PMTA Updates

[Hooked]

If you come across any articles re PMTA please post in this thread and I will add the company to the summary.

SUMMARY (in alphabetical order)

Air Factory – submitted (Post #24)
Adirondack - intended to submit – unknown if it has been done (Post #24)
Alice in Vapeland - intended to submit – unknown if it has been done (Post #24)
AMV Holdings - accepted for review (first product) (Post #20)
Aspire - intended to submit – unknown if it has been done (Post #24)
Avail - accepted for review (Post #6), #24
Bad Drip – first phase accepted (Post #24)
Barista Brew Co. - intended to submit – unknown if it has been done (Post #24)
Baton - submitted (Post #24)
Bead Vape - submitted (Post #24)
Bird E-Liquid - intended to submit – unknown if it has been done (Post #24)
Big Tobacco - accepted for review (Post #12)
Blue Dot – not submitting (Post #24)
BLVK - intended to submit – unknown if it has been done (Post #24)
BRWD (Daddy’s Vapor) - intended to submit – unknown if it has been done (Post #24)
Camelot - submitted (Post #24)
Candy King (Dripmore) – submitted (Post #24)
Charlies' Chalk Dust - submitted (Post #17)
Cloud Nurdz - intended to submit – unknown if it has been done (Post #24)
Cloud Provisions - submitted (Post #24)
Cookie King (Dripmore) – submitted (Post #24)
Cthulhu Mods – not submitting (Post #24)
Cyber Liquids - intended to submit – unknown if it has been done (Post #24)
Daddy’s Vapor (FRYD, BRWD, Twist, Pop Clouds, Jam It (and others) - intended to submit – unknown if it has been done (Post #24)
Decent - submitted (Post #24)
De-Ja e-liquids - DENIED (Post #34)
Dinner Lady - submitted (Post #24)
Dominant Vapor - intended to submit – unknown if it has been done (Post #24)
Dotmod - submitted (Post #24)
Dripmore (Candy King/Cookie King/Milk King/Tobacco King/Tropic King) - submitted (Post #24)
E-Alternative Solutions (Leap) - submitted (Post #14)
ECBlend - submitted (Post #24)
Element - submitted (Post #24)
ELiquidy - intended to submit – unknown if it has been done (Post #24)
Freeman Vape Juice – not submitting (Post #24)
FreeMax - intended to submit – unknown if it has been done (Post #24)
FRYD (Daddy’s Vapor) - intended to submit – unknown if it has been done (Post #24)
Geekvape - intended to submit – unknown if it has been done (Post #24)
Glas - intended to submit – unknown if it has been done (Post #24)
Gost - submitted (Post #24)
Gothic Vapor - submitted (Post #24)
Great American Vapes - DENIED (Post #33)
Halo - submitted (Post #24)
Hometown Hero - intended to submit – unknown if it has been done (Post #24)
Humble - submitted (Post #24)
Ideal Elixirs - DENIED )Post #34)
Imperial Brands (myblu) - submitted (Post #14)
Innavape - intended to submit – unknown if it has been done (Post #24)
Innokin - submitted (Post #24)
Innovated Vapors - submitted (Post #24)
Jam It (Daddy’s Vapor) - intended to submit – unknown if it has been done (Post #24)
Jam Monster - intended to submit – unknown if it has been done (Post #24)
Japan Tobacco (Logic e-cigs) - submitted (Post #14)
Jay Shore Liquids - submitted (Post #24)
JD Nova Group - DENIED (Post #33)
JVapes Keep it 100 - intended to submit – unknown if it has been done (Post #24)
Juul - accepted for review (Post#12, #24)
Kai’s Virgin Vapor - intended to submit – unknown if it has been done (Post #24)
Keep it 100 - intended to submit – unknown if it has been done (Post #24)
Kidney Puncher - submitted (Post #24)
Kilo - intended to submit – unknown if it has been done (Post #24)
Kite in Cloud - intended to submit – unknown if it has been done (Post #24)
Level Up Vapor – not submitting (Post #24)
Liquid Labs (Keep it 100) - intended to submit – unknown if it has been done (Post #24)
Marlin Steam Co. - submitted (Post #24)
Mighty Vapors - intended to submit – unknown if it has been done (Post #24)
Milk King (Dripmore) – submitted (Post #24)
Mi-pod - intended to submit – unknown if it has been done (Post #24)
Mister E-Liquid - submitted (Post #24)
Mom and Pop Vapor Shop - submitted (Post #24)
Mt Baker - intended to submit – unknown if it has been done (Post #24)
Naked 100 (USA Vape Labs) - intended to submit – unknown if it has been done (Post #24)
Nicopure Labs (Halo) - First phase accepted. Through to second phase (scientific review) (Post #15)
NicVape – not submitting (Post #24)
Oasis - submitted (Post #24)
One Hit - submitted (Post #24)
Phillip Morris - IQOS - APPROVED (Post #14)
Phillip Morris - Heatsticks: 3 flavours APPROVED (Post #14)
Pod Juice - submitted (Post #24)
Pop Clouds (Daddy’s Vapor) - intended to submit – unknown if it has been done (Post #24)
Primus Vape Co. - intended to submit – unknown if it has been done (Post #24)
Prism – 19 flavours submitted; so far 3 accepted for first phase (Post #24)
Prophet - submitted (Post #24)
Propogand E-liquids - intended to submit – unknown if it has been done (Post #24)
Pufflabs - submitted (Post #24)
Redwood - intended to submit – unknown if it has been done (Post #24)
Reynolds American - submitted (Post #16)
Riot Squad - intended to submit – unknown if it has been done (Post #24)
Ripe Vapes - submitted (Post #24)
Royal Distro (Caterpillar, British Vapir) - intended to submit – unknown if it has been done (Post #24)
Ruthless - submitted (Post #24)
Sabor Vapors - submitted (Post #24)
Sadboy E-liquid - intended to submit – unknown if it has been done (Post #24)
Savage - submitted (Post #24)
SC Vapors - submitted (Post #24)
Shijn Vapor - intended to submit – unknown if it has been done (Post #24)
Silverback - submitted (Post #24)
SMAX - submitted (Post #24)
SMOK - submitted (Post #24)
SMPL E-juice - submitted (Post #24)
Solace - submitted (Post #24)
Stash E-liquids – not submitting (Post #24)
Streamline Vape Co. - intended to submit – unknown if it has been done (Post #24)
Stronghold Vapery - DENIED (Post #34)
Suicide Bunny - intended to submit – unknown if it has been done (Post #24)
Suorin – first phase accepted (Post #24)
TBD E-Liquid (Uwell Caliburn) - intended to submit – unknown if it has been done (Post #24)
The Sauce LA - intended to submit – unknown if it has been done (Post #24)
The Vape Kitchen/River Supply Co. – not submitting (Post #24)
Tobacco King (Dripmore) – submittted (Post #24)
Tropic King (Dripmore - submitted (Post #24)
Twist (Daddy’s Vapor) - intended to submit – unknown if it has been done (Post #24)
USA Vape Labs (Naked 100) - intended to submit – unknown if it has been done (Post #24)
Uwell Caliburn (TBD E-Liquid) - intended to submit – unknown if it has been done (Post #24)
Vape Craft - submitted (Post #24)
Vape Crusaders - intended to submit – unknown if it has been done (Post #24)
Vape Dojo/Noble/Ten Buck - intended to submit – unknown if it has been done (Post #24)
Vapejoose - intended to submit – unknown if it has been done (Post #24)
VapeWild - business closes (Post #5, #24 )
Vapetasia - submitted (Post #24)
Vapolocity - DENIED (Post #34)
Vapor in a Bottle - intended to submit – unknown if it has been done (Post #24)
VaporSalon - DENIED (Post #33
Vapor Vapes - submitted (Post #24)
Vaporesso – first phase accepted (one or more products) (Post #10, #24)
VaporLAX - intended to submit – unknown if it has been done (Post #24)
VGOD - submitted (Post #24)
Voopoo - First phase accepted. (Post #22)
VUSE - submitted (Post #24)
White Label Juice Co – submitted (Post #24)
Wicked Coils - DENIED (Post #34)
Wotofo – not submitting (Post #24)
Yogi - intended to submit – unknown if it has been done (Post #24)

