Pre-filled pod systems under attack by FDA

[dansus]

FDA sent out letters dated October 12th 2018 to at least 21 makers of pod systems, requesting proof that their product was marketed and sold before 8/8 deeming within 30 days of receiving.

So far Myle has pulled their products and STIG is on the chopping block.

https://www.fda.gov/downloads/Tobac...GBLW_XAhXUupf1nL_QxGdG4khT0f_vE94DrBEidTgOcGA

October 12, 2018
VIA UPS, Electronic Mail, and Facsimile
Mr. xxxxx
President
VGOD Inc.
1506 West 228th Street
Torrance, CA 90501
Submission Tracking Number: TC0003973

Dear Mr. xxxx:
It has come to our attention that VGOD Inc. may be manufacturing new finished tobacco
products including, but not limited to, STIG Disposable Pod devices without premarket
authorization, as required by §910 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).1

STIG Disposable Pod Devices appear to meet the definition of a tobacco product as set forth in §201(rr) of the FD&C Act. Although FDA has extended the compliance deadlines for the
premarketing requirements for deemed products, FDA’s compliance policy applies only to those deemed products that were on the market as of August 8, 2016. FDA has received complaints that VGOD Inc. may have first commercially marketed STIG Disposable Pod Devices in the Unites States after August 8, 2016.

 

[dansus]

Letter To Our Loyal Customers | MYLÉ VAPOR

Myle Vape Inc has decided to temporarily discontinue the distribution of its products in the United States market as of November 15, 2018 at 11:59 p.m. This will provide us time to develop new products which can undergo premarket review by the United States Food and Drug Administration as well as develop the appropriate controls over our developing distribution channels. In the meantime, Myle will continue to honor any warranty returns; however, Myle Vape Inc will not sell or market its products within the United States after November 15, 2018, until further notice. Myle Vape will continue to market its products internationally in those jurisdictions in which it is legally allowed to do so.

 

[bombastinator]

Not all the prefilled pod companies are running. The ones owned by big tobacco are appparently ignoring the order. Iirc myblu is refusing to pull flavored pods. I’m not sure bout vuse.

 

[dansus]

CTP Letters to Industry

 

[sebastianbach]

Hello,

This is my response to the subject : Pod Squonk

I am actually little ignorant about pod systems, so my first question to you is if this is something making sense in the first place.

I haven' t used any pod machines either. Hope this would help.

 

[dansus]

Not all the prefilled pod companies are running. The ones owned by big tobacco are appparently ignoring the order. Iirc myblu is refusing to pull flavored pods. I’m not sure bout vuse.

myBlu (Von Erl) is pre 8/8, so they can afford to be more brazen.

 

[dansus]

Altria, the parent company of Philip Morris USA and maker of Marlboro cigarettes, is halting sales of multiple items:

• MarkTen Elite pod-based products.
  
  
• Apex by MarkTen pod-based products.
  
  
• All favored variants of MarkTen and Green Smoke "cig-a-like products" except tobacco, menthol and mint varieties.
  

 

[bombastinator]

Hello,

This is my response to the subject : Pod Squonk

I am actually little ignorant about pod systems, so my first question to you is if this is something making sense in the first place.

I haven' t used any pod machines either. Hope this would help.

You could actually do a pod squonk. I’m not sure the whales would pay attention though.

 

[dansus]

Pre 8/8 pod systems so far;

• MyJet
• Cync
• Phix
• Juul
• Von Erl
• Envii Fit

 

[United States]

So I suppose the "new" bo system came out after 8/8?

Who filed the complaint? MADD? The folks against rap lyrics? PETA?

It's like me sending a letter to the EPA that my neighbors car was made before catalytic convertors and therefore it's harming the children.....

 

[untar]

This is my response to the subject : Pod Squonk

If it's not made before 8.8.2016 then it solves nothing, that is the date a product has to be on the market to get special treatment from the FDA (then they can send an application as late as 2022).
All other products need to apply right away. As squonk pods don't exist right now there's no chance to escape the PMTA process. That's only for the US market, mind.

 

[stols001]

Wow well that is most certainly a shame for some of the newer (often better) pod systems. I feel bad for the pod folks, honestly. And you know, vaping generally. Etc.

Anna

 

[WillyZee]

They know vaping is the future for helping everyone to quit smoking... and they know the pod systems are their only hope to keep control over those smokers

self sufficient vapers like myself... they've already written us off

 

[dansus]

Who filed the complaint? MADD? The folks against rap lyrics? PETA?

Juul im told.

 

[SupplyDaddy]

self sufficient vapers like myself... they've already written us off

Good! They need to forget about us.. but that doesn't mean we will forget. There is this thing about passing on knowledge that many of us like to do!.

 

[bnrkwest]

What blows my mind is over 2 years ago before the 8/8 date companies were scrambling to get their closed systems to market because that was the only product thought to get thru the PMTA, now they are being attacked. So much for trying to figure out the FDA, they are out to get us no matter what.

 

[Racehorse]

Altria, the parent company of Philip Morris USA and maker of Marlboro cigarettes, is halting sales of multiple items:

• MarkTen Elite pod-based products.
  
  
• Apex by MarkTen pod-based products.
  
  
• All favored variants of MarkTen and Green Smoke "cig-a-like products" except tobacco, menthol and mint varieties.

Altria doesn't need pods, etc. They are going in this direction it appears:

The maker of Marlboro cigarettes is plowing $1.8 billion into the cannabis producer Cronos (MO, CRON) | Markets Insider

That's $2.4 billion Candadian

 

[dansus]

Altria doesn't need pods, etc. They are going in this direction it appears:

The maker of Marlboro cigarettes is plowing $1.8 billion into the ........ producer Cronos (MO, CRON) | Markets Insider

That and investing in Juul.

 

[DawnBella]

This is only about flavors, correct? Tobacco (all I vape) and menthol ok.

 

[VapourFlavour]

This is only about flavors, correct? Tobacco (all I vape) and menthol ok.

For now