Inspections: In March, due to COVID-19, FDA issued a partial stop-work order instructing all of the agencies with which it contracts at the state level to stop doing compliance checks and vape shop inspections. This suspension of in-person retail enforcement activity is likely to continue until COVID-19 restrictions begin to lift, but FDA has stated it plans to continue its monitoring of social media, websites and publications and will issue warning letters when needed.
FDA Will Continue Its Enforcement Priorities: In February 2020, and more recently the FDA outlined and reiterated its enforcement priorities. FDA will continue to focus its enforcement efforts on:
- Flavored cartridge-based ENDS products.
- All other ENDS products for which the manufacturer has failed/fails to take adequate measures to prevent access or use by minors.
- Any ENDS products that are targeted to minors or which are likely to promote use by minors.
- Manufacturers which have not filed PMTAs on or by September 9, 2020.
Thank You for post all this from VTA Katya.
At this point, the above is Probably the Best we could have Realistically hoped for.
At this point, the above is Probably the Best we could have Realistically hoped for.
At this point, we're screwed.
Well the great thing is the PMTA doesn't affect what you own, so we're safe there. It also doesn't affect sales outside of America. So purchasing outside of the US should continue to be without a problem. But it is a huge burden on sales within the country.
Bill, how certain are we that this is true? That the Deeming doesn't affect sales from China or Europe?
My heart breaks for the vaping industry in our country. .......s.
Well there are some technical legal loopholes open. Hardware will be legal to sell, if they are to be intended to be used with 0% nic juice and/or CBD e-liquid (don't ever vape CBD oil, that could kill you). As long as the shop doesn't also sell any tobacco nicotine, they should be technically legal.
The FDA used to say that nicotine from other sources like vegetables, synthetic, etc. are also tobacco products too, but they have since backed off. So nicotine from non-tobacco sources currently appears to be also PMTA exempt.
Oddly enough, all of this is out on the edge. For example, if you manufacture an e-juice flavor in say 0, 3, 6, and 12mg. They all require a PMTA, even the 0mg one. How strange, eh?
The FDA used to say that nicotine from other sources like vegetables, synthetic, etc. are also tobacco products too, but they have since backed off. So nicotine from non-tobacco sources currently appears to be also PMTA exempt.
Oddly enough, all of this is out on the edge. For example, if you manufacture an e-juice flavor in say 0, 3, 6, and 12mg. They all require a PMTA, even the 0mg one. How strange, eh?
Bill, how certain are we that this is true? That the Deeming doesn't affect sales from China or Europe?
My heart breaks for the vaping industry in our country. .......s.
The FDA has no authority outside of the US and no authority over personal use. So as it stands right now, the FDA has nothing to do with this. But it doesn't stop local or Federal laws being created to ban such products.
Are you sure of this? Liquid Nicotine Wholesalers is introducing synthetic nicotine. I wonder how this would be affected by the nicotine tax bill?
That is what I heard was current just a few days ago. But this doesn't mean synthetic nicotine won't be taxed. They could tax water if they wanted to. That has nothing to do with the PMTA.
So at least nicotine will be available in some form after the Deeming, but it might be taxed to Hades and back, right?
Of course it will be illegal to buy/import illegal vape products from from china.
Let's be realistic here. If it were that easy they would not bother with all this nonsense. This is too big a burden for the FDA to take on for such a huge effort to be wasted over silly, simple loopholes like "hey, just buy it from china, it's all good" lol.
Let's be realistic here. If it were that easy they would not bother with all this nonsense. This is too big a burden for the FDA to take on for such a huge effort to be wasted over silly, simple loopholes like "hey, just buy it from china, it's all good" lol.
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The FDA has no authority outside of the US and no authority over personal use. So as it stands right now, the FDA has nothing to do with this. But it doesn't stop local or Federal laws being created to ban such products.
When a product is deemed illegal to sell in the USA, the US govt has the authority to restrict it's importation. It's always been that way and it ain't gonna change.
ETA: The products are going to become illegal to sell (and therefore buy) on Sept 9 under the guise of public safety, so it would make no sense that they would allow the importation of said illegal products when other illegal products are banned/restricted for importation.
ETA2: It doesn't matter if the FDA themselves are not the ones who are going to restrict importation. There are other agencies that are commissioned for that purpose. Who or which agency is responsible for the enforcement is irrelevant.
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The last I read the FDA had synthetic nicotine covered in the PMTA.