OTHER ARTICLES

• FDA refuses PMTA extension. Consequence: Mods will not be permitted to be sold and will have to be removed from the shelves within a week. (PMTA deadline is 9th Sept. (Post #12)
• Big Tobacco is about to dominate the e-cig industry (Post #14)
• FDA will publish list of PMTA applicants (Post #18)
• FDA Issues Threat Letters (Post #25)
• PMTA included in White House Freeze (Post #26)
• FDA threatens more small vape companies (Post #27)
• STASH closed Sept; SMAX closing 15 March (Post #28)
• FDA's promised list of submissions still not done (Post #30)
• Cloud Alchemist closed (Post #31)
• Will Puff Bar force FDA to regulate synthetic nicotine? (Post #32)

 

[CJB85]

https://vaping360.com/vape-news/104591/fda-accepts-a-flavored-e-liquid-pmta-for-substantive-review
11 Aug. 2020

"Virginia-based vaping retailer and e-liquid manufacturer AVAIL Vapor announced today that a PMTA for a flavored e-liquid submitted by AVAIL has been accepted by the FDA for substantive review. All vaping manufacturers must submit PMTAs (Premarket Tobacco Applications) by Sept. 9 for products they intend to sell on the legal market after that date ...

Today’s announcement from AVAIL marks the first known example of a flavored, bottled e-liquid (or open-system vaping product of any kind) being accepted for further study by federal regulators. Reaching the substantive review stage means that the products submitted may remain on the market for up to one year, or until the agency issues a final decision on whether they may be legally marketed.

Acceptance of the AVAIL submission for further review is important in two ways. First, it means that at least some bottled e-liquid will be available legally after the Sept. 9 PMTA deadline. Second, it indicates that the FDA will at least make a pretense of reviewing open-system products and bottled e-juice in flavors other than tobacco.

The Tobacco Control Act and the FDA’s Deeming Rule (which made vaping products subject to tobacco regulation) are both carefully designed to make it difficult for small businesses and open-system vaping products to successfully meet the required standard of being “appropriate for the protection of public health.” Because they can be used in tens of thousands of configurations (making every combination impossible to test), the FDA could have simply refused to review any of them.

I wonder if we will eventually see a blanketed list of pre-approved flavour concentrates and Nicotine brands to cover the "we can't test every liquid" issue. Meaning that as long as a manufacturer uses ingredients from the blanket list, they are excluded from having to test every new product they launch? We might even see the biggest liquid manufacturers looking to acquire some of the concentrate producers, in order to own the entire product life cycle for consistency?

 

[Hooked]

[USERGROUP=3]@Admins[/USERGROUP] Could you please move this thread to https://www.ecigssa.co.za/pmta-updates.t68100/#post-869230

With the PMTA deadline of 9th Sept. looming, there are going to be more and more articles. Instead of having info all over the place, I think it would be much easier to have a single thread communicating all PMTA issues. I've reserved the first post of the PMTA thread for a summary of where each company is in the PMTA process.

 

[Silver]

g0g Could you please move this thread to https://www.ecigssa.co.za/pmta-updates.t68100/#post-869230

With the PMTA deadline of 9th Sept. looming, there are going to be more and more articles. Instead of having info all over the place, I think it would be much easier to have a single thread communicating all PMTA issues. I've reserved the first post of the PMTA thread for a summary of where each company is in the PMTA process.

morning @Hooked
Have moved them here
Thanks for assisting with this

you will see that the posts have moved up above your original post in this thread
But luckily you are the author, so you can just edit those posts and switch things around so your index is on top in first post position

 

[Hooked]

VapeWild To Close Due To the PMTA
https://www.ecigclick.co.uk/pmta-has-closed-vapewild/
19 Aug. 2020

"It’s one of the most popular e-liquid brands around but the upcoming PMTA has closed VapeWild – sad news to say the least…

And even sadder is this could be the first of very many big name American vape brands to shut down, with many smaller companies forced to close.

I said the process would decimate the US vaping industry in my article a little over a year ago: Vaping In America Faces Total Devastation As Anti-Vape Legislation Is Moved Forward – read that for more background.

The deadline for the Pre-Market Tobacco Product Applications [PMTA] is a couple of weeks away – September 9th 2020 to be precise.

So far a mere handful of companies have submitted the mountain of paperwork and scientific evidence required to the FDA – most of those are backed by Big Tobacco cash – including JUUL.

In a nutshell every single vape product from individual e-liquid flavours, coils, mods, kits, pods and even merchandise MUST have a PMTA submitted.

Those that do will be allowed to remain on sale for up to 12 months or until the FDA gives the nod the PMTA has been successful.

The real kick in the balls is each PMTA application can cost up to an eye watering $460,000 – crazy and down right criminal to say the least.

As to why the PMTA has closed VapeWild?

The company issued a statement on its decision yesterday:

Yep, it’s that time. The PMTA deadline is finally upon us – September 9th. It’s been a long road, and we did our best, but, in the end, we just aren’t able to pull it off. So, September 9th will be the end of the line for VapeWild.

Dear John letters always suck, but hey, it’s not you – it’s us.

And while we still have some time left together, we wanted to let you know as soon as we could so that you would have a chance to get everything you need stocked up.

These are crazy times we’re living in, and they just keep getting crazier. Our sincerest hope, though, is that we have somehow made a difference in the world for the better over these last six years.

You’ll probably see emails from other places over the next few weeks with words like “it is with a heavy heart” or “with our deepest regrets”, etc.

But we don’t have a heavy heart or any regrets.

We did the best we could and sure enjoyed the heck out of sharing it with all of you.

It’s been the greatest roller coaster ride any of us have ever been on, and it is with our sincerest thanks that we write to you. We wish you the best on your vape journey!

Thank you for coming along with us on this wild ride.

You are the Best, VapeWild Fam!

I reviewed a few of the VapeWild e-liquids and whilst they were a little bit sweet for me I did meet them at a Vaper Expo and a few I tried really were bloody delicious.

And yeah I still have the inflatable pink flamingo in my bathroom ha!

Your heart has to go out to the staff who will now be out of a job and all we can hope is Trump realizes what this PMTA process is doing to a booming industry and acts.

Please do go over to the website – there’s plenty of deals to be had and let them go out with a boom.

Very sad times indeed…"

 

[Hooked]

https://vaping360.com/vape-news/104591/fda-accepts-a-flavored-e-liquid-pmta-for-substantive-review

11 Aug. 2020

"Virginia-based vaping retailer and e-liquid manufacturer AVAIL Vapor announced today that a PMTA for a flavored e-liquid submitted by AVAIL has been accepted by the FDA for substantive review. All vaping manufacturers must submit PMTAs (Premarket Tobacco Applications) by Sept. 9 for products they intend to sell on the legal market after that date ...


Today’s announcement from AVAIL marks the first known example of a flavored, bottled e-liquid (or open-system vaping product of any kind) being accepted for further study by federal regulators. Reaching the substantive review stage means that the products submitted may remain on the market for up to one year, or until the agency issues a final decision on whether they may be legally marketed.


Acceptance of the AVAIL submission for further review is important in two ways. First, it means that at least some bottled e-liquid will be available legally after the Sept. 9 PMTA deadline. Second, it indicates that the FDA will at least make a pretense of reviewing open-system products and bottled e-juice in flavors other than tobacco.