If not congress would jump in and give them the authority to regulate it.
I don't think they would let the kiddies carry on getting a buzz on synthetic nic.
If not congress would jump in and give them the authority to regulate it.
I don't think they would let the kiddies carry on getting a buzz on synthetic nic.
Except that today I noticed that FT has a "discreet packaging" option. I wonder what that means? Customs can intercept large shipments meant for vendors and resellers, and that's who the FDA intends to target first. However, there's no way they can stop every FT package from China. They are relying on these Chinese companies to comply. Will they?
They've had that for years. It doesn't matter because I have never received a package from Fasttech that had a return address that revealed Fasttech as the retailer or what products were actually inside the package.
I think it's either a gimmick or it has a purpose for other countries outside the USA. I have clicked that option a few times and I saw no difference on the package, the return address or the customs form as opposed to times I didn't click it.
Uh.... yes. Any scheduled products and I would LOVE to know how nicotine is going to be scheduled, while tobacco, which is legal is going to be unscheduled? Well anything illegal here you take your life in your hands importing it let me tell you.
The last time I did it I had a lot to gain and a lot to lose a LOT. It was worth it to me enough that I probably know more about that thing, its history in the US, how to get it iin safely/unsafely and how to use it than ANYONE on earth with access to the internet. I literally RAN out of things to read.
sti
Don't even ask. I'm sure there is a statute of limitations but I do NOT want to have to go back and look it up. LOL. Worked as intended and work every tiny molecule.
There is WAY more at stake than what I imported I promise. This is just the beginning.
Oh well since like, less than 10K without preexisting conditions died, well, more will be to follow from all our friendly Federal Health agencies. Perhaps. I am pretty sure the CDC info is not really being widely publicized.
I am super glad (sort of by chance, a few things happened all smushed together) that my last Vape Purchase, the Lost Vape Centurion will be my last legal, non deemed vape. A lovely end to a very necessary beginning.
NECESSARY AS IN I WAS GONNA DIE IN MY MID FIFTIES IN AWFUL HORRIFIC PAIN THANK YOU SO MUCH FDA.
Also glad I got two Ages Maxes at the last minute.
But that is all, folks.
Anna
The last time I did it I had a lot to gain and a lot to lose a LOT. It was worth it to me enough that I probably know more about that thing, its history in the US, how to get it iin safely/unsafely and how to use it than ANYONE on earth with access to the internet. I literally RAN out of things to read.
sti
Don't even ask. I'm sure there is a statute of limitations but I do NOT want to have to go back and look it up. LOL. Worked as intended and work every tiny molecule.
There is WAY more at stake than what I imported I promise. This is just the beginning.
Oh well since like, less than 10K without preexisting conditions died, well, more will be to follow from all our friendly Federal Health agencies. Perhaps. I am pretty sure the CDC info is not really being widely publicized.
I am super glad (sort of by chance, a few things happened all smushed together) that my last Vape Purchase, the Lost Vape Centurion will be my last legal, non deemed vape. A lovely end to a very necessary beginning.
NECESSARY AS IN I WAS GONNA DIE IN MY MID FIFTIES IN AWFUL HORRIFIC PAIN THANK YOU SO MUCH FDA.
Also glad I got two Ages Maxes at the last minute.
But that is all, folks.
Anna
However, realize that when vape products become illegal, while it will be illegal to import the products, you will not likely go to jail or even get a fine for importain small orders. As long as the order is under $800 and you have a diversity of different skus (meaning you are not likely deemed a reseller), they will destroy the package (aka send it to Jim Bob who will resell it to Janakiramani who will sell it in some small country for a huge profit), send you a letter telling you that and then you have to deal with either losing your money or trying to get it back from the retailer.
There is currently no law importing anything vape related. I could order parts all over the world, assemble them into a complete working AIO and use it myself or ship millions of them for sale outside of the country. It's all currently legal.
Local or Federal laws could be created to ban such devices, but the FDA currently has no such authority and not subject under the PMTA if purchased outside of the country.
This is true. So far there are none.
Yeah... We are.
But this is One Time that the Glacieratic Pace of government will be a small Ray of Light.
Because the FDA is being Deluded with paperwork. And it will take the awhile to Figure Out what is what. So at Least it Won't be like Failing Off a Cliff. More Like Rolling down a Steep Hill.
But this will Also buy some Time to those who have No Clue what is Going On. And Many Retailers are just going to Sell until the Warning Letter(s) hit.
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