The Tobacco Control Act and the FDA’s Deeming Rule (which made vaping products subject to tobacco regulation) are both carefully designed to make it difficult for small businesses and open-system vaping products to successfully meet the required standard of being “appropriate for the protection of public health.” Because they can be used in tens of thousands of configurations (making every combination impossible to test), the FDA could have simply refused to review any of them.

 

[Hooked]

morning @Hooked
Have moved them here
Thanks for assisting with this

you will see that the posts have moved up above your original post in this thread
But luckily you are the author, so you can just edit those posts and switch things around so your index is on top in first post position

Thanks a lot @Silver! I have no idea how to switch things around, so I've just deleted posts and re-inserted elsewhere.

 

[Silver]

Thanks a lot @Silver! I have no idea how to switch things around, so I've just deleted posts and re-inserted elsewhere.

that’s what I meant, you could edit your first post

 

[Hooked]

Small Vape Companies Ask FDA to Postpone the PMTA Deadline
https://vaping360.com/vape-news/105374/small-vape-companies-ask-fda-to-postpone-the-pmta-deadline/
25 Aug. 2020

"A group of small vaping manufacturers and trade organizations has requested that the FDA ask a federal court for permission to postpone the Sept. 9 PMTA deadline for 180 days. The companies say they have been prevented from complying with the process by the coronavirus pandemic. Now they have just two weeks before applications are due.

The request came in the form of a “citizen petition” filed yesterday by Azim Chowdhury of Washington, D.C. law firm Keller Heckman. It included declarations provided by 20 individuals from the businesses and organizations behind the petition.

The previous May 12, 2020 PMTA deadline was postponed until Sept. 9 by the FDA after the agency received permission from both the 4th Circuit Court of Appeals and U.S. District Judge Paul Grimm in April. The agency had requested the delay on March 31, citing “extraordinary circumstances” caused by the coronavirus crisis.

The reasons the FDA cited for the previous postponement still apply, say the vaping industry petitioners in the new request:

• Laboratory testing delays
• Environmental assessment delays
• Supplier response delays
• Travel restrictions
• Employee health concerns

Additionally, they say, small vaping manufacturers have an extra challenge now on top of what they faced in April. Because the pandemic has forced many vaping businesses to be closed for extended periods, there is less income to devote to preparing PMTAs.

“Since the breakout of COVID-19, small manufacturers have seen a dramatic fall in revenues (e.g., ranging between 20%-60%), as well as store closures, which have limited the financial resources that can be dedicated to the PMTA process….In order to just survive day-to-day, these businesses have thus had to curtail what they spend on testing, consulting, legal advice, and scientific experts,” says the petition.

Unlike tobacco companies, small vape businesses have no dependable revenue stream from cigarette sales to finance their vapor product marketing applications to the FDA. Vaping product sales are a vape company’s only business, and their products are primarily sold in vape shops, which—unlike convenience stores and gas stations, where cigarettes are sold—have been closed for part or all of the health crisis.

The petitioners are asking the FDA to grant the delay only for “certain small vapor product manufacturers” that have been working “in good faith” to meet the PMTA deadline. Specifically, they write, each manufacturer receiving a postponement of the deadline would have to show “through documentation and other evidence” that they:

• Have fewer than 50 employees and/or less than $10 million in annual revenue
• Only manufacture open-system products
• Have taken steps to prohibit access by and sales to underage customers
• Will only market to adults
• Are otherwise in compliance with Tobacco Control Act/Deeming Rule requirements
• Have made progress toward completing their PMTA, but have been “materially delayed” due to COVID-19

“If FDA does not seek an additional extension due to COVID-19, these small businesses will likely be forced out of business and have to lay-off thousands of employees soon after the deadline expires,” write the petitioners. “Moreover, adult smokers, who rely on open systems to move away from more dangerous combustible cigarettes, will no longer have access to these products. As evidence is now growing that former smokers are already moving back to cigarettes with current restrictions on vaping products (e.g., flavor bans), it is imperative that these small businesses be given adequate time to assemble and file complete PMTAs.”

The FDA, if it chooses to grant a postponement to small vaping businesses, will again have to request permission from the federal court. That’s because Maryland U.S. District Court Judge Paul Grimm ruled last year that the then-current PMTA deadline was improperly decided by the agency. Judge Grimm changed the deadline to May 12, 2020, and then allowed the agency to move the date to Sept. 9. Any changes the FDA makes to the PMTA process must now be approved by Judge Grimm.

What is a citizen petition?
A citizen petition to the FDA allows members of the public—including businesses—to ask the FDA commissioner to “issue, amend, or revoke a regulation or order,” or “take or refrain from taking any other form of administrative action.” By law, the agency must respond to the request. Citizen Petitions are often used by pharmaceutical companies to ask the FDA to delay generic drug applications.

In May 2017 vape company NJOY employed a citizen petition to ask the FDA to delay implementation of the Deeming Rule, including the Premarket Tobacco Application (PMTA) deadline. Two months later, new FDA Commissioner Scott Gottlieb announced a four-year postponement of the final PMTA deadline (that date has since changed). It’s uncertain if the citizen petition had an effect on Gottlieb’s decision."

 

[Hooked]

VAPORESSO's first-round PMTA applications were accepted by FDA
https://www.newswire.ca/news-releas...lications-were-accepted-by-fda-817458451.html
24 Aug. 2020

"On August 20, 2020, VAPORESSO received the acceptance letter for the first round of its PMTA applications from the FDA - only three days after submission. According to its U.S. scientific CRO agent, the application received positive comments from FDA on its overall preparation...

What has VAPORESSO done for the PMTA?
VAPORESSO was created in 2015 by its parent company SMOORE (founded in 2009, and publicly listed on the Stock Exchange of Hong Kong on July 10 of 2020). As the founder of VAPORESSO, Mr. Simon Lai is a true visionary and veteran in the vaping industry, who call for everyone in VAPORESSO's team to fight for a big dream to make vaping as easy as possible for everyone.

Ever since the deeming rule was released in May 2016, VAPORESSO was fully set to bring its innovative vaping products into the PMTA regulatory framework of FDA. We have been engaging professional service providers and CROs from USA to work closely with our own disciplinary in-house team with various backgrounds and expertises, who are further supported by the strong R&D team from SMOORE's leading laboratories and fundamental research institutes to secure a successful acceptance under a stringent timeline. Due to many years of SMOORE's ODM/OEM experiences with international customers, VAPORESSO has been well known for its manufacturing excellence since the first day one which has led to a critical and fundamental element to the PMTA application..."

 

[Silver]

You on the ball @Hooked

 

[Hooked]

NO PMTA Extension Says FDA – Vape News
https://www.ecigclick.co.uk/no-pmta-extension-vape-news/
2 Sept. 2020

"The FDA has confirmed there will be no PMTA extension leaving vaping as we know it in America in turmoil.

There’s currently around 4 million vape devices on sale within the country and the vast majority of those will be removed from the shelves within a week.

The Pre Market Tobacco Application process means that all vape gear – including coils and merch – needs to have a PMTA submitted or it will not be allowed to sold within the USA.

The documents surrounding the application must include a mountain of scientific evidence proving the product is safe and each submission can cost up to $460,000.

Once a PMTA attached to a single product has been submitted, that item can remain on sale until the FDA gives it the green light which could take up to 12 months.

I’ve written at length about PMTAs as far back as July last year – see the articles below for more background:

• Vaping In America Faces Total Devastation As Anti-Vape Legislation Is Moved Forward
• Forget Flavour Bans the PMTA Process Is the REAL Threat To US Vapers

The Vaper Technology Association had asked for a 12th hour extension to the September 9th 2020 deadline for PMTA submissions.
However the FDA responded and refused adding:

The 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.


So that is pretty much that and as of next week close to 4 million vaping products will simply vanish from sale.

NO PMTA Extension – Chaos Expected
However, and with a tsunami of paperwork heading to the FDA, it doesn’t take a genius to work out it could be chaos to say the least.

As I’ve written before, there’s simply not enough scientists or indeed labs to test each submission and even the FDA admits that.

It told the VTA:

…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.

It looks likely the FDA will need to extend the 12 month approved sale period for vape gear with an accepted PMTA as they simply don’t have the manpower or capacity to deal with the unprecedented number of applications …

Crazy to say the least.

In the meantime the FDA is planning to release a list of vape products with a PMTA attached and this will enable retailers to remove those without…expect that within a month or so.


Petition Launched To Help Smaller Vape Manufacturers
Whilst Big Tobacco, JUUL and Vaporesso has submitted PMTAs it’s the very many smaller vape manufacturers that are facing shut down.

The Consumer Advocates for Smoke Free Alternatives – CASAA – has organized a petition calling on the FDA to extend the September 9th deadline by 180 days.

It says the smaller companies are simply overwhelmed with the documents and scientific evidence needed for a submission, with COVID-19 making it even more difficult.

CASAA says:

If granted, the extension would move the deadline for small, open-system manufacturers to March 8, 2021.

The request is predicated on a recent action taken by FDA in which small cigar manufacturers are being granted a similar extension due to complications and delays to completing PMTA’s associated with COVID-19.

To match the criteria of being classed as a ‘smaller vape company’ CASAA has issued these guidelines:

• Has less than 50 employees and/or 10MM in annual revenue;
• Only manufactures open system products (e.g., e-liquids) and does not produce products used in cartridge- or pod-based products;
• Has taken steps to prohibit access by and sales to underage consumers for brick-and-mortar stores and/or retail websites;
• Will only market to adults and not rely on kid-friendly advertising (e.g., using age-gated social media accounts);
• Is otherwise in compliance with TCA and Deeming Rule requirements (e.g., facility registration, product listings, etc.); and
• Has already made progress in completing PMTAs prior to the September 9, 2020 deadline, but has been materially delayed in one or more tasks due to COVID-19.

Read more and sign the PMTA petition.

For more information read the VTA release: PMTA UPDATE FOR MANUFACTURERS & RETAILERS

 

[DougP]

NO PMTA Extension Says FDA – Vape News
https://www.ecigclick.co.uk/no-pmta-extension-vape-news/
2 Sept. 2020

"The FDA has confirmed there will be no PMTA extension leaving vaping as we know it in America in turmoil.

There’s currently around 4 million vape devices on sale within the country and the vast majority of those will be removed from the shelves within a week.

The Pre Market Tobacco Application process means that all vape gear – including coils and merch – needs to have a PMTA submitted or it will not be allowed to sold within the USA.

The documents surrounding the application must include a mountain of scientific evidence proving the product is safe and each submission can cost up to $460,000.

Once a PMTA attached to a single product has been submitted, that item can remain on sale until the FDA gives it the green light which could take up to 12 months.

I’ve written at length about PMTAs as far back as July last year – see the articles below for more background:

• Vaping In America Faces Total Devastation As Anti-Vape Legislation Is Moved Forward
• Forget Flavour Bans the PMTA Process Is the REAL Threat To US Vapers

The Vaper Technology Association had asked for a 12th hour extension to the September 9th 2020 deadline for PMTA submissions.
However the FDA responded and refused adding:

The 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.


So that is pretty much that and as of next week close to 4 million vaping products will simply vanish from sale.

NO PMTA Extension – Chaos Expected
However, and with a tsunami of paperwork heading to the FDA, it doesn’t take a genius to work out it could be chaos to say the least.

As I’ve written before, there’s simply not enough scientists or indeed labs to test each submission and even the FDA admits that.

It told the VTA:

…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.

It looks likely the FDA will need to extend the 12 month approved sale period for vape gear with an accepted PMTA as they simply don’t have the manpower or capacity to deal with the unprecedented number of applications …

Crazy to say the least.

In the meantime the FDA is planning to release a list of vape products with a PMTA attached and this will enable retailers to remove those without…expect that within a month or so.


Petition Launched To Help Smaller Vape Manufacturers
Whilst Big Tobacco, JUUL and Vaporesso has submitted PMTAs it’s the very many smaller vape manufacturers that are facing shut down.

The Consumer Advocates for Smoke Free Alternatives – CASAA – has organized a petition calling on the FDA to extend the September 9th deadline by 180 days.

It says the smaller companies are simply overwhelmed with the documents and scientific evidence needed for a submission, with COVID-19 making it even more difficult.

CASAA says:

If granted, the extension would move the deadline for small, open-system manufacturers to March 8, 2021.

The request is predicated on a recent action taken by FDA in which small cigar manufacturers are being granted a similar extension due to complications and delays to completing PMTA’s associated with COVID-19.

To match the criteria of being classed as a ‘smaller vape company’ CASAA has issued these guidelines:

• Has less than 50 employees and/or 10MM in annual revenue;
• Only manufactures open system products (e.g., e-liquids) and does not produce products used in cartridge- or pod-based products;
• Has taken steps to prohibit access by and sales to underage consumers for brick-and-mortar stores and/or retail websites;
• Will only market to adults and not rely on kid-friendly advertising (e.g., using age-gated social media accounts);
• Is otherwise in compliance with TCA and Deeming Rule requirements (e.g., facility registration, product listings, etc.); and
• Has already made progress in completing PMTAs prior to the September 9, 2020 deadline, but has been materially delayed in one or more tasks due to COVID-19.

Read more and sign the PMTA petition.

For more information read the VTA release: PMTA UPDATE FOR MANUFACTURERS & RETAILERS

Really sad

Sent from my LYA-L09 using Tapatalk

 

[Hooked]

Big Tobacco Is About to Dominate the E-Cig Industry
https://www.fool.com/investing/2020/09/03/big-tobacco-is-about-to-dominate-the-e-cig-industr/
3 sept. 2020

... Crunch time
Some 650 PMTAs have been submitted to the FDA as of June, the most recent data available, but each application covers a separate product. Philip Morris International (NYSEM), the first company to file an application, had four separate PMTAs approved: one for its IQOS heated tobacco device and three for flavors of its disposable Heatsticks.

Although the FDA estimates a single PMTA costs anywhere from $117,000 to $466,000, those figures are considered low by the industry. The Rocky Mountain Smoke-Free Association estimates a single PMTA costs between $8.6 million and $11.1 million per stock keeping unit (SKU). It forecasts 14,000 small vape businesses employing 166,000 workers will be destroyed, representing $24 billion in economic activity.

The problem is it's not just e-cig manufacturers that need to comply with the regulations, but also manufacturers of the e-liquids the devices use, as well as the vape shops that sell them.

A disproportionate burden
Amanda Wheeler, the owner of five Jvapes vape shops in Arizona, Colorado, and Oklahoma, explained the situation this way: "Let's say I have 100 products and each of the flavors has five nicotine levels, which means five SKUs per flavor, legal and other fees will cost my stores in excess of $5.5 billion. There's not a small business owner in the United States who can afford $5.5 billion for SKU applications."

She likens the situation to what would occur to a liquor store if it had to pay and apply for every SKU in its store. "We wouldn't have liquor today," Wheeler said.

Where British American Tobacco (NYSE:BTI) and Juul Labs (which is backed by Altria (NYSE:MO)) can afford to pay such rates, the vast majority of businesses serving the industry are small ones and will find the technical hurdles difficult to surmount.

The favored few
The FDA doesn't identify companies that have submitted applications until it takes action on them. However, several other companies have applied, including Imperial Brands, which says it has submitted PMTAs for a "wide range of its myblu electronic vaping products," as well as Japan Tobacco, which submitted one for its Logic brand of e-cigs.

At least one independent vape manufacturer was also able to see it through to the end. E-Alternative Solutions, the maker of the Leap brand of devices and pods, submitted over two dozen applications for flavors and nicotine strength, as well as for its devices. Avail Vapor, one of the biggest vape shop chains (in which Altria once had a minority interest), says it also has submitted PMTAs for its products.

It's possible then this small coterie of companies account for the vast majority of PMTAs submitted. With applications running several hundred thousand pages long and containing scientific studies and data to support the application, only the most well-financed company can afford to submit an application.

Up in smoke
Philip Morris, of course, is the only e-cig maker that's successfully made it all the way through, getting approval to market its IQOS as producing less harmful chemicals than cigarettes and reducing exposure to them. It gives the tobacco giant a competitive edge over even its well-heeled rivals.

At least one or two of the PMTAs others have submitted will likely be approved -- maybe even Juul, despite being excoriated regularly for its contribution to teen use of e-cigs. Without these other devices, the IQOS will have a monopoly on the market, and it seems doubtful tobacco regulators would want or allow that.

Yet the e-cig market is about to become significantly smaller in just a few days, a change that is not necessarily better for trying to wean smokers away from traditional cigarettes ... "

 

[Hooked]

Nicopure Labs Has First PMTAs Accepted Quickly by US FDA
https://vaporvoice.net/2020/09/07/nicopure-labs-has-first-pmtas-accepted-quickly-by-us-fda/
7 Sept. 2020

"The U.S. Food and Drug Administration has accepted Nicopure Labs first round of premarket tobacco product applications (PMTA). The application will now move into the substantive scientific review phase of the process, according to a press release...

The regulatory agency took just three day to accept and file the submissions for Tampa-based Nicopure Labs’ Halo Tribeca Tobacco e-liquid, Halo SubZero Menthol e-liquid and Halo Fusion e-liquid [my highlights].

“Halo’s 10-year history as a prominent brand, specializing in the tobacco-flavored e-liquid space has positioned the brand well for what is likely to come for the vaping industry. With California and New York becoming tobacco flavor-only markets, it is expected that more states will follow suit and Halo will be well-prepared with their award-winning tobacco flavors,” the release states. “Once accepted for filing, the final phase of the PMTA review process will be the FDA’s comprehensive evaluation of the scientific data supplied in the (PMTA) After all information has been fully evaluated and inspected, the FDA will make their final approval decision.”

 

[Hooked]

Reynolds American Files Final 6 PMTAs for Vuse Products
https://vaporvoice.net/2020/09/05/reynolds-american-files-6-additional-pmtas-for-vuse-products/
5 Sept. 2020

"Reynolds American, a subsidiary of British American Tobacco (BAT), filed its final round of premarket tobacco product application (PMTA) submissions with the U.S. Food and Drug Administration (FDA) on Friday...

Reynolds has filed six applications for its Vuse Solo, Vuse Ciro and Vuse Vibe vapor products, as well as for its Velo nicotine lozenge and modern oral pouch products. The Vuse Alto-branded device PMTA includes 12 cartridges in various flavors and nicotine strengths in menthol, two tobacco-flavored products and mixed berry.

Across the six applications, over 530,000 pages of scientific data and more than 8,600 scientific documents have been submitted as part of the filings."

 

[Hooked]

Charlie’s Chalk Dust Files First of ‘Multiple’ PMTAs
https://vaporvoice.net/2020/08/31/charlies-chalk-dust-files-first-of-multiple-pmtas/
31 Aug. 2020

"Charlie’s Holdings, parent to the Charlie’s Chalk Dust e-liquid brand, has submitted its initial premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration (FDA).

“Today’s submission marks the first of multiple applications that Charlie’s Chalk Dust (CCD) intends to take through FDA’s approval process as it seeks to create a long-term, robust product portfolio. This is a day we’ve long awaited for in our industry,” stated Charlie’s Holdings’ Chief Operating Officer Ryan Stump in a press release. “After spending nearly $5 million over the past two years on our PMTA preparation and submission, we are extremely excited about the application we filed with the FDA.”

 

[Hooked]

U.S. FDA Will Publish List of E-cigarette PMTA Applicants
https://vaporvoice.net/2020/09/01/u-s-fda-will-publish-list-of-accepted-pmta-applicants/
1 Sept. 2020

"The U.S. Food and Drug Administration (FDA) will release a list to help support retailers. The regulatory agency now says it will break protocol and publish the names of manufacturers and products that have accepted premarket tobacco product applications (PMTAs) on file by the Sept. 9 deadline.

In a press note on Monday, director of the FDA’s Center for Tobacco Products, Mitch Zeller, wrote that the FDA plans to make publicly available a list of the deemed new tobacco products that are subject to the Sept. 9 deadline and were on the market as of Aug. 8, 2016.

“And for which a premarket application is submitted by Sept. 9, 2020,” Zeller wrote. “However, before doing so, we will need to ensure that the publishing of any such information complies with federal disclosure laws and regulations as only certain types of product information from applications can be lawfully disclosed.” ...

The FDA also noted that while the deadline is on September 9, 2020, it will take FDA some time for the agency to compile and confirm that the list is accurate before publication...

Zeller stated that the agency requests patience from stakeholders as the agency works through the appropriate processes to ensure the posted information is accurate and compliant with federal laws. In the interim, Zeller stated that retailers and other interested parties should refer to the public statements made by the companies or contact the companies directly to get information about applications they may have submitted."

 

[Dela Rey Steyn]

Charlie’s Chalk Dust Files First of ‘Multiple’ PMTAs
https://vaporvoice.net/2020/08/31/charlies-chalk-dust-files-first-of-multiple-pmtas/
31 Aug. 2020

"Charlie’s Holdings, parent to the Charlie’s Chalk Dust e-liquid brand, has submitted its initial premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration (FDA).

“Today’s submission marks the first of multiple applications that Charlie’s Chalk Dust (CCD) intends to take through FDA’s approval process as it seeks to create a long-term, robust product portfolio. This is a day we’ve long awaited for in our industry,” stated Charlie’s Holdings’ Chief Operating Officer Ryan Stump in a press release. “After spending nearly $5 million over the past two years on our PMTA preparation and submission, we are extremely excited about the application we filed with the FDA.”

Love Charlie's juices! Really hope they get approved.

 

[Hooked]

AMV Holdings Receives First FDA Premarket Tobacco Product Application Acceptance
https://finance.yahoo.com/news/amv-holdings-receives-first-fda-133000335.html
9 Sept. 2020

“AMV Holdings, LLC (AMV) is pleased to announce that it has been notified by the FDA that its first Premarket Tobacco Product Application (PMTA) filed on 8/25/2020 has been accepted for review. Since receiving the notification, AMV has filed an additional 104 PMTA submissions accounting for over 5,000 SKUs. All of these submissions reflect the same file and information structure as the PMTA for which AMV has already received its acceptance for review notification …

AMV Holdings, which includes the brands Alohma, Kure, Madvapes, ELB Labs, and Wholesale Vaping Supply, is a leading manufacturer and retailer of ENDS products in the United States and Europe. AMV currently operates 113 retail locations in the United States through a combination of corporately owned, franchised, and licensed stores and a further 7 stores in Germany and Ireland. AMV manufactures e-liquids through ELB Labs, to distribute to their brick and mortar vape stores, online (B2C) e-commerce platforms, and third-party vape stores for consumers …

ABOUT AMV HOLDINGS

AMV Holdings is the largest operator of specialty brick and mortar vape stores in the USA and the manufacturer of multiple e-liquid brands, including the exclusive PRIME line of nicotine e-liquids. AMV Holdings operates 120+ retail locations under the Alohma, Kure, Madvapes and MAXX brands in the US and Europe."

 

[takatatak]

So this popped up in my suggested articles...
Vape PMTA
Vape PMTA Vendors

 

[Dela Rey Steyn]

"After more than 2 years of project preparation and research, VOOPOO has formally submitted PMTA on August 27th, US time and passed the first round of review."

https://www.voopoo.com/pmta.html

 

[Hooked]

So this popped up in my suggested articles...
Vape PMTA
Vape PMTA Vendors

Excellent link, thanks @takatatak! Far too much for me to copy here now but I will start doing so from tomorrow onwards.

 

[Hooked]

Thanks to @takatatak for this source
https://vapepmta.com/vendors

 

[Hooked]

The FDA Issues Threat Letters
https://www.planetofthevapes.co.uk/news/vaping-news/2021-01-21_the-fda-issues-threat-letters.html
21 Jan. 2021

"The U.S. Food and Drug Administration (FDA) has sent warning letters to ten companies which manufacture or operate websites selling vape equipment and juice. It has told them that selling products which lack premarket authorisation is illegal and the products cannot be sold or distributed in the United States.

The FDA says this is the first set of warning letters which implies more are to come to other firms that have not submitted premarket applications.

“Per court order,” it writes, “applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016—including e-liquids—were required to be submitted to the FDA by Sept. 9, 2020. For companies that submitted applications by that deadline, the FDA generally intends to continue to defer enforcement for up to one year pending FDA review, unless there is a negative action taken by the FDA on the application. The FDA plans to post a list of products for which the agency has received applications; however, before making such a list available, the FDA is verifying certain information about these products so that publication of a list complies with federal disclosure laws.”

FDA Commissioner Stephen M. Hahn, M.D. commented: “The premarket application process ensures that new tobacco products, including many already on the market, will undergo a robust scientific evaluation by the FDA. Scientific review of new products is a critical part of how we carry out our mission to protect the public—especially kids—from the harms associated with tobacco use. In addition to the important premarket scientific review, prioritising enforcement against those who violate the law by selling unauthorised products is how we help protect public health.”

The companies in receipt of the FDA’s first warning letter:

Little House Vapes LLC
Castle Rock Vapor LLC
Dropsmoke Inc.
Perfection Vapes Inc.
CLS Trading LLC
Vape Dudes HQ
Session Supply Co.
Coastal E-Liquid Laboratory/GC Vapors LLC
Dr. Crimmy LLC
Dr. Crimmy’s V-Liquid
CMM Capital LLC
ETX Vape
E-Cig Barn LLC
Mitch Zeller, the anti-vape director of FDA’s Center for Tobacco Products, added: “These warning letters are the result of continued surveillance and internet monitoring for violations of tobacco laws and regulations. We want to make clear to all tobacco product manufacturers and retailers that the FDA is keeping a close watch on the marketplace and will hold companies accountable for breaking the law. The FDA will continue to prioritize enforcement against companies that market electronic nicotine delivery systems (ENDS), including e-cigarettes, without the required authorization but haven’t submitted a premarket application to the agency, including those products with a likelihood of youth use or initiation.”